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

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.

Conditions

• Leukemia
• Lymphoma
• Myelodysplastic Syndromes

Interventions

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

Sponsors & Collaborators

• Northside Hospital, Inc.

  lead OTHER

Principal Investigators

• Scott R. Solomon, MD · Blood and Marrow Transplant Group of Georgia

• H. Kent Holland, MD · Blood and Marrow Transplant Group of Georgia

• Asad Bashey, MD, PhD · Blood and Marrow Transplant Group of Georgia

• Lawrence E. Morris, MD · Blood and Marrow Transplant Group of Georgia

Study Design

Allocation

NA

Purpose

TREATMENT

Masking

NONE

Model

SINGLE_GROUP

Eligibility

Min Age

18 Years

Max Age

60 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2008-10-31

Primary Completion

2011-04-30

Completion

2012-04-30

Countries

• United States

Study Locations