EUCTR2017-002094-18-IT
Active, not recruiting
Phase 1
Prospective evaluation of a continuation therapy with Midostaurin in adult patients withcore-binding factor leukemia and integrated genetic analysis: a multi-center phase II study - Prospective evaluation of a continuation therapy with Midostaurin in adult patients with core-bindin
AZIENDA OSPEDALIERA AO OSPEDALE NIGUARDA CA' GRANDA0 sites39 target enrollmentJune 17, 2021
Overview
- Phase
- Phase 1
- Intervention
- Not specified
- Conditions
- Acute Myeloid Leukemia (AML)
- Sponsor
- AZIENDA OSPEDALIERA AO OSPEDALE NIGUARDA CA' GRANDA
- Enrollment
- 39
- Status
- Active, not recruiting
- Last Updated
- 4 years ago
Overview
Brief Summary
No summary available.
Investigators
Eligibility Criteria
Inclusion Criteria
- •Patients eligible for inclusion in this study have to meet all of the following criteria:
- •1\. Written informed consent must be obtained prior to any screening procedures.
- •2\. Patients must be 18 to 65 years of age at the time of signing informed consent.
- •3\. Patients must have an unequivocal diagnosis of de novo\-CBFL, prior to start Midostaurin,
- •documented by rearrangement of Core Binding Factor (CBF) genes, namely AML1\-ETO and CBFBMYH11,
- •either with observation of t(8;21\)(q22;q22\) or inv(16\)(p13; q32\)/t(16;16\)(p13; q32\) by
- •conventional cytogenetics or hybridization techniques or detection of fusion genes by PCR
- •4\. Patients must be fit to receive an anthracyclin/AraC\-based induction therapy (i.e. Ara\-C 100
- •mg/m2 or 200 mg/m2 i.v. day, by continuous infusion for 7 days and Idarubicin 12 mg/m2 i.v. day or
- •daunomycin 60 mg/m2 on days 1, 3 and 5\)
Exclusion Criteria
- •Patients eligible for this study must not meet any of the following criteria:
- •1\. Prior therapy for AML with the following exceptions:
- •a. emergency leukapheresis
- •b. emergency treatment for hyperleukocytosis with hydroxyurea for \= 7 days
- •2\. Central nervous system involvement
- •3\. Presence of any uncontrolled bacterial, viral or fungal infection
- •4\. Known human immunodeficiency virus (HIV) positive
- •5\. An active Hepatitis B virus (HBV) or Hepatitis C virus (HCV) infection. Patients whose disease is
- •controlled under antiviral therapy should not be excluded.
- •6\. Presence of other active malignancies
Outcomes
Primary Outcomes
Not specified
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