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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 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.

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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.

Conditions Studied

B Acute Lymphoblastic Leukemia Acute Leukemia of Ambiguous Lineage

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

FieldValue
Enrollment Target 153 participants
Start Date 2025-06-05
Est. Completion 2028-12-31
Phase Phase 2

Sponsor

National Cancer Institute (NCI)

3,257 total trials

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Full Details on ClinicalTrials.gov ↗

What the Registry Record Tells You About NCT06317662

The ClinicalTrials.gov registry entry for NCT06317662 describes a study currently listed as recruiting, categorized as Phase 2. The registered enrollment target is 153 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 1,020-participant average among 20 other B Acute Lymphoblastic Leukemia trials with a reported enrollment target (85% lower). The listed sponsor is National Cancer Institute (NCI), which has 3,257 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 Biospecimen Collection is the first listed.

NCT06317662 reports 20 study locations spanning 10 distinct geographic areas - top geographies include 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.

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Every figure on PlainTrial is rendered directly from the ClinicalTrials.gov registry, no number is typed in by an editor. This page mirrors this trial's own ClinicalTrials.gov registry record, live from the dataset. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error.