OncoMatch/Clinical Trials/NCT05292664
Venetoclax Basket Trial for High Risk Hematologic Malignancies
Is NCT05292664 recruiting? Yes, currently enrolling (Jun 2026). This Phase 1 trial studies multiple treatments for myelodysplastic syndromes, de novo.
Treatment: Venetoclax · Azacitidine · Cytarabine · Methotrexate · Hydrocortisone · Leucovorin · Dexamethasone · Vincristine · Doxorubicin · Dexrazoxane · Calaspargase Pegol · Erwinia asparaginase — 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
Check if I qualifyExtracted eligibility criteria
Treatments studied
Targeted therapy
Chemotherapy
Other
Cancer type
Myelodysplastic Syndrome
Acute Myeloid Leukemia
Acute Lymphoblastic Leukemia
Non-Hodgkin Lymphoma
Biomarker criteria
Required: KMT2A (MLL) rearrangement
KMT2A rearrangement
Required: IKZF1 deletion (without targetable ABL1 fusion)
IKZF1 deletion (without targetable ABL1 fusion)
Demographics
Prior therapy
Must have received: remission induction attempt — at least 1 prior induction attempt
refractory to at least 1 prior remission induction attempt
Cannot have received: hematopoietic stem cell transplant
Exception: Allogeneic HSCT > 90 days of study entry; No evidence of graft-versus-host-disease (GVHD)
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, or who are less than 90 days from stem cell infusion
Lab requirements
Liver function
Serum alanine aminotransferase (ALT) ≤5X upper limit of normal (ULN); Direct bilirubin ≤ 3X upper limit of normal for age and institution.
Cardiac function
Ejection fraction ≥ 50% or shortening fraction of ≥ 24% on screening echocardiogram; Maximum prior cumulative doxorubicin dose ≤ 360 mg/m2 or equivalent (Cohort C)
Adequate organ function, as defined by: Serum alanine aminotransferase (ALT) ≤5X upper limit of normal (ULN); Direct bilirubin ≤ 3X; Ejection fraction ≥ 50% or shortening fraction of ≥ 24% on screening echocardiogram.
Structured fields extracted by AI. May contain errors — verify against the official protocol.
US trial sites
- University of California San Francisco-Benioff Children's Hospital · San Francisco, California
- Children's Hospital Colorado · Aurora, Colorado
- Children's Healthcare of Atlanta at Arthur M. Blank Hospital · Atlanta, Georgia
- Ann & Robert H Lurie Children's Hospital of Chicago · Chicago, Illinois
- Dana-Farber Cancer Institute · Boston, Massachusetts
Showing up to 5 US sites.
See all sites on ClinicalTrials.gov →Frequently asked questions
Is NCT05292664 currently recruiting?
Yes, this trial is currently recruiting patients.
Are there prior therapy exclusions?
Yes. Prior hematopoietic stem cell transplant disqualifies patients from enrollment.
Does this trial require KMT2A?
Yes, KMT2A rearrangement is a required biomarker for enrollment.
Does this trial require IKZF1?
Yes, IKZF1 deletion (without targetable ABL1 fusion) is a required biomarker for enrollment.
Is there an age limit?
Yes. Patients must be 40 years or younger and at least 1 years old.
Could you qualify for this trial?
Enter your biomarker results to see how this trial's eligibility criteria match your specific cancer profile.
Check if I qualify