Romidepsin and Lenalidomide in Treating Patients With Previously Untreated Peripheral T-Cell Lymp… (NCT02232516) | Clinical Trial Compass
CompletedPhase 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 range
18 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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…
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1This trial combined romidepsin and lenalidomide as a first treatment for peripheral T-cell lymphoma — since it's now completed, has the response rate data been published, and does it look strong enough that you'd consider this combination over standard chemotherapy for my specific subtype?
2Since this was a Phase 2 trial, what do we know so far about the safety profile of romidepsin plus lenalidomide together, and are there side effects I should be especially aware of given my overall health?
3My diagnosis falls under the broad umbrella of peripheral T-cell lymphoma — do you think the results from this trial are relevant to my specific subtype, since the study included many different T-cell lymphoma types that can behave very differently?
4Given that this trial was for previously untreated patients, does it matter that I haven't had any prior therapy yet — and would starting with a standard regimen first potentially close the door on other options later?
5Are there any currently open trials building on what this completed study found, or would you recommend a different path based on how my disease looks right now?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
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