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

Status

Active, not recruiting

Phases

Phase 4

Study type

Interventional

Source

EU CTR

Registry ID

EUCTR2006-006154-97-IT

Enrollment

Registered

2007-05-15

Start date

2007-01-09

Completion date

Unknown

Last updated

2025-01-27

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

B-ALL, Burkitt and Burkitt like and Non-Hodgkin?s Lymphoma in Adults MedDRA version: 9.1 Level: LLT Classification code 10006595 Term: Burkitt's lymphoma

Interventions

Trade Name: ENDOXAN BAXTER*EV 1FL 500MG Pharmaceutical Form: Powder for solution for injection INN or Proposed INN: Cyclophosphamide Concentration unit: mg milligram(s) Concentration type: equal Conce

Eligibility

Sex/Gender

All

Inclusion criteria

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

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

Design outcomes

Primary

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

Measure

Time frame

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

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Countries

Italy

Outcome results

None listed

Source: EU CTR (via WHO ICTRP) · Data processed: Feb 4, 2026