Non-Hodgkin's Lymphoma (NHL) Clinical Trial
Official title:
A Randomized Phase III Study to Compare Conventional Chemotherapy (CHOEP-14) + Rituximab vs High-dose Chemotherapy Followed by Autologous Stem Cell Transplantation (Mega-CHOEP-21) + Rituximab in Younger Patients With Aggressive NHL
Verified date | May 2023 |
Source | Universität des Saarlandes |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
According to amendment 3 this study addresses the question if intensification of administration of rituximab in standard treatment for patients with newly diagnosed aggressive B-Non Hodgkin Lymphoma (B-NHL) and high risk (aaIPI 2 or 3) results in a better time to treatment failure (TTTF)
Status | Completed |
Enrollment | 450 |
Est. completion date | October 2017 |
Est. primary completion date | October 2014 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years to 60 Years |
Eligibility | Inclusion Criteria: - 18-60 years of age - Risk group International Prognostic Index (IPI) 2 and 3 (age adjusted) - Performance status: Eastern Cooperative Oncology Group (ECOG) 0-3 - Patient's written informed consent - Aggressive non-Hodgkin's lymphoma with CD20+ histology Exclusion Criteria: - Already initiated lymphoma therapy - Serious accompanying disorder or impaired organ function - Bone marrow involvement > 25% - Known hypersensibility to the medications to be used - Known HIV-positivity - Active hepatitis infection - Suspicion that patient compliance will be poor - Simultaneous participation in other trials - Prior chemo- or radiotherapy for previous disorder - Other concomitant tumour disease |
Country | Name | City | State |
---|---|---|---|
Germany | AK St. Georg | Hamburg |
Lead Sponsor | Collaborator |
---|---|
German High-Grade Non-Hodgkin's Lymphoma Study Group | Deutsche Krebshilfe e.V., Bonn (Germany) |
Germany,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | time to treatment failure | At 3 year follow up rate of treatments and time to treatment failure will be determined | 3 years after study inclusion |
Status | Clinical Trial | Phase | |
---|---|---|---|
Completed |
NCT01448928 -
Zevalin Post-marketing Surveillance in Japan
|
||
Terminated |
NCT00089284 -
Phase I/II Trial of Redox Regulation in Patients With Relapsed or Refractory CD20+ NHL
|
Phase 1/Phase 2 | |
Unknown status |
NCT01983761 -
Study of ASC-101 in Patients With Hematologic Malignancies Who Receive Dual-cord Umbilical Cord Blood Transplantation
|
Phase 1/Phase 2 | |
Recruiting |
NCT01758042 -
Bone Marrow and Kidney Transplant for Patients With Chronic Kidney Disease and Blood Disorders
|
N/A | |
Terminated |
NCT00185679 -
Haploid Allogeneic Transplant Using the CliniMACS System
|
Phase 2 | |
Completed |
NCT01108341 -
Study to Evaluate the Efficacy and Safety of Treatment With Bendamustine in Combination With Ofatumumab in Previously Untreated Patients With Indolent B-Cell Non-Hodgkin's Lymphoma (NHL)
|
Phase 2 | |
Completed |
NCT01527838 -
Single Treatment With FT1050 of an Ex-vivo Modulated Umbilical Cord Blood Unit
|
Phase 1 | |
Completed |
NCT00923910 -
Wilm's Tumor 1 Protein Vaccine to Treat Cancers of the Blood
|
Phase 1/Phase 2 | |
Completed |
NCT00614042 -
Phase 1/1b Study of TRU-016 in Patients With Previously Treated CLL or Select Subtypes of Non-Hodgkin's Lymphoma
|
Phase 1 | |
Completed |
NCT02071888 -
Study of the Glutaminase Inhibitor CB-839 in Hematological Tumors
|
Phase 1 | |
Recruiting |
NCT04696705 -
Allogeneic γδ T Cells Immunotherapy in r/r Non-Hodgkin's Lymphoma (NHL) or Peripheral T Cell Lymphomas (PTCL) Patients
|
Early Phase 1 | |
Completed |
NCT01479387 -
Zevalin Post-marketing Surveillance for Adequateness of Image Interpretation Criteria in Japan
|
N/A | |
Completed |
NCT00889798 -
Tumor Registry of Lymphatic Neoplasia
|
||
Terminated |
NCT05144347 -
Study of XL114 in Subjects With Non-Hodgkin's Lymphoma
|
Phase 1 |