Acute Lymphoblastic LeukemiaPhase 2NCT05268003
A Phase II Study of the Combination of Ponatinib With Mini-hyper CVD Chemotherapy and Venetoclax in Patients With Relapsed or Refractory T-cell Acute Lymphoblastic Leukemia
A Phase 2 study testing Ponatinib, Venetoclax and Mini-hyper CVD in people with Acute Lymphoblastic Leukemia and Leukemia, run by M.D. Anderson Cancer Center at 1 site in United States.
Trial summary
The addition of ponatinib to mini-hyper-CVD chemotherapy and venetoclax will improve the complete remission rate in patients with relapsed or refractory T-cell acute lymphoblastic leukemia Read more about this study
- Who is it for?
- Ages 12 years and older
- Conditions the study is for
- Acute Lymphoblastic Leukemia, Leukemia
- What is being tested?
- Ponatinib, Venetoclax and Mini-hyper CVD
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 4 participants
- Where
- 1 siteUnited States
- Study dates
- 7 Jun 2022to 21 Apr 2026
- Phase
- Phase 2
- Are there results?
- None posted in the registry
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 12 years and older
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Participants with relapsed or refractory T-cell acute lymphoblastic leukemia defined as receiving one or more cytotoxic containing regimens and A. Bone marrow involvement with ≥ 5% lymphoblasts B. Age ≥ 12 Years and greater than 40kg
- Eastern Cooperative Oncology Group (ECOG) performance status ≤2
- Adequate organ function
- Serum total bilirubin ≤1.5 x upper limit of normal (ULN) or ≤3 x ULN for participants with Gilbert's disease
- Alanine aminotransferase (ALT) and aspartate aminotransferase (AST) ≤3.0 x ULN, unless clearly due to disease involvement
- Creatinine clearance ≥50 mL/min (calculated according to institutional standards or using Cockcroft-Gault or Modification of Diet in Renal Disease (MDRD) formula)
- Women 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 an effective contraception method during the study and for 30 days following the last dose of study drug. Women of non- childbearing potential are those who are postmenopausal greater than 1 year or who have had a bilateral tubal ligation or hysterectomy. Men who have partners of childbearing potential must agree to use an effective contraceptive method during the study and for 30 days following the last dose of study drug
- Participants must provide written informed consent
Who cannot join
- Participant is pregnant or breastfeeding
- Participants under 40kg
- Participants with uncontrolled active infection
- Hepatitis B or C infection, or known seropositivity for human immunodeficiency virus (HIV)
- Major surgery or radiation therapy within 4 weeks prior to the first study dose
- Systemic chemotherapy/radiotherapy/investigational therapy within 14 days (with the exception of hydroxyurea, dexamethasone, or one dose of cytarabine) prior to starting therapy
Show all 21Show fewer
- No clinical, radiological or laboratory evidence of pancreatitis, including:
- Serum lipase must be <2 times the ULN, and
- Serum amylase must be <2 times the ULN
- Symptomatic or untreated leptomeningeal disease or spinal cord compression. Participants with prior h/o CNS disease are eligible as long as no active CNS disease as documented by recent CSF analysis and/or imaging studies.
- Participants with active heart disease [New York Heart Association (NYHA) class 3-4 as assessed by history and physical examination, unstable angina/stroke/myocardial infarction within the last 6 months]
- Clinically significant, uncontrolled, or active cardiovascular disease, specifically including, but not restricted to:
- Myocardial infarction (MI), stroke, revascularization, unstable angina or transient ischemic attack within 6 months
- Left ventricular ejection fraction (LVEF) less than 50%
- Diagnosed or suspected congenital long QT syndrome
- Clinically significant atrial or ventricular arrhythmias (such as uncontrolled, clinically significant atrial fibrillation, ventricular tachycardia, ventricular fibrillation, or Torsades de pointes) as determined by the treating physician
- Prolonged QTc interval on pre-entry electrocardiogram (> 480 msec) unless corrected after electrolyte replacement or Currently taking drugs that are known to have a risk of causing prolonged QTc or torsades de pointes (TdP) (unless these can be changed to acceptable alternatives or discontinued)
- History of venous thromboembolism including deep venous thrombosis or pulmonary embolism within the past 3 months, excluding line-associated DVT of the upper extremity
- Uncontrolled hypertension (diastolic blood pressure >100mmHg; systolic >150mmHg).
- 10. Uncontrolled hypertriglyceridemia (triglycerides > 450mg/dL) 11. History of another primary invasive malignancy that has not been definitively treated or in remission for at least 2 years. Participants with non-melanoma skin cancers or with carcinomas in situ are eligible regardless of the time from diagnosis (including concomitant diagnoses) 12. Taking any medications or herbal supplements that are known to be strong inhibitors (such as fluconazole, ketoconazole, voriconazole, and clarithromycin) or inducers (such as rifampin, rifabutin, phenytoin, carbamazepine, and St. John's Wort) of cytochrome P450 (CYP)3A4 within at least 7 days before the first dose of ponatinib or within 3 days of starting venetoclax.
- 13. Consumed grapefruit, grapefruit products, Seville oranges, or star fruit within 3 days prior to starting venetoclax 14. Malabsorption syndrome or other conditions that preclude enteral route of administration 15. Other severe 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 participants inappropriate for enrollment into this study
Trial locations and contacts
1 site in 1 country.
About this study
The addition of ponatinib to mini-hyper-CVD chemotherapy and venetoclax will improve the complete remission rate in patients with relapsed or refractory T-cell acute lymphoblastic leukemia
Read the detailed description
OBJECTIVES
The addition of ponatinib to mini-hyper-CVD chemotherapy and venetoclax will improve the complete remission rate in patients with relapsed or refractory T-cell acute lymphoblastic leukemia.
Primary Objective:
To assess complete remission (CR) / CR with incomplete count recovery (CRi) rate with the combination of Ponatinib and mini-hyper-CVD chemotherapy and venetoclax.
Secondary Objectives:
To assess the safety of the regimen To assess rate of measurable residual disease (MRD) negative remission To assess duration of response (DOR), progression-free survival (PFS) and overall survival (OS)
Exploratory Objectives:
To assess the level of phospho-LCK in pretreatment samples and correlation with the To assess expression of BCL-2 family proteins
- Conditions
- Acute Lymphoblastic Leukemia, Leukemia
- Being tested
- Ponatinib, Venetoclax, Mini-hyper CVD
- 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.
PonatinibDrug
Given by PO
VenetoclaxDrug
Given by PO
Mini-hyper CVDDrug
Given by IV (vein)
| Study group | Role | What they receive |
|---|---|---|
| Ponatinib | Experimental | Participants will receive ponatinib (45mg daily) as a single agent for 3 days. These will be called Days -3, -2 and -1 Receives: Drug: Ponatinib |
| Venetoclax | Experimental | Patients will continue venetoclax 400mg daily on days 1-14 of each 28-day cycle. Receives: Drug: Venetoclax |
| Mini-hyper-CVD | Experimental | Chemotherapy will be administered in the inpatient setting, starting on day 1 of each of the cycles 2-8. Receives: Drug: Mini-hyper CVD |
What is being measured
The primary outcome is the main question the study is designed to answer.
To determine the complete remission (CR) / CR with incomplete count recovery (CRi) rate with the combination of Ponatinib and mini-hyper-CVD chemotherapy and venetoclax.
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 posted7 Mar 2022
- Study start7 Jun 2022
- Primary completion21 Apr 2026
- Study completion21 Apr 2026
Why it stopped: \< 75% participation
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 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
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 4 participants (actual)
Sponsor and investigators
- Lead sponsor
- M.D. Anderson Cancer Center
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Jain Nitin, MD, Principal investigator, M.D. Anderson Cancer Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05268003
- Sponsor's protocol ID
- 2021-0802
- Other IDs
- NCI-2022-01686
- Status last verified
- Apr 2026
- First submitted
- 17 Feb 2022
- Last updated
- 27 Apr 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 27 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase II Study of the Combination of Ponatinib With Mini-hyper CVD Chemotherapy and Venetoclax in Patients With Relapsed or Refractory T-cell Acute Lymphoblastic Leukemia
- ClinicalTrials.gov ID
- NCT05268003
- Acronym / sponsor ID
- 2021-0802
- Conditions
- Acute Lymphoblastic Leukemia, Leukemia
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: \< 75% participation
- Enrolment
- 4 participants (actual)
- Lead sponsor
- M.D. Anderson Cancer CenterUniversity, hospital or other
- Study start
- 7 Jun 2022 (actual)
- Primary completion
- 21 Apr 2026 (actual)
- Study completion
- 21 Apr 2026 (actual)
- First posted
- 7 Mar 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 addition of ponatinib to mini-hyper-CVD chemotherapy and venetoclax will improve the complete remission rate in patients with relapsed or refractory T-cell acute lymphoblastic leukemia
Detailed description
OBJECTIVES
The addition of ponatinib to mini-hyper-CVD chemotherapy and venetoclax will improve the complete remission rate in patients with relapsed or refractory T-cell acute lymphoblastic leukemia.
Primary Objective:
To assess complete remission (CR) / CR with incomplete count recovery (CRi) rate with the combination of Ponatinib and mini-hyper-CVD chemotherapy and venetoclax.
Secondary Objectives:
To assess the safety of the regimen To assess rate of measurable residual disease (MRD) negative remission To assess duration of response (DOR), progression-free survival (PFS) and overall survival (OS)
Exploratory Objectives:
To assess the level of phospho-LCK in pretreatment samples and correlation with the To assess expression of BCL-2 family proteins
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Ponatinib | Experimental | Drug: PonatinibParticipants will receive ponatinib (45mg daily) as a single agent for 3 days. These will be called Days -3, -2 and -1 |
| Venetoclax | Experimental | Drug: VenetoclaxPatients will continue venetoclax 400mg daily on days 1-14 of each 28-day cycle. |
| Mini-hyper-CVD | Experimental | Drug: Mini-hyper CVDChemotherapy will be administered in the inpatient setting, starting on day 1 of each of the cycles 2-8. |
Who may qualify
- Ages
- 12 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (8 listed)
- Participants with relapsed or refractory T-cell acute lymphoblastic leukemia defined as receiving one or more cytotoxic containing regimens and A. Bone marrow involvement with ≥ 5% lymphoblasts B. Age ≥ 12 Years and greater than 40kg
- Eastern Cooperative Oncology Group (ECOG) performance status ≤2
- Adequate organ function
- Women 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 an effective contraception method during the study and for 30 days following the last dose of study drug. Women of non- childbearing potential are those who are postmenopausal greater than 1 year or who have had a bilateral tubal ligation or hysterectomy. Men who have partners of childbearing potential must agree to use an effective contraceptive method during the study and for 30 days following the last dose of study drug
- Participants must provide written informed consent
Key exclusion criteria (21 listed)
- Participant is pregnant or breastfeeding
- Participants under 40kg
- Participants with uncontrolled active infection
- Hepatitis B or C infection, or known seropositivity for human immunodeficiency virus (HIV)
- Major surgery or radiation therapy within 4 weeks prior to the first study dose
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 |
|---|---|---|
| PonatinibGiven by PO | Drug | Ponatinib |
| VenetoclaxGiven by PO | Drug | Venetoclax |
| Mini-hyper CVDGiven by IV (vein) | Drug | Mini-hyper-CVD |
Primary outcome
To determine the complete remission (CR) / CR with incomplete count recovery (CRi) rate with the combination of Ponatinib and mini-hyper-CVD chemotherapy and venetoclax.
Time frame: through study completion, an average of 1 year
Results and safety
The study was stopped early (reason given: \< 75% participation). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Apr 2026.
- M D Anderson Cancer CenterLink 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. This study is not recruiting at the moment.
Jain Nitin, 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 Ponatinib, Venetoclax and Mini-hyper CVD in people with Acute Lymphoblastic Leukemia and Leukemia, 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 8 inclusion and 21 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: stopped early, as of the sponsor's last update on 27 Apr 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?
The study was stopped early (reason given: \< 75% participation). Results are not available in the source record.
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?
To determine the complete remission (CR) / CR with incomplete count recovery (CRi) rate with the combination of Ponatinib and mini-hyper-CVD chemotherapy and venetoclax. (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 27 Apr 2026.