This is a clinical research study designed to evaluate whether a conditioning regimen consisting of the combination of three drugs named melphalan, alemtuzumab and clofarabine supported by donor blood cells will result in rapid recovery and a high rate of long-lasting remissions in patients with leukemia, lymphoma and myeloma.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
82
Clofarabine will be administered as a 2-hour IV infusion on Days 1 through 5 at approximately the same time everyday (4 dose levels).
Doses ranging from 100 to 140 mg/m2
20mg/d x5
The University of Chicago
Chicago, Illinois, United States
Number of Participants With Hepatic Adverse Events During the Conditioning Regimen Prior to Stem Cell Transplantation
Toxicity was scored according to NCI/CTC version 3
Time frame: Day 7 until Day 30
Number of Participants With Renal Adverse Events During the Conditioning Regimen Prior to Stem Cell Transplantation
Toxicity was scored according to NCI/CTC version 3
Time frame: Day 7 until Day 30
Number of Participants With Skin Adverse Events During the Conditioning Regimen Prior to Stem Cell Transplantation
Toxicity was scored according to NCI/CTC version 3
Time frame: Day 7 until Day 30
Number of Participants With Other Adverse Events During the Conditioning Regimen Prior to Stem Cell Transplantation
Toxicity was scored according to NCI/CTC version 3
Time frame: Day 7 until Day 30
Overall Survival (OS)
Time frame: 1 year
Progression-free Survival (PFS)
Progression is defined from stem cell infusion to disease relapse, i.e., recurrence of hematologic malignancy and/or need for treatment after transplant for disease or death from any cause, whichever occurred first.
Time frame: 1 year
Treatment-related Mortality (TRM)
Time frame: 1 year
Relapse Rate
Time frame: 1 year
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Infusion of donor, bone marrow and auto.