Health Trials

Venetoclax Basket Trial for High Risk Hematologic Malignancies

ConditionsMyelodysplastic Syndromes, de NovoMyelodysplastic Syndromes, SecondaryMyelodysplastic Syndromes, Previously TreatedTreatment-Related Acute Myeloid LeukemiaTherapy-Related Myelodysplastic SyndromeAcute Lymphoblastic Leukemia, in RelapseAcute Lymphoblastic Leukemia With Failed RemissionLymphoblastic Lymphoma, in RelapseLymphoblastic Lymphoma, RefractoryAcute Leukemia of Ambiguous Lineage in RelapseAcute Leukemia of Ambiguous Lineage
Trial statusRecruiting
Trial phasePhase 1
Trial typeInterventional
Biological sexAll
Age1-40
SponsorAndrew E. Place, MD

About this trial

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

Eligibility criteria

Qualifiers

MDS with excess blasts (>10%)

MDS with blasts <10% with high-risk features

MDS refractory to initial treatment

Relapsed MDS

Disqualifiers

Use of strong or moderate CYP3A inhibitors/inducers within 3 days of study entry

Individuals who have had a stem cell transplant and are still receiving treatment for GVHD or GVHD prophylaxis, or who have evidence of acute GVHD

Individuals with known active hepatitis; baseline testing not required.

Patients with systemic infection that is exhibiting ongoing signs/symptoms related to the infection without improvement despite appropriate antibiotics or other treatment.

Trial design

Treatments tested in this trial

  • Venetoclax
  • Azacitidine
  • Cytarabine
  • Methotrexate
  • Hydrocortisone
  • Leucovorin
  • Dexamethasone
  • Vincristine
  • Doxorubicin
  • Dexrazoxane
  • Calaspargase Pegol
  • Erwinia asparaginase

Treatment groups

30 Participants
are divided into 3 treatment groups

Sponsors and collaborators

Andrew E. Place, MD

Lead sponsor

Dana-Farber Cancer Institute

Sponsor institution

AbbVie

Collaborator

Servier

Collaborator

Children's Cancer Research Fund

Collaborator

University of Colorado, Denver

Collaborator

Boston Children's Hospital

Collaborator

Gateway for Cancer Research

Collaborator

Source ClinicalTrials.gov