Lenalidomide Therapy After Chemotherapy & Stem Cell Transplant in Treating Chemotherapy Resistan … (NCT01035463) | Clinical Trial Compass
CompletedPhase 1/2
Lenalidomide Therapy After Chemotherapy & Stem Cell Transplant in Treating Chemotherapy Resistan Non-Hodgkin Lymphoma
United States74 participantsStarted 2009-11-12
Plain-language summary
This phase I/II trial studies the side effects and best dose of lenalidomide when given after combination chemotherapy with or without rituximab and stem cell transplant and to see how well it works in treating patients with non-Hodgkin lymphoma that has not responded to treatment or has returned after a period of improvement and is resistant to chemotherapy. Biological therapies, such as lenalidomide, may stimulate the immune system in different ways and stop cancer cells from growing. Drugs used in chemotherapy, such as carmustine, etoposide, cytarabine, and melphalan, 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, may block cancer growth by targeting certain cells. Giving lenalidomide after combination chemotherapy with or without rituximab may work better in treating patients with non-Hodgkin lymphoma.
Who can participate
Age range19 Years
SexALL
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Inclusion Criteria:
* Persistent, or relapsed non-Hodgkin's lymphoma (NHL) (any histology) that is chemo-resistant (\< a partial response \[PR\]), subjects who have received \>= 3 prior chemotherapy regimens, or subjects with lymphomas that have a high relapse rate following autologous or syngeneic stem cell transplantation (transformed NHL, peripheral T-cell lymphoma \[PTCL\], mantle cell lymphoma, anaplastic lymphoma kinase \[ALK\]-negative anaplastic large cell lymphoma \[ALCL, alk neg\]), intermediate International Prognostic Index (IPI) or high risk IPI or subjects with a positive positron emission tomography (PET) scan prior to transplant, and otherwise eligible for transplantation with adequate end-organ function
* Subjects that relapse within one year of diagnosis
* Able to collect \>= 1.5 x 10\^6 CD34+/kg cell for transplantation
* Absolute neutrophil count (ANC) \>= 1000 cells/mm\^3 and platelet count \>= 60 K when maintenance lenalidomide is started (day 100 post-transplant)
* Subjects must have calculated creatinine clearance \>= 30 ml/min
* Total bilirubin =\< 1.5 x upper limit of normal (ULN)
* Aspartate aminotransferase (AST) (serum glutamic oxaloacetic transaminase \[SGOT\]) and alanine aminotransferase (ALT) (serum glutamate pyruvate transaminase \[SGPT\]) =\< 3 x ULN
* Subjects who are seropositive because of hepatitis B virus vaccine
* Subjects must be willing to give written informed consent, and sign an institutionally approved consent form before perfor…