Status:
COMPLETED
Protocol in Acute Myeloid Leukemia With FLT3-ITD
Lead Sponsor:
University of Ulm
Collaborating Sponsors:
Novartis Pharmaceuticals
Conditions:
Acute Myeloid Leukemia
Eligibility:
All Genders
18-70 years
Phase:
PHASE2
Brief Summary
This is a phase II, single-arm, open-label, multi-center study in adult patients with Acute Myeloid Leukemia (AML) and FLT3-ITD as defined in inclusion/exclusion criteria. The primary efficacy object...
Eligibility Criteria
Inclusion
- Patients with suspected diagnosis of AML or related precursor neoplasm, or acute leukemia of ambiguous lineage (classified according to the World Health Organization (WHO) 2008 classification)
- Presence of FLT3-ITD assessed in the central AMLSG reference laboratories
- Patients considered eligible for intensive chemotherapy
- WHO performance status of ≤ 2
- Age ≥ 18 years and ≤ 70 years
- No prior chemotherapy for leukemia except hydroxyurea to control hyperleukocytosis (≤ 7 days)
- Non-pregnant and non-nursing. Women of childbearing potential (WOCBP) must have a negative serum or urine pregnancy test within a sensitivity of at least 25 mIU/mL within 72 hours prior to registration ("Women of childbearing potential" is defined as a sexually active mature woman who has not undergone a hysterectomy or who has had menses at any time in the preceding 24 consecutive months)
- Female patients in the reproductive age and male patients must agree to avoid getting pregnant or to father a child while on therapy and for 5 months after the last dose of chemotherapy
- Women of child-bearing potential must either commit to continued abstinence from heterosexual intercourse or begin one acceptable method of birth control (IUD, tubal ligation, or partner's vasectomy). Hormonal contraception is an inadequate method of birth control
- Men must use a latex condom during any sexual contact with women of childbearing potential, even if they have undergone a successful vasectomy (while on therapy and for 5 months after the last dose of chemotherapy)
- Signed written informed consent.
Exclusion
- •AML with the following recurrent genetic abnormalities (according to WHO 2008): AML with t(8;21)(q22;q22); RUNX1-RUNX1T1 AML with inv(16)(p13.1q22) or t(16;16)(p13.1;q22); CBFB-MYH11 AML with t(15;17)(q22;q12); PML-RARA (or variant translocations with other RARA gene fusions)
- Performance status WHO \>2
- Patients with ejection fraction \< 50% by MUGA or ECHO scan within 14 days of day 1
- Organ insufficiency (creatinine \>1.5x upper normal serum level; bilirubin, AST or ALP \>2.5x upper normal serum level, not attributable to AML; heart failure NYHA III/IV; severe obstructive or restrictive ventilation disorder)
- Uncontrolled infection
- Severe neurological or psychiatric disorder interfering with ability of giving an informed consent
- Patients with a "currently active" second malignancy other than non-melanoma skin cancers. Patients are not considered to have a "currently active" malignancy if they have completed therapy and are considered by their physician to be at less than 30% risk of relapse within one year
- Known positive for HIV; active HBV, HCV, or Hepatitis A infection
- Bleeding disorder independent of leukemia
- No consent for registration, storage and processing of the individual disease-characteristics and course as well as information of the family physician and/or other physicians involved in the treatment of the patient about study participation.
- No consent for biobanking.
Key Trial Info
Start Date :
May 1 2012
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
February 26 2020
Estimated Enrollment :
451 Patients enrolled
Trial Details
Trial ID
NCT01477606
Start Date
May 1 2012
End Date
February 26 2020
Last Update
June 4 2020
Active Locations (55)
Enter a location and click search to find clinical trials sorted by distance.
1
Medizinische Universität Innsbruck
Innsbruck, Austria, 3020
2
Krankenhaus der Barmherzigen Schwestern Linz
Linz, Austria, 4010
3
Krankenhaus der Elisabethinen Linz GmbH
Linz, Austria, 4020
4
Universitätsklinik für Innere Medizin III Salzburg
Salzburg, Austria, 5020