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

NCT03699475 · Status: TERMINATED · Phase: PHASE2/PHASE3 · Type: INTERVENTIONAL · Enrollment: 1

Last updated 2023-09-29

Study results available
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Summary

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.

Conditions

Interventions

BIOLOGICAL

rivogenlecleucel

Biological: T cells transduced with caspase 9 safety switch

DRUG

rimiducid

administered to inactivate rivogenlecleucel in the event of GVHD

DRUG

Cyclophosphamide

GVHD prophylaxis

PROCEDURE

haplo-HSCT

treatment for disease

Sponsors & Collaborators

  • Bellicum Pharmaceuticals

    lead INDUSTRY

Principal Investigators

  • Bellicum Pharmaceuticals · Bellicum Pharmaceuticals, Inc.

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
SEQUENTIAL

Eligibility

Min Age
12 Years
Max Age
70 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2018-12-27
Primary Completion
2019-07-23
Completion
2019-07-23
FDA Drug
Yes

Countries

  • United States

Study Locations

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Entities

Drugs
Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03699475 on ClinicalTrials.gov