EUCTR2016-004836-39-DE
Active, not recruiting
Phase 1
An open label phase II study to evaluate the efficacy and safety of Inotuzumab Ozogamicin for Induction Therapy followed by a conventional chemotherapy based consolidation and maintenance therapy In patients aged 56 years and older with Acute Lymphoblastic leukemia (ALL). - INITIAL-1
Goethe Universität0 sites45 target enrollmentMay 17, 2017
ConditionsAcute lymphoblastic leukemia, Philadelphia-chromosome and BCR-ABL negative disease, patient aged 56 years or olderMedDRA version: 21.0Level: LLTClassification code 10000845Term: Acute lymphoblastic leukemiaSystem Organ Class: 100000004864Therapeutic area: Diseases [C] - Cancer [C04]
DrugsBESPONSA
Overview
- Phase
- Phase 1
- Intervention
- Not specified
- Conditions
- Acute lymphoblastic leukemia, Philadelphia-chromosome and BCR-ABL negative disease, patient aged 56 years or older
- Sponsor
- Goethe Universität
- Enrollment
- 45
- Status
- Active, not recruiting
- Last Updated
- 4 years ago
Overview
Brief Summary
No summary available.
Investigators
Eligibility Criteria
Inclusion Criteria
- •1\. Male or female patients, \>56 years of age and fit for therapy
- •2\. Newly diagnosed acute lymphoblastic leukemia (\>25% marrow blasts, assessed by morphology; i.e., M2 or M3 marrow)
- •3\. Leukemic blasts must have CD22 surface expression of a least 20%, assessed by local/institutional flow cytometry of a bone marrow aspirate sample (assessment of CD22 via the reference lab for immungenetics is strongly recommended). In the case of an inadequate aspirate sample (dry tap), flow cytometry of peripheral blood specimen may be substituted if the patient has circulating blasts; alternatively, CD22 expression may be documented by immunohistochemistry of a bone marrow biopsy specimen
- •4\. No previous ALL\-specific treatment with the exception of corticosteroids and/or single dose vincristine and/or a maximum of three doses of cyclophosphamide (cumulative dose of 600mg/m2\) and the standard prephase treatment
- •5\. With or without documented CNS involvement
- •6\. Adequate liver function, including total serum bilirubin \<2\.0 x ULN unless the patient has documented Gilbert syndrome, and aspartate and alanine aminotransferase (AST and ALT) \<2\.5 x ULN
- •If organ function abnormalities are considered due to leukemic infiltration of the liver, total serum bilirubin must be \< 2\.5 x ULN and AST/ALT \<5 x ULN
- •7\. Serum creatinine \<1\.5 x upper limit of normal (ULN) or any serum creatinine level associated with a measured or calculated creatinine clearance of \>40 mL/min
- •8\. WHO performance status \<2
- •9\. Signed written inform consent
Exclusion Criteria
- •1\. Philadelphia\-chromosome or BCR\-ABL positive ALL
- •2\. Burkitt’s or mixed phenotype acute leukemia based on the WHO 2008 criteria
- •3\. Peripheral absolute lymphoblast count \>10,000/µL after pre\-phase treatment and before start of study medication
- •4\. Known systemic vasculitis (e.g., Wegener’s granulomatosis, polyarteritis nodosa, systemic lupus erythematosus), primary or secondary immunodeficiency (such as HIV infection or severe inflammatory disease)
- •5\. Current or chronic hepatitis B or C infection as evidenced by hepatitis B surface antigen and anti\-hepatitis C antibody positivity, respectively, or known seropositivity for human immunodeficiency virus (HIV)
- •6\. Major surgery within \<4 weeks before entry on study
- •7\. Unstable or severe uncontrolled medical condition (e.g., unstable cardiac function or unstable pulmonary condition)
- •8\. Concurrent active malignancy other than non\-melanoma skin cancer, carcinoma in situ of the cervix, or localized prostate cancer that has been definitely treated with radiation or surgery; patients with previous malignancies are eligible provided that they have been disease free for \>2 years
- •9\. Cardiac function, as measured by left ventricular ejection fraction (LVEF) that is less than 45%, or the presence of New York Heart Association (NYHA) stage III or IV congestive heart failure
- •10\. Myocardial infarction \<6 months before entry on study
Outcomes
Primary Outcomes
Not specified
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