CI

At a glance

ClinicalIndex Comparison Record
Phase 2Completed· 27 enrolled
Drug / intervention
fludarabine phosphate +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/NCT02248597
NCT02248597Phase 2Completed
CompareCT.gov

Haploidentical Stem Cell Transplant Using Post Transplant Cyclophosphamide for GvHD Prophylaxis: A Pilot Study

Wake Forest University Health Sciences·interventional·Posted Sep 25, 2014·Updated Oct 11, 2023

In Brief

A Phase 2 clinical trial evaluating fludarabine phosphate, busulfan, and 4 other interventions for Graft Versus Host Disease and Hematopoietic/Lymphoid Cancer. Completed, enrolled 27 participants across 1 site.

Detailed Summary

This pilot clinical trial studies donor stem cell transplant followed by cyclophosphamide in treating patients with hematological diseases. Giving chemotherapy before a donor stem cell transplant helps stop the growth of cells in the bone marrow, including normal blood-forming cells (stem cells) and cancer cells. When the healthy stem cells from a donor are infused into the patient they may help the patient's bone marrow make stem cells, red blood cells, white blood cells, and platelets. Sometimes the transplanted cells from a donor can make an immune response against the body's normal cells (called graft-versus-host disease). Giving cyclophosphamide after the transplant may stop this from happening.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsGraft Versus Host Disease, Hematopoietic/Lymphoid Cancer
CountriesUnited States
CollaboratorsNational Cancer Institute (NCI)

Timeline

Phase 2CompletedFinished
201520162017201820192020202120222023202420252026
First PostedSep 25, 2014
Enrollment StartFeb 25, 2015
Primary CompletionJan 18, 2022
Study CompletionJan 18, 2023
TodayJul 2, 2026
Enrollment to primary: 6.9 yearsPosted 11.8 years ago

Interventions

fludarabine phosphatedrug

Given IV

busulfandrug

Given IV

cyclophosphamidedrug

Given IV

allogeneic hematopoietic stem cell transplantationprocedure

Undergo myeloablative or reduced intensity allogeneic stem cell transplant

tacrolimusdrug

mycophenolate mofetildrug