GEMHDM2014 : Gem-HDM HDT and ASCT for Relapsed/ Refractory Lymphoma (GEMHDM2014)
Hodgkin's Lymphoma - Relapsed/Refractory, Non-Hodgkin's Lymphoma - Aggressive, Follicular Lymphoma
About this trial
This is an interventional treatment trial for Hodgkin's Lymphoma - Relapsed/Refractory focused on measuring eligible for high-dose therapy and stem cell transplantation
Eligibility Criteria
Inclusion Criteria:
- Ability to provide written informed consent
- Age over 18 years
Relapsed/refractory lymphoma after at least 1 prior chemotherapy treatment:
- Hodgkin's lymphoma
- Aggressive non-Hodgkin's lymphoma
- Follicular lymphoma
- Chemosensitive disease at time of transplantation (i.e. partial response or better to salvage chemotherapy)
- ECOG (Eastern Cooperative Oncology Group) performance 0-2
Adequate organ function:
- Cardiac: LVEF (left ventricular ejection fraction)>40%
- Pulmonary: FEV1 (forced expiratory volume at one second) and DLCO (diffusing capacity of lung for carbon monoxide)>60% predicted
- Renal: creatinine <150 µmol/L unless caused by ureteric obstruction from lymphoma
- Liver: No evidence of cirrhosis. ALT (Alanine Aminotransferase) and bilirubin <2x upper limit of normal unless caused by biliary tract obstruction from lymphoma
Exclusion Criteria:
- Clinically significant active infection
- Active secondary central nervous system disease
- Other serious co-morbid illness that would compromise study participation.
- Pregnant or lactating females
- Prior HDCT/ASCT
Sites / Locations
- Tom Baker Cancer Center
Arms of the Study
Arm 1
Experimental
Gemcitabine/Melphalan Condition + ASCT
Day -1 - IV gemcitabine 1.5-2.5 g/m2 (depending on dose level assigned) administered as a loading bolus of 75 mg/m2, followed by a continuous infusion of 10 mg/m2/min. immediately following gemcitabine - IV melphalan 200 mg/m2 over 5 minutes. Day 0 •Stem cell infusion Patients will be assigned a dose level using the continual reassessment method based on the toxicity data available at the time of their enrollment. The dosing will start at 1.5 g/m2 and will increase by 0.5 mg/m2 at each level to a maximum of 2.5 g/m2. Dose-limiting toxicity is defined as grade 3 mucositis or skin toxicity lasting more than 3 days before downgrading, or any grade 4 non-hematological toxicity.