Acute Lymphoblastic LeukemiaPhase 4NCT06289673
Identification of Necessary Information for Treatment Induction in Newly Diagnosed Acute Lymphoblastic Leukemia/Lymphoma
A Phase 4 study testing Dexamethasone, Vincristine and Daunorubicin in people with Acute Lymphoblastic Leukemia and Lymphoblastic Lymphoma, run by St. Jude Children's Research Hospital at 5 sites in United States.
Trial summary
The goal of this study is to provide sufficient therapy during the time a patients' B-cell Acute Lymphoblastic Leukemia (ALL) or Lymphoblastic Lymphoma (LLy) risk category is being determined. The term "risk" refers to the chance of the ALL or LLy coming back after treatment. Read more about this study
- Who is it for?
- Ages 1 year to 18 years
- Conditions the study is for
- Acute Lymphoblastic Leukemia, Lymphoblastic Lymphoma, Mixed Phenotype Acute Leukemia
- What is being tested?
- Dexamethasone, Vincristine and Daunorubicin
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 850 participants
- Where
- 5 sitesUnited States
- Study dates
- 26 Dec 2024to May 2039
- Phase
- Phase 4
- 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 1 year to 18 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- Age 1-18.99 years
- Diagnosis of acute leukemia / lymphoma as below:
- Acute lymphoblastic leukemia (ALL) with at least 25% bone marrow blasts or definitive evidence of ALL in peripheral blood (in those without an available bone marrow sample).
- Lymphoblastic lymphoma (LLy) with immunophenotypic evidence of a lymphoblastic population and <25% bone marrow blasts and less than 1,000 circulating blasts/ microL.
- Mixed phenotype acute leukemia (MPAL) with or without 25% bone marrow involvement (i.e. patients with either leukemia or lymphoma are eligible).
Who cannot join
- Pregnant or breastfeeding
- Receipt of prior cancer directed therapy with the exclusion of up to 1 dose of intrathecal chemotherapy, 1 dose of vincristine, or emergency radiotherapy due to organ compromising malignant mass. There is no exclusion for prior steroid therapy.
- Known to be currently ineligible for available SJALL therapeutic studies (e.g. receipt of prohibited therapy, no appropriate SJALL therapeutic study available, enrolled on competing trial, etc.).
- Note: The intention of this exclusion criterion is to enroll all newly diagnosed ALL/ LLy/ MPAL patients. If participant is screened as a potential participant for subsequent SJALL and later found to be ineligible due to information obtained during INITIALL, this will not make the participant ineligible for INITIALL.
- Inability or unwillingness of research participant or legal guardian/representative to give written informed consent.
- Major pre-existing abnormalities such as ataxia telangiectasia, Fanconi anemia, Charcot Marie Tooth, etc.
Trial locations and contacts
5 sites in 1 country. Contact the study team or a site near you to ask about taking part.
5 sites in 1 country
United States5 sites, 5 recruiting
- Recruiting
Our Lady of the Lakes Regional Medical Center
Baton Rouge, Louisiana, 70809
Sakshi Bami, MD, 901-595-0341, sakshi.bami@fmolhs.org
Sakshi Bami, MD
- Recruiting
Novant Health Presbyterian Hemby Children's Hospital
Charlotte, North Carolina, 28204
Jessica Bell, MD, 704-384-1900, jbell@novanthealth.org
Jessica Bell, MD
- Recruiting
St. Jude Children's Research Hospital
Memphis, Tennessee, 38105
Seth E. Karol, MD, 888-226-4343, referralinfo@stjude.org
Seth E. Karol, MD
- Recruiting
Rady Children's Hospital
San Diego, California, 92123
Victor Wong, MD, 858-966-5811, vwong@rchsd.org
Victor Wong, MD
- Recruiting
Saint Francis Children's Hospital
Tulsa, Oklahoma, 74136
Ashraf Mohamed, MD, 918-502-6720, ammohamed@saintfrancis.com
Ashraf Mohamed, MD
About this study
Official title: INITIALL: Identification of Necessary Information for Treatment Induction in Newly Diagnosed Acute Lymphoblastic Leukemia/Lymphoma
The goal of this study is to provide sufficient therapy during the time a patients' B-cell Acute Lymphoblastic Leukemia (ALL) or Lymphoblastic Lymphoma (LLy) risk category is being determined. The term "risk" refers to the chance of the ALL or LLy coming back after treatment.
Primary Objectives
Read more
- To provide sufficient therapy to enable testing of newly diagnosed acute lymphoblastic leukemia/lymphoma and mixed phenotype acute leukemia/lymphoma tumor samples to determine eligibility and appropriate risk stratification for SJALL therapeutic studies.
- To develop a central database of genomic and clinical findings.
Secondary Objectives
- To assess event free and overall survival data of patients enrolled on this study.
Read the detailed description
Patients with newly diagnosed acute lymphoblastic leukemia/lymphoma (ALL/LLy) and mixed phenotype acute leukemia/lymphoma (MPAL) will undergo diagnostic procedures either during screening or on Day 1. They will receive 7 days of chemotherapy including 13 doses of dexamethasone, 1 dose of vincristine, and 1 dose of daunorubicin (for patients with T-ALL/LLy or MPAL only). Patients will also undergo their initial lumbar puncture with intrathecal chemotherapy on Days 4 or 5 or 6 of therapy. After the completion of 7 days of chemotherapy, patients will begin therapy on either a SJALL therapeutic trial or will receive non-protocol therapy.
- Being tested
- Dexamethasone, Vincristine, Daunorubicin, Intrathecal triple therapy (methotrexate + hydrocortisone + cytarabine), Methotrexate
- Keywords
- Newly Diagnosed, Risk Category, Acute Lymphoblastic Leukemia, Lymphoblastic Lymphoma, Mixed Phenotype Acute Leukemia (MPAL), Children, Young Adults
- Medical subject headings
- Precursor Cell Lymphoblastic Leukemia-Lymphoma, Leukemia, Biphenotypic, Acute
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
DexamethasoneDrug
Also called Decadron
Per mouth (PO) or intravenously (IV) once on Day 1 and PO or IV divided BID (every 12 hours) days 2-7
VincristineDrug
Also called Vincristine Sulfate, Oncovin
Intravenously (IV) for 1 dose on Day 1 or 2
DaunorubicinDrug
Also called Daunomycin
Intravenously (IV) for 1 dose on Day 2 or 3 (T-ALL/ T-LLy/ MPAL only)
Intrathecal triple therapy (methotrexate + hydrocortisone + cytarabine)Drug
Also called ITMHA
Intrathecal (Age adjusted) for 1 dose on Day 4 or 5 or 6
MethotrexateDrug
Also called MTX, Trexall®
Given IT as part of Intrathecal triple therapy.
CytarabineDrug
Also called Cytosine arabinoside, Ara-C
Given IT as part of Intrathecal triple therapy.
| Study group | Role | What they receive |
|---|---|---|
| Newly diagnosed ALL, LLy, and MPAL patients | Experimental | All eligible patients receive the following intervention:
Dexamethasone, Vincristine, Daunorubicin, Intrathecal triple therapy (methotrexate + hydrocortisone + cytarabine) Receives: Drug: Dexamethasone; Drug: Vincristine; Drug: Daunorubicin; Drug: Intrathecal triple therapy (methotrexate + hydrocortisone + cytarabine); Drug: Methotrexate; Drug: Cytarabine |
What is being measured
The primary outcome is the main question the study is designed to answer.
Sufficient phenotypic and/or genomic data necessary for therapeutic protocol assignment by Day 8 (completion of INITIALL therapy).
The proportion of patients with sufficient immunophenotypic, genomic, and clinical data to allow determination of eligibility for currently open trials at the enrolling institution.
Measured: 1 week from study entry
Complete data within the INITIALL database
The proportion of patients with complete data within the INITIALL protocol database as described in the protocol.
Measured: 3 months, 1 year, 3, 5 years from study entry
Secondary outcomes (2)
Event Free Survival (EFS)
EFS will be reported as estimates using the Kaplan-Meier method.
Measured: 1, 3, 5 years from study entry
Overall Survival (OS)
OS will be reported as estimates using the Kaplan-Meier method.
Measured: 1, 3, 5 years from study entry
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Mar 2024
- Study start26 Dec 2024
- Primary completionMay 2034 (estimated)
- Study completionMay 2039 (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 St. Jude Children's Research HospitalThe 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 4
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 850 participants (estimated)
Sponsor and investigators
- Lead sponsor
- St. Jude Children's Research Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Seth E. Karol, MD, Principal investigator, St. Jude Children's Research Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06289673
- Sponsor's protocol ID
- INITIALL
- Other IDs
- NCI-2024-01659
- Status last verified
- Jul 2026
- First submitted
- 23 Feb 2024
- Last updated
- 14 Jul 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- Yes: Individual participant de-identified datasets containing the variables analyzed in the published article will be made available (related to the study primary or secondary objectives contained in the publication). Supporting documents such as the protocol, statistical analyses plan, and informed consent are available through the CTG website for the specific study. Data used to generate the published article will be made available at the time of article publication. Investigators who seek access to individual level de-identified data will contact the computing team in the Department of Biostatistics (ClinTrialDataRequest@stjude.org) who will respond to the data request.
Study at a glance
From the registry record, last updated by the sponsor on 14 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- INITIALL: Identification of Necessary Information for Treatment Induction in Newly Diagnosed Acute Lymphoblastic Leukemia/Lymphoma
- ClinicalTrials.gov ID
- NCT06289673
- Acronym / sponsor ID
- INITIALL
- Keywords
- Newly Diagnosed, Risk Category, Acute Lymphoblastic Leukemia, Lymphoblastic Lymphoma, Mixed Phenotype Acute Leukemia (MPAL), Children, Young Adults
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 850 participants (estimated)
- Lead sponsor
- St. Jude Children's Research HospitalUniversity, hospital or other
- Study start
- 26 Dec 2024 (actual)
- Primary completion
- May 2034 (estimated)
- Study completion
- May 2039 (estimated)
- First posted
- 4 Mar 2024 (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 study is to provide sufficient therapy during the time a patients' B-cell Acute Lymphoblastic Leukemia (ALL) or Lymphoblastic Lymphoma (LLy) risk category is being determined. The term "risk" refers to the chance of the ALL or LLy coming back after treatment.
Primary Objectives
- To provide sufficient therapy to enable testing of newly diagnosed acute lymphoblastic leukemia/lymphoma and mixed phenotype acute leukemia/lymphoma tumor samples to determine eligibility and appropriate risk stratification for SJALL therapeutic studies.
- To develop a central database of genomic and clinical findings.
Secondary Objectives
- To assess event free and overall survival data of patients enrolled on this study.
Detailed description
Patients with newly diagnosed acute lymphoblastic leukemia/lymphoma (ALL/LLy) and mixed phenotype acute leukemia/lymphoma (MPAL) will undergo diagnostic procedures either during screening or on Day 1. They will receive 7 days of chemotherapy including 13 doses of dexamethasone, 1 dose of vincristine, and 1 dose of daunorubicin (for patients with T-ALL/LLy or MPAL only). Patients will also undergo their initial lumbar puncture with intrathecal chemotherapy on Days 4 or 5 or 6 of therapy. After the completion of 7 days of chemotherapy, patients will begin therapy on either a SJALL therapeutic trial or will receive non-protocol therapy.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Newly diagnosed ALL, LLy, and MPAL patients | Experimental | Drug: Dexamethasone, Drug: Vincristine, Drug: Daunorubicin, Drug: Intrathecal triple therapy (methotrexate + hydrocortisone + cytarabine), Drug: Methotrexate, Drug: CytarabineAll eligible patients receive the following intervention: Dexamethasone, Vincristine, Daunorubicin, Intrathecal triple therapy (methotrexate + hydrocortisone + cytarabine) |
Who may qualify
- Ages
- 1 year to 18 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (5 listed)
- Age 1-18.99 years
- Diagnosis of acute leukemia / lymphoma as below:
Key exclusion criteria (6 listed)
- Pregnant or breastfeeding
- Receipt of prior cancer directed therapy with the exclusion of up to 1 dose of intrathecal chemotherapy, 1 dose of vincristine, or emergency radiotherapy due to organ compromising malignant mass. There is no exclusion for prior steroid therapy.
- Known to be currently ineligible for available SJALL therapeutic studies (e.g. receipt of prohibited therapy, no appropriate SJALL therapeutic study available, enrolled on competing trial, etc.).
- Note: The intention of this exclusion criterion is to enroll all newly diagnosed ALL/ LLy/ MPAL patients. If participant is screened as a potential participant for subsequent SJALL and later found to be ineligible due to information obtained during INITIALL, this will not make the participant ineligible for INITIALL.
- Inability or unwillingness of research participant or legal guardian/representative to give written informed consent.
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 |
|---|---|---|
| DexamethasoneAlso: DecadronPer mouth (PO) or intravenously (IV) once on Day 1 and PO or IV divided BID (every 12 hours) days 2-7 | Drug | Newly diagnosed ALL, LLy, and MPAL patients |
| VincristineAlso: Vincristine Sulfate, OncovinIntravenously (IV) for 1 dose on Day 1 or 2 | Drug | Newly diagnosed ALL, LLy, and MPAL patients |
| DaunorubicinAlso: DaunomycinIntravenously (IV) for 1 dose on Day 2 or 3 (T-ALL/ T-LLy/ MPAL only) | Drug | Newly diagnosed ALL, LLy, and MPAL patients |
| Intrathecal triple therapy (methotrexate + hydrocortisone + cytarabine)Also: ITMHAIntrathecal (Age adjusted) for 1 dose on Day 4 or 5 or 6 | Drug | Newly diagnosed ALL, LLy, and MPAL patients |
| MethotrexateAlso: MTX, Trexall®Given IT as part of Intrathecal triple therapy. | Drug | Newly diagnosed ALL, LLy, and MPAL patients |
| CytarabineAlso: Cytosine arabinoside, Ara-CGiven IT as part of Intrathecal triple therapy. | Drug | Newly diagnosed ALL, LLy, and MPAL patients |
Primary outcome
Sufficient phenotypic and/or genomic data necessary for therapeutic protocol assignment by Day 8 (completion of INITIALL therapy).
Time frame: 1 week from study entry
The proportion of patients with sufficient immunophenotypic, genomic, and clinical data to allow determination of eligibility for currently open trials at the enrolling institution.
Complete data within the INITIALL database
Time frame: 3 months, 1 year, 3, 5 years from study entry
The proportion of patients with complete data within the INITIALL protocol database as described in the protocol.
2 secondary outcomes
Event Free Survival (EFS)
Time frame: 1, 3, 5 years from study entry
Overall Survival (OS)
Time frame: 1, 3, 5 years from study entry
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 14 Jul 2026.
- St. Jude Children's Research HospitalLink provided by the sponsor.
- Clinical Trials Open at St. JudeLink provided by the sponsor.
- Individual participant dataSharing planned: Yes. Individual participant de-identified datasets containing the variables analyzed in the published article will be made available (related to the study primary or secondary objectives contained in the publication). Supporting documents such as the protocol, statistical analyses plan, and informed consent are available through the CTG website for the specific study. Data used to generate the published article will be made available at the time of article publication. Investigators who seek access to individual level de-identified data will contact the computing team in the Department of Biostatistics (ClinTrialDataRequest@stjude.org) who will respond to the data request.
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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.
Seth E. Karol, MD principal investigator
St. Jude Children's Research Hospital
5 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Dexamethasone, Vincristine and Daunorubicin in people with Acute Lymphoblastic Leukemia and Lymphoblastic Lymphoma, run by St. Jude Children's Research Hospital at 5 sites 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 5 inclusion and 6 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 14 Jul 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 5 sites 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 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
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 Seth E. Karol, MD (888-226-4343, referralinfo@stjude.org), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Sufficient phenotypic and/or genomic data necessary for therapeutic protocol assignment by Day 8 (completion of INITIALL therapy). (time frame: 1 week from study entry). The study lists 2 primary outcomes in all. 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 14 Jul 2026.