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Chemotherapy Agent
Combination Chemotherapy for Acute Lymphoblastic Leukemia
Phase 2
Recruiting
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
Timeline
Screening 3 weeks
Treatment Varies
Follow Up through study completion, an average of 1 year
Awards & highlights
Study 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.Check my eligibility
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.See study design
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.
Select...
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.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ through study completion, an average of 1 year
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~through study completion, an average of 1 year
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
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.
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-
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
~820
Venetoclax
2019
Completed Phase 3
~1990
Find a Location
Who is running the clinical trial?
M.D. Anderson Cancer CenterLead Sponsor
2,972 Previous Clinical Trials
1,787,291 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.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
How many participants are currently enrolled in this clinical experiment?
"Affirmative. Clinicaltrials.gov reveals that the medical trial, originally posted on June 7th 2022 and recently amended on August 23rd 2022 is currently seeking participants. 20 prospective volunteers are necessary across one hospital facility."
Answered by AI
Are there any opportunities for enrolment in this research project?
"Correct. Clinicaltrials.gov data confirms that this clinical study, which was initially posted on 6/7/2022, is currently recruiting patients. About 20 participants must be sourced from 1 medical centre."
Answered by AI
Has the US Food and Drug Administration approved Ponatinib for patient use?
"Ponatinib's safety is thought to be a 2 on our team at Power's scale, since this Phase 2 trial has not yet provided evidence of its efficacy but there exists some data that suggests it may be safe."
Answered by AI
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