Gemcitabine Plus Busulfan, Melphalan and Hematopoietic Cell Transplant for Advanced Lymphoid Malignancies
|ClinicalTrials.gov Identifier: NCT00410982|
Recruitment Status : Completed
First Posted : December 13, 2006
Last Update Posted : June 3, 2016
|Condition or disease||Intervention/treatment||Phase|
|Leukemia Lymphoma Myeloma||Drug: Busulfan Drug: Gemcitabine Drug: Melphalan Other: Hematopoietic Cell Transplantation Drug: Rituximab for Patients with B-Cell Malignancies Drug: Palifermin||Phase 1|
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|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||145 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||Gemcitabine Combined With Busulfan and Melphalan, With Hematopoietic Cell Transplantation, for Patients With Poor-prognosis Advanced Lymphoid Malignancies|
|Study Start Date :||December 2006|
|Actual Primary Completion Date :||September 2012|
|Actual Study Completion Date :||September 2012|
Experimental: Gemcitabine + Busulfan + Melphalan + HCT
HCT = Hematopoietic Cell Transplantation
Day -10 = 32 mg/m^2 Intravenous Test Dose; Days -8 thru -5 = 105 mg/m^2 Intravenous
Other Names:Drug: Gemcitabine
Day -8 = 75 mg/m^2 Intravenous bolus; Day -3 = 75 mg/m^2 Intravenous bolus.
Other Names:Drug: Melphalan
Day -3 and Day -2 = 60 mg/m^2 Intravenous.
Other Name: AlkeranOther: Hematopoietic Cell Transplantation
Infusion of stem cells on Day 0.
Other Names:Drug: Rituximab for Patients with B-Cell Malignancies
375 mg/m^2 Intravenous on Days 1 and 8.
Other Name: RituxanDrug: Palifermin
60 microgram/kg by vein on Days -13 to -11 and Days 0, +1, +2
Other Name: Kepivance
- Maximum Tolerated Dose (MTD) of Gemcitabine with Busulfan + Melphalan [ Time Frame: Baseline to Day 100 post transplant, up to 115 days ]MTD defined as dose level where one of two participants enrolled at a given time have no dose limiting toxcities (DLT) at that dose level. Continual reassessment from baseline for DLT, monitored daily during hospitalization, weekly to Day 30 and monthly to Day 100. Dose level assessed with each 21-day dose escalation cycle, Gemcitabine delivered Day -8 to Day -5 of 21 day cycle.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00410982
|United States, Texas|
|UT MD Anderson Cancer Center|
|Houston, Texas, United States, 77030|
|Principal Investigator:||Yago Nieto, MD, PhD||M.D. Anderson Cancer Center|