Clofarabine and Non-Myeloablative Allogeneic Hematopoietic Transplantation
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|ClinicalTrials.gov Identifier: NCT00626626|
Recruitment Status : Terminated (Investigator decision)
First Posted : February 29, 2008
Last Update Posted : January 10, 2013
|Condition or disease||Intervention/treatment||Phase|
|Leukemia Myelodysplastic Syndrome Chronic Myelogenous Leukemia Lymphoma Hodgkin's Lymphoma Multiple Myeloma||Drug: Dose Level I Drug: Dose Level 2||Phase 1 Phase 2|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||10 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||Clofarabine and Non-Myeloablative Allogeneic Hematopoietic Transplantation|
|Study Start Date :||May 2007|
|Primary Completion Date :||January 2010|
|Study Completion Date :||January 2010|
Phase 1: 1-3 patients will be treated in order to establish Cyclophosphamide and Clofarabine dose and to confirm reasonable safety and engraftment efficacy.
Drug: Dose Level I
Hydrocortisone 100 mg IV 30 minutes prior to each dose of Clofarabine. Ondansetron 16 mg PO or IV or another comparable antiemetic should be given prior to each dose of Clofarabine. An additional similar dose should be given prior to Cyclophosphamide dose. Clofarabine 30 mg/M2 -8 through - 4 (5 doses) infusion. Alemtuzumab on day -8 only and after Clofarabine. Cyclophosphamide 500 mg/m2 Days -8 and -7 (2 doses) given over 1 hour beginning 4 hours after the beginning of Clofarabine infusion.
Other Name: CLOLAR
Phase II patients 4-9 will treat at the selected dose level of Clofarabine and Cyclophosphamide.
Drug: Dose Level 2
Hydrocortisone 100 mg IV 30 minutes prior to each dose of Clofarabine. Ondansetron 16 mg PO or IV or another comparable antiemetic should be given prior to each dose of Clofarabine. An additional similar dose should be given prior to Cyclophosphamide dose. Clofarabine 30 mg/M2 -8 through - 4 (5 doses) infusion. Alemtuzumab on day -8 only and after Clofarabine. Cyclophosphamide 1000 mg/m2 Days -8 and -7 (2 doses) given over 1 hour beginning 4 hours after the beginning of Clofarabine infusion (patients 4-9)
- Establish the safety of Clofarabine and cyclophosphamide preceding allogeneic hematopoietic engraftment. Assess the efficacy of Clofarabine and cyclophosphamide as conditioning for promoting allogeneic hematopoietic engraftment. [ Time Frame: two years ]
- Observe disease free and overall survivals in acute leukemia and lymphoma patients receiving allogeneic hematopoietic transplant after Clofarabine and cyclophosphamide conditioning. [ Time Frame: Two years ]
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00626626
|United States, Pennsylvania|
|Penn State College of Medicine, Penn State Milton S. Hershey Medical Center|
|Hershey, Pennsylvania, United States, 17033|
|Principal Investigator:||David F Claxton, MD||Penn State College of Medicine|