Acute Lymphoblastic LeukemiaPhase 2NCT07227584
ALL Backbone in AYAs
A Phase 2 study testing Blinatumomab, Oncaspar and Cyclophosphamide in people with Acute Lymphoblastic Leukemia and Philadelphia Chromosome-Negative Lymphoblastic Leukemia, run by Dana-Farber Cancer Institute at 1 site in United States.
Trial summary
The goal of this research study is to evaluate a chemotherapy regiment for the treatment of newly diagnosed Philadelphia chromosome-negative acute lymphoblastic leukemia (ALL) in adolescents and young adults (AYAs). Read more about this study
- Who is it for?
- Ages 18 to 51 years
- Conditions the study is for
- Acute Lymphoblastic Leukemia, Philadelphia Chromosome-Negative Lymphoblastic Leukemia, Acute Lymphoblastic Leukemia (ALL)
- What is being tested?
- Blinatumomab, Oncaspar and Cyclophosphamide
- Type of treatment
- Pill or oral medicine, Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 67 participants
- Where
- 1 siteUnited States
- Study dates
- 3 Apr 2026to 31 Jul 2035
- Phase
- Phase 2
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 51 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- 3.1.1Confirmed diagnosis of Philadelphia chromosome-negative acute lymphoblastic leukemia.
- Diagnosis should be made by peripheral blood, bone marrow aspirate, bone marrow biopsy, or tissue biopsy demonstrating ≥25% involvement by lymphoblasts, with flow cytometry or immunohistochemistry confirming B-ALL or T-ALL.
- o Participants with B-cell and T-cell lymphoblastic lymphoma are eligible regardless of bone marrow involvement Participants with mixed phenotype acute leukemia (MPAL) ARE eligible, if an ALL regimen is felt to be most appropriate treatment.
- Participants with CNS leukemia ARE eligible. 3.1.2 Allowed prior therapy:
- Corticosteroids, hydroxyurea, all-trans retinoic acid (ATRA).
- IT chemotherapy.
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- Emergent radiation therapy or leukapheresis for life threatening complications.
- One cycle of prior chemotherapy (i.e. an induction cycle given at another institution and participant transfers care for post-induction treatment; OR a participant does not meet eligibility prior to induction but does meet eligibility after remission induction).
- 3.1.3 Age 18.00 - 50.99 years 3.1.4 Direct bilirubin <1.4 mg/dL (total bilirubin < 1.4 mg/dL is acceptable). 3.1.5 Willingness to use effective means of birth control. The effects of chemotherapy on the developing human fetus are unknown. For this reason and because therapeutic agents used in this trial are known to be teratogenic, women of child-bearing potential and men must agree to use adequate contraception (hormonal or barrier method of birth control; abstinence) prior to study entry and for the duration of study participation. Should a woman become pregnant or suspect she is pregnant while she or her partner is participating in this study, she should inform her treating physician immediately. Men treated or enrolled on this protocol must also agree to use adequate contraception prior to the study, for the duration of study participation, and 4 months after completion of study.
- 3.1.6 Ability to understand and the willingness to sign a written informed consent document.
Who cannot join
- Philadelphia chromosome-positive / BCR::ABL1 fusion 3.2.2 Participants with mature B-cell (Burkitt's) ALL. Mature B-cell ALL is defined by the presence of surface immunoglobulin AND any of the following: t(8;14)(q24;q32), t(8;22), t(2;8), or c-myc-gene rearrangement by FISH, PCR or other testing. [FISH/PCR testing for c-myc rearrangements is not required prior to study entry, but it is suggested for participants with surface immunoglobulin expression or L3 morphology]. 3.2.3 Participants with acute undifferentiated leukemia. 3.2.4 Participants receiving any other investigational agent for this condition.
- 3.2.5 Uncontrolled intercurrent illness including but not limited to ongoing infection with vital sign instability (hypotension, respiratory insufficiency), life-threatening acute tumor lysis syndrome (e.g., with renal failure), symptomatic congestive heart failure, cardiac arrhythmia, intracranial or other uncontrolled bleeding. Circumstances that may significantly interfere with a participant's ability to safely comply with study procedures, such as attend scheduled study visits, adhere to treatment protocols, or complete study assessments. These include a lack of reliable transportation, unstable housing, or psychiatric illness, but reasonable attempts should be made to overcome these circumstances, including but not limited to identifying sponsor, institutional, or thirdparty financial or social support as well as psychiatric consultation for objective assessment. 3.2.6 Sexually active participants of reproductive potential who have not agreed to use an effective contraceptive method for the duration of study participation are ineligible.
- 3.2.7 Pregnant women are excluded from this study because many of the agents used on this protocol have potential for teratogenic or abortifacient effects. Because there is an unknown but potential risk for adverse events in nursing infants secondary to treatment of the mother with these chemotherapy agents, breastfeeding should be discontinued if the mother is enrolled.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
Dana Farber Cancer Institute
Boston, Massachusetts, 02215
Marlise R Luskin, MD, MSCE, 617-632-1906, marlise_luskin@dfci.harvard.edu
Hunter Smith, hunter_smith@dfci.harvard.edu
About this study
Official title: Treatment of Newly Diagnosed Philadelphia Chromosome-Negative Acute Lymphoblastic Leukemia in Adolescents and Young Adults (AYAs)
The goal of this research study is to evaluate a chemotherapy regiment for the treatment of newly diagnosed Philadelphia chromosome-negative acute lymphoblastic leukemia (ALL) in adolescents and young adults (AYAs).
The names of the study drugs involved in this study are:
- blinatumomab (a type of immunotherapy drug)
- cyclophosphamide (a type of chemotherapy drug)
- cytarabine (a type of antineoplastic agent)
- dexamethasone (a type of synthetic glucocorticoid)
- doxorubicin (a type of antineoplastic agent)
- etoposide (a type of antineoplastic agent)
- mercaptopurine (a type of antineoplastic agent)
- methotrexate (a type of chemotherapy drug)
- pegaspargase (a type of antineoplastic agent)
- vincristine (a type of antineoplastic agent)
Read the detailed description
This Phase 2, single-arm research study is to evaluate a chemotherapy regiment the treatment of newly diagnosed Philadelphia chromosome-negative acute lymphoblastic leukemia (ALL) in adolescents and young adults (AYAs).
The U.S. Food and Drug Administration (FDA) has approved all of the drugs of treatment being studied but the investigators of this research study want to understand more about the safety and effectiveness of the chemotherapy regimen in adolescents and young adults with newly diagnosed Philadelphia chromosome-negative ALL.
The research study procedures include screening for eligibility, in-clinic visits, blood tests, urine tests, saliva tests, X-rays, electrocardiograms (ECGs), echocardiograms (ECHOs), Dual-Energy X-ray Absorptiometry (DEXA) scans, bone marrow aspirations/biopsies.
Participation in this study is expected to last about 10 years, 2 years of treatment followed by 8 years of follow up.
It is expected that about 67 people will take part in this research study.
- Conditions
- Acute Lymphoblastic Leukemia, Philadelphia Chromosome-Negative Lymphoblastic Leukemia, Acute Lymphoblastic Leukemia (ALL), Leukemia
- Being tested
- Blinatumomab, Oncaspar, Cyclophosphamide, Cytarabine, Dexamethasone
- Keywords
- Acute Lymphoblastic Leukemia, Philadelphia Chromosome-Negative lymphoblastic leukemia, Acute Lymphoblastic Leukemia (ALL), Leukemia
- Medical subject headings
- Precursor Cell Lymphoblastic Leukemia-Lymphoma, Leukemia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
BlinatumomabDrug
Also called Blincyto, NSC# 765986
A bispecific T-cell engager (BiTE) antibody, single-use vial via intravenous infusion, per standard of care
OncasparDrug
Also called PEGASPARGASE, NSC #624239)
A modified enzyme L-asparaginase, single-use vial via intravenous infusion, per standard of care
CyclophosphamideDrug
Also called Cytoxan, NSC #26271
An alkylating agent, single-use vial via intravenous infusion, per standard of care
CytarabineDrug
Also called Cytosine Arabinoside, Ara-C, Cytostar, NSC#63878
An antineoplastic antimetabolite, multi-dose vial via intrathecal injection (through the spinal space), per standard of care
DexamethasoneDrug
Also called Decadron, Hexadrol, Dexone, Dexameth
A synthetic glucocorticoid, tablets or single-use vials via orally or intravenous infusion (through the vein), per standard of care
Also called Adriamycin, NSC#123127
An anthracycline antibiotic, single-use or multi-dose vials via intravenous infusion, per standard of care
EtoposideDrug
Also called VePesid, Etopophos, VP-16, NSC#141540
A derivative of podophyllotoxin, multi-dose vial via intravenous infusion, per standard of care
MercaptopurineDrug
Also called 6-MP, Purinethol, 6-Mercaptopurine, Purixan
A purine antagonist, tablet via orally, per standard of care
MethotrexateDrug
Also called MTX, Amethopterin, Trexall, NSC#000740
A folate analogue, multi-dose and single-use vials via intrathecal injection, per standard of care
VincristineDrug
Also called Oncovin, VCR, LCR, NSC#67574
A vinca alkaloid, single-use vials via intravenous injection, per standard of care
| Study group | Role | What they receive |
|---|---|---|
| ALL Backbone Regimen for B-Cell | Experimental | * Steroid Prophase (3-dy cycle): Dexamethasone \& cytarabine
* Induction IA (29-dy cycle): Vincristine, dexamethasone, pegaspargase, doxorubicin, IT chemotherapy
* Induction IB (42-dy cycle): Cyclophosphamide, cytarabine, mercaptopurine, IT chemotherapy
* Blinatumomab Cycle 1, 2 (42-dy cycles): Blinatumomab, dexamethasone, IT chemotherapy
* Consolidation I:
* Phase IA (28-dy cycle), Phase IC (21-dy cycle): Vincristine, mercaptopurine, methotrexate, dexamethasone, cytarabine, etoposide, pegaspargase, IT chemotherapy
* Blinatumomab Cycle 3 (42-dy cycle): Dexamethasone, Blinatumomab, IT chemotherapy
* Consolidation II (21-dy cycles for 30 wks): Vincristine, dexamethasone, mercaptopurine, doxorubicin, methotrexate, pegaspargase, IT chemotherapy
* Blinatumomab Cycle 4 (42-dy cycle): Dexamethasone, Blinatumomab, IT chemotherapy
* Continuation (21-dy cycles): Vincristine, dexamethasone, mercaptopurine, methotrexate, IT chemotherapy
* End of treatment visit
* Follow up Receives: Drug: Blinatumomab; Drug: Oncaspar; Drug: Cyclophosphamide; Drug: Cytarabine; Drug: Dexamethasone; Drug: Doxorubicin Hydrochloride; Drug: Etoposide; Drug: Mercaptopurine; Drug: Methotrexate |
| ALL Backbone Regimen for T-Cell | Experimental | * Steroid Prophase (3-day cycle): Dexamethasone and cytarabine
* Induction IA (29-day cycle): Vincristine, dexamethasone, pegaspargase, doxorubicin, IT chemotherapy
* Induction IB (42-day cycle): Cyclophosphamide, cytarabine, mercaptopurine, IT chemotherapy
* Consolidation I:
* Phase IA (28-day cycle) and Phase IC (21-day cycle): Vincristine, mercaptopurine, methotrexate, dexamethasone, cytarabine, etoposide, pegaspargase, IT chemotherapy
* CNS Phase (21-day cycle): Dexamethasone, vincristine, mercaptopurine, pegaspargase, IT chemotherapy
* Consolidation II (21-day cycles for 30 weeks): Vincristine, dexamethasone, mercaptopurine, doxorubicin, methotrexate, pegaspargase, IT chemotherapy
* Continuation (21-day cycles): Vincristine, dexamethasone, mercaptopurine, methotrexate, IT chemotherapy
* End of treatment visit
* Follow up Receives: Drug: Blinatumomab; Drug: Oncaspar; Drug: Cyclophosphamide; Drug: Cytarabine; Drug: Dexamethasone; Drug: Doxorubicin Hydrochloride; Drug: Etoposide; Drug: Mercaptopurine; Drug: Methotrexate; Drug: Vincristine |
What is being measured
The primary outcome is the main question the study is designed to answer.
Treatment Completion Rate Through Time Point 3 (TP3)
Treatment completion rate through TP3 is defined as the proportion of Adolescents and Young Adults (AYAs) participants who receive all protocol-specified therapy through TP3, without early discontinuation.
Measured: Timeframe for TP3 depends on disease immunophenotype. Participants with CD19-positive B-ALL, TP3 occurs at the end of Blinatumomab Cycle 2 on Day 28 (130 days from study start). For participants with T-cell ALL or those who do not receive blinatum
Secondary outcomes (16)
Rate of Treatment-Related Mortality (TRM)
Rate of TRM is defined as the proportion of participants who die due to treatment-related causes.
Measured: Up to 115 weeks
Rate of Treatment Discontinuation due to Toxicity or Disease
Rate of treatment discontinuation during Induction, Consolidation, and Continuation phases, defined as the proportion of participants who stop protocol-specified therapy due to regimen-related toxicity and/or treatment failure.
Measured: Up to 115 weeks
Rate of Asparaginase Non-Completion
Rate of asparaginase non-completion is defined as the proportion of participants who did not complete all planned doses of asparaginase per protocol.
Measured: This endpoint is assessed during Consolidation II, which occurs approximately from Day 270 to Day 480 of study treatment.
Reason of Asparaginase Non-Completion
This outcome summarizes the reasons participants discontinue asparaginase treatment earlier than planned.
Measured: Up to 115 weeks
Grade 3 Infections Toxicity Rate
Grade 3 infection toxicity rate is defined as the proportion of participants who experience grade 3 bacterial or fungal infections that are assessed as possibly, probably, or definitely related to the study treatment during the induction, consolidation, and continuation phases. Toxicity grades are determined according to the Common Terminology Criteria for Adverse Events (CTCAE) version 6.0.
Measured: Adverse events will be followed for 30 days after completion of protocol treatment, with the overall treatment period up to 115 weeks.
Grade 3 Asparaginase-associated Toxicities Rate
Grade 3 asparaginase-associated toxicity rate is defined as the proportion of participants who experience grade 3 asparaginase-associated toxicities (including thromboembolic events, pancreatitis, hypertriglyceridemia, hyperbilirubinemia, hypersensitivity, and hyperglycemia) that are assessed as possibly, probably, or definitely related to the study treatment during the induction, consolidation, or continuation phases. Toxicity grades are determined according to the Common Terminology Criteria for Adverse Events (CTCAE) version 6.0.
Measured: Adverse events will be followed for 30 days after completion of protocol treatment, with the overall treatment period up to 115 weeks.
Grade 3 Orthopedic Toxicity Rate
Grade 3 orthopedic toxicity rate is defined as the proportion of participants who experience grade 3 osteopenia or osteoporosis that are assessed as possibly, probably, or definitely related to the study treatment at the end of treatment, or osteonecrosis (ON) or fractures during or after treatment. Toxicity grades are assigned according to the Common Terminology Criteria for Adverse Events (CTCAE) version 6.0.
Measured: Adverse events will be followed for 30 days after completion of protocol treatment, with the overall treatment period up to 115 weeks. Ostenonecrosis and fractures will be followed up to 10 years.
Complete remission Rate (CRR)
CRR is defined as proportion of participants who achieve CR. Complete response (CR) is defined as an interpretable bone marrow with less than 5% malignant lymphoblasts, no lymphoblasts in peripheral blood, an absolute phagocyte count greater than 1000/µL and platelets above 100,000/µL (for participants with M2 marrow at Day 32 who achieve CR at TP2, APC above 500/µL and platelets above 50,000/µL are acceptable), no evidence of extramedullary leukemia or blasts in spinal fluid, at least a 70% reduction in the anterior mediastinal mass if present at diagnosis as measured by the sum of the products of the two greatest diameters on CT or chest X-ray, and for any other large radiographic masses at diagnosis, a 70% reduction in SPD if restaging imaging is obtained.
Measured: CR can be documented either at the end of Induction IA (32 days) or Induction IB (74 days).
Measurable Residual Disease (MRD) Negativity Rate at the end of Induction IA (Time Point 1)
The proportion of who achieve measurable residual disease (MRD) negativity at the end of Induction IA (Time Point 1). MRD negativity is assessed by multiparameter flow cytometry (MPFC), next-generation sequencing (NGS), and/or KMT2A::AFF4 RT-PCR.
Measured: At the end of Induction IA (32 days from study start)
Measurable Residual Disease (MRD) Negativity Rate at the end of Induction IB (Time Point 2)
The proportion of who achieve measurable residual disease (MRD) negativity at the end of Induction IB (Time Point 2). MRD negativity is assessed by multiparameter flow cytometry (MPFC), next-generation sequencing (NGS), and/or KMT2A::AFF4 RT-PCR.
Measured: At the end of Induction IB (74 days from study start)
Measurable Residual Disease (MRD) Negativity Rate at Time Point 3 (TP3)
The proportion of who achieve measurable residual disease (MRD) negativity at TP3. MRD negativity is assessed by multiparameter flow cytometry (MPFC), next-generation sequencing (NGS), and/or KMT2A::AFF4 RT-PCR.
Measured: For CD19-positive B-ALL, TP3 is reached at the end of Blinatumomab Cycle 2 on Day 28 (Day 130 from study start). For T-cell ALL or participants not receiving blinatumomab, TP3 occurs on Day 28 of Consolidation IC (Day 102 from study start).
Median Event-Free Survival (EFS)
EFS based on Kaplan-Meier method is defined as the time from registration to induction failure, relapse, second malignancy, or death due to any cause. Relapse is defined as the presence of more than 5% lymphoblasts in bone marrow confirmed by flow cytometry, cytogenetics, FISH, immunohistochemistry, or other tests; the development of biopsy-proven extramedullary disease (e.g., CSF, testicle, lymph node, skin); or CNS relapse, defined as a CSF sample with more than 5 WBCs per high-power field with lymphoblasts on cytospin, or two consecutive CSF specimens meeting the CNS-2 criteria (<5 WBC/µL with lymphoblasts) obtained at least three weeks apart. Participants alive without disease relapse are censored at date of last disease evaluation (which can include clinical evaluation and blood counts, does not require a bone marrow examination).
Measured: Up to 10 years
Median Disease-Free Survival (DFS)
DFS based on Kaplan-Meier method is defined as the time from confirmed complete remission (CR) to the earlier of relapse or death due to any cause. Relapse is defined as the presence of more than 5% lymphoblasts in bone marrow confirmed by flow cytometry, cytogenetics, FISH, immunohistochemistry, or other tests; the development of biopsy-proven extramedullary disease (e.g., CSF, testicle, lymph node, skin); or CNS relapse, defined as a CSF sample with more than 5 WBCs per high-power field with lymphoblasts on cytospin, or two consecutive CSF specimens meeting the CNS-2 criteria (<5 WBC/µL with lymphoblasts) obtained at least three weeks apart. Participants who are alive without disease relapse are censored at the date of last disease evaluation.
Measured: Up to 10 years
Median Overall Survival (OS)
Overall Survival (OS) based on Kaplan-Meier method is defined as the time from registration to death due to any cause or censored at date last known alive.
Measured: Up to 10 years
Rate of Allogeneic Transplantation
Rate of allogeneic transplantation is defined as the proportion of participants who undergo allogeneic transplantation while in their first complete remission (CR).
Measured: CR can be documented either at the end of Induction IA (32 days) or Induction IB (74 days).
Reason of Allogeneic Transplantation
This outcome measures the number of participants who undergo allogeneic transplantation in their first complete remission (CR) and the reasons for transplantation.
Measured: CR can be documented either at the end of Induction IA (32 days) or Induction IB (74 days).
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Nov 2025
- Study start3 Apr 2026
- Primary completion31 Jul 2030 (estimated)
- Study completion31 Jul 2035 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Acute Lymphoblastic LeukemiaStudies of the same condition, open and under way.
- More trials run by Dana-Farber Cancer InstituteThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 67 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Dana-Farber Cancer Institute
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Marlise Luskin, MD, Dana-Farber Cancer Institute
- Investigators
- Marlise R Luskin, MD, MSCE, Principal investigator, Dana-Farber Cancer Institute
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07227584
- Sponsor's protocol ID
- 25-533
- Status last verified
- Aug 2026
- First submitted
- 10 Nov 2025
- Last updated
- 17 Aug 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- Yes: The Dana-Farber / Harvard Cancer Center encourages and supports the responsible and ethical sharing of data from clinical trials. De-identified participant data from the final research dataset used in the published manuscript may only be shared under the terms of a Data Use Agreement. Requests may be directed to: \[contact information for Sponsor Investigator or designee\]. The protocol and statistical analysis plan will be made available on Clinicaltrials.gov only as required by federal regulation or as a condition of awards and agreements supporting the research.
Study at a glance
From the registry record, last updated by the sponsor on 17 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Treatment of Newly Diagnosed Philadelphia Chromosome-Negative Acute Lymphoblastic Leukemia in Adolescents and Young Adults (AYAs)
- ClinicalTrials.gov ID
- NCT07227584
- Acronym / sponsor ID
- 25-533
- Conditions
- Acute Lymphoblastic Leukemia, Philadelphia Chromosome-Negative Lymphoblastic Leukemia, Acute Lymphoblastic Leukemia (ALL), Leukemia
- Keywords
- Acute Lymphoblastic Leukemia, Philadelphia Chromosome-Negative lymphoblastic leukemia, Acute Lymphoblastic Leukemia (ALL), Leukemia
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 67 participants (estimated)
- Lead sponsor
- Dana-Farber Cancer InstituteUniversity, hospital or other
- Study start
- 3 Apr 2026 (actual)
- Primary completion
- 31 Jul 2030 (estimated)
- Study completion
- 31 Jul 2035 (estimated)
- First posted
- 12 Nov 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The goal of this research study is to evaluate a chemotherapy regiment for the treatment of newly diagnosed Philadelphia chromosome-negative acute lymphoblastic leukemia (ALL) in adolescents and young adults (AYAs).
The names of the study drugs involved in this study are:
- blinatumomab (a type of immunotherapy drug)
- cyclophosphamide (a type of chemotherapy drug)
- cytarabine (a type of antineoplastic agent)
- dexamethasone (a type of synthetic glucocorticoid)
- doxorubicin (a type of antineoplastic agent)
- etoposide (a type of antineoplastic agent)
- mercaptopurine (a type of antineoplastic agent)
- methotrexate (a type of chemotherapy drug)
- pegaspargase (a type of antineoplastic agent)
- vincristine (a type of antineoplastic agent)
Detailed description
This Phase 2, single-arm research study is to evaluate a chemotherapy regiment the treatment of newly diagnosed Philadelphia chromosome-negative acute lymphoblastic leukemia (ALL) in adolescents and young adults (AYAs).
The U.S. Food and Drug Administration (FDA) has approved all of the drugs of treatment being studied but the investigators of this research study want to understand more about the safety and effectiveness of the chemotherapy regimen in adolescents and young adults with newly diagnosed Philadelphia chromosome-negative ALL.
The research study procedures include screening for eligibility, in-clinic visits, blood tests, urine tests, saliva tests, X-rays, electrocardiograms (ECGs), echocardiograms (ECHOs), Dual-Energy X-ray Absorptiometry (DEXA) scans, bone marrow aspirations/biopsies.
Participation in this study is expected to last about 10 years, 2 years of treatment followed by 8 years of follow up.
It is expected that about 67 people will take part in this research study.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| ALL Backbone Regimen for B-Cell | Experimental | Drug: Blinatumomab, Drug: Oncaspar, Drug: Cyclophosphamide, Drug: Cytarabine, Drug: Dexamethasone, Drug: Doxorubicin Hydrochloride, Drug: Etoposide, Drug: Mercaptopurine, Drug: Methotrexate* Steroid Prophase (3-dy cycle): Dexamethasone \& cytarabine * Induction IA (29-dy cycle): Vincristine, dexamethasone, pegaspargase, doxorubicin, IT chemotherapy * Induction IB (42-dy cycle): Cyclophosphamide, cytarabine, mercaptopurine, IT chemotherapy * Blinatumomab Cycle 1, 2 (42-dy cycles): Blinatumomab, dexamethasone, IT chemotherapy * Consolidation I: * Phase IA (28-dy cycle), Phase IC (21-dy cycle): Vincristine, mercaptopurine, methotrexate, dexamethasone, cytarabine, etoposide, pegaspargase, IT chemotherapy * Blinatumomab Cycle 3 (42-dy cycle): Dexamethasone, Blinatumomab, IT chemotherapy * Consolidation II (21-dy cycles for 30 wks): Vincristine, dexamethasone, mercaptopurine, doxorubicin, methotrexate, pegaspargase, IT chemotherapy * Blinatumomab Cycle 4 (42-dy cycle): Dexamethasone, Blinatumomab, IT chemotherapy * Continuation (21-dy cycles): Vincristine, dexamethasone, mercaptopurine, methotrexate, IT chemotherapy * End of treatment visit * Follow up |
| ALL Backbone Regimen for T-Cell | Experimental | Drug: Blinatumomab, Drug: Oncaspar, Drug: Cyclophosphamide, Drug: Cytarabine, Drug: Dexamethasone, Drug: Doxorubicin Hydrochloride, Drug: Etoposide, Drug: Mercaptopurine, Drug: Methotrexate, Drug: Vincristine* Steroid Prophase (3-day cycle): Dexamethasone and cytarabine * Induction IA (29-day cycle): Vincristine, dexamethasone, pegaspargase, doxorubicin, IT chemotherapy * Induction IB (42-day cycle): Cyclophosphamide, cytarabine, mercaptopurine, IT chemotherapy * Consolidation I: * Phase IA (28-day cycle) and Phase IC (21-day cycle): Vincristine, mercaptopurine, methotrexate, dexamethasone, cytarabine, etoposide, pegaspargase, IT chemotherapy * CNS Phase (21-day cycle): Dexamethasone, vincristine, mercaptopurine, pegaspargase, IT chemotherapy * Consolidation II (21-day cycles for 30 weeks): Vincristine, dexamethasone, mercaptopurine, doxorubicin, methotrexate, pegaspargase, IT chemotherapy * Continuation (21-day cycles): Vincristine, dexamethasone, mercaptopurine, methotrexate, IT chemotherapy * End of treatment visit * Follow up |
Who may qualify
- Ages
- 18 to 51 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (10 listed)
- 3.1.1Confirmed diagnosis of Philadelphia chromosome-negative acute lymphoblastic leukemia.
- Diagnosis should be made by peripheral blood, bone marrow aspirate, bone marrow biopsy, or tissue biopsy demonstrating ≥25% involvement by lymphoblasts, with flow cytometry or immunohistochemistry confirming B-ALL or T-ALL.
- o Participants with B-cell and T-cell lymphoblastic lymphoma are eligible regardless of bone marrow involvement Participants with mixed phenotype acute leukemia (MPAL) ARE eligible, if an ALL regimen is felt to be most appropriate treatment.
- Participants with CNS leukemia ARE eligible. 3.1.2 Allowed prior therapy:
- Corticosteroids, hydroxyurea, all-trans retinoic acid (ATRA).
Key exclusion criteria (3 listed)
- Philadelphia chromosome-positive / BCR::ABL1 fusion 3.2.2 Participants with mature B-cell (Burkitt's) ALL. Mature B-cell ALL is defined by the presence of surface immunoglobulin AND any of the following: t(8;14)(q24;q32), t(8;22), t(2;8), or c-myc-gene rearrangement by FISH, PCR or other testing. [FISH/PCR testing for c-myc rearrangements is not required prior to study entry, but it is suggested for participants with surface immunoglobulin expression or L3 morphology]. 3.2.3 Participants with acute undifferentiated leukemia. 3.2.4 Participants receiving any other investigational agent for this condition.
- 3.2.5 Uncontrolled intercurrent illness including but not limited to ongoing infection with vital sign instability (hypotension, respiratory insufficiency), life-threatening acute tumor lysis syndrome (e.g., with renal failure), symptomatic congestive heart failure, cardiac arrhythmia, intracranial or other uncontrolled bleeding. Circumstances that may significantly interfere with a participant's ability to safely comply with study procedures, such as attend scheduled study visits, adhere to treatment protocols, or complete study assessments. These include a lack of reliable transportation, unstable housing, or psychiatric illness, but reasonable attempts should be made to overcome these circumstances, including but not limited to identifying sponsor, institutional, or thirdparty financial or social support as well as psychiatric consultation for objective assessment. 3.2.6 Sexually active participants of reproductive potential who have not agreed to use an effective contraceptive method for the duration of study participation are ineligible.
- 3.2.7 Pregnant women are excluded from this study because many of the agents used on this protocol have potential for teratogenic or abortifacient effects. Because there is an unknown but potential risk for adverse events in nursing infants secondary to treatment of the mother with these chemotherapy agents, breastfeeding should be discontinued if the mother is enrolled.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| BlinatumomabAlso: Blincyto, NSC# 765986A bispecific T-cell engager (BiTE) antibody, single-use vial via intravenous infusion, per standard of care | Drug | ALL Backbone Regimen for B-Cell, ALL Backbone Regimen for T-Cell |
| OncasparAlso: PEGASPARGASE, NSC #624239)A modified enzyme L-asparaginase, single-use vial via intravenous infusion, per standard of care | Drug | ALL Backbone Regimen for B-Cell, ALL Backbone Regimen for T-Cell |
| CyclophosphamideAlso: Cytoxan, NSC #26271An alkylating agent, single-use vial via intravenous infusion, per standard of care | Drug | ALL Backbone Regimen for B-Cell, ALL Backbone Regimen for T-Cell |
| CytarabineAlso: Cytosine Arabinoside, Ara-C, Cytostar, NSC#63878An antineoplastic antimetabolite, multi-dose vial via intrathecal injection (through the spinal space), per standard of care | Drug | ALL Backbone Regimen for B-Cell, ALL Backbone Regimen for T-Cell |
| DexamethasoneAlso: Decadron, Hexadrol, Dexone, DexamethA synthetic glucocorticoid, tablets or single-use vials via orally or intravenous infusion (through the vein), per standard of care | Drug | ALL Backbone Regimen for B-Cell, ALL Backbone Regimen for T-Cell |
| Doxorubicin HydrochlorideAlso: Adriamycin, NSC#123127An anthracycline antibiotic, single-use or multi-dose vials via intravenous infusion, per standard of care | Drug | ALL Backbone Regimen for B-Cell, ALL Backbone Regimen for T-Cell |
| EtoposideAlso: VePesid, Etopophos, VP-16, NSC#141540A derivative of podophyllotoxin, multi-dose vial via intravenous infusion, per standard of care | Drug | ALL Backbone Regimen for B-Cell, ALL Backbone Regimen for T-Cell |
| MercaptopurineAlso: 6-MP, Purinethol, 6-Mercaptopurine, PurixanA purine antagonist, tablet via orally, per standard of care | Drug | ALL Backbone Regimen for B-Cell, ALL Backbone Regimen for T-Cell |
| MethotrexateAlso: MTX, Amethopterin, Trexall, NSC#000740A folate analogue, multi-dose and single-use vials via intrathecal injection, per standard of care | Drug | ALL Backbone Regimen for B-Cell, ALL Backbone Regimen for T-Cell |
| VincristineAlso: Oncovin, VCR, LCR, NSC#67574A vinca alkaloid, single-use vials via intravenous injection, per standard of care | Drug | ALL Backbone Regimen for T-Cell |
Primary outcome
Treatment Completion Rate Through Time Point 3 (TP3)
Time frame: Timeframe for TP3 depends on disease immunophenotype. Participants with CD19-positive B-ALL, TP3 occurs at the end of Blinatumomab Cycle 2 on Day 28 (130 days from study start). For participants with T-cell ALL or those who do not receive blinatum
Treatment completion rate through TP3 is defined as the proportion of Adolescents and Young Adults (AYAs) participants who receive all protocol-specified therapy through TP3, without early discontinuation.
16 secondary outcomes
Rate of Treatment-Related Mortality (TRM)
Time frame: Up to 115 weeks
Rate of Treatment Discontinuation due to Toxicity or Disease
Time frame: Up to 115 weeks
Rate of Asparaginase Non-Completion
Time frame: This endpoint is assessed during Consolidation II, which occurs approximately from Day 270 to Day 480 of study treatment.
Reason of Asparaginase Non-Completion
Time frame: Up to 115 weeks
Grade 3 Infections Toxicity Rate
Time frame: Adverse events will be followed for 30 days after completion of protocol treatment, with the overall treatment period up to 115 weeks.
Grade 3 Asparaginase-associated Toxicities Rate
Time frame: Adverse events will be followed for 30 days after completion of protocol treatment, with the overall treatment period up to 115 weeks.
Grade 3 Orthopedic Toxicity Rate
Time frame: Adverse events will be followed for 30 days after completion of protocol treatment, with the overall treatment period up to 115 weeks. Ostenonecrosis and fractures will be followed up to 10 years.
Complete remission Rate (CRR)
Time frame: CR can be documented either at the end of Induction IA (32 days) or Induction IB (74 days).
Measurable Residual Disease (MRD) Negativity Rate at the end of Induction IA (Time Point 1)
Time frame: At the end of Induction IA (32 days from study start)
Measurable Residual Disease (MRD) Negativity Rate at the end of Induction IB (Time Point 2)
Time frame: At the end of Induction IB (74 days from study start)
Measurable Residual Disease (MRD) Negativity Rate at Time Point 3 (TP3)
Time frame: For CD19-positive B-ALL, TP3 is reached at the end of Blinatumomab Cycle 2 on Day 28 (Day 130 from study start). For T-cell ALL or participants not receiving blinatumomab, TP3 occurs on Day 28 of Consolidation IC (Day 102 from study start).
Median Event-Free Survival (EFS)
Time frame: Up to 10 years
Median Disease-Free Survival (DFS)
Time frame: Up to 10 years
Median Overall Survival (OS)
Time frame: Up to 10 years
Rate of Allogeneic Transplantation
Time frame: CR can be documented either at the end of Induction IA (32 days) or Induction IB (74 days).
Reason of Allogeneic Transplantation
Time frame: CR can be documented either at the end of Induction IA (32 days) or Induction IB (74 days).
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Aug 2026.
- Individual participant dataSharing planned: Yes. The Dana-Farber / Harvard Cancer Center encourages and supports the responsible and ethical sharing of data from clinical trials. De-identified participant data from the final research dataset used in the published manuscript may only be shared under the terms of a Data Use Agreement. Requests may be directed to: [contact information for Sponsor Investigator or designee]. The protocol and statistical analysis plan will be made available on Clinicaltrials.gov only as required by federal regulation or as a condition of awards and agreements supporting the research.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Marlise R Luskin, MD, MSCE principal investigator
Dana-Farber Cancer Institute
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Blinatumomab, Oncaspar and Cyclophosphamide in people with Acute Lymphoblastic Leukemia and Philadelphia Chromosome-Negative Lymphoblastic Leukemia, run by Dana-Farber Cancer Institute at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 10 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 17 Aug 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Marlise R Luskin, MD, MSCE (617-632-1906, marlise_luskin@dfci.harvard.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Treatment Completion Rate Through Time Point 3 (TP3) (time frame: Timeframe for TP3 depends on disease immunophenotype. Participants with CD19-positive B-ALL, TP3 occurs at the end of Blinatumomab Cycle 2 on Day 28 (130 days from study start). For participants with T-cell ALL or those who do not receive blinatum). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 Aug 2026.