Safety and Efficacy of Pentostatin and Low Dose TBI With Allogenic Peripheral Blood Stem Cell Transplant

PHASE2CompletedINTERVENTIONAL
Enrollment

76

Participants

Timeline

Start Date

December 8, 2000

Primary Completion Date

December 30, 2008

Study Completion Date

December 30, 2008

Conditions
Acute Myelogenous LeukemiaAcute Lymphocytic LeukemiaChronic Myelogenous LeukemiaChronic Lymphocytic LeukemiaMyelodysplastic SyndromesMultiple MyelomaNon-Hodgkins LymphomaHodgkins DiseasePeripheral T-cell Lymphoma
Interventions
DRUG

Pentostatin

4 mg/m\^2 intravenous(IV)once a day(QD)x3days (days -10, -9, -8)

RADIATION

Total-body irradiation (TBI)

TBI will consist of 2.0 GY at 8-12cGy/min via 6MV photons delivered AP/PA fields, without lung blocks or via lateral fields with lucite compensator along the head and neck region. TLD (thermal luminescent dosimetry) will be used to verify dose uniformity. TBI will be given on day -1.

DRUG

Cyclosporine A (CsA)

CsA will be given at 2.0 mg/kg intravenous (IV) Q 12hrs on days -1,0,and+1 (total 6 doses) then converted to oral at 2 mg/kg by mouth (PO) twice a day (BID) until day+80, then tapered 10% per week over approximately 3 months if no GVHD for related donor transplants. For unrelated CsA will be given at same dose and schedule until day+100 then tapered by 10% per week if no GVHD

DRUG

Mycophenolate Mofetil (MMF)

MMF 15 mg/kg by mouth twice a day (PO BID) will be given from day 0-27 then stopped without tapering for related donor transplants. For unrelated donor transplants MMF will be given at same dose until day+40 then tapered over 2months. in absence of GVHD. Doses will be rounded to nearest 250 mg.

DRUG

G-CSF

10 mcg/kg/day subcutaneously for at least 4 consecutive days.

Trial Locations (1)

68198

University of Nebraska Medical Center, Section of Oncology/Hematology, Omaha

Sponsors
All Listed Sponsors
collaborator

Astex Pharmaceuticals, Inc.

INDUSTRY

lead

University of Nebraska

OTHER