GEMHDM2014 : Gem-HDM HDT and ASCT for Relapsed/ Refractory Lymphoma

• Status: Unknown status
• Trial end date: 2018-01-01
• Target enrollment: 0
• Participant gender: All

Summary

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.

• Phase: Phase 1/Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: AHS Cancer Control Alberta
• Collaborator: Tom Baker Cancer Centre
• Treatments: Gemcitabine; Melphalan

Criteria

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