NCT01982682

Allogeneic Hematopoietic Stem Cell Transplantation for High-Risk Hematologic Malignancies Using One Haploidentical Donor

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

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 41 (actual)
• Sponsor: Sidney Kimmel Comprehensive Cancer Center at Thomas Jefferson University · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Detailed description

PRIMARY OBJECTIVES: 1\) To assess 1 year relapse free survival in high risk patients undergoing hematopoietic stem cell transplant (HSCT) using the Thomas Jefferson University (TJU) 2 step approach with 2 days inserted between the last fraction of total-body irradiation (TBI) and the infusion of donor T cells (donor lymphocyte infusion \[DLI\]). SECONDARY OBJECTIVES: 1. To assess regimen related toxicity in this updated conditioning regimen, graft-versus-host disease (GVHD) incidence and severity, and overall survival in patients undergoing treatment on this protocol. 2. To assess the consistency and pace of engraftment. 3. To assess the pace of T cell and B cell immune recovery. OUTLINE: CONDITIONING REGIMEN: Patients undergo TBI twice daily (BID) on days -10 to -8, undergo DLI on day -6, and receive cyclophosphamide intravenously (IV) over 2 hours on days -3 and -2. TRANSPLANT: Patients undergo cluster of differentiation (CD) 34+ selected allogeneic HSCT on day 0. GVHD PROPHYLAXIS: Patients receive tacrolimus IV or orally (PO) beginning on day -1 with taper beginning by day 42, and mycophenolate mofetil IV BID on days -1 to 28. After completion of study treatment, patients are followed up for 1 year.

Conditions

• Hematopoietic/Lymphoid Cancer

Interventions

Type	Name	Description
RADIATION	Total-Body Irradiation (TBI)	Undergo TBI
BIOLOGICAL	Donor Lymphocyte Infusion (DLI)	Undergo DLI
DRUG	Cyclophosphamide	Given IV
PROCEDURE	Allogeneic hematopoietic stem cell transplantation (HSCT)	Undergo CD34+ selected allogeneic HSCT
DRUG	Mycophenolate mofetil	Given IV

Timeline

• Start date: 2013-11-04
• Primary completion: 2017-03-27
• Completion: 2017-03-27
• First posted: 2013-11-13
• Last updated: 2025-04-30
• Results posted: 2018-06-07

Locations

1 site across 1 country: United States