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

The recruitment status of this study is unknown because the information has not been verified recently.
Verified September 2009 by University of Bologna.
Recruitment status was  Recruiting
Sponsor:
Information provided by:
University of Bologna
ClinicalTrials.gov Identifier:
NCT00797810
First received: November 24, 2008
Last updated: September 14, 2009
Last verified: September 2009
  Purpose

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 Intervention Phase
Acute Lymphoblastic Leukemia
Non-Hodgkin's Lymphoma
Drug: Rituximab
Phase 4

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: 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

Resource links provided by NLM:


Further study details as provided by University of Bologna:

Primary Outcome Measures:
  • 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:
  • 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

Estimated Enrollment: 25
Study Start Date: December 2006
Arms Assigned Interventions
Experimental: therapy Drug: Rituximab
Other Name: Cyclophosphamide, Prednisone, Dexamethasone, Vincristine, Ifosfamide, Cytarabine, Adriamycin, G-CSF

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00797810

Contacts
Contact: Giovanni Martinelli, MD 0516363829 gmartino@alma.unibo.it

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

No publications provided

Responsible Party: Giovanni Martinelli, Dipartiemento di Ematoogia "seragnoli"- Policlinico Sant'Orsola di Bologna
ClinicalTrials.gov Identifier: NCT00797810     History of Changes
Other Study ID Numbers: HEMOS ALL1105
Study First Received: November 24, 2008
Last Updated: September 14, 2009
Health Authority: Italy: Ethics Committee
Italy: The Italian Medicines Agency

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:
Leukemia
Leukemia, Lymphoid
Precursor Cell Lymphoblastic Leukemia-Lymphoma
Lymphoma
Lymphoma, Non-Hodgkin
Neoplasms by Histologic Type
Neoplasms
Lymphoproliferative Disorders
Lymphatic Diseases
Immunoproliferative Disorders
Immune System Diseases
Cyclophosphamide
Rituximab
Immunosuppressive Agents
Immunologic Factors
Physiological Effects of Drugs
Pharmacologic Actions
Antirheumatic Agents
Therapeutic Uses
Antineoplastic Agents, Alkylating
Alkylating Agents
Molecular Mechanisms of Pharmacological Action
Antineoplastic Agents
Myeloablative Agonists

ClinicalTrials.gov processed this record on July 28, 2014