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

Phase 2

• Conditions: C85.1; C91.0; B-cell lymphoma, unspecified; Acute lymphoblastic leukaemia [ALL]

• Registration Number: DRKS00000908
• Lead Sponsor: niversitäts-KinderklinikPädiatrische Hämatologie und Onkologie

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2012-03-22
• Last Update Posted: 19 August 2024

Recruitment & Eligibility

• Status: Complete
• Sex: All
• Target Recruitment: 90

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.
11. Existence of a lymphoma manifestation which is accessible for the assessment of response (measurement of size within 24 hours before application of Rituximab)

Exclusion Criteria

Pregnant or nursing,
Allergies against proteins,
Known disease that would preclude protocol therapy with rituximab,
Significant therapy prior to protocol therapy

Study & Design

• Study Type: interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Primary outcome measure:<br>Primary outcome measure is the response to therapy on day 5: Reduction of tumor size by =25%. This will be assessed on the basis of the largest measurable tumor manifestation, the so-called index manifestation. In this manifestation, the two largest vertical diameters will be measured and their values multiplied. A distinct response is defined as a reduction in the product of the diameter of =25%. In the case if bone marrow affliction, a distinct response is defined as a reduction in the proportion of blasts (e.g. a reduction of the proportion of blasts from 60% to 32% in the bone marrow).<br>

Secondary Outcome Measures

Name	Time	Method
Secondary outcome measures:<br>1. It will be examined if there is a correlation between a response to Rituximab before the onset of chemotherapy and the overall therapy success of each patient.<br>2. It will be examined if there is a difference regarding the response to Rituximab in different histological subtypes of mature B-NHL.<br>3. It will be examined if the response to Rituximab correlates with the tumor mass (LDH).<br>4. It will be examined if lymphoma manifestations in different areas (bone marrow, bulky disease) respond to Rituximab to the same extent. <br>5. The toxicity profile of Rituximab in children and adolescents will be measured.<br>6. The liquor patency of Rituximab will be controlled.<br>7. Through thorough accompanying research, data in regards to pharmacokinetics will be gathered and parameters for the predictive relevancy of the Rituximab response will be identified.<br>