Donor Stem Cell Transplant in Treating Patients With Relapsed Hematologic Cancer

Summary

RATIONALE: Giving low doses of chemotherapy, such as fludarabine and busulfan, before a donor bone marrow or peripheral blood stem cell transplant helps stop the growth of cancer cells. It also stops the patient's immune system from rejecting the donor's stem cells. The donated stem cells may replace the patient's immune system and help destroy any remaining cancer cells (graft-versus-tumor effect). Giving an infusion of the donor's T cells (donor lymphocyte infusion) after the transplant may help increase this effect. Sometimes the transplanted cells from a donor can also make an immune response against the body's normal cells. Giving immunosuppressive therapy after the transplant may stop this from happening.

PURPOSE: This phase II trial is studying how well donor bone marrow or peripheral stem cell transplant works in treating patients with relapsed hematologic cancer after treatment with chemotherapy and autologous stem cell transplant.

Conditions

• Leukemia
• Lymphoma
• Multiple Myeloma
• Plasma Cell Neoplasm
• Myelodysplastic Syndromes
• Myeloproliferative Neoplasms

Interventions

BIOLOGICAL

anti-thymocyte globulin

2.5mg/kg/day IV infusion over 6 hrs x 4 doses Days -4 to -1 (for MUD and 9/10 related donor transplants only)

BIOLOGICAL

G-CSF

5 ug/kg/day subQ injection Day 7 until ANC\> 1000/uL for 3 consec days

DRUG

busulfan

0.8mg/kg IV infusion over 2 hrs q 6 hrs x 8 doses Days -4 thru -3

DRUG

fludarabine phosphate

30 mg/sq m/day IVBP over 30 min Days -7 thru -3

DRUG

methotrexate

5 mg/sq m/day IV infusion Days 1, 3, \& 6 for HLA-identical donor transplants and Days 1, 3, 6, \& 11 for MUD \& 9/10 related donor transplants

DRUG

mycophenolate mofetil

15mg/kg PO bid Day -2 to Day 60, then taper as tolerated (for MUD and 9/10 related donor transplants only)

DRUG

tacrolimus

target serum level is 5-10 ng/mL. Start with 0.03mg/kg PO bid Day -1 to Day 90, then taper thru Day 150 for HLA identical donor transplants and Day -1 to Day 180 then taper for MUD and 9/10 related donor transplants

PROCEDURE

allogeneic cell transplantation

2,000,000-8,000,000 CD34+ cells total via infusion Days 0 and 1

DRUG

allopurinol

300 mg/day PO Days -8 thru -1

Sponsors & Collaborators

• National Cancer Institute (NCI)

  collaborator NIH

• Alliance for Clinical Trials in Oncology

  lead OTHER

Principal Investigators

• Asad Bashey, MD, PhD · University of California, San Diego

Study Design

Allocation

NON_RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Model

SINGLE_GROUP

Eligibility

Max Age

69 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2002-12-31

Primary Completion

2006-11-30

Completion

2010-08-31

Countries

• United States

Study Locations