CI

At a glance

ClinicalIndex Comparison Record
Phase 2Completed· 38 enrolled
Drug / intervention
Busulfan +10 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/NCT03128359
NCT03128359Phase 2Completed
CompareCT.gov

A Pilot Study of Post-transplant High Dose Cyclophosphamide (PTCY) as Part of Graft-Versus-Host Disease (GVHD) Prophylaxis in T-Cell Replete HLA-Mismatched Unrelated Donor (MMUD) Ablative and Reduced Intensity Hematopoietic Cell Transplantation (HCT) for Hematological Malignancies

City of Hope Medical Center·interventional·Posted Apr 25, 2017·Updated Jan 9, 2024

In Brief

A Phase 2 clinical trial evaluating Busulfan, Cyclophosphamide, and 9 other interventions for Acute Leukemia and 14 related conditions. Completed, enrolled 38 participants across 1 site.

Detailed Summary

This pilot phase II trial studies how well high dose cyclophosphamide, tacrolimus, and mycophenolate mofetil work in preventing graft versus host disease in patients with hematological malignancies undergoing myeloablative or reduced intensity donor stem cell transplant. Sometimes the transplanted cells from a donor can make an immune response against the body's normal cells (called graft versus host disease). Giving high dose cyclophosphamide, tacrolimus, and mycophenolate mofetil after the transplant may stop this from happening.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsAcute Leukemia, Chronic Lymphocytic Leukemia/Small Lymphocytic Lymphoma, Chronic Myelogenous Leukemia, BCR-ABL1 Positive, Diffuse Large B-Cell Lymphoma, Follicular Lymphoma, Graft Versus Host Disease, Hodgkin Lymphoma, Mantle Cell Lymphoma, Marginal Zone Lymphoma, Myelodysplastic Syndrome, Myeloproliferative Neoplasm, Recurrent Acute Myeloid Leukemia With Myelodysplasia-Related Changes, Recurrent Plasma Cell Myeloma, Refractory Plasma Cell Myeloma, Secondary Myelodysplastic Syndrome
CountriesUnited States
CollaboratorsNational Cancer Institute (NCI)

Timeline

Phase 2CompletedFinished
201820192020202120222023202420252026
First PostedApr 25, 2017
Enrollment StartMay 30, 2017
Primary CompletionAug 1, 2020
Study CompletionSep 15, 2021
TodayJul 2, 2026
Enrollment to primary: 3.2 yearsPosted 9.2 years ago

Interventions

Busulfandrug

Given IV

Cyclophosphamidedrug

Given IV

Fludarabine Phosphatedrug

Given IV

Hematopoietic Cell Transplantationprocedure

Undergo PBSC HCT

Laboratory Biomarker Analysisother

Correlative studies

Melphalan Hydrochloridedrug

Given IV

Mycophenolate Mofetildrug

Given IV or PO

Peripheral Blood Stem Cell Transplantationprocedure

Undergo PBSC HCT

Quality-of-Life Assessmentother

Ancillary studies

Tacrolimusdrug

Given IV

Total-Body Irradiationradiation

Undergo TBI