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NCT05292664 · ClinicalTrials.gov registry record · Phase 1

Venetoclax Basket Trial for High Risk Hematologic Malignancies

A Phase 1 study of Therapy-Related Myelodysplastic Syndrome and Acute Lymphoblastic Leukemia, in Relapse, sponsored by Andrew E. Place, MD.

Recruiting
Registry status
Phase 1
Development phase
30
Enrollment target
5
Study locations

NCT05292664: Recruiting Phase 1 study of Therapy-Related Myelodysplastic Syndrome and Acute Lymphoblastic Leukemia, in Relapse, sponsored by Andrew E. Place, MD.

NCT05292664 is a Phase 1 study of Therapy-Related Myelodysplastic Syndrome and Acute Lymphoblastic Leukemia, in Relapse that is actively recruiting participants, run by Andrew E. Place, MD. The registered enrollment target is 30 participants, below the 82-participant average among 4 other Therapy-Related Myelodysplastic Syndrome trials with a reported enrollment target (63% lower). The trial reports 5 study locations across 5 states. According to ClinicalTrials.gov, the official US trial registry.

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The verdict

NCT05292664, a Phase 1 study of Therapy-Related Myelodysplastic Syndrome and Acute Lymphoblastic Leukemia, in Relapse, is actively recruiting participants, sponsored by Andrew E. Place, MD.

RECRUITING
Registry status
Phase 1
Development phase
30 participants
Enrollment target
5
Study locations

Study Summary

This trial is evaluating the safety and tolerability of venetoclax with chemotherapy in pediatric and young adult patients with hematologic malignancies, including myelodysplastic syndrome (MDS), acute myeloid leukemia derived from myelodysplastic syndrome (MDS/AML), and acute lymphoblastic leukemia (ALL)/lymphoblastic lymphoma (LBL). The names of the study drugs involved in this study are below. Please note this is a list for the study as a whole, participants will receive drugs according to disease cohort. * Venetoclax * Azacitidine * Cytarabine * Methotrexate * Hydrocortisone * Leucovorin * Dexamethasone * Vincristine * Doxorubicin * Dexrazoxane * Calaspargase pegol * Hydrocortisone

Primary Outcome

To determine the maximum tolerated dose (MTD of venetoclax given in combination with regimen-prescribed chemotherapy. The MTD is defined as the dose level associated with observed DLTs in \<33% of enrolled subjects

Conditions Studied

Therapy-Related Myelodysplastic Syndrome Acute Lymphoblastic Leukemia, in Relapse Myelodysplastic Syndromes, Previously Treated Acute Leukemia of Ambiguous Lineage in Relapse Myelodysplastic Syndromes, de Novo Myelodysplastic Syndromes, Secondary Treatment-Related Acute Myeloid Leukemia Acute Lymphoblastic Leukemia With Failed Remission Lymphoblastic Lymphoma, in Relapse Lymphoblastic Lymphoma, Refractory

Interventions

  • DRUG Venetoclax
  • DRUG Azacitidine
  • DRUG Cytarabine
  • DRUG Methotrexate
  • DRUG Hydrocortisone

Study Locations (5)

California

  • University of California San Francisco-Benioff Children's Hospital - San Francisco

Colorado

  • Children's Hospital Colorado - Aurora

Georgia

  • Children's Healthcare of Atlanta at Arthur M. Blank Hospital - Atlanta

Illinois

  • Ann & Robert H Lurie Children's Hospital of Chicago - Chicago

Massachusetts

  • Dana-Farber Cancer Institute - Boston

Trial Details

FieldValue
Enrollment Target 30 participants
Start Date 2023-03-29
Est. Completion 2030-07-02
Phase Phase 1
Andrew E. Place, MD

1 total trials

What NCT05292664 shows while recruiting

NCT05292664 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 30 participants, a relatively small participant target, below the 82-participant average among 4 other Therapy-Related Myelodysplastic Syndrome trials with a reported enrollment target (63% lower).

The record links to 10 conditions, with Therapy-Related Myelodysplastic Syndrome appearing as the primary indexed condition, and to 5 interventions - of which Venetoclax is the first listed.

NCT05292664 lists 5 locations in 5 states (California, Colorado, Georgia).

Frequently Asked Questions

What is clinical trial NCT05292664 about?

NCT05292664 is a clinical study titled "Venetoclax Basket Trial for High Risk Hematologic Malignancies". This trial is evaluating the safety and tolerability of venetoclax with chemotherapy in pediatric and young adult patients with hematologic malignancies, including myelodysplastic syndrome (MDS), acute myeloid leukemia derived from myelodysplastic syndrome (MDS/AML), and acute lymphoblastic leukemia...

What is the current status of trial NCT05292664?

This trial is currently recruiting. It is a Phase 1 study. The enrollment target is 30 participants. The study started on 2023-03-29. Estimated completion is 2030-07-02.

What conditions does trial NCT05292664 study?

This clinical trial studies the following conditions: Therapy-Related Myelodysplastic Syndrome, Acute Lymphoblastic Leukemia, in Relapse, Myelodysplastic Syndromes, Previously Treated, Acute Leukemia of Ambiguous Lineage in Relapse, Myelodysplastic Syndromes, de Novo.

What interventions are being tested in trial NCT05292664?

The interventions under investigation include: Venetoclax (DRUG), Azacitidine (DRUG), Cytarabine (DRUG), Methotrexate (DRUG), Hydrocortisone (DRUG).

Who is sponsoring clinical trial NCT05292664?

This trial is sponsored by Andrew E. Place, MD, which has 1 total clinical trials registered on ClinicalTrials.gov.

Where is trial NCT05292664 being conducted?

This trial has 5 study locations across California, Colorado, Georgia, Illinois, Massachusetts. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.

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More recruiting context for NCT05292664

Source: ClinicalTrials.gov NCT05292664, the US trial registry maintained by the National Library of Medicine. NCT05292664 (small enrollment · multi site footprint · recruiting) retrieved and formatted by PlainTrial, see methodology.