NCT00143845

Study of Low-Intensity Conditioning for Allogeneic Stem Cell Transplant

Phase II Trial of Adjuvant Cellular Immunotherapy for High-Risk Hematologic Malignancy After Reduced Intensity Allogeneic Stem Cell Transplantation

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 54 (actual)
• Sponsor: University of Michigan Rogel Cancer Center · Academic / Other
• Sex: All
• Age: —
• Healthy volunteers: Not accepted

Summary

The purpose of this study is to determine whether a reduced intensity conditioning regimen for stem cell transplant with donor cells will allow the donor cells to be effective without causing health problems.

Detailed description

In this research study patients will receive dosages of chemotherapy that are lower than the usual dosages. The study will determine whether a shorter duration of immunosuppression will permit the donor cells to be effective against the cancer without causing more severe GVHD (Graft Versus Host Disease). Also to be determined is whether the patient's cancer can be prevented from relapsing after blood stem cell transplant by using prophylactic treatment, giving a donor leukocyte infusion BEFORE a relapse happens. In this research study samples of blood and bone marrow will be analyzed. These samples will be examined to study the cellular production of inflammatory cytokine levels in attempt to be able to predict which patients will have complications like GVHD or relapse.

Conditions

• Multiple Myeloma
• Lymphocytic Leukemia, Chronic
• Lymphoma, Low-Grade

Interventions

Type	Name	Description
PROCEDURE	Reduced intensity conditioning	Busulfan and Fludarabine regimen
PROCEDURE	Rapid immunosuppressive taper	Taper of Tacrolimus, Methotrexate and Mycophenolate Mofetil
PROCEDURE	Prophylactic donor leukocyte infusions	If the patient has GVHD overall grade 0-1 or skin grade 1 on day +100, then 5 x 107 CD3+ cells/kg recipient weight are given.

Timeline

• Start date: 2003-04-01
• Primary completion: 2010-11-01
• Completion: 2013-02-01
• First posted: 2005-09-02
• Last updated: 2017-03-08
• Results posted: 2014-06-20

Locations

1 site across 1 country: United States