Gemcitabine Hydrochloride, Rituximab, Oxaliplatin, and Lenalidomide in Treating Patients With Relapsed or Refractory, Aggressive Non-Hodgkin Lymphoma
Recruitment status was: Recruiting
RATIONALE: Drugs used in chemotherapy, such as gemcitabine hydrochloride, oxaliplatin, and , work in different ways to stop the growth of cancer cells, either by killing the cells or by stopping them from dividing. Monoclonal antibodies, such as rituximab, can block cancer cell growth in different ways. Some block the ability of cancer cells to grow and spread. Others find cancer cells and help kill them or carry cancer-killing substances to them. Lenalidomide may stop the growth of non-Hodgkin lymphoma by blocking blood flow to the cancer. Giving rituximab and chemotherapy together with lenalidomide may kill more cancer cells.
PURPOSE: This phase II trial is studying how well giving rituximab, gemcitabine hydrochloride, and oxaliplatin together with lenalidomide works in treating patients with relapsed or refractory, aggressive non-Hodgkin lymphoma.
Drug: gemcitabine hydrochloride
|Study Design:||Allocation: Non-Randomized
Masking: Open Label
Primary Purpose: Treatment
|Official Title:||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|
- Rate of conversion to complete response (CR) after switching to lenalidomide [ Designated as safety issue: No ]
- Overall survival [ Designated as safety issue: No ]
- Progression-free survival [ Designated as safety issue: No ]
- Safety of this regimen combination [ Designated as safety issue: Yes ]
- Rate of conversion to partial response and CR of non-responders treated with lenalidomide [ Designated as safety issue: No ]
|Study Start Date:||February 2011|
|Estimated Primary Completion Date:||February 2013 (Final data collection date for primary outcome measure)|
- 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 patients.
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 toxicity.
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 unacceptable toxicity.
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 months thereafter.
Please refer to this study by its ClinicalTrials.gov identifier: NCT01307592
|Centro de Cancer del Hospital Auxilio Mutuo|
|San Juan, Puerto Rico, 00936-2712|
|Principal Investigator:||Fernando Cabanillas, MD||Auxilio Mutuo Cancer Center|