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NCT06317662 · ClinicalTrials.gov registry record · Phase 2
Testing the Addition of the Anti-cancer Drug Venetoclax and/or the Anti-cancer Immunotherapy Blinatumomab to the Usual Chemotherapy Treatment for Infants With Newly Diagnosed KMT2A-rearranged or KMT2A-non-rearranged Leukemia
A Phase 2 study of B Acute Lymphoblastic Leukemia and Acute Leukemia of Ambiguous Lineage, sponsored by National Cancer Institute (NCI).
- Recruiting
- Registry status
- Phase 2
- Development phase
- 153
- Enrollment target
- 20
- Study locations
NCT06317662: Recruiting Phase 2 study of B Acute Lymphoblastic Leukemia and Acute Leukemia of Ambiguous Lineage, sponsored by National Cancer Institute (NCI).
NCT06317662 is a Phase 2 study of B Acute Lymphoblastic Leukemia and Acute Leukemia of Ambiguous Lineage that is actively recruiting participants, run by National Cancer Institute (NCI). The registered enrollment target is 153 participants, below the 1,020-participant average among 20 other B Acute Lymphoblastic Leukemia trials with a reported enrollment target (85% lower). The trial reports 20 study locations across 10 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT06317662, a Phase 2 study of B Acute Lymphoblastic Leukemia and Acute Leukemia of Ambiguous Lineage, is actively recruiting participants, sponsored by National Cancer Institute (NCI).
- RECRUITING
- Registry status
- Phase 2
- Development phase
- 153 participants
- Enrollment target
- 20
- Study locations
Study Summary
This phase II trial tests the addition of venetoclax and/or blinatumomab to usual chemotherapy for treating infants with newly diagnosed acute lymphoblastic leukemia (ALL) with a KMT2A gene rearrangement (KMT2A-rearranged \[R\]) or without a KMT2A gene rearrangement (KMT2A-germline \[G\]). Venetoclax is in a class of medications called B-cell lymphoma-2 (Bcl-2) inhibitors. It may stop the growth of cancer cells by blocking Bcl-2, a protein needed for cancer cell survival. Blinatumomab is a monoclonal antibody that may interfere with the ability of cancer cells to grow and spread. Chemotherapy drugs 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. Adding venetoclax and/or blinatumomab to standard chemotherapy may be more effective at treating patients with ALL than standard chemotherapy alone, but it may also cause more side effects. This clinical trial evaluates the safety and effectiveness of adding venetoclax and/or blinatumomab to chemotherapy for the treatment of infants with KMT2A-R or KMT2A-G ALL.
Primary Outcome
For the safety phase, DLTs of the induction + venetoclax cycle of KMT2A-rearranged (R) patients will be assessed.
Conditions Studied
Interventions
- PROCEDURE Biospecimen Collection
- PROCEDURE Bone Marrow Aspiration
- BIOLOGICAL Blinatumomab
- DRUG Asparaginase Erwinia chrysanthemi
- DRUG Calaspargase Pegol
Study Locations (20)
Florida
- UF Health Cancer Institute - Gainesville - Gainesville
- Memorial Regional Hospital/Joe DiMaggio Children's Hospital - Hollywood
- Nemours Children's Clinic-Jacksonville - Jacksonville
- University of Miami Miller School of Medicine-Sylvester Cancer Center - Miami
- AdventHealth Orlando - Orlando
- Arnold Palmer Hospital for Children - Orlando
- Nemours Children's Hospital - Orlando
California
- Loma Linda University Medical Center - Loma Linda
- UCSF Benioff Children's Hospital Oakland - Oakland
- Kaiser Permanente-Oakland - Oakland
- Children's Hospital of Orange County - Orange
- UCSF Medical Center-Mission Bay - San Francisco
Alabama
- Children's Hospital of Alabama - Birmingham
Alaska
- Providence Alaska Medical Center - Anchorage
Arizona
- Banner Children's at Desert - Mesa
Arkansas
- Arkansas Children's Hospital - Little Rock
Colorado
- Children's Hospital Colorado - Aurora
Connecticut
- Connecticut Children's Medical Center - Hartford
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 153 participants |
| Start Date | 2025-06-05 |
| Est. Completion | 2028-12-31 |
| Phase | Phase 2 |
What NCT06317662 shows while recruiting
NCT06317662 is an interventional study that assigns participants to a tested intervention. The registered 153 participants enrollment target is mid-sized for trials with a published cap, below the 1,020-participant average among 20 other B Acute Lymphoblastic Leukemia trials with a reported enrollment target (85% lower).
The record links to 2 conditions, with B Acute Lymphoblastic Leukemia appearing as the primary indexed condition, and to 5 interventions - of which Biospecimen Collection is the first listed.
NCT06317662 names 20 study sites across 10 states, led by Florida, California, Alabama.
Frequently Asked Questions
What is clinical trial NCT06317662 about?
NCT06317662 is a clinical study titled "Testing the Addition of the Anti-cancer Drug Venetoclax and/or the Anti-cancer Immunotherapy Blinatumomab to the Usual Chemotherapy Treatment for Infants With Newly Diagnosed KMT2A-rearranged or KMT2A-non-rearranged Leukemia". This phase II trial tests the addition of venetoclax and/or blinatumomab to usual chemotherapy for treating infants with newly diagnosed acute lymphoblastic leukemia (ALL) with a KMT2A gene rearrangement (KMT2A-rearranged \[R\]) or without a KMT2A gene rearrangement (KMT2A-germline \[G\]). Venetocla...
What is the current status of trial NCT06317662?
This trial is currently recruiting. It is a Phase 2 study. The enrollment target is 153 participants. The study started on 2025-06-05. Estimated completion is 2028-12-31.
What conditions does trial NCT06317662 study?
This clinical trial studies the following conditions: B Acute Lymphoblastic Leukemia, Acute Leukemia of Ambiguous Lineage.
What interventions are being tested in trial NCT06317662?
The interventions under investigation include: Biospecimen Collection (PROCEDURE), Bone Marrow Aspiration (PROCEDURE), Blinatumomab (BIOLOGICAL), Asparaginase Erwinia chrysanthemi (DRUG), Calaspargase Pegol (DRUG).
Who is sponsoring clinical trial NCT06317662?
This trial is sponsored by National Cancer Institute (NCI), which has 3,257 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT06317662 being conducted?
This trial has 20 study locations across Alabama, Alaska, Arizona, Arkansas, 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 NCT06317662's enrollment target sits among peer trials
153 7th of 20 higher than 14 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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