CI

At a glance

ClinicalIndex Comparison Record
Phase 2Completed· 25 enrolled
Drug / intervention
Donor Lymphocyte Infusion (DLI) +6 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/NCT01341301
NCT01341301Phase 2Completed

A Two Step Approach to Allogeneic Hematopoietic Stem Cell Transplantation for High-Risk Hematologic Malignancies Using One Human Leukocyte Antigen Partially-Matched Related Donor

Sidney Kimmel Comprehensive Cancer Center at Thomas Jefferson University·interventional·Posted Apr 25, 2011·Updated Apr 30, 2025

In Brief

A Phase 2 clinical trial evaluating Total Body Irradiation, Donor Lymphocyte Infusion (DLI), and 5 other interventions for Hematologic Malignancy. Completed, enrolled 25 participants across 1 site.

Detailed Summary

The purpose of this research study is to examine the survival of patients undergoing partially matched hematopoietic stem cell transplant (HSCT) on a new type of treatment approach, which has been developed specifically for patients who have evidence of their disease at the time of transplant. In this research study, a way of strengthening the response of the donor cells against the disease has been developed. Patients will undergo one additional day between the two steps of the transplant which may allow their donor's cells to fight the disease more effectively.

Study Details

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

Timeline

Phase 2CompletedFinished
20102011201220132014201520162017201820192020202120222023202420252026
First PostedApr 25, 2011
Enrollment StartMay 1, 2010
Primary CompletionNov 4, 2013
Study CompletionAug 7, 2014
TodayJul 2, 2026
Enrollment to primary: 3.5 yearsPosted 15.2 years ago

Interventions

Total Body Irradiationradiation

Undergo TBI

Donor Lymphocyte Infusion (DLI)biological

Undergo DLI

Cyclophosphamidedrug

Given IV

Tacrolimusdrug

Given IV or PO

Mycophenolate mofetildrug

Given IV or PO

Allogeneic hematopoietic stem cell transplantationprocedure

Undergo allogeneic HSCT

Laboratory biomarker analysisother

Correlative studies