HEMOS ALL 0105 Intensification therapy of mature B-ALL, Burkitt and Burkitt like and other HIgh Grade Non-Hodgkin?s Lymphoma in Adults - HEMOS ALL 1105

• Conditions: B-ALL, Burkitt and Burkitt likeand Non-Hodgkin?s Lymphoma in Adults; MedDRA version: 9.1Level: LLTClassification code 10006595Term: Burkitt's lymphoma

• Registration Number: EUCTR2006-006154-97-IT
• Lead Sponsor: AZIENDA OSPEDALIERA DI BOLOGNA POLICLINICO S. ORSOLA M. MALPIGHI

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2007-05-15
• Last Update Posted: 24 February 2014

Recruitment & Eligibility

• Status: Authorised-recruitment may be ongoing or finished
• Sex: All
• Target Recruitment: Not specified

Inclusion Criteria

? Mature B-cell-ALL (L3-ALL)

? High-grade non-Hodgkin's lymphoma of the following subtypes

(WHO classification)

- Burkitt?s lymphoma (incl. atypical Burkitt?s lymphoma)

- Precursor B-lymphoblastic lymphoma

- Anaplastic large-cell lymphoma (Ki1+, B-, T- or Null-cell type) -

Mediastinal large B-cell lymphoma (subtype of diffuse large B-Cell

lymphoma)

? Age = 18 years

? Patient?s Informed Consent
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range

Exclusion Criteria

Serious secondary diseases including psychiatric conditions, under

which the required therapy compliance is not to be expected

? HIV infection

? Secondary lymphoma following prior chemotherapy/radiotherapy or an

active second malignancy

? Known severe allergy to foreign proteins

Pre-treatment (Exception: 1 cycle CHOP or similar, < 1 week of another chemotherapy)

Pregnancy or nursing

? Absence of patient?s written informed consent

? Participation in other studies that interfere with the study therapy

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Main Objective: 1. Test of the tolerability and efficacy of new therapy elements to<br><br>improve remission rates, overall survival and remission duration:<br><br>- Administration of anti-CD20 (rituximab ) together with<br><br>combination chemotherapy<br><br>- Combination therapy with high-dose methotrexate and<br><br>high-dose cytarabine together with conventional<br><br>cytostatic agents (cycle C)<br><br>- Prophylactic administration of G-CSF after every<br><br>chemotherapy cycle<br><br>- Localised irradiation after 6 cycles in patients with<br><br>mediastinal tumor, CNS involvement and residual tumor;Secondary Objective: Test of the age-adapted therapy stratification according to<br><br>biological age (<> 55 years)<br><br>Definition of prognostic factors<br><br>Setting up of a central pathology reference panel;Primary end point(s): improve remission<br><br>rates, overall survival and remission duration: