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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00797810
Recruitment Status : Unknown
Verified September 2009 by University of Bologna.
Recruitment status was:  Recruiting
First Posted : November 25, 2008
Last Update Posted : September 15, 2009
Information provided by:
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.

Condition or disease Intervention/treatment Phase
Acute Lymphoblastic Leukemia Non-Hodgkin's Lymphoma Drug: Rituximab Phase 4

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 25 participants
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Intensification Therapy of Mature B-ALL, Burkitt and Burkitt Like and Other High Grade Non-Hodgkin's Lymphoma in Adults
Study Start Date : December 2006

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Lymphoma
Drug Information available for: Rituximab

Arm Intervention/treatment
Experimental: therapy Drug: Rituximab
Other Name: Cyclophosphamide, Prednisone, Dexamethasone, Vincristine, Ifosfamide, Cytarabine, Adriamycin, G-CSF

Primary Outcome Measures :
  1. Test of the tolerability and efficacy of new therapy elements to improve remission
  2. Rates, overall survival and remission duration
  3. Administration of anti-CD20 (rituximab ®) together with combination chemotherapy
  4. Combination therapy with high-dose methotrexate and high-dose cytarabine together with conventional cytostatic agents (cycle C)
  5. Prophylactic administration of G-CSF after every cycle of chemotherapy
  6. Localised irradiation after 6 cycles in mediastinal tumor cases, CNS involvement and residual tumor

Secondary Outcome Measures :
  1. Test of the age-adapted therapy stratification according to biological age
  2. (18< age <55)
  3. Definition of prognostic factors
  4. Setting up of a central reference pathology panel

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00797810

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Contact: Giovanni Martinelli, MD 0516363829

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Institute of Haematology "L. e A. Seragnoli" Recruiting
Bologna, Italy
Contact: Giovanni Martinelli, MD         
Sponsors and Collaborators
University of Bologna
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Principal Investigator: Giovanni Martinelli, MD Institute of Haematology "L.e A. Seragnoli" Bologne-Italy

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Responsible Party: Giovanni Martinelli, Dipartiemento di Ematoogia "seragnoli"- Policlinico Sant'Orsola di Bologna Identifier: NCT00797810     History of Changes
Other Study ID Numbers: HEMOS ALL1105
First Posted: November 25, 2008    Key Record Dates
Last Update Posted: September 15, 2009
Last Verified: September 2009
Keywords provided by University of Bologna:
Acute lymphoblastic leukemia of the mature B-cell type
High-grade non-Hodgkin's lymphoma
Additional relevant MeSH terms:
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Lymphoma, Non-Hodgkin
Precursor Cell Lymphoblastic Leukemia-Lymphoma
Leukemia, Lymphoid
Neoplasms by Histologic Type
Lymphoproliferative Disorders
Lymphatic Diseases
Immunoproliferative Disorders
Immune System Diseases
Physiological Effects of Drugs
Antineoplastic Agents
Antineoplastic Agents, Immunological
Immunologic Factors
Antirheumatic Agents