High-Dose Gemcitabine, Busulfan and Melphalan for Patients With Refactory Hodgkin's Disease
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|ClinicalTrials.gov Identifier: NCT01200329|
Recruitment Status : Completed
First Posted : September 13, 2010
Results First Posted : December 16, 2019
Last Update Posted : December 16, 2019
|Condition or disease||Intervention/treatment||Phase|
|Lymphoma||Drug: Gemcitabine Drug: Busulfan Drug: Melphalan Procedure: Stem Cell Transplantation Drug: Palifermin||Phase 2|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||81 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||High-Dose Gemcitabine, Busulfan and Melphalan With Hematopoietic Cell Support for Patients With Relapsed/Refractory Hodgkin's Disease|
|Actual Study Start Date :||June 2011|
|Actual Primary Completion Date :||December 6, 2018|
|Actual Study Completion Date :||December 6, 2018|
Experimental: Gemcitabine + Busulfan + Melphalan
Gemcitabine 2775 mg/m2 by vein over about 3 hours on days -8 and -3. Busulfan 32 mg/m2 test dose with PKs as outpatient and on day -10 as inpatient. AUC 4,000 by vein over about 3 hours on days -8 to -5. Melphalan 60 mg/m2 by vein over about 30 minutes on days -3 and -2. Palifermin 60 mg/kg by vein over 30 seconds daily, Days -12 to -10 and Days 0 to 2. Infusion of stem cells on Day 0.
2775 mg/m2 by vein over about 3 hours on days -8 and -3.
32 mg/m2 test dose with PKs as outpatient and on day -10 as inpatient
AUC 4,000 by vein over about 3 hours on days -8 to -5.
60 mg/m2 by vein over about 30 minutes on days -3 and -2.
Other Name: Alkeran
Procedure: Stem Cell Transplantation
Infusion of stem cells on Day 0.
Other Name: SCT
60 mg/kg by vein over 30 seconds daily, Days -12 to -10 and Days 0 to 2.
Other Name: Kepivance
- Event-free Survival (EFS) of Patients [ Time Frame: Enrollment up to 2 years post transplant ]The event-free survival (EFS) of patients with poor prognosis relapse or refractory Hodgkin's disease (HD) after high-dose chemotherapy (HDC) with Gemcitabine/Busulfan/Melphalan (GemBuMel). Event is defined as relapse, tumor progression or death.Progression free survival is the length of time during and after the treatment of disease that a patient lives with the disease but it does not get worse. Toxicity is defined as the treatment related mortality (TRM) rate, which will be evaluated within 30 days post transplant, and this rate will be compared with the 5% maximum rate. For EFS analysis, patients who experience the tumor relapse, disease progression, or death will be considered to be an event.
- Overall Survival (OS) of These Patients. [ Time Frame: Beyond 100 days post transplant up to 84 months. ]The overall survival is the length of time from the start of treatment (Auto SCT) for the cancer, that patients are diagnosed with are still alive until date of first documented progression or date of death from any cause. It is measured in months and assessed up to 84 months.
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): NCT01200329
|United States, Texas|
|University of Texas MD Anderson Cancer Center|
|Houston, Texas, United States, 77030|
|Principal Investigator:||Yago Nieto, MD, PHD||M.D. Anderson Cancer Center|