Study of Haplo-HSCT + Rivogenlecleucel vs Haplo-HSCT + Post Transplant Cyclophosphamide in Patients With AML or MDS

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

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Basic Information

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Recruitment Status

TERMINATED

Clinical Phase

PHASE2/PHASE3

Total Enrollment

1 participants

Study Classification

INTERVENTIONAL

Study Start Date

2018-12-27

Study Completion Date

2019-07-23

Brief Summary

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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.

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Detailed Description

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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.

Conditions

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Acute Myeloid Leukemia Myelodysplastic Syndromes

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

SEQUENTIAL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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single-arm Phase II: 3 x 10E6 BPX-501 cell/kg

Determining the safety of maximum allowable Dose for BPX-501 starting at 3 x 10E6 cells/kg

Rimiducid will be administered to inactivate rivogenlecleucel in the event of GVHD not responsive to standard of care treatment

Group Type EXPERIMENTAL

rivogenlecleucel

Intervention Type BIOLOGICAL

Biological: T cells transduced with caspase 9 safety switch

rimiducid

Intervention Type DRUG

administered to inactivate rivogenlecleucel in the event of GVHD

haplo-HSCT

Intervention Type PROCEDURE

treatment for disease

phase 3 Arm A: Dose Determined in phase 2 group (never completed)

αβ T cell and CD19+ B cell-depleted, related haploidentical hematopoietic stem cell transplantation (haplo-HSCT) plus rivogenlecleucel

Group Type EXPERIMENTAL

rivogenlecleucel

Intervention Type BIOLOGICAL

Biological: T cells transduced with caspase 9 safety switch

rimiducid

Intervention Type DRUG

administered to inactivate rivogenlecleucel in the event of GVHD

haplo-HSCT

Intervention Type PROCEDURE

treatment for disease

phase 3 Arm B: dose determined in the phase 2 group (never completed)

haplo-HSCT followed by post-transplant cyclophosphamide (PTCy) in patients with acute myeloid leukemia (AML) or myelodysplastic syndrome (MDS)

Group Type ACTIVE_COMPARATOR

Cyclophosphamide

Intervention Type DRUG

GVHD prophylaxis

haplo-HSCT

Intervention Type PROCEDURE

treatment for disease

Interventions

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rivogenlecleucel

Biological: T cells transduced with caspase 9 safety switch

Intervention Type BIOLOGICAL

rimiducid

administered to inactivate rivogenlecleucel in the event of GVHD

Intervention Type DRUG

Cyclophosphamide

GVHD prophylaxis

Intervention Type DRUG

haplo-HSCT

treatment for disease

Intervention Type PROCEDURE

Other Intervention Names

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BPX-501 T cells AP1903 Cytoxan

Eligibility Criteria

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Inclusion Criteria

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

MDS Patients

* 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

Exclusion Criteria

* 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)

Minimum Eligible Age

12 Years

Maximum Eligible Age

70 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No