Status:
TERMINATED
GEMHDM2014 : Gem-HDM HDT and ASCT for Relapsed/ Refractory Lymphoma
Lead Sponsor:
AHS Cancer Control Alberta
Collaborating Sponsors:
Tom Baker Cancer Centre
Conditions:
Hodgkin's Lymphoma - Relapsed/Refractory
Non-Hodgkin's Lymphoma - Aggressive
Eligibility:
All Genders
18+ years
Phase:
PHASE1
PHASE2
Brief 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 i...
Detailed Description
High-dose chemotherapy with autologous stem cell transplantation is the current standard of care for patients with chemosensitive relapsed Hodgkin's lymphoma and aggressive non-Hodgkin's lymphoma, and...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
April 1 2015
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
February 1 2023
Estimated Enrollment :
100 Patients enrolled
Trial Details
Trial ID
NCT02295722
Start Date
April 1 2015
End Date
February 1 2023
Last Update
July 8 2024
Active Locations (1)
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1
Tom Baker Cancer Center
Calgary, Alberta, Canada, T2N 4N2