Intensification Therapy of Mature B-ALL, Burkitt and Burkitt Like and Other High Grade Non-Hodgkin's Lymphoma in Adults

Phase 4

• Conditions: Acute Lymphoblastic Leukemia; Non-Hodgkin's Lymphoma
• Interventions: Drug: Rituximab

• Registration Number: NCT00797810
• Lead Sponsor: University of Bologna

Brief Summary

All patients are treated according to the same therapy regimen. Therapy duration (number of cycles) and radiotherapy vary according to age group, stage and response. Chemotherapy consists of a pre-phase-treatment (for all patients) and varying A, B and C cycles. Therapy for Patients in the 18-55 Age Group

* Patients in stages III-IV and all patients with mediastinal tumors or extranodal involvement are administered 6 cycles (A1, B1, A2, B2, A3, B3).

* Chemotherapy is stopped after 4 cycles (A1, B1, A2, B2) for patients with stage I/ II if a clear CR has been achieved and there is initially no mediastinal or extranodal involvement.

* In cases of refractory or progressive disease after 4 cycles, study therapy is stopped. These patients are to be given salvage therapy with subsequent stem cell transplantation. Therapy for Patients older than 55 years

* The course corresponds to that of patients in the younger age group, but the regimen is dose reduced (A1\*, B1\*,A2\*, B2\*, A3\*, B3\*). Antibody therapy with anti-CD20 is to be administered on day 1 of each chemotherapy cycle (A, B). After end of chemotherapy (6 or 4 cycles) 2 more cycles of anti-CD 20 are to be administered to reach a total number of 8 resp. 6 cycles antibody therapy.

Detailed Description

Not available

Basic Information
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Recruitment & Eligibility
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Study & Design
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Trial Locations

Study Timeline

• Study Start: 2006-12
• Study First Submitted: 2008-11-24
• Study First Submitted QC: 2008-11-24
• Study First Posted: 2008-11-25
• Status Verified: 2009-09
• Last Update Submitted: 2009-09-14
• Last Update Posted: 2009-09-15

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 25

Inclusion Criteria

• Acute lymphoblastic leukemia of the mature B-cell type (L3-ALL)

• High-grade non-Hodgkin's lymphoma of the following subtypes (WHO classification)

  • Burkitt's lymphoma (including atypical Burkitt's lymphoma)
  • Precursor B-lymphoblastic lymphoma
  • Anaplastic large-cell lymphoma (Ki1+, B-, T- oder Null-cell-type)
  • Mediastinal large B-cell-lymphoma (subtype of diffuse large B-cell lymphoma)

• Age = 18 years

• Patient's Informed Consent

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Exclusion Criteria

• Serious complications caused by leukemia/ lymphoma or by a second illness: e.g.

  • Severe, unmanageable complications such as sepsis, pneumonia with oxygen deficiency,
  • Shock, hemorrhage at the time of diagnosis
  • Renal insufficiency from leukemia/lymphoma-unrelated causes
  • Severe cardiac or hepatic insufficiency
  • Severe obstructive or restrictive lung disease that would compromise patient's treatment with intensified chemotherapy
  • HIV infection
  • Secondary lymphoma following prior chemotherapy/ radiotherapy or an active second malignancy
  • Known severe allergy to foreign proteins

• Cytostatic pretreatment for B-ALL/lymphoma (exceptions: short-term administration of steroids = 7 days, single administration of vincristine or cyclophosphamide, one cycle of CHOP, a single administration in an emergency of other cytostatic agents) for another malignant disease within the last 5 years

• Pregnancy/ nursing period

• Severe psychiatric illness or other circumstances giving ground to the assumption that a patient cannot give his consent to therapy or act co-operatively

• Absence of patient's informed consent

• Participation in another clinical study that would possibly interfere with study therapy

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
therapy	Rituximab	-

Primary Outcome Measures

Name	Time	Method
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 cycle of chemotherapy
Localised irradiation after 6 cycles in mediastinal tumor cases, CNS involvement and residual tumor

Secondary Outcome Measures

Name	Time	Method
Test of the age-adapted therapy stratification according to biological age
(18< age <55)
Definition of prognostic factors
Setting up of a central reference pathology panel

Trial Locations

Locations (1)

Institute of Haematology "L. e A. Seragnoli"; 🇮🇹 Bologna, Italy