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

Primary Purpose

Acute Lymphoblastic Leukemia, Non-Hodgkin's Lymphoma

Status
Unknown status
Phase
Phase 4
Locations
Italy
Study Type
Interventional
Intervention
Rituximab
Sponsored by
University of Bologna
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Acute Lymphoblastic Leukemia focused on measuring Acute lymphoblastic leukemia of the mature B-cell type, High-grade non-Hodgkin's lymphoma

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Institute of Haematology "L. e A. Seragnoli"Recruiting

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

therapy

Arm Description

Outcomes

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

Full Information

First Posted
November 24, 2008
Last Updated
September 14, 2009
Sponsor
University of Bologna
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1. Study Identification

Unique Protocol Identification Number
NCT00797810
Brief Title
Intensification Therapy of Mature B-ALL, Burkitt and Burkitt Like and Other High Grade Non-Hodgkin's Lymphoma in Adults
Official Title
Intensification Therapy of Mature B-ALL, Burkitt and Burkitt Like and Other High Grade Non-Hodgkin's Lymphoma in Adults
Study Type
Interventional

2. Study Status

Record Verification Date
September 2009
Overall Recruitment Status
Unknown status
Study Start Date
December 2006 (undefined)
Primary Completion Date
undefined (undefined)
Study Completion Date
undefined (undefined)

3. Sponsor/Collaborators

Name of the Sponsor
University of Bologna

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Acute Lymphoblastic Leukemia, Non-Hodgkin's Lymphoma
Keywords
Acute lymphoblastic leukemia of the mature B-cell type, High-grade non-Hodgkin's lymphoma

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
25 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
therapy
Arm Type
Experimental
Intervention Type
Drug
Intervention Name(s)
Rituximab
Other Intervention Name(s)
Cyclophosphamide, Prednisone, Dexamethasone, Vincristine, Ifosfamide, Cytarabine, Adriamycin, G-CSF
Primary Outcome Measure Information:
Title
Test of the tolerability and efficacy of new therapy elements to improve remission
Title
Rates, overall survival and remission duration
Title
Administration of anti-CD20 (rituximab ®) together with combination chemotherapy
Title
Combination therapy with high-dose methotrexate and high-dose cytarabine together with conventional cytostatic agents (cycle C)
Title
Prophylactic administration of G-CSF after every cycle of chemotherapy
Title
Localised irradiation after 6 cycles in mediastinal tumor cases, CNS involvement and residual tumor
Secondary Outcome Measure Information:
Title
Test of the age-adapted therapy stratification according to biological age
Title
(18< age <55)
Title
Definition of prognostic factors
Title
Setting up of a central reference pathology panel

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility 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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Giovanni Martinelli, MD
Phone
0516363829
Email
gmartino@alma.unibo.it
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Giovanni Martinelli, MD
Organizational Affiliation
Institute of Haematology "L.e A. Seragnoli" Bologne-Italy
Official's Role
Principal Investigator
Facility Information:
Facility Name
Institute of Haematology "L. e A. Seragnoli"
City
Bologna
Country
Italy
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Giovanni Martinelli, MD

12. IPD Sharing Statement

Learn more about this trial

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

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