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Open-Label, Multicenter Phase Ib/IIa Study For the Evaluation of Dasatinib (Sprycel™) Following Induction and Consolida-tion Therapy as Well as in Maintenance Therapy in Patients With Newly Diagnosed Core Binding Factor (CBF) Acute Myeloid Leukemia (AML)


Phase 1/Phase 2
18 Years
N/A
Open (Enrolling)
Both
Acute Myeloid Leukemia (AML)

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Trial Information

Open-Label, Multicenter Phase Ib/IIa Study For the Evaluation of Dasatinib (Sprycel™) Following Induction and Consolida-tion Therapy as Well as in Maintenance Therapy in Patients With Newly Diagnosed Core Binding Factor (CBF) Acute Myeloid Leukemia (AML)


Inclusion Criteria:



- Core binding factor (CBF) AML with molecular diagnosis of RUNX1-RUNX1T1 fusion
transcript resulting from t(8;21)(q22;q22) (or a variant form) or of CBFB-MYH11
fusion transcript resulting from inv(16)(p13.1q22)/t(16;16)(p13.1;q22) as assessed in
one of the central AMLSG reference laboratories.

- Age ≥ 18; there is no upper age limit.

- No prior chemotherapy for leukemia except hydroxyurea for up to 5 days during the
diag-nostic screening phase.

- Non-pregnant and non-nursing. Due to the unknown teratogenic potential of dasatinib
in humans, pregnant or nursing patients may not be enrolled. Women of childbearing
poten-tial (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
child-bearing potential must either commit to continued abstinence from heterosexual
intercourse or begin TWO acceptable methods of birth control - one highly effective
method (e.g., IUD, hormonal, tubal ligation, or partner's vasectomy), and one
additional effective method (e.g., latex condom, diaphragm, or cervical cap) - AT THE
SAME TIME, at least four weeks before she begins dasatinib therapy. "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.

- Men must agree not to father a child and must use a latex condom during any sexual
con-tact with women of childbearing potential while taking dasatinib and for 4 weeks
after therapy is stopped, even if they have undergone a successful vasectomy.

- Signed written informed consent

Exclusion Criteria:

- Performance status WHO >2

- Pulmonary edema and/or pleural/pericardial effusion within 14 days of Day 1. If
edema/effusion resolves to CTC Grade ≤ 1, patients can be treated with dasatinib.

- Patients with ejection fraction < 50% by echocardiography within 14 days of day 1

- Organ insufficiency (creatinine >1.5x upper normal serum level; bilirubin, AST or AP
>2.5x upper normal serum level; 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

- Known positive for HIV

- Bleeding disorder independent of leukemia

- No consent for registration, storage and processing of the individual
disease-characteristics and course

Type of Study:

Interventional

Study Design:

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

Outcome Measure:

Feasibility as combined endpoint: Rate of ED/HD Rate of pleural/pericardial effusion grade 3/4 Rate of liver toxicity grade 3/4 that does not improve to <= grade 2 within 14 days after discontinuing responsible medication Rate of refractory disease

Outcome Time Frame:

after 4 weeks

Safety Issue:

Yes

Principal Investigator

Hartmut Doehner, MD

Investigator Role:

Principal Investigator

Investigator Affiliation:

University Hospital of Ulm

Authority:

Germany: Federal Institute for Drugs and Medical Devices

Study ID:

AMLSG 11-08

NCT ID:

NCT00850382

Start Date:

June 2009

Completion Date:

December 2014

Related Keywords:

  • Acute Myeloid Leukemia (AML)
  • CBF AML
  • Dasatinib
  • Core Binding Factor (CBF)
  • Leukemia
  • Leukemia, Myeloid, Acute
  • Leukemia, Myeloid

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