Venetoclax Basket Trial for High Risk Hematologic Malignancies

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

Conditions

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

Interventions

DRUG

Venetoclax

Tablet taken orally

DRUG

Azacitidine

Taken intravenously

DRUG

Cytarabine

Lumbar Puncture

DRUG

Methotrexate

Lumbar Puncture

DRUG

Hydrocortisone

Lumbar Puncture

DRUG

Leucovorin

Taken Orally or intravenously

DRUG

Dexamethasone

Taken Orally or intravenously

DRUG

Vincristine

Taken intravenously

DRUG

Doxorubicin

Taken intravenously

DRUG

Dexrazoxane

Taken intravenously

DRUG

Calaspargase Pegol

Taken intravenously

DRUG

Erwinia asparaginase

Given as intramuscular injection

Sponsors & Collaborators

• AbbVie

  collaborator INDUSTRY

• Servier

  collaborator INDUSTRY

• Children's Cancer Research Fund

  collaborator OTHER

• University of Colorado, Denver

  collaborator OTHER

• Boston Children's Hospital

  collaborator OTHER

• Gateway for Cancer Research

  collaborator OTHER

• Andrew E. Place, MD

  lead OTHER

Principal Investigators

• Andrew E Place, MD, PhD · Dana-Farber Cancer Institute

Study Design

Allocation

NON_RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Model

PARALLEL

Eligibility

Min Age

1 Year

Max Age

40 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2023-03-29

Primary Completion

2028-07-02

Completion

2030-07-02

FDA Drug

Yes

Countries

• United States

Study Locations