Reduced-Intensity Conditioning Before Donor Stem Cell Transplant in With High-Risk Hematologic Malignancies

Phase 2 Completed 62 enrolled Sidney Kimmel Comprehensive Cancer Center at Thomas Jefferson University

NaSingle-groupOpen-labelTreatment

Summary

This phase II trial studies reduced-intensity conditioning before donor stem cell transplant in treating patients with high-risk hematologic malignancies. Giving low-doses of chemotherapy and total-body irradiation before a donor stem cell transplant helps stop the growth of cancer cells. It may also stop the patient's immune system from rejecting the donor's stem cells. The donated stem cells may replace the patient's immune cells and help destroy any remaining cancer cells (graft-versus-tumor effect). Giving an infusion of the donor's T cells (donor lymphocyte infusion) before the transplant may help increase this effect.

Timeline

Start: 2012-12-24
Primary completion: 2022-04-15
Completion: 2022-12-05

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	Busulfan	Small molecule	—	Intravenous
Subject	Cyclophosphamide	Other / unclassified	—	Intravenous
Subject	Fludarabine	Small molecule	—	Intravenous
Subject	therapeutic allogeneic lymphocytes	Cell therapy	—	—
Background	Mycophenolate Mofetil	Small molecule	—	Intravenous
Background	Tacrolimus	Small molecule	—	Intravenous

Reduced-Intensity Conditioning Before Donor Stem Cell Transplant in With High-Risk Hematologic Malignancies

Summary

Timeline

Drugs

Indications