Lymphoma, Malignant Clinical Trial
— MIROfficial title:
Therapy of Nodal Follicular Lymphoma (Grade I/II) Clinical Stage I or II Using Involved Field Radiotherapy in Combination With Rituximab
| Verified date | January 2020 |
| Source | Heidelberg University |
| Contact | n/a |
| Is FDA regulated | No |
| Health authority | |
| Study type | Interventional |
Combination of involved field radiotherapy for the control of macroscopic disease and CD20 antibody Rituximab for the control of microscopic remainders in other regions in patients with early stage nodal follicular lymphoma /grade I or II). Evaluation of DFSl and toxicity.
| Status | Completed |
| Enrollment | 85 |
| Est. completion date | April 2013 |
| Est. primary completion date | April 2013 |
| Accepts healthy volunteers | No |
| Gender | All |
| Age group | 18 Years to 75 Years |
| Eligibility |
Inclusion Criteria: - verified follicular lymphoma grade 1 or 2 - only nodal involvement (incl. Waldeyer) clinical stage I or II - largest tumor = 7 cm - adequate bone marrow reserves Exclusion Criteria: - ECOG >2 - Follicular lymphoma grade 3 - buky disease (>7 cm) - involvement of the spleen - neoplasia in PMH (except: basalioma, spinalioma) - Immunodeficiency syndromes, viral hepatitis, connective tissue disease - severe psychiatric disease - pregnancy or breast feeding - known allergies against foreign proteins |
| Country | Name | City | State |
|---|---|---|---|
| Germany | Charité Campus Benjamin-Franklin | Berlin | |
| Germany | Charité Campus Buch | Berlin | |
| Germany | Charité Campus Mitte | Berlin | |
| Germany | University of Cologne | Cologne | |
| Germany | University of Dresden | Dresden | |
| Germany | University of Essen | Essen | |
| Germany | University of Göttingen | Göttingen | |
| Germany | University of Hannover | Hannover | |
| Germany | University of Heidelberg | Heidelberg | |
| Germany | University of Kiel | Kiel | |
| Germany | University of Mainz | Mainz | |
| Germany | University of Heidelberg (Campus Mannheim) | Mannheim | |
| Germany | University of Marburg | Marburg | |
| Germany | LMU | Munich | |
| Germany | TU | Munich | |
| Germany | University of Münster | Münster | |
| Germany | University of Ulm | Ulm |
| Lead Sponsor | Collaborator |
|---|---|
| Klaus Herfarth, MD | German Low Grade Lymphoma Study Group, Roche Pharma AG |
Germany,
Herfarth K, Borchmann P, Schnaidt S, Hohloch K, Budach V, Engelhard M, Viardot A, Engenhart-Cabillic R, Keller U, Reinartz G, Eich HT, Witzens-Harig M, Hess CF, Dörken B, Dürig J, Wiegel T, Hiddemann W, Hoster E, Pott C, Dreyling M. Rituximab With Involve — View Citation
Witzens-Harig M, Hensel M, Unterhalt M, Herfarth K. Treatment of limited stage follicular lymphoma with Rituximab immunotherapy and involved field radiotherapy in a prospective multicenter Phase II trial-MIR trial. BMC Cancer. 2011 Feb 26;11:87. doi: 10.1186/1471-2407-11-87. — View Citation
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | progression free survival | 2 years | ||
| Secondary | Response to Rituximab | 7 weeks | ||
| Secondary | Rate of CR | 18 weeks | ||
| Secondary | Toxicity (CTC Vers. 3) | 2 yrs | ||
| Secondary | Relapse rate, Relapse pattern, DSF | 2 yrs | ||
| Secondary | Overall survival | 2 yrs | ||
| Secondary | QoL | 2 yrs |
| Status | Clinical Trial | Phase | |
|---|---|---|---|
| Completed |
NCT02916979 -
Myeloid-Derived Suppressor Cells and Checkpoint Immune Regulators' Expression in Allogeneic SCT Using FluBuATG
|
Phase 1 | |
| Completed |
NCT00600353 -
Multi-day Doses in Prevention of Nausea and Emesis
|
Phase 2 | |
| Completed |
NCT01432951 -
A Study of Enzastaurin in Chinese Patients With Advanced and/or Metastatic Solid Tumors or Lymphoma
|
Phase 1 | |
| Terminated |
NCT02440685 -
A Phase 1/2 Study To Evaluate ASN002 In Relapsed/Refractory Lymphoma And Advanced Solid Tumors
|
Phase 1/Phase 2 | |
| Completed |
NCT02249429 -
Open-Label, Non Randomized Phase 2 Study With Safety Run-In
|
Phase 2 | |
| Active, not recruiting |
NCT02732275 -
DS-3201b in Participants With Lymphomas
|
Phase 1 | |
| Recruiting |
NCT00619879 -
Myeloablative Hematopoietic Progenitor Cell Transplantation (HPCT) for Pediatric Malignancies
|
Phase 3 | |
| Completed |
NCT00146055 -
Low-Intensity Preparation and Allogeneic Transplant in Patients With Cancers of the Blood
|
Phase 2 | |
| Completed |
NCT00741871 -
A Phase 1 Study of SB1518 for the Treatment of Advanced Lymphoid Malignancies
|
Phase 1 | |
| Recruiting |
NCT04947618 -
Efficacy of Patient Management for Lymphoma Diagnosed at Nimes University Hospital From 1999 to 2018. DVR-Lym-Nim
|
||
| Recruiting |
NCT02441972 -
Clinic Study of 18F-Al-NOTA-PRGD2 in Cancer Diagnostics
|
Phase 1 | |
| Completed |
NCT00078637 -
Dosing and Safety Study of E7820 in Patients With a Malignant Solid Tumor or Lymphoma
|
Phase 1 | |
| Withdrawn |
NCT03359733 -
A Study to Evaluate the Effect of Food on the Pharmacokinetics (PK) of TAK-659 in Participants With Advanced Solid Tumor
|
Phase 1 | |
| Completed |
NCT00037791 -
Safety and Efficacy of (PN-152,243)/PN-196,444 in the Prevention of Thrombocytopenia
|
Phase 3 | |
| Completed |
NCT01388335 -
A Drug Interaction Study to Assess the Effect of LY317615 on the Metabolic Pathway of Warfarin
|
Phase 1 |