Follicular Lymphoma (FL) Clinical Trial
Official title:
A Randomized, Open-label, Multi-center Phase III Trial Comparing Tisagenlecleucel to Standard of Care in Adult Participants With Relapsed or Refractory Follicular Lymphoma (FL)
This trial will compare tisagenlecleucel to standard of care in adult participants with relapsed or refractory (r/r) follicular lymphoma.
The purpose of this phase III study is to verify the clinical benefit of tisagenlecleucel for the treatment of r/r FL by comparing the tisagenlecleucel treatment strategy to standard of care therapy in patients with r/r FL after two or more lines of systemic therapy, with progression-free survival (PFS) as the primary endpoint. The primary objective is to demonstrate superiority of the tisagenlecleucel treatment strategy over standard of care (SOC) therapy with respect to progression-free survival (PFS) determined by blinded independent review committee (BIRC) based on the Lugano response criteria. Participants randomized to Arm A (tisagenlecleucel treatment) will receive a single infusion of 0.6 to 6 x 10^8 CAR-positive viable T-cells. Participants randomized to Arm B (Standard of Care) will receive R2 or R-CHOP based on investigator choice and this has to be determined prior to randomization. ;
| Status | Clinical Trial | Phase | |
|---|---|---|---|
| Recruiting |
NCT06043011 -
Registry Platform Hematologic Malignancies (RUBIN) - Extension of Tumor Registry Lymphatic Neoplasms
|
||
| Recruiting |
NCT05409066 -
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 Follicular Lymphoma
|
Phase 3 | |
| 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 |
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 |