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Anti-tumor antibiotic

Treatment w/Calaspargase pegol-mknl + Decitabine + Venetoclax for T-Cell Lymphoblastic Leukemia

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
1. Pediatric, adolescent, or young adult patients who have relapse or refractory T-cell lymphoblastic leukemia (T-ALL) or T-Cell lymphoblastic lymphoma (T-LLy) according to 2017 WHO classification and NCCN v1 2021.
2. Patients have adequate performance status (ECOG ≤2) for patients≥16 years old, Lansky score \>50 for patients\<16 years old.
Timeline
Screening 3 weeks
Treatment Varies
Follow Up through study completion; an average of 1 year
Awards & highlights

Summary

To learn if giving the study drugs calaspargase pegol-mknl and decitabine in combination with venetoclax can help to control relapsed/refractory T-ALL and T-LLy. The safety of this drug combination will also be studied.

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

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)

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
~1990
Decitabine
2004
Completed Phase 3
~1680

Find a Location

Who is running the clinical trial?

M.D. Anderson Cancer CenterLead Sponsor
3,030 Previous Clinical Trials
1,797,225 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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