Description:

ODM derived from http://clinicaltrials.gov/show/NCT00560794

Link:

http://clinicaltrials.gov/show/NCT00560794

Keywords:
Versions (2) ▾
  1. 12/10/13
  2. 4/14/14
Uploaded on:

April 14, 2014

DOI:
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License:
Creative Commons BY-NC 3.0 Legacy
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Eligibility NCT00560794 Acute Lymphoblastic Leukemia

Eligibility

  1. StudyEvent: Eligibility
    1. Eligibility
Inclusion Criteria
age at least 18 Years
B-precursor ALL patients in complete hematological remission with molecular failure or molecular relapse starting at any time after consolidation I of front-line therapy within GMALL standards or at any time outside GMALL standards.
Patients must have a molecular marker for evaluation of minimal residual disease which is either Bcr/abl at any detection level or individual rearrangements of immunoglobulin or TCR-genes measured by an assay with a sensitivity of minimum 10-4: At least one individual marker at a quantitative level 10-4.
ECOG performance status finding < 2
Ability to understand and willingness to sign a written informed consent
Signed and dated written informed consent is available
Exclusion Criteria
Current extra medullar involvement
History of or current relevant CNS pathology (except migraine/headache and/or previous infiltration of cerebrospinal fluid (CSF) by ALL)
Current infiltration of cerebrospinal fluid by ALL
History of or current autoimmune disease
Autologous stem cell transplantation within 6 weeks prior to study entry
Any prior allogeneic stem cell transplantation
Cancer chemotherapy within 4 weeks prior to study treatment (except for intrathecal prophylaxis and/or low dose maintenance therapy such as vincalkaloids, mercaptopurine, methotrexate, steroids)
Radiotherapy within 4 weeks prior to study treatment
Therapy with monoclonal antibodies (Rituximab, MabCampath) within 6 weeks prior to study treatment
Known hypersensitivity to immunoglobulins or to any other component of the study drug formulation
Presence of human anti-murine antibodies (HAMA)
Abnormal bone marrow, renal or hepatic function
Indication for a hypercoagulative state
History of malignancy other than ALL within 5 years prior to study entry, with the exception of basal cell carcinoma of the skin or cervix carcinoma in situ
Active severe infection, any other concurrent disease or medical condition that are deemed to interfere with the conduct of the study as judged by the investigator
Known infection with human immunodeficiency virus (HIV) or chronic infection with hepatitis B virus (HbsAg positive) or hepatitis C virus (anti-HCV positive
Pregnant or nursing women
Women of childbearing potential not willing to use an effective form of contraception during participation in the study and at least 3 months thereafter or male patients not willing to ensure effective contraception dur-ing participation in the study and at least three months thereafter