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Myeloablative Haploidentical BMT With Post-transplant Cyclophosphamide for Pediatric Patients With Hematologic Malignancies

NCT02120157 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 35

Last updated 2021-11-26

Study results available
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Summary

This is a multi-institutional phase II haploidentical T cell replete bone marrow transplant (BMT) study in children with high-risk leukemia. The myeloablative conditioning regimen prescribed will be Total body irradiation (TBI)-based for lymphoid leukemia and busulfan-based for myeloid leukemia. Our goal is to establish an easily exportable, inexpensive platform for haplotransplantation that has a safety profile equivalent to matched related and unrelated BMTs. The primary objective will be to estimate the incidence of 6-month non-relapse mortality (NRM), hypothesizing that NRM is \< 18%.

Conditions

  • Myeloablative Conditioning
  • HLA-mismatched Bone Marrow Transplantation
  • Graft Survival
  • Transplantation, Bone Marrow

Interventions

DRUG

Cyclophosphamide

Chemotherapy administration

RADIATION

TBI

Radiation Therapy

DRUG

Busulfan

Chemotherapy Administered

OTHER

Unmanipulated Bone Marrow

Bone Marrow Transplant

DRUG

Tacrolimus

Immunosuppressive Drug Administered

DRUG

Mycophenolate mofetil

Immunosuppressive Drug Administered

Sponsors & Collaborators

  • Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins

    lead OTHER

Principal Investigators

  • Heather Symons, MD, MHS · SKCCC Johns Hopkins Hospital

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
6 Months
Max Age
25 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2015-07-02
Primary Completion
2018-06-15
Completion
2020-10-01

Countries

  • United States
  • Canada

Study Locations

More Related Trials

Entities

Drugs

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 NCT02120157 on ClinicalTrials.gov