Acute Lymphoblastic LeukemiaEarly Phase 1NCT05386576
A Study of Venetoclax in Combination With Chemotherapy to Treat Newly Diagnosed Acute Lymphoblastic Leukemia (ALL)
A Early Phase 1 study testing Venetoclax in people with Acute Lymphoblastic Leukemia, run by Memorial Sloan Kettering Cancer Center at 1 site in United States.
Trial summary
The researchers are doing this study to find out whether combining venetoclax with several different standard chemotherapy drugs used to treat acute lymphoblastic leukemia (ALL) in children is safe and effective in adults with newly diagnosed ALL. Read more about this study
- Who is it for?
- Ages 18 to 60 years
- Conditions the study is for
- Acute Lymphoblastic Leukemia
- What is being tested?
- Venetoclax
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 12 participants
- Where
- 1 siteUnited States
- Study dates
- 16 Jun 2022to May 2027
- Phase
- Early Phase 1
- 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 60 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- Adult patients with newly diagnosed Philadelphia chromosome (Ph) negative ALL.
- Patients with T- or B-cell lymphoblastic lymphoma with no bone marrow involvement will also be eligible for the study.
- Age 18-60
- ECOG performance status of 0-2
- Adequate renal function as demonstrated by a calculated creatinine clearance of ≥ 60 ml/min.
- Adequate hepatic function as demonstrated by a total bilirubin ≤ 2.0 mg/dl (unless attributable to Gilbert's disease) and an alkaline phosphatase, AST, and ALT ≤ 4 times the upper limit of normal (unless clinically considered to be related to liver involvement with leukemia)
- Patients with central nervous system (CNS) involvement by ALL are eligible and may receive concomitant treatment with radiation therapy and/or intrathecal chemotherapy in accordance with standard medical practice. For patients with CNS disease, dexamethasone may be temporarily administered instead of prednisone to reduce CNS pressure, at the discretion of the treating physician and after discussion with the MSK PI. Once dexamethasone is no longer needed, prednisone should be given as per protocol for 28 days.
- Negative serum pregnancy test in women of childbearing potential
Who cannot join
- CML in lymphoid blast crisis, mature B-cell (i.e. Burkitt's) lymphoma or mixed phenotype acute leukemia (MPAL)
- Prior treatments for ALL, except any doses of corticosteroids and hydroxyurea or one dose of vincristine
- Patients who received strong and/or moderate CYP3A inducers within 7 days prior to the initiation of study treatment
- Unstable angina and/or MI or stroke within 6 months prior to screening, and/or impaired cardiac function with EF <40% or NYHA class III/IV
- Pregnant or lactating women. Women and men of childbearing age should use effective contraception while on this study and continue for 1 year after all treatment is finished.
- Patients with HIV or active hepatitis B or hepatitis C infection are ineligible.
- Patients with concurrent active malignancies as defined by malignancies requiring any therapy other than expectant observation or hormonal therapy, with the exception of squamous and basal cell carcinoma of the skin, in situ cervical cancer, adequately treated stage I/II cancer from which the patient is current in complete remission, or any other cancer from which the patient has been disease free for five years.
Trial locations and contacts
1 site in 1 country.
United States1 site
Memorial Sloan Kettering Cancer Center
New York, New York, 10065
About this study
Official title: Venetoclax in Combination With Asparaginase-Containing Pediatric-Inspired Chemotherapy in Adult Patients With Newly Diagnosed Acute Lymphoblastic Leukemia
The researchers are doing this study to find out whether combining venetoclax with several different standard chemotherapy drugs used to treat acute lymphoblastic leukemia (ALL) in children is safe and effective in adults with newly diagnosed ALL. Participants in this study will be under the age of 60, and they will have T- or B-cell ALL.
Read the detailed description
All patients will complete Induction I and II of the treatment regimens, consisting of several chemotherapy agents including Peg-ASP.
- For Dose Level 1: Venetoclax will be administered at a dose of 100mg on day 5, 200mg on day 6 and 400mg on days 7-28 during Induction I. During Induction II, venetoclax will be administered at 400mg daily from days 1-14 and 29-42.
- For Dose Level -1: Venetoclax will be administered at a dose of 100mg on day 5 and 200mg on days 6-28 during Induction I. During Induction II, venetoclax will be administered at 200mg daily from days 1-14 and 29-42.
- Bone marrow aspirate and biopsy will be performed at day 14 of Induction I, after Induction I and Induction II for disease assessment.
For those who remain on study after Induction II, they will proceed to consolidation therapy. Consolidation blocks contain 2 Intensification blocks (22 days each) and 2 Re-Induction blocks (43 days each), consisting of several chemotherapy agents including Peg-ASP.
- Venetoclax will be administered at a dose of 400mg daily (Dose Level 1) or 200mg daily (Dose Level -1) from days 1-22 during Intensification blocks, and from days 1-14 and 29-42 during Re-Induction blocks.
- Bone marrow aspirate and biopsy will be performed after Re-Induction I and Re-Induction II for disease assessment.
- Patients who relapse either with MRD or morphologically will be removed from study to pursue alternative therapy.
- Patients who remain in MRD negative CR will remain on study and proceed to Maintenance.
- Maintenance block contains 4-drug regimen (vincristine, oral methotrexate, oral mercaptopurine, and prednisone) for 2 years. No venetoclax will be administered during this block. Bone marrow aspirate and biopsy will be performed every 3 months during the Maintenance block. Patients who remain in MRD negative CR will remain on study to complete the study treatment. Patients who relapse either with MRD or morphologically will be removed from study to pursue alternative therapy.
- Conditions
- Acute Lymphoblastic Leukemia
- Being tested
- Venetoclax
- Keywords
- Venetoclax, 21-372
- Medical subject headings
- Precursor Cell Lymphoblastic Leukemia-Lymphoma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
VenetoclaxDrug
During Induction I, for patients on Dose Level 1, venetoclax will be administered at a dose of 100mg on day 5, 200mg on day 6 and 400mg on days 7-28. For patients on Dose Level 01, venetoclax will be administered at a dose of 100mg on day 5 and 200mg on days 6-28.
During Induction II, venetoclax will be administered at either 400mg daily (Dose Level 1) or 200mg daily (Dose Level -1) from days 1-14 and 29-42.
| Study group | Role | What they receive |
|---|---|---|
| Venetoclax in Combination With Chemotherapy | Experimental | All patients will complete Induction I and II of the treatment regimens, consisting of several chemotherapy agents including Peg-ASP. Receives: Drug: Venetoclax |
What is being measured
The primary outcome is the main question the study is designed to answer.
proportion of patients who have a Dose Limiting Toxicities
Measured: up to 6 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 May 2022
- Study start16 Jun 2022
- Primary completionMay 2027 (estimated)
- Study completionMay 2027 (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 Memorial Sloan Kettering 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
- Early Phase 1
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- This is a phase I single-arm, single-center study.
- Masking
- None (open label)
- Enrolment
- 12 participants (actual)
Sponsor and investigators
- Lead sponsor
- Memorial Sloan Kettering Cancer Center
- Sponsor type
- University, hospital or other
- Collaborators
- Genentech, Inc.
- Responsible party
- Sponsor
- Investigators
- Jae Park, MD, Principal investigator, Memorial Sloan Kettering Cancer Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05386576
- Sponsor's protocol ID
- 21-372
- Status last verified
- Jun 2026
- First submitted
- 18 May 2022
- Last updated
- 16 Jun 2026
- Results posted
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- Yes: Memorial Sloan Kettering Cancer Center supports the international committee of medical journal editors (ICMJE) and the ethical obligation of responsible sharing of data from clinical trials. The protocol summary, a statistical summary, and informed consent form will be made available on clinicaltrials.gov when required as a condition of Federal awards, other agreements supporting the research and/or as otherwise required. Requests for deidentified individual participant data can be made beginning 12 months after publication and for up to 36 months post publication. Deidentified individual participant data reported in the manuscript will be shared under the terms of a Data Use Agreement and may only be used for approved proposals. Requests may be made to: crdatashare@mskcc.org.
Study at a glance
From the registry record, last updated by the sponsor on 16 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Venetoclax in Combination With Asparaginase-Containing Pediatric-Inspired Chemotherapy in Adult Patients With Newly Diagnosed Acute Lymphoblastic Leukemia
- ClinicalTrials.gov ID
- NCT05386576
- Acronym / sponsor ID
- 21-372
- Conditions
- Acute Lymphoblastic Leukemia
- Keywords
- Venetoclax, 21-372
- Phase
- Early Phase 1
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 12 participants (actual)
- Lead sponsor
- Memorial Sloan Kettering Cancer CenterUniversity, hospital or other
- Collaborators
- Genentech, Inc.
- Study start
- 16 Jun 2022 (actual)
- Primary completion
- May 2027 (estimated)
- Study completion
- May 2027 (estimated)
- First posted
- 23 May 2022 (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 researchers are doing this study to find out whether combining venetoclax with several different standard chemotherapy drugs used to treat acute lymphoblastic leukemia (ALL) in children is safe and effective in adults with newly diagnosed ALL. Participants in this study will be under the age of 60, and they will have T- or B-cell ALL.
Detailed description
All patients will complete Induction I and II of the treatment regimens, consisting of several chemotherapy agents including Peg-ASP.
- For Dose Level 1: Venetoclax will be administered at a dose of 100mg on day 5, 200mg on day 6 and 400mg on days 7-28 during Induction I. During Induction II, venetoclax will be administered at 400mg daily from days 1-14 and 29-42.
- For Dose Level -1: Venetoclax will be administered at a dose of 100mg on day 5 and 200mg on days 6-28 during Induction I. During Induction II, venetoclax will be administered at 200mg daily from days 1-14 and 29-42.
- Bone marrow aspirate and biopsy will be performed at day 14 of Induction I, after Induction I and Induction II for disease assessment.
For those who remain on study after Induction II, they will proceed to consolidation therapy. Consolidation blocks contain 2 Intensification blocks (22 days each) and 2 Re-Induction blocks (43 days each), consisting of several chemotherapy agents including Peg-ASP.
- Venetoclax will be administered at a dose of 400mg daily (Dose Level 1) or 200mg daily (Dose Level -1) from days 1-22 during Intensification blocks, and from days 1-14 and 29-42 during Re-Induction blocks.
- Bone marrow aspirate and biopsy will be performed after Re-Induction I and Re-Induction II for disease assessment.
- Patients who relapse either with MRD or morphologically will be removed from study to pursue alternative therapy.
- Patients who remain in MRD negative CR will remain on study and proceed to Maintenance.
- Maintenance block contains 4-drug regimen (vincristine, oral methotrexate, oral mercaptopurine, and prednisone) for 2 years. No venetoclax will be administered during this block. Bone marrow aspirate and biopsy will be performed every 3 months during the Maintenance block. Patients who remain in MRD negative CR will remain on study to complete the study treatment. Patients who relapse either with MRD or morphologically will be removed from study to pursue alternative therapy.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- This is a phase I single-arm, single-center study.
| Arm | Type | Receives |
|---|---|---|
| Venetoclax in Combination With Chemotherapy | Experimental | Drug: VenetoclaxAll patients will complete Induction I and II of the treatment regimens, consisting of several chemotherapy agents including Peg-ASP. |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (8 listed)
- Adult patients with newly diagnosed Philadelphia chromosome (Ph) negative ALL.
- Patients with T- or B-cell lymphoblastic lymphoma with no bone marrow involvement will also be eligible for the study.
- Age 18-60
- ECOG performance status of 0-2
- Adequate renal function as demonstrated by a calculated creatinine clearance of ≥ 60 ml/min.
Key exclusion criteria (7 listed)
- CML in lymphoid blast crisis, mature B-cell (i.e. Burkitt's) lymphoma or mixed phenotype acute leukemia (MPAL)
- Prior treatments for ALL, except any doses of corticosteroids and hydroxyurea or one dose of vincristine
- Patients who received strong and/or moderate CYP3A inducers within 7 days prior to the initiation of study treatment
- Unstable angina and/or MI or stroke within 6 months prior to screening, and/or impaired cardiac function with EF <40% or NYHA class III/IV
- Pregnant or lactating women. Women and men of childbearing age should use effective contraception while on this study and continue for 1 year after all treatment is finished.
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 |
|---|---|---|
| VenetoclaxDuring Induction I, for patients on Dose Level 1, venetoclax will be administered at a dose of 100mg on day 5, 200mg on day 6 and 400mg on days 7-28. For patients on Dose Level 01, venetoclax will be administered at a dose of 100mg on day 5 and 200mg on days 6-28. During Induction II, venetoclax will be administered at either 400mg daily (Dose Level 1) or 200mg daily (Dose Level -1) from days 1-14 and 29-42. | Drug | Venetoclax in Combination With Chemotherapy |
Primary outcome
proportion of patients who have a Dose Limiting Toxicities
Time frame: up to 6 weeks
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 16 Jun 2026.
- Memorial Sloan Kettering Cancer CenterLink provided by the sponsor.
- Individual participant dataSharing planned: Yes. Memorial Sloan Kettering Cancer Center supports the international committee of medical journal editors (ICMJE) and the ethical obligation of responsible sharing of data from clinical trials. The protocol summary, a statistical summary, and informed consent form will be made available on clinicaltrials.gov when required as a condition of Federal awards, other agreements supporting the research and/or as otherwise required. Requests for deidentified individual participant data can be made beginning 12 months after publication and for up to 36 months post publication. Deidentified individual participant data reported in the manuscript will be shared under the terms of a Data Use Agreement and may only be used for approved proposals. Requests may be made to: crdatashare@mskcc.org.
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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. This study is not recruiting at the moment.
Jae Park, MD principal investigator
Memorial Sloan Kettering Cancer Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Early Phase 1 study testing Venetoclax in people with Acute Lymphoblastic Leukemia, run by Memorial Sloan Kettering 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 8 inclusion and 7 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: under way, not looking for participants, as of the sponsor's last update on 16 Jun 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?
Early Phase 1 (sometimes called Phase 0) studies give a very small amount of a treatment to a few people, mainly to see how the body handles it.
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?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
proportion of patients who have a Dose Limiting Toxicities (time frame: up to 6 weeks). 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 16 Jun 2026.