Lymphoma, Follicular Clinical Trial
Official title:
Treatment of Relapsed CBCC, CC and LPIC Lymphoma With FCM Chemotherapy Alone or in Combination With the Monoclonal Anti CD 20 Antibody Rituximab Followed by Anti-CD 20 Maintenance or Observation Only
The aim of this phase III trial is to assess the safety and efficacy of treatment with rituximab in combination with FCM chemotherapy (R-FCM) versus FCM chemotherapy alone for remission induction and to asses the safety and efficacy of rituximab maintenance versus observation only after response to induction therapy. Both questions are addressed in way of a prospective randomized comparison in patients with relapsed FL, MCL and LP lymphoma.
Patients with relapsed centroblastic/centrocytic (FL), centrocytic (MCL)or lymphoplasmacytoid lymphoma are randomly assigned to either FCM chemotherapy alone or to FCM chemotherapy in combination with the monoclonal anti-CD20 antibody rituximab (R-FCM). FCM chemotherapy will be given for 4 cycles in intervals of 4 weeks. In patients assigned to cytoreductive therapy with FCM plus rituximab, the monoclonal antibody is given as one infusion (375 mg/m2) on the day before the respective FCM course for a total of four applications. Four weeks after the end of FCM chemotherapy patients with CR or PR are randomly assigned to either no further treatment or maintenance therapy with rituximab. Rituximab will be given 4 times (one infusion per week with 375 mg/m2). After six months rituximab treatment will be repeated with another 4 infusions. In case of relapse patients will receive an alternative treatment according to the decision of the investigator. The aim of this phase III trial is to assess the safety and efficacy of treatment with rituximab in combination with FCM chemotherapy versus FCM chemotherapy alone for remission induction and to asses the safety and efficacy of rituximab maintenance versus observation only after response to induction therapy. Both questions are addressed in way of a prospective randomized comparison in patients with relapsed FCL, MCL and LP lymphoma. Primary objectives of this trial are to compare (1) the remission rates (CR and PR) achieved after FCM plus rituximab versus FCM alone and (2) the progression free interval of rituximab maintenance versus observation only. ;
Status | Clinical Trial | Phase | |
---|---|---|---|
Completed |
NCT01950273 -
Pharmacokinetics and Pharmacodynamics of BI 695500 vs. Rituximab as First Line-treatment in Patients With Low Tumor Burden Follicular Lymphoma
|
Phase 1 | |
Completed |
NCT00930514 -
A Pharmacokinetic Study of Subcutaneous and Intravenous Rituximab in Participants With Follicular Lymphoma
|
Phase 1 | |
Completed |
NCT02472756 -
Open, Noninterventional Trial of MabThera in Combination With Chemotherapy (CVP, CHOP or FCM) in Patients With Relapsed/Refractory Follicular Lymphoma
|
N/A | |
Withdrawn |
NCT00319332 -
A Comparative Study Of Iodine I 131 Tositumomab Therapeutic Regimen Versus Ibritumomab Tiuxetan Therapeutic Regimen
|
Phase 3 | |
Completed |
NCT00193492 -
A Study of Rituximab and Bevacizumab in Patients With Follicular Non-Hodgkin's Lymphoma
|
Phase 2 | |
Withdrawn |
NCT00092274 -
Study of HuMax-CD20, a New Drug to Treat Early Stage Non-Hodgkin´s Follicular Lymphoma
|
Phase 1/Phase 2 | |
Completed |
NCT03087929 -
Follow-up Trial of Rituximab Interferon Transplant Trial: Study Drug-Rituximab and Alpha Interferon
|
N/A | |
Terminated |
NCT02413489 -
An Efficacy and Safety Proof of Concept Study of Daratumumab in Relapsed/Refractory Mantle Cell Lymphoma, Diffuse Large B-Cell Lymphoma, and Follicular Lymphoma
|
Phase 2 | |
Completed |
NCT00915096 -
Positron Emission Tomography (PET)-Scan in the Evaluation of High Tumor Burden Follicular Lymphoma
|
||
Recruiting |
NCT05849857 -
Mosunetuzumab for Early Relapse of Follicular Lymphoma in the Nordic Countries
|
Phase 2 | |
Recruiting |
NCT05410418 -
Mosunetuzumab and Polatuzumab Vedotin for Untreated Follicular Lymphoma
|
Phase 2 | |
Terminated |
NCT01609036 -
An Observational Study of MabThera/Rituxan (Rituximab) in Patients With Follicular Lymphoma
|
N/A | |
Completed |
NCT01234766 -
Bendamustine and Rituximab Followed by 90-yttrium (Y) Ibritumomab Tiuxetan for Untreated Follicular Lymphoma
|
Phase 2 | |
Completed |
NCT00849147 -
Bone Marrow Transplant From Partially Matched Donors and Nonmyeloablative Conditioning for Blood Cancers (BMT CTN 0603)
|
Phase 2 | |
Terminated |
NCT00384111 -
Phase 3 Study of Zevalin Following R-CVP in Previously Untreated Patients With Follicular Non Hodgkin's Lymphoma (NHL)
|
Phase 3 | |
Completed |
NCT03682796 -
Study of TRPH-222 in Patients With Relapsed and/or Refractory B-Cell Lymphoma
|
Phase 1 | |
Recruiting |
NCT04982471 -
Connect® Lymphoma Disease Registry: A US-Based Prospective Observational Cohort Study
|
||
Active, not recruiting |
NCT02996773 -
Haploidentical BMT With Post-Transplant Cyclophosphamide and Bendamustine
|
Phase 1 | |
Terminated |
NCT00562965 -
Study Comparing Inotuzumab Ozogamicin In Combination With Rituximab Versus Defined Investigator's Choice In Follicular Non-Hodgkin's Lymphoma (NHL)
|
Phase 3 | |
Not yet recruiting |
NCT06213636 -
Fourth-gen CAR T Cells Targeting CD19/CD22 for Highly Resistant B-cell Lymphoma/Leukemia (PMBCL/CNS-BCL).
|
Phase 1/Phase 2 |