NCT00782379

Combination Chemotherapy, Donor Stem Cell Transplant, Tacrolimus, Mycophenolate Mofetil, and Cyclophosphamide in Treating Patients With Hematologic Cancer

A Phase II Trial of Myeloablative Conditioning and Transplantation of Partially HLA-Mismatched Peripheral Blood Stem Cells for Patients With Hematologic Malignancies

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 20 (actual)
• Sponsor: Northside Hospital, Inc. · Academic / Other
• Sex: All
• Age: 18 Years – 60 Years
• Healthy volunteers: Not accepted

Summary

RATIONALE: Giving chemotherapy, such as fludarabine, busulfan, and cyclophosphamide, before a donor peripheral blood stem cell transplant helps stop the growth of cancer cells and helps 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. Sometimes the transplanted cells from a donor can make an immune response against the body's normal cells. Giving high-dose cyclophosphamide together with tacrolimus and mycophenolate mofetil after transplant may stop this from happening. PURPOSE: This phase II trial is studying how well combination chemotherapy works when given together with a donor stem cell transplant, followed by tacrolimus, mycophenolate mofetil, and high-dose cyclophosphamide, in treating patients with high-risk hematologic cancer.

Detailed description

OBJECTIVES: Primary * To estimate the incidence of graft rejection and severe graft-versus-host disease after myeloablative HLA-mismatched peripheral blood stem cell transplantation (PBSCT) from first-degree relatives in patients with high-risk hematologic malignancies. Secondary * To estimate overall survival, relapse, non-relapse mortality, and event-free survival in these patients. * To characterize additional hematologic and non-hematologic toxicities of myeloablative haploidentical PBSCT. * To characterize donor hematopoietic chimerism in peripheral blood stem cells after PBSCT. OUTLINE: * Preparative regimen: Patients receive fludarabine phosphate IV over 30 minutes on days -7 to -2, busulfan IV over 3 hours on days -7 to -4, and cyclophosphamide IV over 1-2 hours on days -3 and -2. * Allogeneic peripheral blood stem cell transplantation (PBSCT): Patients undergo infusion of unmanipulated peripheral blood stem cells on day 0. * Post-transplant regimen: Patients receive high-dose cyclophosphamide IV over 1-2 hours on days 3 and 4, tacrolimus IV over 24 hours or orally twice daily on days 5-180, and oral mycophenolate mofetil 3 times daily on days 5-34 followed by a taper to day 90. Treatment continues in the absence of disease progression or clinically significant graft-vs-host disease. After completion of PBSCT, patients are followed periodically for 1 year.

Conditions

• Leukemia
• Lymphoma
• Myelodysplastic Syndromes

Interventions

Type	Name	Description
DRUG	busulfan	110 mg/m2 infused over 3 hours once daily on 4 consecutive days (Days -7, -6, -5, -4)
DRUG	cyclophosphamide	14.5 mg/kg infused over 1-2 hours once daily on 2 consecutive days (days -3,-2).
DRUG	fludarabine phosphate	30mg/m2 infused over 30 minutes once daily on three consecutive days (days -5, -4, -3)
DRUG	mycophenolate mofetil	15 mg/kg po three times a daily with a maximum dose of 3gm/day starting D+5. To be discontinued on Day +35 in the absence of clinically significant GVHD.
DRUG	tacrolimus	0.03 mg/kg/day infuse over 24 hours starting on day +5 (adjusted to maintain trough level of 5-15 ng/ml). Switch to oral (twice daily divided dose) on day +21 or when able to tolerate PO. Discontinue on day +180 in the absence of clinically significant GVHD.
PROCEDURE	allogeneic hematopoietic stem cell transplantation	Patients to received unmanipulated PBSCs on Day 0
PROCEDURE	peripheral blood stem cell transplantation	patients to receive unmanipulated PBSCs on day 0

Timeline

• Start date: 2008-10-01
• Primary completion: 2011-04-01
• Completion: 2012-04-01
• First posted: 2008-10-31
• Last updated: 2013-11-21
• Results posted: 2013-05-03

Locations

1 site across 1 country: United States