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


Phase 4
18 Years
N/A
Open (Enrolling)
Both
Acute Lymphoblastic Leukemia, Non-Hodgkin's Lymphoma

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Trial Information

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


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

Type of Study:

Interventional

Study Design:

Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

Test of the tolerability and efficacy of new therapy elements to improve remission

Principal Investigator

Giovanni Martinelli, MD

Investigator Role:

Principal Investigator

Investigator Affiliation:

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

Authority:

Italy: Ethics Committee

Study ID:

HEMOS ALL1105

NCT ID:

NCT00797810

Start Date:

December 2006

Completion Date:

Related Keywords:

  • Acute Lymphoblastic Leukemia
  • Non-Hodgkin's Lymphoma
  • Acute lymphoblastic leukemia of the mature B-cell type
  • High-grade non-Hodgkin's lymphoma
  • Leukemia
  • Leukemia, Lymphoid
  • Precursor Cell Lymphoblastic Leukemia-Lymphoma
  • Lymphoma
  • Lymphoma, Non-Hodgkin

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