Stem Cell Transplant in Treating Patients With Hematological Cancer or Other Disorders

Phase 2

• Conditions: Graft Versus Host Disease; Leukemia; Lymphoma; Multiple Myeloma and Plasma Cell Neoplasm; Precancerous Condition

• Registration Number: NCT00740467
• Lead Sponsor: Institut Paoli-Calmettes

Brief Summary

RATIONALE: Giving chemotherapy, such as fludarabine, busulfan, and cyclophosphamide, together with antithymocyte globulin before a donor stem cell transplant helps stop the growth of cancer and abnormal cells. Giving chemotherapy before or after transplant also stops 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 and abnormal cells (graft-versus-tumor effect). Sometimes the transplanted cells from a donor can also make an immune response against the body's normal cells. Giving cyclosporine and mycophenolate mofetil after the transplant may stop this from happening.

PURPOSE: This phase II trial is studying how well stem cell transplant works in treating patients with hematological cancer or other disorders.

Detailed Description

OBJECTIVES:

Primary

* Evaluate the incidence of graft acceptance in patients with hematological disorders treated with combined immunosuppression before and after HLA-haploidentical hematopoietic stem cell transplantation.

Secondary

* Evaluate efficacy of this regimen in these patients.

* Evaluate toxicity of this regimen in these patients.

* Assess survival of patients treated with this regimen.

OUTLINE: This is a multicenter study.

* Reduced-intensity conditioning: Patients receive fludarabine phosphate IV on days -6 to -1, busulfan IV on days -6 to -5, and anti-thymocyte globulin IV on days -4 to -1.

* Transplantation: Patients undergo transplantation of donor hematopoietic stem cells on day 0. Patients also receive cyclophosphamide IV on day 3 and filgrastim (G-CSF) beginning on day 4 and continuing until blood counts recover.

* Immunosuppression: Patients receive cyclosporine IV beginning on day -2 and continuing for 6 months and mycophenolate mofetil 4 times a day on days 4-84.

Study Timeline

• Study Start: 2008-01
• Study First Submitted: 2008-08-22
• Study First Submitted QC: 2008-08-22
• Study First Posted: 2008-08-25
• Status Verified: 2009-07
• Primary Completion: 2010-01
• Last Update Submitted: 2010-01-27
• Last Update Posted: 2010-01-28

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 50

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Incidence of graft acceptance

Trial Locations

Locations (1)

Marseille Institute of Cancer - Institut J. Paoli and I. Calmettes; 🇫🇷 Marseille, France