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Chemotherapy Agent

Combination Chemotherapy for Acute Lymphoblastic Leukemia

Phase 2
Waitlist Available
Led By Jain Nitin, MD
Research Sponsored by M.D. Anderson Cancer Center
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Patients aged 18 years or older
Eastern Cooperative Oncology Group (ECOG) performance status of 2 or lower
Must not have
Patients with active heart disease (New York Heart Association class 3-4)
Clinically significant, uncontrolled, or active cardiovascular disease including specific conditions related to myocardial infarction, stroke, left ventricular ejection fraction, long QT syndrome, arrhythmias, venous thromboembolism, hypertension, and hypertriglyceridemia
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to 5 years
Awards & highlights
No Placebo-Only Group

Summary

This trial suggests that adding ponatinib to mini-hyper-CVD chemotherapy and venetoclax may improve remission rates in patients with relapsed or refractory T-cell acute lymphoblastic leukemia.

Who is the study for?
Adults with relapsed or refractory T-cell acute lymphoblastic leukemia who've had previous treatments, have a certain level of bone marrow involvement, and are in decent physical condition (ECOG ≤2). They must have proper liver and kidney function, not be pregnant or breastfeeding, agree to use contraception, and can't join if they have uncontrolled infections, recent heart issues, or other serious health problems.
What is being tested?
The trial is testing whether adding the drug Ponatinib to a combination of mini-hyper CVD chemotherapy and Venetoclax improves remission rates in patients with tough-to-treat T-cell acute lymphoblastic leukemia.
What are the potential side effects?
Possible side effects include liver problems (elevated bilirubin), pancreatitis risk (indicated by lipase/amylase levels), heart complications like arrhythmias or low ejection fraction. Patients should also avoid certain drugs that affect liver enzymes.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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I am 18 years old or older.
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I can walk and take care of myself, but I can't do heavy physical work.
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My liver and kidneys are working well.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:
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I do not have severe heart disease.
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I do not have uncontrolled heart or blood vessel problems.
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I am taking medications or supplements that interact with certain drugs.
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I have a history of hepatitis B or C, or I am HIV positive.
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I have had another type of invasive cancer in the last 2 years.
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I cannot take medications by mouth due to absorption issues.
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I do not have any uncontrolled infections.
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I have not had major surgery or radiation therapy in the last 4 weeks.
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I have symptoms or untreated spinal cord or brain lining issues.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to 5 years
This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 5 years for reporting.

Treatment Details

Side effects data

From 2017 Phase 2 trial • 171 Patients • NCT01935336
67%
Grade 2 hypertension
67%
Grade 3 AE
100%
80%
60%
40%
20%
0%
Study treatment Arm
Ponatinib SISH-/ISH+
Ponatinib SISH-/ISH-
Ponatinib SISH+/ISH+
Ponatinib SISH+/ISH-

Awards & Highlights

No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.

Trial Design

3Treatment groups
Experimental Treatment
Group I: VenetoclaxExperimental Treatment1 Intervention
Patients will continue venetoclax 400mg daily on days 1-14 of each 28-day cycle.
Group II: PonatinibExperimental Treatment1 Intervention
Participants will receive ponatinib (45mg daily) as a single agent for 3 days. These will be called Days -3, -2 and -1
Group III: Mini-hyper-CVDExperimental Treatment1 Intervention
Chemotherapy will be administered in the inpatient setting, starting on day 1 of each of the cycles 2-8.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Ponatinib
2015
Completed Phase 2
~830
Venetoclax
2019
Completed Phase 3
~2200

Find a Location

Who is running the clinical trial?

M.D. Anderson Cancer CenterLead Sponsor
3,059 Previous Clinical Trials
1,800,642 Total Patients Enrolled
Jain Nitin, MDPrincipal InvestigatorM.D. Anderson Cancer Center

Media Library

Mini-hyper CVD (Chemotherapy Agent) Clinical Trial Eligibility Overview. Trial Name: NCT05268003 — Phase 2
Acute Lymphoblastic Leukemia Research Study Groups: Mini-hyper-CVD, Ponatinib, Venetoclax
Acute Lymphoblastic Leukemia Clinical Trial 2023: Mini-hyper CVD Highlights & Side Effects. Trial Name: NCT05268003 — Phase 2
Mini-hyper CVD (Chemotherapy Agent) 2023 Treatment Timeline for Medical Study. Trial Name: NCT05268003 — Phase 2
~11 spots leftby Oct 2026
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