T-cell Acute Lymphoblastic LeukemiaPhase 2NCT06561074
A Phase 2 Study to Evaluate Efficacy of Calaspargase Pegol-mknl and Decitabine Combined With Venetoclax in Pediatric, Adolescent, and Young Adult Patients With Relapsed/Refractory T-cell Acute Lymphoblastic Leukemia (T-ALL) and T- Cell Lymphoblastic Lymphoma (T-LLy)
A Phase 2 study testing Decitabine, Venetoclax and Calaspargase pegol-mknl in people with T-cell Acute Lymphoblastic Leukemia and T-Cell Lymphoblastic Lymphoma, run by M.D. Anderson Cancer Center at 1 site in United States.
Trial summary
To learn if giving the study drugs calaspargase pegol-mknl and decitabine in combination with venetoclax can help to control relapsed/refractory T-ALL and T-LLy. The safety of this drug combination will also be studied. Read more about this study
- Who is it for?
- Ages 1 month to 21 years
- Conditions the study is for
- T-cell Acute Lymphoblastic Leukemia, T-Cell Lymphoblastic Lymphoma
- What is being tested?
- Decitabine, Venetoclax and Calaspargase pegol-mknl
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 22 participants
- Where
- 1 siteUnited States
- Study dates
- 25 Sep 2025to 31 Dec 2031
- 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 1 month to 21 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- Pediatric, adolescent, or young adult patients who have relapse or refractory T-cell lymphoblastic leukemia (T-ALL) or T-Cell lymphoblastic lymphoma (T-LLy) according to 2017 WHO classification and NCCN v1 2021.
- Patients have adequate performance status (ECOG ≤2) for patients≥16 years old, Lansky score >50 for patients<16 years old.
- Patients must be 1mo to 21 years of age at time of signing/or having proxy sign the informed consent.
- Patients with asymptomatic CNS disease are eligible (see also Exclusion Criterion #2 in section 4.2.)
- The following conditions are allowed on study: conditions requiring systemic glucocorticoid use, such as autoimmune disease, acute or chronic controlled graft versus host disease (GVHD) or severe asthma. Patients are also allowed up to 5 days of glucocorticoids as cytoreduction in combination with up to 3 doses of cyclophosphamide (200 mg/m2/day) are allowed as standard pre-phase treatment up to 1 day before start of study treatment or cytarabine up to 2gm/m2. This can also be discussed with PI.
- Patients must have adequate organ function and laboratory results (obtained within 14 days of enrolment:
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- Total serum bilirubin ≤1.5 x upper limit of normal (ULN). Patients with known Gilbert's syndrome may have a total bilirubin up to ≤3 x ULN.
- Adequate renal function (creatinine clearance ≥ 30 mL/min) unless related to disease.
- Alanine aminotransferase (ALT) and/or aspartate aminotransferase (AST) ≤3 x ULN; ≤5 x ULN unless in case of suspected leukemic liver involvement
- Amylase, Lipase and Triglycerides must be WNL prior to administration of calaspargase pegol-mknl. If the lab values are outside the normal range, the treating physicians can discuss dosing/enrolling per PI discretion.
- Females of childbearing potential must have a negative serum or urine beta-human chorionic gonadotropin (β-HCG) pregnancy test result within 14 days prior to the first dose of study drugs and must agree to use one of the following effective contraception methods during the study and for 3 months following the last dose of study drug. Effective methods of birth control include:
- Birth control pills, skin patches, birth control injections, implants (placed under the skin by a health care provider)
- Intrauterine devices (IUDs) and intra-uterine hormone-releasing systems (IUS)
- Condom
- Abstinence
- Bilateral tubal occlusion/ligation or Bilateral tubal occlusion/ligation by hysteroscopy with a hysterosalpingogram to confirm the procedure's success
- Males need to inform the doctor right away if the partner becomes pregnant or suspects pregnancy. While in this study and for 90 days after the last treatment the patient should not donate sperm for the purposes of reproduction. He will need to use a condom while in this study and for 90 days after the last treatment.
- Patients must have had at least 30 days between prior hematopoietic stem cell transplant and first dose of study drug.
- Patients able and willing to swallow tablets or use oral dispersible tablets. No liquid formulation is available.
Who cannot join
- Past or current history of a secondary or other primary tumor or a chronic myeloid leukemia (CML) blast crisis with exception of:
- uratively treated non-melanomatous skin cancer, other primary solid tumor treated with curative intent and no known active disease present, and no treatment administered during the last 2 years
- Presence of clinically significant uncontrolled CNS pathology such as epilepsy, paresis, aphasia, stroke, severe brain injuries, organic brain syndrome, or psychosis.
- Presence of the following are allowed: headaches, vomiting, nerve palsy
- Significant traumatic injury or major surgery (major surgery means opening of a body cavity, e.g., thoracotomy, laparotomy, laparoscopic organ resection, and major orthopedic procedures, e.g. joint replacement, open reduction, and internal fixation) within 14 days of scheduled dosing day 1.
- Male or female subjects of childbearing potential, unwilling to use an approved, effective means of contraception in accordance with institution's standards.
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- Patients with uncontrolled infections (viral, bacterial, or fungal) per PI's discretion. Infections controlled on concurrent anti-microbial agents are acceptable, and anti-microbial prophylaxis per institutional guidelines are acceptable.
- Medical history of cardiovascular disease such as:
- Clinically significant cardiac disease including congestive heart failure (NYHA class III or IV), arrhythmia or conduction abnormality requiring medication, or cardiomyopathy.
- Female patient who is pregnant or breastfeeding. Female patient who is considering becoming pregnant during the study; or within approximately 30 days after the last dose of venetoclax, 3 months after the last dose of calaspargase or 6 months after the last dose of decitabine. For decitabine and calaspargase, also see the study drugs product label for pregnancy precautions. Male patient who is considering fathering a child within approximately 30 days or donating sperm during the study, within approximately 90 days after the last dose to venetoclax, calaspargase and decitabine. For all study drugs, also see the relevant chemotherapy product label for not fathering a child and donating sperm.
- Patients may be excluded if they are currently enrolled in another ongoing clinical trial with investigational products
- Liver cirrhosis or other active severe liver disease or with suspected active alcohol abuse.
- Patients who are unable or unwilling to comply with all study requirements for clinical visits, examinations, tests, and procedures.
- If patient has not recovered from grade 2 clinically significant adverse effect(s)/toxicity(s) of the previous therapy- (exception no grade 3 or higher peripheral neuropathy) from previous chemotherapy, surgery, radiation before the start of study drugs.
- Pancreatitis: Patients will be excluded in the presence of Grade 3 or 4 pancreatitis or if history of anaphylaxis or grade 3 pancreatitis from asparaginase.
- Other severe, uncontrolled acute or chronic medical or psychiatric condition or laboratory abnormality that in the opinion of the Investigator may increase the risk associated with study participation or investigational product administration or may interfere with the interpretation of study results and/or would make the patient inappropriate for enrollment into this study.
- History of serious hypersensitivity reactions including anaphylaxis to pegylated L-Asparaginase therapy.
- Known history of coagulopathy (e.g., hemophilia and know protein S deficiency).
- Active thromboembolic event(s) (i.e., symptomatic despite initiation of anti-coagulation therapy), or history of CNS thromboses.
- Patients should not have received the following within 7days prior to the first dose of study drug: Strong and moderate CYP3A inducers.
- Malabsorption syndrome or any other condition that precludes enteral administration.
- Has consumed grapefruit, grapefruit products, Seville oranges (including marmalade containing Seville oranges) or Star fruit or used a strong or moderate CYP3A inhibitor within 2 days prior to the first dose of venetoclax.
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
MD Anderson Cancer Center
Houston, Texas, 77090
David McCall, MD, 713-792-6604, dmccall1@mdanderson.org
David McCall, MD
About this study
To learn if giving the study drugs calaspargase pegol-mknl and decitabine in combination with venetoclax can help to control relapsed/refractory T-ALL and T-LLy. The safety of this drug combination will also be studied.
Read the detailed description
Primary Objectives:
To characterize the clinical efficacy of Calaspargase pegol-mknl and Decitabine in combination with Venetoclax in pediatric, adolescent, and young adult patients with relapsed/refractory T-ALL/T-LLy based upon the complete response rate (CR).
Secondary Objectives:
To summarize efficacy per response rate, overall survival (OS), event free survival (EFS), and minimal residual disease (MRD) negativity rate.
To summarize the incidence, prevalence, and severity of adverse drug reactions according to common terminology criteria for adverse events (CTCAE) NCI CTCAE version 5.0.
- To summarize the effect of this treatment combination on patients transitioning to Hematopoietic stem cell transplant (HSCT) i.e., number and percentage of patients that are able to proceed to HSCT.
To evaluate calaspargase pegol-mknl pharmacokinetics in relapsed refractory patients and investigate its correlation with asparagine levels.
Exploratory Objectives:
To summarize associations between the genomic alterations in ALL (current biomarker expression of the disease) with relation to the incidence of proceeding to HSCT in patients with PR or stable disease (SD) after the induction cycle(s).
To evaluate the effect of anti-PEG and anti-ASP antibodies (PEG-ASP) on calaspargase enzyme levels, and effect of calaspargase pegol-mknl pharmacokinetics on toxicities and treatment outcomes.
- Being tested
- Decitabine, Venetoclax, Calaspargase pegol-mknl
- Medical subject headings
- Precursor T-Cell Lymphoblastic Leukemia-Lymphoma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
DecitabineDrug
Also called Dacogen
Given by vein
VenetoclaxDrug
Also called ABT-199, GDC-0199
Given by mouth
Calaspargase pegol-mknlDrug
Given by vein
| Study group | Role | What they receive |
|---|---|---|
| Treatment w/Calaspargase pegol-mknl + Decitabine + Venetoclax | Experimental | Not described Receives: Drug: Decitabine; Drug: Venetoclax; Drug: Calaspargase pegol-mknl |
What is being measured
The primary outcome is the main question the study is designed to answer.
Safety and adverse events (AEs)
Incidence of Adverse Events, Graded According to National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) Version (v) 5.0
Measured: Through study completion; an average of 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Aug 2024
- Study start25 Sep 2025
- Primary completion31 Dec 2029 (estimated)
- Study completion31 Dec 2031 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for T-cell Acute Lymphoblastic LeukemiaStudies of the same condition, open and under way.
- More trials run by M.D. Anderson Cancer CenterThe 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
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 22 participants (estimated)
Sponsor and investigators
- Lead sponsor
- M.D. Anderson Cancer Center
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- David McCall, MD, Principal investigator, M.D. Anderson Cancer Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06561074
- Sponsor's protocol ID
- 2022-0416
- Other IDs
- NCI-2024-06907
- Status last verified
- Sep 2026
- First submitted
- 16 Aug 2024
- Last updated
- 18 Sep 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 18 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase 2 Study to Evaluate Efficacy of Calaspargase Pegol-mknl and Decitabine Combined With Venetoclax in Pediatric, Adolescent, and Young Adult Patients With Relapsed/Refractory T-cell Acute Lymphoblastic Leukemia (T-ALL) and T- Cell Lymphoblastic Lymphoma (T-LLy)
- ClinicalTrials.gov ID
- NCT06561074
- Acronym / sponsor ID
- 2022-0416
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 22 participants (estimated)
- Lead sponsor
- M.D. Anderson Cancer CenterUniversity, hospital or other
- Study start
- 25 Sep 2025 (actual)
- Primary completion
- 31 Dec 2029 (estimated)
- Study completion
- 31 Dec 2031 (estimated)
- First posted
- 19 Aug 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.
To learn if giving the study drugs calaspargase pegol-mknl and decitabine in combination with venetoclax can help to control relapsed/refractory T-ALL and T-LLy. The safety of this drug combination will also be studied.
Detailed description
Primary Objectives:
To characterize the clinical efficacy of Calaspargase pegol-mknl and Decitabine in combination with Venetoclax in pediatric, adolescent, and young adult patients with relapsed/refractory T-ALL/T-LLy based upon the complete response rate (CR).
Secondary Objectives:
To summarize efficacy per response rate, overall survival (OS), event free survival (EFS), and minimal residual disease (MRD) negativity rate.
To summarize the incidence, prevalence, and severity of adverse drug reactions according to common terminology criteria for adverse events (CTCAE) NCI CTCAE version 5.0.
- To summarize the effect of this treatment combination on patients transitioning to Hematopoietic stem cell transplant (HSCT) i.e., number and percentage of patients that are able to proceed to HSCT.
To evaluate calaspargase pegol-mknl pharmacokinetics in relapsed refractory patients and investigate its correlation with asparagine levels.
Exploratory Objectives:
To summarize associations between the genomic alterations in ALL (current biomarker expression of the disease) with relation to the incidence of proceeding to HSCT in patients with PR or stable disease (SD) after the induction cycle(s).
To evaluate the effect of anti-PEG and anti-ASP antibodies (PEG-ASP) on calaspargase enzyme levels, and effect of calaspargase pegol-mknl pharmacokinetics on toxicities and treatment outcomes.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Treatment w/Calaspargase pegol-mknl + Decitabine + Venetoclax | Experimental | Drug: Decitabine, Drug: Venetoclax, Drug: Calaspargase pegol-mknl |
Who may qualify
- Ages
- 1 month to 21 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (19 listed)
- Pediatric, adolescent, or young adult patients who have relapse or refractory T-cell lymphoblastic leukemia (T-ALL) or T-Cell lymphoblastic lymphoma (T-LLy) according to 2017 WHO classification and NCCN v1 2021.
- Patients have adequate performance status (ECOG ≤2) for patients≥16 years old, Lansky score >50 for patients<16 years old.
- Patients must be 1mo to 21 years of age at time of signing/or having proxy sign the informed consent.
- Patients with asymptomatic CNS disease are eligible (see also Exclusion Criterion #2 in section 4.2.)
- The following conditions are allowed on study: conditions requiring systemic glucocorticoid use, such as autoimmune disease, acute or chronic controlled graft versus host disease (GVHD) or severe asthma. Patients are also allowed up to 5 days of glucocorticoids as cytoreduction in combination with up to 3 doses of cyclophosphamide (200 mg/m2/day) are allowed as standard pre-phase treatment up to 1 day before start of study treatment or cytarabine up to 2gm/m2. This can also be discussed with PI.
Key exclusion criteria (22 listed)
- Past or current history of a secondary or other primary tumor or a chronic myeloid leukemia (CML) blast crisis with exception of:
- uratively treated non-melanomatous skin cancer, other primary solid tumor treated with curative intent and no known active disease present, and no treatment administered during the last 2 years
- Presence of clinically significant uncontrolled CNS pathology such as epilepsy, paresis, aphasia, stroke, severe brain injuries, organic brain syndrome, or psychosis.
- Presence of the following are allowed: headaches, vomiting, nerve palsy
- Significant traumatic injury or major surgery (major surgery means opening of a body cavity, e.g., thoracotomy, laparotomy, laparoscopic organ resection, and major orthopedic procedures, e.g. joint replacement, open reduction, and internal fixation) within 14 days of scheduled dosing day 1.
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 |
|---|---|---|
| DecitabineAlso: DacogenGiven by vein | Drug | Treatment w/Calaspargase pegol-mknl + Decitabine + Venetoclax |
| VenetoclaxAlso: ABT-199, GDC-0199Given by mouth | Drug | Treatment w/Calaspargase pegol-mknl + Decitabine + Venetoclax |
| Calaspargase pegol-mknlGiven by vein | Drug | Treatment w/Calaspargase pegol-mknl + Decitabine + Venetoclax |
Primary outcome
Safety and adverse events (AEs)
Time frame: Through study completion; an average of 1 year
Incidence of Adverse Events, Graded According to National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) Version (v) 5.0
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 18 Sep 2026.
- MD Anderson Cancer Center WebsiteLink provided by the sponsor.
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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.
David McCall, MD principal investigator
M.D. Anderson Cancer Center
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 Decitabine, Venetoclax and Calaspargase pegol-mknl in people with T-cell Acute Lymphoblastic Leukemia and T-Cell Lymphoblastic Lymphoma, run by M.D. Anderson Cancer Center 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 19 inclusion and 22 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 18 Sep 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 David McCall, MD ((713) 792-6604, dmccall1@mdanderson.org), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Safety and adverse events (AEs) (time frame: Through study completion; an average of 1 year). 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 18 Sep 2026.