CompletedPhase 2

A Phase II Trial of Panobinostat and Lenalidomide in Patients With Relapsed or Refractory Hodgkin's Lymphoma

United States24 participantsStarted 2011-10-13

Plain-language summary

This phase II trial studies how well giving panobinostat together with lenalidomide works in treating patients with relapsed or refractory Hodgkin lymphoma. Panobinostat may stop the growth of cancer cells by blocking some of the enzymes needed for cell growth. Biological therapies, such as lenalidomide, may stimulate the immune system in different ways and stop cancer cells from growing. Giving panobinostat together with lenalidomide may be an effective treatment for Hodgkin lymphoma

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 classical or lymphocyte predominant Hodgkin's lymphoma that is relapsed or refractory after at least one prior chemotherapy; patients with Hodgkin's lymphoma may have one of the following World Health Organization (WHO) subtypes: * Nodular sclerosis Hodgkin's lymphoma * Mixed cellularity Hodgkin's lymphoma * Lymphocyte-rich Hodgkin's lymphoma * Lymphocyte-deplete Hodgkin's lymphoma * Nodular Lymphocyte-predominant Hodgkin's lymphoma * Patients must have relapsed or progressed after at least one prior cytotoxic chemotherapy * Previous autologous or allogeneic stem cell transplantation is permitted * Previous treatment with either single agent panobinostat or lenalidomide is permitted * Absolute neutrophil count (ANC) \>= 1200/μL * Platelets \>= 100,000/μl * Aspartate aminotransferase (AST) and alanine aminotransferase (ALT) =\< 2.5 x upper limit normal (ULN) * Serum bilirubin =\< 1.5 x ULN * Calculated creatinine clearance \>= 60ml/min by Cockcroft-Gault estimation of CrCI * Measurable Disease must be present either on physical examination or imaging studies; non-measurable disease alone is not acceptable; any tumor mass \> 1 cm is acceptable; lesions that are considered non-measurable include the following: * Bone lesions * Leptomeningeal disease * Ascites * Pleural/pericardial effusion * Inflammatory breast disease * Lymphangitis cutis/pulmonis * Bone marrow involvement (involvement by non-Hodgkin…

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.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

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

Determine the Overall Response Rate (ORR), Including Complete Responses (CR) and Partial Responses (PR)

Timeframe: up to 24 months

Trial details

NCT IDNCT01460940

SponsorOhio State University Comprehensive Cancer Center

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2016-11-16

Results submitted2017-01-24

View on ClinicalTrials.gov More Adult Lymphocyte Depletion Hodgkin Lymphoma trials