Follicular Lymphoma (FL) Clinical Trial
Official title:
A Phase 3, Open-Label Study to Evaluate Safety and Efficacy of Epcoritamab in Combination With Rituximab and Lenalidomide (R2) Compared to R2 in Subjects With Relapsed or Refractory Follicular Lymphoma (EPCORE FL-1)
Follicular Lymphoma (FL) is the second most common B-cell cancer and the most common type of cancer of lymphocytes. Unfortunately, this disease is incurable with conventional treatment and the disease recurs in almost all patients. This study will assess how safe and effective epcoritamab is in combination with lenalidomide and rituximab (R2) in treating adult participants with relapsed or refractory (R/R) FL. Adverse events and change in disease condition will be assessed. Epcoritamab is an investigational drug being developed for the treatment of FL. Study doctors put the participants in 1 of 3 groups, called treatment arms. Each group receives a different treatment. Enrollment to one of the groups is closed. Around 500 adult participants with R/R FL will be enrolled in approximately 300 sites across the world. Participants will receive R2 (375 mg/m^2 intravenous infusion of rituximab up to 5 cycles and oral capsules of 20 mg lenalidomide for up to 12 cycles) alone or in combination with subcutaneous injections of epcoritamab for up to 12 cycles (each cycle is 28 days). There may be higher treatment burden for participants in this trial compared to their standard of care. Participants will attend regular visits during the study at a hospital or clinic. The effect of the treatment will be checked by medical assessments, blood tests, checking for side effects and completing questionnaires.
n/a
| Status | Clinical Trial | Phase | |
|---|---|---|---|
| Recruiting |
NCT06043011 -
Registry Platform Hematologic Malignancies (RUBIN) - Extension of Tumor Registry Lymphatic Neoplasms
|
||
| Terminated |
NCT03571828 -
Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Efficacy of AMG 562 in Subjects With r/r Diffuse Large B-cell Lymphoma, Mantle Cell Lymphoma, or Follicular Lymphoma
|
Phase 1 | |
| Terminated |
NCT02914938 -
A Study of ME-401 in Subjects With CLL/SLL, FL, and B-cell Non Hodgkin's Lymphoma
|
Phase 1 | |
| Recruiting |
NCT05888493 -
A Phase III Trial Comparing Tisagenlecleucel to Standard of Care (SoC) in Adult Participants With r/r Follicular Lymphoma
|
Phase 3 | |
| Active, not recruiting |
NCT04049513 -
ENABLE (Engaging Toll-like Receptor Signalling for B-cell Lymphoma Chimeric Antigen Receptor Therapy)
|
Phase 1 | |
| Recruiting |
NCT06097364 -
A Study to Learn How Well Odronextamab Combined With Chemotherapy Works and How Safe it is Compared to Rituximab and Chemotherapy in Adult Participants With Previously Untreated Follicular Lymphoma
|
Phase 3 | |
| Recruiting |
NCT03869619 -
REal World Data in LYmphoma and Survival in Adults
|
||
| Active, not recruiting |
NCT04830137 -
A Study of NX-2127 in Adults With Relapsed/Refractory B-cell Malignancies
|
Phase 1 | |
| Recruiting |
NCT03547115 -
A Study of Voruciclib Alone or in Combination With Venetoclax in Subjects With B-Cell Malignancies or AML
|
Phase 1 | |
| Not yet recruiting |
NCT04767308 -
Safety and Efficacy of CT125A Cells for Treatment of Relapsed/Refractory CD5+ Hematopoietic Malignancies
|
Early Phase 1 | |
| Terminated |
NCT03768505 -
Zandelisib (ME-401) in Subjects With Follicular Lymphoma or Marginal Zone Lymphoma After Failure of Two or More Prior Therapies (TIDAL)
|
Phase 2 | |
| Recruiting |
NCT03265158 -
Blood Immunophenotyping in Staging of Indolent B-cell Lymphomas V1.0
|
N/A | |
| Enrolling by invitation |
NCT04488354 -
Long-term Follow-up Study for Patients Treated With CLBR001 CAR-T
|
Phase 1 | |
| Recruiting |
NCT05720052 -
A Study of MS-553 in Patients With Relapsed or Refractory B-cell Lymphoma
|
Phase 1/Phase 2 | |
| Recruiting |
NCT06191744 -
Study of Subcutaneous Epcoritamab in Combination With Intravenous Rituximab and Oral Lenalidomide (R2) to Assess Adverse Events and Change in Disease Activity in Adult Participants With Previously Untreated Follicular Lymphoma
|
Phase 3 | |
| Active, not recruiting |
NCT02362035 -
ACP-196 (Acalabrutinib) in Combination With Pembrolizumab, for Treatment of Hematologic Malignancies
|
Phase 1/Phase 2 | |
| Recruiting |
NCT06091254 -
A Trial to Learn if Odronextamab is Safe and Well-tolerated and How Well it Works Compared to Rituximab Combined With Different Types of Chemotherapy for Participants With Follicular Lymphoma
|
Phase 3 | |
| Enrolling by invitation |
NCT02875548 -
A Study to Assess the Long-term Safety of Tazemetostat
|
Phase 1/Phase 2 | |
| Active, not recruiting |
NCT04450069 -
CLBR001 and SWI019 in Patients With Relapsed / Refractory B-cell Malignancies
|
Phase 1 | |
| Terminated |
NCT04745832 -
Phase 3 Study of Zandelisib (ME-401) in Combination With Rituximab in Patients With iNHL - (COASTAL)
|
Phase 3 |