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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 belowSelect...
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:Select...
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 weeks3 visits
Treatment ~ Varies
Follow Up ~ up to 5 years
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to 5 years
Treatment Details
Side effects data
From 2017 Phase 2 trial • 171 Patients • NCT0193533667%
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
~2240
Find a Location
Who is running the clinical trial?
M.D. Anderson Cancer CenterLead Sponsor
3,070 Previous Clinical Trials
1,802,801 Total Patients Enrolled
Jain Nitin, MDPrincipal InvestigatorM.D. Anderson Cancer Center
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I don't have any severe health or mental conditions that could affect the study.My T-cell acute lymphoblastic leukemia has not responded to previous treatments.I do not have severe heart disease.I do not have uncontrolled heart or blood vessel problems.I am taking medications or supplements that interact with certain drugs.I have a history of hepatitis B or C, or I am HIV positive.I have had another type of invasive cancer in the last 2 years.I cannot take medications by mouth due to absorption issues.I am 18 years old or older.I can walk and take care of myself, but I can't do heavy physical work.I agree to use contraception if my partner can become pregnant.I do not have any uncontrolled infections.I haven't had chemotherapy, radiotherapy, or experimental treatments in the last 14 days.I have not had major surgery or radiation therapy in the last 4 weeks.My liver and kidneys are working well.I have symptoms or untreated spinal cord or brain lining issues.
Research Study Groups:
This trial has the following groups:- Group 1: Mini-hyper-CVD
- Group 2: Ponatinib
- Group 3: Venetoclax
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.