Gemcitabine Hydrochloride, Rituximab, Oxaliplatin, and Lenalidomide in Treating Patients With Rel… (NCT01307592) | Clinical Trial Compass
UnknownPhase 2
Gemcitabine Hydrochloride, Rituximab, Oxaliplatin, and Lenalidomide in Treating Patients With Relapsed or Refractory, Aggressive Non-Hodgkin Lymphoma
Puerto Rico70 participantsStarted 2011-02
Plain-language summary
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.
Who can participate
Age range18 Years
SexALL
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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
DISEASE CHARACTERISTICS:
* Histologically or cytologically confirmed aggressive non-Hodgkin lymphoma, including any of the following subtypes:
* Follicular large cell lymphoma
* Diffuse large cell lymphoma
* Peripheral T-cell lymphoma
* Transformed lymphoma
* Lymphoblastic lymphoma
* Burkitt or Burkitt-like lymphoma
* Refractory or relapsed disease meeting the following criteria:
* Patients who either did not respond to prior therapy or whose best response was partial response after ≥ 4 courses of chemotherapy
* Histologic confirmation of relapsed or refractory disease is desirable but not mandatory and will be left to the discretion of the investigator
* Must have evaluable or measurable disease
* Patients who are candidates for stem cell or bone marrow transplantation allowed
* No CNS involvement by lymphoma
PATIENT CHARACTERISTICS:
* ECOG performance status 0-3
* Absolute neutrophil count ≥ 1,000/mm³ (unless due to marrow infiltration by lymphoma)
* Platelet count ≥ 100,000/mm³ (unless thrombocytopenia is due to marrow infiltration by lymphoma)
* Total bilirubin ≤ 1.5 times upper limit of normal (ULN) (unless liver is involved with lymphoma, hemolysis, or Gilbert syndrome)
* Serum creatinine ≤ 2.0 mg/dl or creatinine clearance ≥ 30 ml/min (unless creatinine elevation is due to lymphoma)
* ALT ≤ 2 times ULN (≤ 5 times ULN if liver metastasis is involved with lymphoma)
* Not pregnant or nursing
* Negative pregnancy test
* Fertile patients must use effect…
What they're measuring
1
Rate of conversion to complete response (CR) after switching to lenalidomide