CI

At a glance

ClinicalIndex Comparison Record
Phase 2Completed· 35 enrolled
Drug / intervention
Cyclophosphamide +5 moredrug
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT02120157
NCT02120157Phase 2Completed
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Pediatric Blood & Marrow Transplant Consortium (PBMTC) Phase II Myeloablative Haploidentical BMT With Post-transplantation Cyclophosphamide for Pediatric Patients With Hematologic Malignancies

Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins·interventional·Posted Apr 22, 2014·Updated Nov 26, 2021

In Brief

A Phase 2 clinical trial evaluating Cyclophosphamide, TBI, and 4 other interventions for Myeloablative Conditioning and 3 related conditions. Completed, enrolled 35 participants across 9 sites in 2 countries.

Detailed 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%.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsMyeloablative Conditioning, HLA-mismatched Bone Marrow Transplantation, Graft Survival, Transplantation, Bone Marrow
CountriesCanada, United States
Collaborators--

Timeline

Phase 2CompletedFinished
2014201520162017201820192020202120222023202420252026
First PostedApr 22, 2014
Enrollment StartJul 2, 2015
Primary CompletionJun 15, 2018
Study CompletionOct 1, 2020
TodayJul 2, 2026
Enrollment to primary: 3.0 yearsPosted 12.2 years ago

Interventions

Cyclophosphamidedrug

Chemotherapy administration

TBIradiation

Radiation Therapy

Busulfandrug

Chemotherapy Administered

Unmanipulated Bone Marrowother

Bone Marrow Transplant

Tacrolimusdrug

Immunosuppressive Drug Administered

Mycophenolate mofetildrug

Immunosuppressive Drug Administered