EUCTR2011-005818-10-AT
Active, not recruiting
Not Applicable
PHASE II TRIAL OF RITUXIMAB (MABTHERA®) PLUS LENALIDOMIDE (REVLIMID®) IN PATIENTS WITH LYMPHOMA OF THE MUCOSA ASSOCIATED LYMPHOID TISSUE (MALT) - AGMT_MALT-2
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- ymphoma of the Mucosa-Associated Lymphoid Tissue (MALT)
- Sponsor
- Arbeitsgemeinschaft medikamentöse Tumortherapie gemeinnützige GmbH
- Status
- Active, not recruiting
- Last Updated
- 11 years ago
Overview
Brief Summary
No summary available.
Investigators
Eligibility Criteria
Inclusion Criteria
- •For inclusion in the study, all of the following inclusion criteria must be fulfilled:
- •Patient understands and voluntarily signs the informed consent prior to any study
- •related assessments/procedures
- •Male or female \= 18 years of age
- •Histologically verified diagnosis of MALT lymphoma of any localization
- •Measurable disease upon diagnosis or first or greater relapse after local therapy
- •(including gastrectomy or any type of surgery or radiation), prior chemotherapy or HP\-eradication. In addition, also patients with gastric MALT\-lymphoma judged refractory to HP\-eradication by a minimum follow\-up of 12 months after successful HP\-eradication will be included in the study. Patients with gastric MALT lymphoma and no evidence of HP\-infection (as judged by histology and ultimately serology) may be enrolled immediately)
- •Ann Arbor Stage I\-IV
- •In case of prior treatment with Rituximab, the presence of CD20 on lymphoma cells
- •must have been demonstrated before inclusion in the trial.
Exclusion Criteria
- •No patient may be included into the study if she/he fulfills any of the following criteria:
- •Lymphoma histology other than MALT lymphoma or MALT lymphoma with a diffuse
- •large cell lymphoma (high grade lymphoma”) \- component
- •Use of any investigational agent within 28 days prior to initiation of treatment with lenalidomide
- •History of malignancy other than squamous cell carcinoma, basal cell carcinoma of
- •the skin or carcinoma in situ of the cervix within the last 5 years
- •Major surgery, other than diagnostic surgery, within the last 4 weeks
- •Evidence of CNS involvement
- •A history of uncontrolled seizures, central nervous system disorders or psychiatric disability judged by the investigator to be clinically significant and adversely affecting compliance to study drugs
- •Severe peripheral polyneuropathy
Outcomes
Primary Outcomes
Not specified
Similar Trials
Completed
Phase 2
A phase II study of the combination of Rituximab, Mitoxantrone, Etoposide, and Prednisolone for relapsed elderly patients with diffuse large B-cell lymphoma (R-MEP07)Diffuse large B-cell lymphomaJPRN-UMIN000001050Clinical Hematology Study Group of National Hospital Organization (CHSG-NHO)40
Active, not recruiting
Not Applicable
Phase II Trial of Rituximab Plus 2CdA in Patients with Advanced or Relapsed Lymphoma of the Mucosa Associated Lymphoid Tissue (MALT)ymphoma of the Mucosa-Associated Lymphoid Tissue (MALT)MedDRA version: 9.1Level: LLTClassification code 10060707Term: MALT lymphomaEUCTR2008-000767-41-ATArbeitsgemeinschaft medikamentöse Tumortherapie gemeinnützige GmbH
Completed
Phase 2
Rituximab Plus Lenalidomide in Patients With Mucosa Associated Lymphoid TissueLymphoma of the Mucosa Associated Lymphoid Tissue (MALT)NCT01611259Arbeitsgemeinschaft medikamentoese Tumortherapie50
Completed
Phase 2
Phase II study of Bendamustine-Rituximab therapy for CD20-positive untreated and advanced follicular lymphoma with poor response to R-CHOP therapyuntreated and advanced follicular lymphomaJPRN-UMIN000013795Department of Hematology and Rheumatology,Kinki University Faculty of Medicine60
Active, not recruiting
Phase 1
Multicenter study of phase II with Rituximab, cyclophosphamide, doxorubicin liposomal (Myocet), vincristine, Prednisone, (R-COMP) in diffuse Non-Hodgkin`s lymphoma, large B cells of the cardiopathic patient - HEART01Diffuse Non-Hodgkin`s lymphoma, large B cells of the cardiopathic patientMedDRA version: 9.1Level: PTClassification code 10012818EUCTR2009-012143-42-ITIIL INTERGRUPPO ITALIANO LINFOMI ONLUS50