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NCT05157971 · ClinicalTrials.gov registry record · Phase 1
Venetoclax and a Pediatric-Inspired Regimen for the Treatment of Newly Diagnosed B Cell Acute Lymphoblastic Leukemia
A Phase 1 study of B Acute Lymphoblastic Leukemia and Ph-Like Acute Lymphoblastic Leukemia, sponsored by City of Hope Medical Center.
- Recruiting
- Registry status
- Phase 1
- Development phase
- 24
- Enrollment target
- 1
- Study location
NCT05157971: Recruiting Phase 1 study of B Acute Lymphoblastic Leukemia and Ph-Like Acute Lymphoblastic Leukemia, sponsored by City of Hope Medical Center.
NCT05157971 is a Phase 1 study of B Acute Lymphoblastic Leukemia and Ph-Like Acute Lymphoblastic Leukemia that is actively recruiting participants, run by City of Hope Medical Center. The registered enrollment target is 24 participants, below the 1,026-participant average among 20 other B Acute Lymphoblastic Leukemia trials with a reported enrollment target (98% lower). The trial reports 1 study location across 1 state. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT05157971, a Phase 1 study of B Acute Lymphoblastic Leukemia and Ph-Like Acute Lymphoblastic Leukemia, is actively recruiting participants, sponsored by City of Hope Medical Center.
- RECRUITING
- Registry status
- Phase 1
- Development phase
- 24 participants
- Enrollment target
- 1
- Study location
Study Summary
This phase I trial tests the safety, side effects, and best dose of venetoclax in combination with a pediatric-inspired chemotherapy regimen known as C10403 in treating patients with newly diagnosed B cell acute lymphoblastic leukemia. Venetoclax may stop the growth of cancer cells by blocking Bcl-2, a protein needed for cancer cell survival. The C10403 regimen is composed of the chemotherapy drugs cytarabine, cyclophosphamide, daunorubicin, mercaptopurine, pegaspargase, vincristine, and methotrexate, all which 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. It also consists of prednisone, which is an anti-inflammatory drug that lowers the body's immune response and is used with other drugs in the treatment of some types of some types of cancer. This study may help researchers learn if adding venetoclax to the pediatric-inspired C10403 regimen can be tolerated and help treat older patients.
Primary Outcome
Will be graded according to the National Cancer Institute (NCI)-Common Terminology Criteria for Adverse Events (CTCAE) version 5.0. Observed toxicities will be summarized in terms of type (organ affected or laboratory determination), severity, time of onset, duration, frequency, probable association with the study treatment and reversibility or outcome.
Conditions Studied
Interventions
- DRUG Cyclophosphamide
- DRUG Cytarabine
- DRUG Methotrexate
- DRUG Daunorubicin Hydrochloride
- DRUG Mercaptopurine
Study Locations (1)
California
- City of Hope Medical Center - Duarte
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 24 participants |
| Start Date | 2022-03-17 |
| Est. Completion | 2026-05-12 |
| Phase | Phase 1 |
What NCT05157971 shows while recruiting
NCT05157971 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 24 participants, a relatively small participant target, below the 1,026-participant average among 20 other B Acute Lymphoblastic Leukemia trials with a reported enrollment target (98% lower).
The record links to 2 conditions, with B Acute Lymphoblastic Leukemia appearing as the primary indexed condition, and to 5 interventions - of which Cyclophosphamide is the first listed.
NCT05157971 reports a single indexed study location in California.
Frequently Asked Questions
What is clinical trial NCT05157971 about?
NCT05157971 is a clinical study titled "Venetoclax and a Pediatric-Inspired Regimen for the Treatment of Newly Diagnosed B Cell Acute Lymphoblastic Leukemia". This phase I trial tests the safety, side effects, and best dose of venetoclax in combination with a pediatric-inspired chemotherapy regimen known as C10403 in treating patients with newly diagnosed B cell acute lymphoblastic leukemia. Venetoclax may stop the growth of cancer cells by blocking Bcl-2...
What is the current status of trial NCT05157971?
This trial is currently recruiting. It is a Phase 1 study. The enrollment target is 24 participants. The study started on 2022-03-17. Estimated completion is 2026-05-12.
What conditions does trial NCT05157971 study?
This clinical trial studies the following conditions: B Acute Lymphoblastic Leukemia, Ph-Like Acute Lymphoblastic Leukemia.
What interventions are being tested in trial NCT05157971?
The interventions under investigation include: Cyclophosphamide (DRUG), Cytarabine (DRUG), Methotrexate (DRUG), Daunorubicin Hydrochloride (DRUG), Mercaptopurine (DRUG).
Who is sponsoring clinical trial NCT05157971?
This trial is sponsored by City of Hope Medical Center, which has 582 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT05157971 being conducted?
This trial has 1 study location across California. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
Similar trials for 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 NCT05157971's enrollment target sits among peer trials
24 18th of 20 higher than 3 of 20 other B Acute Lymphoblastic Leukemia trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other 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.
Source ClinicalTrials.gov registry export · 2026-08-08
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