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NCT03504644 · ClinicalTrials.gov registry record · Phase 1
Venetoclax and Vincristine in Treating Patients With Relapsed or Refractory T-cell or B-cell Acute Lymphoblastic Leukemia
A Phase 1 study of Recurrent B Acute Lymphoblastic Leukemia and Refractory B Acute Lymphoblastic Leukemia, sponsored by ECOG-ACRIN Cancer Research Group.
- Active
- Registry status
- Phase 1
- Development phase
- 40
- Enrollment target
- 20
- Study locations
NCT03504644: Active Phase 1 study of Recurrent B Acute Lymphoblastic Leukemia and Refractory B Acute Lymphoblastic Leukemia, sponsored by ECOG-ACRIN Cancer Research Group.
NCT03504644 is a Phase 1 study of Recurrent B Acute Lymphoblastic Leukemia and Refractory B Acute Lymphoblastic Leukemia that is active but no longer recruiting, run by ECOG-ACRIN Cancer Research Group. The registered enrollment target is 40 participants, below the 148-participant average among 12 other Recurrent B Acute Lymphoblastic Leukemia trials with a reported enrollment target (73% lower). The trial reports 20 study locations across 7 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT03504644, a Phase 1 study of Recurrent B Acute Lymphoblastic Leukemia and Refractory B Acute Lymphoblastic Leukemia, is active but no longer recruiting, sponsored by ECOG-ACRIN Cancer Research Group.
- ACTIVE NOT RECRUITING
- Registry status
- Phase 1
- Development phase
- 40 participants
- Enrollment target
- 20
- Study locations
Study Summary
This phase Ib/II trial studies the side effects and best dose of venetoclax and how well it works when given together with vincristine in treating patients with T-cell or B-cell acute lymphoblastic leukemia that has come back (recurrent) or does not respond to treatment (refractory). Venetoclax may stop the growth of cancer cells by blocking Bcl-2, a protein needed for cancer cell survival. Chemotherapy drugs, such as vincristine, work in different ways to stop the growth of cancer cells, either by killing the cells, by stopping them from dividing, or by stopping them from spreading. Giving venetoclax together with vincristine may work better in treating patients with acute lymphoblastic leukemia compared to vincristine alone.
Primary Outcome
A dose limiting toxicity (DLT) was defined by the occurrence of any protocol-listed toxicities (CTCAE version 5.0 criteria) possibly, probably, or definitely related to study medication or combination within the first cycle (i.e., ≤ 42 days of first dose of study drug). The phase I portion of this study will use a standard 3+3 design. Escalation would continue until \> 33% of a particular dose arm experiences a DLT. The next lower dose arm would be considered the MTD. If \< two (2) patients expe
Conditions Studied
Interventions
- DRUG Venetoclax
- PROCEDURE Biospecimen Collection
- PROCEDURE Computed Tomography
- PROCEDURE Lumbar Puncture
- PROCEDURE Positron Emission Tomography
Study Locations (20)
Alaska
- Anchorage Associates in Radiation Medicine - Anchorage
- Anchorage Radiation Therapy Center - Anchorage
- Alaska Breast Care and Surgery LLC - Anchorage
- Alaska Oncology and Hematology LLC - Anchorage
- Alaska Women's Cancer Care - Anchorage
- Anchorage Oncology Centre - Anchorage
- Katmai Oncology Group - Anchorage
- Providence Alaska Medical Center - Anchorage
Connecticut
- Smilow Cancer Hospital Care Center at Saint Francis - Hartford
- Smilow Cancer Center/Yale-New Haven Hospital - New Haven
- Yale University - New Haven
Arizona
- Mayo Clinic Hospital in Arizona - Phoenix
- Mayo Clinic in Arizona - Scottsdale
Arkansas
- Mercy Hospital Fort Smith - Fort Smith
- CARTI Cancer Center - Little Rock
Florida
- University of Florida Health Science Center - Jacksonville - Jacksonville
- Mayo Clinic in Florida - Jacksonville
Idaho
- Saint Luke's Cancer Institute - Boise - Boise
- Saint Luke's Cancer Institute - Fruitland - Fruitland
California
- Providence Saint Joseph Medical Center/Disney Family Cancer Center - Burbank
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 40 participants |
| Start Date | 2018-08-13 |
| Est. Completion | 2028-12-31 |
| Phase | Phase 1 |
What the registry record for NCT03504644 still lists
NCT03504644 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 40 participants, a relatively small participant target, below the 148-participant average among 12 other Recurrent B Acute Lymphoblastic Leukemia trials with a reported enrollment target (73% lower).
The record links to 9 conditions, with Recurrent B Acute Lymphoblastic Leukemia appearing as the primary indexed condition, and to 5 interventions - of which Venetoclax is the first listed.
NCT03504644 names 20 study sites across 7 states, led by Alaska, Connecticut, Arizona.
Frequently Asked Questions
What is clinical trial NCT03504644 about?
NCT03504644 is a clinical study titled "Venetoclax and Vincristine in Treating Patients With Relapsed or Refractory T-cell or B-cell Acute Lymphoblastic Leukemia". This phase Ib/II trial studies the side effects and best dose of venetoclax and how well it works when given together with vincristine in treating patients with T-cell or B-cell acute lymphoblastic leukemia that has come back (recurrent) or does not respond to treatment (refractory). Venetoclax may ...
What is the current status of trial NCT03504644?
This trial is currently active not recruiting. It is a Phase 1 study. The enrollment target is 40 participants. The study started on 2018-08-13. Estimated completion is 2028-12-31.
What conditions does trial NCT03504644 study?
This clinical trial studies the following conditions: Recurrent B Acute Lymphoblastic Leukemia, Refractory B Acute Lymphoblastic Leukemia, Recurrent Adult Lymphoblastic Lymphoma, Recurrent T Acute Lymphoblastic Leukemia, Refractory T Acute Lymphoblastic Leukemia.
What interventions are being tested in trial NCT03504644?
The interventions under investigation include: Venetoclax (DRUG), Biospecimen Collection (PROCEDURE), Computed Tomography (PROCEDURE), Lumbar Puncture (PROCEDURE), Positron Emission Tomography (PROCEDURE).
Who is sponsoring clinical trial NCT03504644?
This trial is sponsored by ECOG-ACRIN Cancer Research Group, which has 75 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT03504644 being conducted?
This trial has 20 study locations across Alaska, Arizona, Arkansas, California, Connecticut. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
Similar trials for Recurrent B Acute Lymphoblastic Leukemia
Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.
Where NCT03504644's enrollment target sits among peer trials
40 8th of 12 higher than 4 of 12 other Recurrent B Acute Lymphoblastic Leukemia trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Recurrent B Acute Lymphoblastic Leukemia trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
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