CI

At a glance

ClinicalIndex Comparison Record
Phase 2Completed· 18 enrolled
Drug / intervention
Anti-Thymocyte Globulin +5 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/NCT02424968
NCT02424968Phase 2Completed

Post Transplant Infusion of Allogeneic CD8 Memory T-Cells as Consolidative Therapy After Non-myeloablative Allogeneic Hematopoietic Cell Transplantation in Patients With Leukemia and Lymphoma

Robert Lowsky·interventional·Posted Apr 23, 2015·Updated Jun 24, 2021

In Brief

A Phase 2 clinical trial evaluating Anti-Thymocyte Globulin, Cyclosporine, and 4 other interventions for Acute Myeloid Leukemia and 6 related conditions. Completed, enrolled 18 participants across 1 site.

Detailed Summary

This phase 2 trial studies how well cluster of differentiation 8 (CD8)+ memory T-cells work as a consolidative therapy following a donor non-myeloablative hematopoietic cell transplant in treating patients with leukemia or lymphoma. Giving total lymphoid irradiation and anti-thymocyte globulin before a donor hematopoietic 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 cyclosporine and mycophenolate mofetil after the transplant may stop this from happening. Once the donated stem cells begin working, the patient's immune system may see the remaining cancer cells as not belonging in the patient's body and destroy them. Giving an infusion of the donor's white blood cells, such as CD8+ memory T-cells, may boost this effect and may be an effective treatment to kill any cancer cells that may be left in the body (consolidative therapy).

Study Details

Timeline

Phase 2CompletedFinished
201520162017201820192020202120222023202420252026
First PostedApr 23, 2015
Enrollment StartJun 1, 2015
Primary CompletionJul 3, 2020
Study CompletionApr 1, 2021
TodayJul 2, 2026
Enrollment to primary: 5.1 yearsPosted 11.2 years ago

Interventions

Anti-Thymocyte Globulinbiological

Given per standard institutional practice

Cyclosporinedrug

Given PO

Mycophenolate Mofetildrug

Given PO

Nonmyeloablative Allogeneic Hematopoietic Stem Cell Transplantprocedure

Undergo nonmyeloablative allogeneic HSCT

Allogeneic Cluster of Differentiation 8 (CD8)+ Memory T-cellsbiological

Receive CD8+ memory T-cells via IV

Total Nodal Irradiationradiation

Undergo TLI