Pilot Study of GC. (Gemcitabine-Rituximab-Oxaliplatin Combination) Given Every 14 Days With Maintenance Lenalidomide for the Treatment of Patients With Relapsed or Refractory Aggressive Non-Hodgkin's Lymphoma
- To determine the rate of conversion to complete response (CR) after switching to
lenalidomide in patients with relapsed or refractory, aggressive non-Hodgkin lymphoma
whose maximum response to gemcitabine hydrochloride, rituximab, and oxaliplatin is a
partial response (PR).
- To determine the overall survival of these patients treated with this regimen.
- To determine the progression-free survival of patients with CR and PR.
- To determine the treatment-related toxicity of this regimen combination in these
OUTLINE: This is a multicenter study.
- Rituximab, gemcitabine hydrochloride, and oxaliplatin: Patients with B-cell lymphoma
receive rituximab IV on day 1; all patients receive gemcitabine hydrochloride IV over
30 minutes and oxaliplatin IV over 2 hours on day 1 or day 2*. Treatment repeats every
14 days for up to 6 courses in the absence of disease progression or unacceptable
NOTE: *Patients with T-cell lymphoma proceed to chemotherapy on day 1 without receiving
rituximab; patients with B-cell lymphoma receive chemotherapy on day 2.
Patients are reevaluated after 4 courses of therapy. Patients who achieve a complete
response (CR) receive 2 more courses of therapy and then proceed to bone marrow
transplantation (BMT); those that do not receive a BMT receive maintenance lenalidomide for
2 years. Patients who achieve a partial response (PR) and who are not candidate for
autologous stem cell transplantation (ACT) are treated with lenalidomide**. Once patients
with PR achieve a CR or < CR with lenalidomide treatment, they proceed to maintenance
lenalidomide for 2 years, unless they become candidates for ACT***. Patients with stable
disease or progressive disease after 4 courses of therapy are treated with lenalidomide,
unless they become eligible for ACT***.
NOTE: **Patients in whom a delay of > 4 months would occur for ACT are treated with
lenalidomide until 3 weeks prior to ACT.
NOTE: **Once eligible, patients proceed to ACT as soon as feasible.
- Maintenance lenalidomide: Patients receive oral lenalidomide once daily on days 1-21.
Courses repeat every 28 days for up to 2 years in the absence of disease progression or
Blood samples are collected at baseline and periodically for toxicity analysis.
After completion of study treatment, patients are followed up at 28 days and then every 3
Allocation: Non-Randomized, Masking: Open Label, Primary Purpose: Treatment
Rate of conversion to complete response (CR) after switching to lenalidomide
Fernando Cabanillas, MD
Auxilio Mutuo Cancer Center