DRKS00000908
Completed
Phase 2
Rituximab in Treating Young Patients Who Are Receiving Chemotherapy for B-Cell Non-Hodgkin's Lymphoma or B-Cell Acute Lymphoblastic LeukemiaMulticenter Therapy Study for Children With Mature B-NHL or B-ALL With a Rituximab - Window Before Chemotherapy
niversitäts-KinderklinikPädiatrische Hämatologie und Onkologie0 sites90 target enrollmentMarch 22, 2012
Overview
- Phase
- Phase 2
- Intervention
- Not specified
- Conditions
- C85.1
- Sponsor
- niversitäts-KinderklinikPädiatrische Hämatologie und Onkologie
- Enrollment
- 90
- Status
- Completed
- Last Updated
- last year
Overview
Brief Summary
No summary available.
Investigators
Eligibility Criteria
Inclusion Criteria
- •1\. Newly diagnosed and histologically/immunohistologically or cytomorphologically/immunologically verified mature B\-NHL or B\-ALL (not: lymphoblastic lymphoma of precursor B\-CELL type, protocol EURO\-LB 02\)
- •2\. Immunological or immuno\-histo\-chemical proof of a CD20\-expression of the lymphoma cells
- •3\. Written informed consent and consent for the processing and disclosure of data by each patient and/or their legal guardian.
- •4\. Diagnosis prior to 19th birthday.
- •5\. Begin of protocol therapy within the duration of the study
- •6\. Treatment in one of the participating study clinics
- •7\. Contraception in women of child\-bearing age
- •8\. No participation in any other study with the exception of B\-NHL BFM 04
- •9\. Stratification according to stage, extent of resection, and initial LDH in the therapy arms R2, R3, or R4
- •10\. Good general health; adequate liver, cardiac, and renal functions.
Exclusion Criteria
- •Pregnant or nursing,
- •Allergies against proteins,
- •Known disease that would preclude protocol therapy with rituximab,
- •Significant therapy prior to protocol therapy
Outcomes
Primary Outcomes
Not specified
Similar Trials
Active, not recruiting
Phase 1
Rituximab in the Treatment of Refractory Adult and Juvenile Dermatomyositis (DM)and Adult Polmyositis (PM) - Rituximab in myositis (RIM)Adult polymyositis or adult dermatomyositis or juvenile dermatomyositis.MedDRA version: 9.1Level: LLTClassification code 10036102Term: PolymyositisEUCTR2006-000078-65-CZKarolinska University Hospital202
Active, not recruiting
Phase 1
Rituximab in the Treatment of Refractory Adult and Juvenile Dermatomyositis (DM) and Adult Polymyositis (PM) - Rituximab in myositisAdult polymyositis or adult dermatomyositis or juvenile dermatomyositisMedDRA version: 8.1Level: LLTClassification code 10036102Term: PolymyositisEUCTR2006-000078-65-GBKarolinska University Hospital202
Active, not recruiting
Not Applicable
Rituximab in the Treatment of Refractory Adult and Juvenile Dermatomyositis (DM) and Adult Polymyositis (PM) - Rituximab in myositisAdult polymyositis or adult dermatomyositis or juvenile dermatomyositisMedDRA version: 8.1Level: LLTClassification code 10036102Term: PolymyositisEUCTR2006-000078-65-SEKarolinska University Hospital202
Recruiting
Phase 2
Safety and Efficacy of Rituximab in patients with juvenile dermatomyositisJuvenile dermatomyositis.Juvenile dermatomyositisM33.0IRCT20231119060108N1Shahid Beheshti University of Medical Sciences7
Active, not recruiting
Phase 3
IDEC-C2B8 clinical phase III trialAdult-onset frequently relapsing or steroid dependent nephrotic syndromenephrotic syndromeJPRN-jRCT2051200045Isaka Yoshitaka64