Golcadomide in Combination With Rituximab for the Treatment of Patients With Relapsed or Refracto… (NCT07578077) | Clinical Trial Compass
Not Yet RecruitingPhase 1/2
Golcadomide in Combination With Rituximab for the Treatment of Patients With Relapsed or Refractory Mantle Cell Lymphoma
United States58 participantsStarted 2026-12-21
Plain-language summary
This phase I/II trial tests the safety, side effects, best dose and effectiveness of golcadomide in combination with rituximab in treating patients with mantle cell lymphoma that has come back after a period of improvement (relapsed) or that does not respond to treatment (refractory). Golcadomide may help block the formation, growth or spread of cancer cells. Rituximab is a monoclonal antibody. It binds to a protein called CD20, which is found on B cells (a type of white blood cell) and some types of cancer cells. This may help the immune system kill cancer cells. Giving golcadomide in combination with rituximab may better treat patients with relapsed or refractory mantle cell 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:
* Documented informed consent of the participant and/or legally authorized representative
* Agreement to allow the use of archival tissue from diagnostic tumor biopsies
* If unavailable, exceptions may be granted with study principal investigator (PI) approval
* Ability to adhere to the study protocol
* Age: ≥ 18 years
* Eastern Clinical Oncology Group (ECOG) ≤ 2
* Histologically confirmed diagnosis of MCL
* Immunohistochemistry of the biopsy
* Flow cytometry of the biopsy
* Relapsed/ refractory disease
* Relapsed/refractory (R/R) MCL after at least one line of therapy including resistant or intolerant to a cBTKi
* Fully recovered from the acute toxic effects (except alopecia) to ≤ grade 1 to prior anti-cancer therapy
* Ability to swallow pills
* Without bone marrow involvement: Absolute neutrophil count (ANC) \> 1.5 × 10\^9/L (ANC \> 1,500/mm\^3)
* With bone marrow involvement: ANC \> 1.0 × 10\^9/L (ANC \> 1000/mm\^3)
* NOTE: Growth factor is not permitted within 14 days of ANC assessment unless cytopenia is secondary to disease involvement. For patients with significant marrow involvement, eligibility may be confirmed at the discretion of the treating investigator
* Without bone marrow involvement: Platelets ≥ 75,000/mm\^3
* With bone marrow involvement: Platelets ≥ 50,000/mm\^3
* NOTE: Platelet transfusions are not permitted within 14 days of platelet assessment unless cytopenia is secondary to disease involvement
* Total bilirubin ≤ …
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
1
Incidence of dose limiting toxicities (DLT)
Timeframe: During cycle 1 (Cycle length = 28 days)
2
Maximum tolerated dose (MTD) of golcadomide
Timeframe: Up to 3 years
3
MTD of golcadomide in combination with rituximab
Timeframe: Up to 3 years
4
Overall response rate (ORR)
Timeframe: Up to 3 years
5
Progression free survival (PFS)
Timeframe: From start of protocol treatment to time of disease relapse/progression or death due to any cause, whichever occurs earlier, assessed up to 3 years