Clinical trial NCT00797810: 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
Overall status: UNKNOWN
Phase: PHASE4
Conditions: Acute Lymphoblastic Leukemia
Non-Hodgkin's Lymphoma
Keywords: Acute lymphoblastic leukemia of the mature B-cell type
High-grade non-Hodgkin's lymphoma
Lead sponsor: University of Bologna
Sponsor class: OTHER
First posted: 2008-11-25
Enrollment: 25
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.


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

Primary outcomes:
measure: Test of the tolerability and efficacy of new therapy elements to improve remission
measure: Rates, overall survival and remission duration
measure: Administration of anti-CD20 (rituximab ®) together with combination chemotherapy
measure: Combination therapy with high-dose methotrexate and high-dose cytarabine together with conventional cytostatic agents (cycle C)
measure: Prophylactic administration of G-CSF after every cycle of chemotherapy
measure: Localised irradiation after 6 cycles in mediastinal tumor cases, CNS involvement and residual tumor
Secondary outcomes:
measure: Test of the age-adapted therapy stratification according to biological age
measure: (18< age <55)
measure: Definition of prognostic factors
measure: Setting up of a central reference pathology panel
Other outcomes:
Locations:
city: Bologna
country: Italy
facility: Institute of Haematology "L. e A. Seragnoli"
Study officials:
affiliation: Institute of Haematology "L.e A. Seragnoli" Bologne-Italy
name: Giovanni Martinelli, MD
role: PRINCIPAL_INVESTIGATOR
References: