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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 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.
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.
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 |
Interested in This Trial?
Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT05157971
The ClinicalTrials.gov registry entry for NCT05157971 describes a study currently listed as recruiting, categorized as Phase 1. The registered enrollment target is 24 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 1,026-participant average among 20 other B Acute Lymphoblastic Leukemia trials with a reported enrollment target (98% lower). The listed sponsor is City of Hope Medical Center, which has 582 total studies on file at ClinicalTrials.gov.
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 1 study location spanning 1 distinct geographic area - top geographies include 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.
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