Status:
ACTIVE_NOT_RECRUITING
Venetoclax and Sequential Busulfan, Cladribine, and Fludarabine Phosphate Before Donor Stem Cell Transplant in Treating Patients With Acute Myelogenous Leukemia or Myelodysplastic Syndrome
Lead Sponsor:
M.D. Anderson Cancer Center
Collaborating Sponsors:
National Cancer Institute (NCI)
Conditions:
Acute Myeloid Leukemia
Myelodysplastic Syndrome
Eligibility:
All Genders
2-70 years
Phase:
PHASE2
Brief Summary
This randomized phase II trial studies how well venetoclax and sequential busulfan, cladribine, and fludarabine phosphate before donor stem cell transplant work in treating patients with acute myeloge...
Detailed Description
PRIMARY OBJECTIVE: I. To compare progression free survival of two schedules of venetoclax, timed sequential busulfan, cladribine and fludarabine conditioning regimen in patients with acute myelogenou...
Eligibility Criteria
Inclusion
- Patients with biopsy-proven acute myeloid leukemia or myelodysplastic syndrome with persistent disease or in remission
- Human leukocyte antigen (HLA)-identical sibling or 8/8 matched unrelated donor transplant
- Patients age 18 to 70 years old; eligibility for pediatric patients will be determined in conjunction with an MD Anderson Cancer Center (MDACC) pediatrician; patients age 2-17 years may be enrolled after at least 10 adults (ages 18-70 years old) have been assessed for safety at day 30
- Direct bilirubin \< 1 mg/dl
- Alanine aminotransferase (ALT) \< 3 times upper limit of normal
- Creatinine clearance \> 50 ml/min (calculated creatinine clearance is permitted)
- Forced expiratory volume in 1 second (FEV1) \>= 50% of expected corrected for hemoglobin and/or volume
- Forced vital capacity (FVC) \>= 50% of expected corrected for hemoglobin and/or volume
- Diffusing capacity of the lungs for carbon monoxide (DLCO) \>= 50% of expected corrected for hemoglobin and/or volume
- Children unable to perform pulmonary function tests (e.g., less than 7 years old) pulse oximetry of \>= 92% on room air
- Left ventricular ejection fraction (LVEF) \>= 40%
- Patient, legally authorized representative (LAR), or parent able to sign informed consent; able to give assent for patients age 7-17
- Negative beta human chorionic gonadotropin (HCG) test in a woman with child bearing potential, defined as not post-menopausal for 12 months or no previous surgical sterilization; women of child bearing potential must be willing to use an effective contraceptive measure while on study
- Performance score of \>= 70 by Karnofsky/Lansky or performance status (PS) 0 or 1 (Eastern Cooperative Oncology Group \[ECOG\] =\< 1)
Exclusion
- Prior allogeneic or autologous transplantation
- Uncontrolled infections
- Human immunodeficiency virus (HIV) seropositivity
- Hematopoietic cell transplantation (HCT) co-morbidity index score \> 3; the principal investigator is the final arbiter of eligibility for comorbidity score \> 3
- Patients with prior coronary artery disease
Key Trial Info
Start Date :
October 27 2014
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
October 31 2027
Estimated Enrollment :
116 Patients enrolled
Trial Details
Trial ID
NCT02250937
Start Date
October 27 2014
End Date
October 31 2027
Last Update
October 6 2025
Active Locations (1)
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1
M D Anderson Cancer Center
Houston, Texas, United States, 77030