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NCT06561074 · ClinicalTrials.gov registry record · Phase 2
A Phase 2 Study to Evaluate Efficacy of Calaspargase Pegol-mknl and Decitabine Combined With Venetoclax in Pediatric, Adolescent, and Young Adult Patients With Relapsed/Refractory T-cell Acute Lymphoblastic Leukemia (T-ALL) and T- Cell Lymphoblastic Lymphoma (T-LLy)
A Phase 2 study of T-cell Acute Lymphoblastic Leukemia and T-Cell Lymphoblastic Lymphoma, sponsored by M.D. Anderson Cancer Center.
- Recruiting
- Registry status
- Phase 2
- Development phase
- 22
- Enrollment target
- 1
- Study location
NCT06561074: Recruiting Phase 2 study of T-cell Acute Lymphoblastic Leukemia and T-Cell Lymphoblastic Lymphoma, sponsored by M.D. Anderson Cancer Center.
NCT06561074 is a Phase 2 study of T-cell Acute Lymphoblastic Leukemia and T-Cell Lymphoblastic Lymphoma that is actively recruiting participants, run by M.D. Anderson Cancer Center. The registered enrollment target is 22 participants, below the 59-participant average among 6 other T-cell Acute Lymphoblastic Leukemia trials with a reported enrollment target (63% lower). The trial reports 1 study location across 1 state. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT06561074, a Phase 2 study of T-cell Acute Lymphoblastic Leukemia and T-Cell Lymphoblastic Lymphoma, is actively recruiting participants, sponsored by M.D. Anderson Cancer Center.
- RECRUITING
- Registry status
- Phase 2
- Development phase
- 22 participants
- Enrollment target
- 1
- Study location
Study 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.
Primary Outcome
Incidence of Adverse Events, Graded According to National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) Version (v) 5.0
Conditions Studied
Interventions
- DRUG Venetoclax
- DRUG Decitabine
- DRUG Calaspargase pegol-mknl
Study Locations (1)
Texas
- MD Anderson Cancer Center - Houston
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 22 participants |
| Start Date | 2025-09-25 |
| Est. Completion | 2031-12-31 |
| Phase | Phase 2 |
What NCT06561074 shows while recruiting
NCT06561074 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 22 participants, a relatively small participant target, below the 59-participant average among 6 other T-cell Acute Lymphoblastic Leukemia trials with a reported enrollment target (63% lower).
The record links to 2 conditions, with T-cell Acute Lymphoblastic Leukemia appearing as the primary indexed condition, and to 3 interventions - of which Venetoclax is the first listed.
NCT06561074 reports a single indexed study location in Texas.
Frequently Asked Questions
What is clinical trial NCT06561074 about?
NCT06561074 is a clinical study titled "A Phase 2 Study to Evaluate Efficacy of Calaspargase Pegol-mknl and Decitabine Combined With Venetoclax in Pediatric, Adolescent, and Young Adult Patients With Relapsed/Refractory T-cell Acute Lymphoblastic Leukemia (T-ALL) and T- Cell Lymphoblastic Lymphoma (T-LLy)". 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.
What is the current status of trial NCT06561074?
This trial is currently recruiting. It is a Phase 2 study. The enrollment target is 22 participants. The study started on 2025-09-25. Estimated completion is 2031-12-31.
What conditions does trial NCT06561074 study?
This clinical trial studies the following conditions: T-cell Acute Lymphoblastic Leukemia, T-Cell Lymphoblastic Lymphoma.
What interventions are being tested in trial NCT06561074?
The interventions under investigation include: Venetoclax (DRUG), Decitabine (DRUG), Calaspargase pegol-mknl (DRUG).
Who is sponsoring clinical trial NCT06561074?
This trial is sponsored by M.D. Anderson Cancer Center, which has 2,692 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT06561074 being conducted?
This trial has 1 study location across Texas. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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