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

NCT00797810 | Unknown Phase 4 DMC

• 1 other identifier: HEMOS ALL1105
• Study Type: interventional
• Target: 25
• Locations: 1 country
• Sites: 1

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.

Conditions

Acute Lymphoblastic Leukemia; Non-Hodgkin's Lymphoma

Keywords

Acute lymphoblastic leukemia of the mature B-cell type; High-grade non-Hodgkin's lymphoma

Outcome Measures

Primary Outcomes (6)

• 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 Outcomes (4)

• 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

Study Arms (1)

therapy

EXPERIMENTAL

Drug: Rituximab

Interventions

Rituximab DRUG

Also known as: Cyclophosphamide, Prednisone, Dexamethasone, Vincristine, Ifosfamide, Cytarabine, Adriamycin, G-CSF

therapy

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Bologna: lead

Study Sites (1)

Institute of Haematology "L. e A. Seragnoli"

Bologna, Italy

RECRUITING

MeSH Terms

Conditions

Precursor Cell Lymphoblastic Leukemia-Lymphoma; Lymphoma, Non-Hodgkin

Interventions

Rituximab; Cyclophosphamide; Prednisone; Dexamethasone; Vincristine; Ifosfamide; Cytarabine; Doxorubicin; Granulocyte Colony-Stimulating Factor

Condition Hierarchy (Ancestors)

Leukemia, Lymphoid; Leukemia; Neoplasms by Histologic Type; Neoplasms; Hematologic Diseases; Hemic and Lymphatic Diseases; Lymphoproliferative Disorders; Lymphatic Diseases; Immunoproliferative Disorders; Immune System Diseases; Lymphoma

Intervention Hierarchy (Ancestors)

Antibodies, Monoclonal, Murine-Derived; Antibodies, Monoclonal; Antibodies; Immunoglobulins; Immunoproteins; Blood Proteins; Proteins; Amino Acids, Peptides, and Proteins; Serum Globulins; Globulins; Phosphoramide Mustards; Nitrogen Mustard Compounds; Mustard Compounds; Hydrocarbons, Halogenated; Hydrocarbons; Organic Chemicals; Phosphoramides; Organophosphorus Compounds; Pregnadienediols; Pregnadienes; Pregnanes; Steroids; Fused-Ring Compounds; Polycyclic Compounds; Pregnadienetriols; Steroids, Fluorinated; Vinca Alkaloids; Secologanin Tryptamine Alkaloids; Indole Alkaloids; Alkaloids; Heterocyclic Compounds; Indoles; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Indolizidines; Indolizines; Oxazines; Heterocyclic Compounds, 1-Ring; Cytidine; Pyrimidine Nucleosides; Pyrimidines; Arabinonucleosides; Nucleosides; Nucleic Acids, Nucleotides, and Nucleosides; Daunorubicin; Anthracyclines; Naphthacenes; Polycyclic Aromatic Hydrocarbons; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Aminoglycosides; Glycosides; Carbohydrates; Colony-Stimulating Factors; Glycoproteins; Glycoconjugates; Hematopoietic Cell Growth Factors; Cytokines; Intercellular Signaling Peptides and Proteins; Peptides; Biological Factors

Study Officials

• Giovanni Martinelli, MD

  Institute of Haematology "L.e A. Seragnoli" Bologne-Italy

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Giovanni Martinelli, MD

CONTACT

0516363829; gmartino@alma.unibo.it

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: November 24, 2008
• First Posted: November 25, 2008
• Study Start: December 1, 2006
• Last Updated: September 15, 2009

Record last verified: 2009-09

Locations

IT (1)