Status:
TERMINATED
Omacetaxine and Venetoclax for the Treatment of Relapsed or Refractory Acute Myeloid Leukemia or Myelodysplastic Syndrome Harboring Mutant RUNX1
Lead Sponsor:
M.D. Anderson Cancer Center
Conditions:
Hematopoietic and Lymphoid Cell Neoplasm
Recurrent Acute Biphenotypic Leukemia
Eligibility:
All Genders
18+ years
Phase:
PHASE1
PHASE2
Brief Summary
This phase Ib/II trial best dose, possible benefits and/or side effects of omacetaxine and venetoclax in treating patients with acute myeloid leukemia or myelodysplastic syndrome that has come back (r...
Detailed Description
PRIMARY OBJECTIVES: I. To determine the safety and tolerability and recommended phase 2 dose (RP2D) of omacetaxine in combination with venetoclax for patients with relapsed/refractory acute myeloid l...
Eligibility Criteria
Inclusion
- Patients with a diagnosis of relapsed or refractory acute myeloid leukemia (AML) (or biphenotypic or bilineage leukemia including a myeloid component) or myelodysplastic syndrome
- For myelodysplastic syndrome (MDS) patients, patients must have no response, progression, or relapse following at least 4 cycles of azacytidine or decitabine; and/or intolerance defined as grade \>= 3 drug-related toxicity precluding continued therapy
- Age \>= 18 years
- Subjects must have documented RUNX1 gene mutation
- Eastern Cooperative Oncology Group (ECOG) performance status =\< 2
- Creatinine \< 2 unless related to the disease
- Direct bilirubin \< 2x upper limit of normal (ULN) unless increase is due to Gilbert's disease or leukemic involvement
- Aspartate aminotransferase (AST) and/or alanine aminotransferase (ALT) \< 3x ULN unless considered due to leukemic involvement
- In the absence of rapidly proliferative disease, the interval from prior treatment to time of initiation will be at least 7 days for cytotoxic or non-cytotoxic (i.e. immunotherapy) agents. Oral hydroxyurea and/or cytarabine (up to 2 g/m\^2) for patients with rapidly proliferative disease is allowed before the start of study therapy, as needed, for clinical benefit and after discussion with the principal investigator (PI)
- Male subjects must agree to refrain from unprotected sex and sperm donation from initial study drug administration until 90 days after the last dose of study drug
- Willing and able to provide informed consent
Exclusion
- Patients with t(15;17) karyotypic abnormality or acute promyelocytic leukemia (French-American-British \[FAB\] class M3-AML)
- Patients with any concurrent uncontrolled clinically significant medical condition including active infection or psychiatric illness, which could place the patient at unacceptable risk of study treatment
- Patients with active graft-versus-host-disease (GVHD) status post stem cell transplant (patients without active GVHD on chronic suppressive immunosuppression and/or phototherapy for chronic skin GVHD are permitted after discussion with the PI)
- Patients with any severe gastrointestinal or metabolic condition which could interfere with the absorption of oral study medications
- Known active hepatitis B virus (HBV) or hepatitis C virus (HCV) infection or known human immunodeficiency virus (HIV) infection
- Subject has a white blood cell count \> 25 x 10\^9/L. (Note: Hydroxyurea is permitted to meet this criterion.)
- Nursing women, women of childbearing potential (WOCBP) with positive urine pregnancy test, or women of childbearing potential who are not willing to maintain adequate contraception
- Appropriate highly effective method(s) of contraception include oral or injectable hormonal birth control, intrauterine device (IUD), and double barrier methods (for example a condom in combination with a spermicide)
Key Trial Info
Start Date :
December 17 2021
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
September 16 2024
Estimated Enrollment :
24 Patients enrolled
Trial Details
Trial ID
NCT04874194
Start Date
December 17 2021
End Date
September 16 2024
Last Update
November 3 2025
Active Locations (1)
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1
M D Anderson Cancer Center
Houston, Texas, United States, 77030