CI

At a glance

ClinicalIndex Comparison Record
Phase 2Completed· 41 enrolled
Drug / intervention
Donor Lymphocyte Infusion (DLI) +4 morebiological
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/NCT01982682
NCT01982682Phase 2Completed

A Two Step Approach to Allogeneic Hematopoietic Stem Cell Transplantation for High-Risk Hematologic Malignancies Using One Haploidentical Donor

Sidney Kimmel Comprehensive Cancer Center at Thomas Jefferson University·interventional·Posted Nov 13, 2013·Updated Apr 30, 2025

In Brief

A Phase 2 clinical trial evaluating Total-Body Irradiation (TBI), Donor Lymphocyte Infusion (DLI), and 3 other interventions for Hematopoietic/Lymphoid Cancer. Completed, enrolled 41 participants across 1 site.

Detailed Summary

This phase II trial studies how well total-body irradiation, donor lymphocyte infusion, and cyclophosphamide before donor stem cell transplant works in treating patients with high-risk hematologic malignancies. Giving total-body irradiation, donor lymphocyte infusion, and chemotherapy before a donor stem cell transplant helps stop the growth of cancer and abnormal cells and helps stop the patient's immune system from rejecting the donor's stem cells. When certain 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. Removing the T cells from the donor cells before transplant and giving tacrolimus and mycophenolate mofetil may stop this from happening.

Study Details

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

Timeline

Phase 2CompletedFinished
2014201520162017201820192020202120222023202420252026
First PostedNov 13, 2013
Enrollment StartNov 4, 2013
Primary CompletionMar 27, 2017
TodayJul 2, 2026
Enrollment to primary: 3.4 yearsPosted 12.6 years ago

Interventions

Total-Body Irradiation (TBI)radiation

Undergo TBI

Donor Lymphocyte Infusion (DLI)biological

Undergo DLI

Cyclophosphamidedrug

Given IV

Allogeneic hematopoietic stem cell transplantation (HSCT)procedure

Undergo CD34+ selected allogeneic HSCT

Mycophenolate mofetildrug

Given IV