Allogeneic Bone Marrow Transplantation Using Less Intensive Therapy

Summary

RATIONALE: A peripheral stem cell transplant may be able to replace blood-forming cells that were destroyed by chemotherapy and radiation therapy, or that have become cancer. Sometimes the transplanted cells from a donor can make an immune response against the body's normal cells. Giving cyclophosphamide and fludarabine together with total-body irradiation followed by cyclosporine and mycophenolate mofetil before the transplant may stop this from happening.

PURPOSE: This clinical trial is studying how well giving combination chemotherapy together with radiation therapy followed by cyclosporine and mycophenolate mofetil works in treating patients who are undergoing a donor stem cell transplant for hematologic cancer, metastatic breast cancer, or kidney cancer.

Conditions

• Kidney Cancer
• Leukemia
• Lymphoma
• Multiple Myeloma
• Plasma Cell Neoplasm
• Myelodysplastic Syndromes

Interventions

BIOLOGICAL

anti-thymocyte globulin

ATG dose is 15 mg/kg intravenous (IV) every 12 hours for 6 doses on days -6, -5, and -4. Those that should/will receive ATG in the preparative regimen: * Related donor recipients who have not had exposure to combination chemotherapy in the 6 months preceding transplant should * Unrelated donor recipients who have not had exposure to combination chemotherapy in the 3 months preceding transplant will * Unrelated donor recipients who have had only a single induction cycle for the treatment of ALL/AML or MDS or CML blast crisis should * Recipients with a prior autologous transplant in the year prior to second transplant do not require ATG.

DRUG

cyclophosphamide

Cyclophosphamide will be given in a two hour infusion, total dose 50 mg/kg on day -6.

DRUG

cyclosporine

Patients will receive cyclosporine A (CSA) therapy beginning on day -3 maintaining a level of \>200. For adults the initial dose will be 2.5 mg/kg IV over 2 hours every 12 hours. For children \< 40 kg the initial dose will be 2.5 mg/kg IV over 2 hours every 8 hours. Patients will receive CSA until day +100.

DRUG

fludarabine

Fludarabine 30 mg/m\^2/day intravenous (IV) on day -6 through day -2., total dose 150 mg/m\^2 for 5 days.

DRUG

mycophenolate mofetil

Mycophenolate mofetil (MMF) 1.5 gram twice a day (BID) or if \< 50 kg will be given 15 mg/kg orally(po) BID,beginning on day -3, and discontinue at day +30 or 7 days after engraftment (3 consecutive days of absolute neutrophil count (ANC) \> 0.5 x 109 /L).

PROCEDURE

stem cell transplantation

On day 0, if related donor, stem cells are infused via central line. If unrelated donor, marrow/PBSC is infused after arrival and processing on day 0.

RADIATION

total body irradiation

The dose of TBI will be 200 cGy given in a single fraction on day -1.

DRUG

filgrastim

Patients with white blood cell (WBC) counts \< 2500 any time after stem cell infusion will be started on G-CSF support at Day +5 at a dose of 5 mcg/kg intravenously or subcutaneously (IV/SQ) daily rounded to vial size until absolute neutrophil count (ANC) \> 2500 for 2 consecutive days.

Sponsors & Collaborators

• Masonic Cancer Center, University of Minnesota

  lead OTHER

Principal Investigators

• Erica Warlick, MD · Masonic Cancer Center, University of Minnesota

Study Design

Allocation

NON_RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Model

PARALLEL

Eligibility

Max Age

75 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2002-03-26

Primary Completion

2019-05-08

Completion

2019-05-08

Countries

• United States

Study Locations