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Anti-tumor antibiotic

Drug Combination for T-Cell Leukemia-Lymphoma

Phase 2
Waitlist Available
Led By David McCall, 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
Females of childbearing potential must have a negative pregnancy test and agree to use effective contraception methods
Males need to inform the doctor if the partner becomes pregnant and should not donate sperm for reproduction purposes
Must not have
Liver cirrhosis, severe liver disease, or suspected active alcohol abuse
Presence of clinically significant uncontrolled CNS pathology
Timeline
Screening 3 weeks
Treatment Varies
Follow Up through study completion; an average of 1 year
Awards & highlights
No Placebo-Only Group

Summary

This trial will test if a combination of drugs can help treat relapsed/refractory T-cell acute lymphoblastic leukemia and T-cell lymphoblastic lymphoma. The study will also look at the

Who is the study for?
This trial is for young patients with T-cell acute lymphoblastic leukemia or lymphoma who have not responded to previous treatments. Participants should be in a specific age range, typically pediatric to young adult.
What is being tested?
The study tests if calaspargase pegol-mknl and decitabine combined with venetoclax can control relapsed/refractory T-ALL and T-LLy. It's a phase 2 trial, which means it focuses on the efficacy of the treatment and monitors safety.
What are the potential side effects?
Potential side effects may include nausea, fatigue, bleeding problems due to low platelet counts, liver issues from drug metabolism changes, infections because of weakened immune systems, and possible allergic reactions.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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I am not pregnant and agree to use birth control.
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I will inform my doctor if my partner becomes pregnant and will not donate sperm.
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I am a young patient with a specific type of leukemia or lymphoma that has not responded to treatment.
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I am over 16 and can care for myself, or if under 16, I can do most activities.
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I am between 1 month and 21 years old.
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I have brain involvement but no symptoms.
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I can swallow pills or use dissolvable tablets.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:
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I have severe liver disease, cirrhosis, or I actively abuse alcohol.
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I have a serious brain condition that is not under control.
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I have not had major surgery or a serious injury in the last 2 weeks.
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I have a history of heart disease.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~through study completion; an average of 1 year
This trial's timeline: 3 weeks for screening, Varies for treatment, and through study completion; an average of 1 year for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Safety and adverse events (AEs)

Awards & Highlights

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

Trial Design

1Treatment groups
Experimental Treatment
Group I: Treatment w/Calaspargase pegol-mknl + Decitabine + VenetoclaxExperimental Treatment3 Interventions
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Venetoclax
2019
Completed Phase 3
~2200
Decitabine
2004
Completed Phase 3
~1680

Find a Location

Who is running the clinical trial?

M.D. Anderson Cancer CenterLead Sponsor
3,066 Previous Clinical Trials
1,802,223 Total Patients Enrolled
David McCall, MDPrincipal InvestigatorM.D. Anderson Cancer Center
4 Previous Clinical Trials
95 Total Patients Enrolled
~15 spots leftby Dec 2029
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