NCT03032783

A Two Step Approach to Allogeneic Hematopoietic Stem Cell Transplantation for Patients With Hematologic Malignancies-Increasing GVT Effects Without Increasing Toxicity

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 51 (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 the how well donor stem cell transplant works in treating patients with high risk hematologic malignancies. Giving total-body irradiation and chemotherapy before a donor stem cell transplant helps stop the growth of cells in the bone marrow, including normal blood-forming cells (stem cells) and cancer cells. It may also stop the patient's immune system from rejecting the donor's stem 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. The donated stem cells may also replace the patient's immune cells and help destroy any remaining cancer cells.

Detailed description

Primary Objective: 1\. To assess 2 year probability of OS in high risk patients undergoing a myeloablative 2 step HSCT utilizing strategies to decrease relapse. Secondary Objective: 1. To assess relapse incidence at 2 years post-HSCT of patients undergoing treatment on this protocol. 2. To assess regimen related toxicity and GVHD incidence at 2 years post-HSCT and severity in patients undergoing treatment on this protocol. 3. To assess the consistency and pace of engraftment. 4. To assess the pace of T cell and B cell immune recovery.

Conditions

• Hematopoietic and Lymphoid Cell Neoplasm

Interventions

Type	Name	Description
RADIATION	Total-Body Irradiation	Undergo Total Body Irradiation
PROCEDURE	Donor Lymphocyte Infusion	Undergo Donor Lymphocyte Infusion
DRUG	Cyclophosphamide	Given IV
DRUG	Tacrolimus	Given IV
DRUG	Mycophenolate Mofetil	Given IV
PROCEDURE	Allogeneic Hematopoietic Stem Cell Transplantation	Undergo Hematopoietic Stem Cell Transplantation

Timeline

• Start date: 2017-01-31
• Primary completion: 2025-12-02
• Completion: 2025-12-02
• First posted: 2017-01-26
• Last updated: 2026-01-29

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated device study