Acute Myeloid Leukemia Clinical Trial
Study of Haplo-HSCT + Rivogenlecleucel vs Haplo-HSCT + Post Transplant Cyclophosphamide in Patients With AML or MDS
This study compares the safety and effectiveness of giving rivogenlecleucel (BPX-501 T cells) to patients with AML or MDS post haploidentical hematopoietic stem cell transplant compared to post-transplant cyclophosphamide.
In the Phase 2 portion, participants will undergo αβ T cell and CD19+ B cell depleted haploidentical HSCT followed by an infusion of a fixed dose of rivogenlecleucel (BPX-501 T cells) per kg. These participants will be evaluated for prespecified dose limiting toxicities (DLTs) for a 100-day dose limiting toxicity window.
Following completion of the Phase 2 portion, participants will be enrolled and randomized to one of two treatment arms in the Phase 3 portion.
Arm A:αβ T-cell and CD19+ B-cell-depleted haplo-HSCT plus treatment with rivogenlecleucel
Arm B: haplo-HSCT plus post transplant cyclophosphamide
Pediatric patients ages 12-17 will also be included in US only.
Signed informed consent
Meeting institutional criteria to undergo allogenic HSCT
Age 18-70 y/o (12-70 y/o in US only)
Patients with AML or MDS as defined below:
AML Patients Patients with intermediate to adverse AML as defined by ELN (Dohner, 2017).
AML in first complete remission (CR1) with high-risk features defined as > 1 cycle of induction therapy required to achieve remission OR preceding MDS or myeloproliferative disease
AML in CR1 with intermediate-risk features
AML in second or subsequent complete response
AML with myelodysplasia-related changes (AML-MRC)
Therapy related AML in first or subsequent complete remission
De novo AML in second or subsequent complete remission
High or very-high risk MDS by IPSS-R classification
Intermediate risk or higher MDS patients who failed a hypomethylating agent
Lack of suitable conventional donor (i.e. HLA 10/10 related or unrelated donor)
At least a 5/10 genotypic identical haplotype match
The donor and recipient must be identical, at least one allele of each of the following genetic loci: HLA-A, HLA-B, HLA-C, HLA-DRB1, and HLA-DQB1
Patients with adequate organ function
Eastern Cooperative Oncology Group (ECOG) performance status: 0-2
HLA 10/10 allele matched (HLA-A,-B,-C,-DRBl, and DQB1) related donor or unrelated donor
Autologous hematopoietic stem cell transplant ≤ 3 months before enrollment
Prior allogeneic transplantation
Active CNS involvement by malignant cells (less than 2 months from the conditioning)
Current uncontrolled clinically active bacterial, viral or fungal infection
Positive HIV serology or viral RNA
Pregnancy (positive serum or urine βHCG test) or breast-feeding
Fertile men or women unwilling to use effective forms of birth control or abstinence for a year after transplantation
Radiographic, histologic, or known history of cirrhosis
Overlapping MDS and myeloproliferative neoplasms (MPN) disease
Patients with acute promyelocytic leukemia (APL)
Known hypersensitivity to dimethyl sulfoxide (DMSO)
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There are 2 Locations for this study
Nashville Tennessee, 37203, United States
San Antonio Texas, 78229, United States
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