Infusional Gemcitabine and High-dose Melphalan (HDM) Conditioning Prior to (ASCT) Autologous Stem Cell Transplantation for Patients With Relapsed/Refractory Lymphoma

GEMHDM2014

Objective of study: To evaluate the safety and efficacy of infusional gemcitabine prior to HDM (high-dose melphalan) as HDCT (High Dose Chemotherapy) followed by autologous stem cell transplantation in patients with relapsed/refractory lymphoma.

2015-04-01

2023-01-01

2023-01-01

Terminated

Early phase I

100

Inclusion Criteria: 1. Ability to provide written informed consent 2. Age over 18 years 3. Relapsed/refractory lymphoma after at least 1 prior chemotherapy treatment: 1. Hodgkin's lymphoma 2. Aggressive non-Hodgkin's lymphoma 3. Follicular lymphoma 4. Chemosensitive disease at time of transplantation (i.e. partial response or better to salvage chemotherapy) 5. ECOG (Eastern Cooperative Oncology Group) performance 0-2 6. Adequate organ function: 1. Cardiac: LVEF (left ventricular ejection fraction)\>40% 2. Pulmonary: FEV1 (forced expiratory volume at one second) and DLCO (diffusing capacity of lung for carbon monoxide)\>60% predicted 3. Renal: creatinine \<150 µmol/L unless caused by ureteric obstruction from lymphoma 4. 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: 1. Clinically significant active infection 2. Active secondary central nervous system disease 3. Other serious co-morbid illness that would compromise study participation. 4. Pregnant or lactating females 5. Prior HDCT/ASCT

{'studyType': 'INTERVENTIONAL', 'phases': ['PHASE1', 'PHASE2'], 'designInfo': {'allocation': 'NA', 'interventionModel': 'SINGLE_GROUP', 'primaryPurpose': 'TREATMENT', 'maskingInfo': {'masking': 'NONE'}}, 'enrollmentInfo': {'count': 100, 'type': 'ACTUAL'}}

2023-03-27