CI

At a glance

ClinicalIndex Comparison Record
Phase 2Completed· 78 enrolled
Drug / intervention
Cyclophosphamide +6 moredrug
Likely dose
Cyclophosphamide 60 mg/kgfrom 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/NCT01349101
NCT01349101Phase 2Completed

Post Transplant Cyclophosphamide for Unrelated and Related Allogeneic Hematopoietic Stem Cell Transplantation for Hematological Malignancies

Sidney Kimmel Comprehensive Cancer Center at Thomas Jefferson University·interventional·Posted May 6, 2011·Updated Dec 15, 2025

In Brief

A Phase 2 clinical trial evaluating Total Body Irradiation, Cyclophosphamide, and 5 other interventions for Hematological Malignancies. Completed, enrolled 78 participants across 1 site.

Detailed Summary

It is hypothesized that engraftment when administering cyclophosphamide post the stem cell infusion will increase, the incidence of graft versus host disease (GVHD) and day 100 mortality will decrease, and the use of cyclophosphamide post stem cell infusion with alternative donors will be as safe and as effective as traditional matched transplants.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
CountriesUnited States
Collaborators--

Timeline

Phase 2CompletedFinished
2011201220132014201520162017201820192020202120222023202420252026
First PostedMay 6, 2011
Enrollment StartFeb 10, 2011
Primary CompletionOct 31, 2022
Study CompletionDec 7, 2022
TodayJul 2, 2026
Enrollment to primary: 11.7 yearsPosted 15.2 years ago

Interventions

Total Body Irradiationradiation

Myeloablative HSCT Arm: Total body irradiation (TBI) is given in 8 fractions over 4 days (total dose of 12 Gy) Reduced Intensity HSCT Arm: TBI is given in one fraction (total dose of 2 Gy)

Cyclophosphamidedrug

Cyclophosphamide is administered on the third day after the hematopoietic stem cell transplantation (HSCT) to help reduce graft-versus-host disease (GVHD). It is given at a dose of 60 mg/kg/d for 2 days on days +3 and +4.

Tacrolimusdrug

Started the fifth day after the transplant to help prevent graft-versus-host disease (GVHD).

Mycophenolate mofetildrug

Started the fifth day after the transplant to help prevent graft-versus-host disease (GVHD).

Fludarabinedrug

Started the fifth day before the transplant. Given for four days at 30 mg/m2/d.

Busulfandrug

Started the fourth day before the transplant. Given for two days at 3.2 mg/kg.

Hematopoietic stem cell transplantationgenetic

Allogeneic marrow transplantation given after the last dose of total body irradiation (TBI)