Romidepsin and Lenalidomide in Treating Patients With Previously Untreated Peripheral T-Cell Lymp… (NCT02232516) | Clinical Trial Compass
UnknownPhase 2
Romidepsin and Lenalidomide in Treating Patients With Previously Untreated Peripheral T-Cell Lymphoma
United States30 participantsStarted 2015-06-11
Plain-language summary
The purpose of this study is to evaluate how safe and effective the combination of the study drugs romidepsin and lenalidomide is for treating patients with peripheral t-cell lymphoma (PTCL) who have not been previously treated for this cancer. Currently, there is no standard treatment for patients with PTCL; the most common treatment used is a combination of drugs called CHOP, but this can be a difficult treatment to tolerate because of side effects, and is not particularly effective for most patients with PTCL. Romidepsin (Istodax®) is a type of drug called an HDAC inhibitor. It interacts with DNA (genetic material in cells) in ways that can stop tumors from growing. It is given as an infusion through the veins. Lenalidomide (Revlimid®) is a type of drug known as an immunomodulatory drug, or IMID for short. This drug affects how tumor cells grow and survive, including affecting blood vessel growth in tumors. It is given as an oral tablet (by mouth).
Who can participate
Age range18 Years
SexALL
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Inclusion Criteria:
* Histologically confirmed diagnosis of PTCL (using the most recent edition of the World Health Organization \[WHO\] Classification of Tumors of Hematopoietic and Lymphoid Tissues as guidance) including:
* Anaplastic large cell lymphoma, anaplastic large cell kinase (ALK)-negative
* Angioimmunoblastic T-cell lymphoma
* Enteropathy-type T-cell lymphoma
* Extranodal natural killer (NK)/T-cell lymphoma, nasal type
* Hepatosplenic gamma-delta T-cell lymphoma
* Peripheral T-cell lymphoma, unspecified (not otherwise specified \[NOS\])
* Transformed mycosis fungoides
* Subcutaneous panniculitis-like T-cell lymphoma.
* NOTE: Patients with adequate archived (well-preserved, formalin-fixed) biopsy tissue remaining will be required to submit a portion for exploratory studies; this is not optional if tissue is available; however, lack of adequate tissue for exploratory studies will not preclude patients from participating
* Patients must have bi-dimensionally measurable disease (\>= 1 cm) by CT imaging
* NOTE: Patients with marrow-only disease are eligible; response for these patients will be assessed by repeat bone marrow biopsy
* Patients must fit into one of the following categories:
* Age \>= 18 years to \< 60 years with a cumulative illness rating scale (CIRS) score \>= 6 OR deemed ineligible for cytotoxic chemotherapy by the treating investigator
* \>= 60 years
* Patients must have adequate organ and marrow function (documented within…
What they're measuring
1
Objective Response Rate (ORR), as Defined Per Cheson Criteria
Timeframe: Assessed after cycles 3 and 6, then every 6 months up to 3 years