A Pilot Study of Rituximab-Gemcitabine-Navelbine for Relapsed/Refractory Hodgkin's Lymphoma
- Assess the response rate (complete response/remission, unconfirmed complete response,
partial response/remission) in patients with relapsed or refractory Hodgkin lymphoma
treated with 3 courses of rituximab, gemcitabine hydrochloride, and vinorelbine
- Assess progression-free survival, failure-free survival, and overall survival of
patients treated with this regimen.
- Characterize the safety profile of this regimen in these patients.
- Determine the rate of adequate stem cell collection (≥ 2 million CD34+ cells) in
patients eligible for stem cell transplantation.
OUTLINE: Patients are assigned to 1 of 2 treatment groups according to eligibility for stem
cell transplantation (SCT).
- Group 1 (eligible for SCT): Patients receive rituximab IV, vinorelbine ditartrate IV
over 6-10 minutes, and gemcitabine hydrochloride IV over 30 minutes on day 1 and
pegfilgrastim subcutaneously on day 2. Treatment repeats every 14 days for up to 3
courses in the absence of disease progression or unacceptable toxicity. Patients with
complete response (CR) or partial response (PR) undergo SCT.
- Group 2 (ineligible for SCT): Patients receive rituximab, vinorelbine ditartrate,
gemcitabine hydrochloride, and pegfilgrastim as in group 1. Patients with CR, PR, or
stable disease after 3 courses continue to receive therapy in the absence of disease
progression or unacceptable toxicity.
After completion of study therapy, patients are followed for at least 2 years.
Allocation: Non-Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
Response rate (complete response, unconfirmed complete response, partial response)
After first 3 cycles of treatment
Alexandra Stefanovic, MD
University of Miami Sylvester Comprehensive Cancer Center
United States: Food and Drug Administration
|University of Miami Sylvester Comprehensive Cancer Center - Miami||Miami, Florida 33136|