An Open-Label Randomized Phase 2 Study of the X-Linked Inhibitor of Apoptosis (XIAP) Antisense AEG35156 Given in Combination with High-dose Cytarabine and Idarubicin in AML Following Failure of a Single Standard Dose Cytarabine Based Frontline Induction Regimen.
- Conditions
- Acute myeloid leukemia after failure of a single standard dose cytarabine based frontline induction regimen.MedDRA version: 12.0Level: LLTClassification code 10001941Term: AM
- Registration Number
- EUCTR2009-013669-25-DE
- Lead Sponsor
- Aegera Therapeutics Inc.
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- All
- Target Recruitment
- 60
- Patients with AML, except those with APL (acute promyelocytic leukemia), failing a
single standard dose cytarabine based frontline induction regimen. The diagnosis of
refractory AML is based on the presence of either > 10% blasts in marrow or blood
or 5-10% blasts in either site together with cytopenia (Hb < 10 g/dL, or platelets <
100 x 10^9/L, or neutrophil count < 1.0 x 10^9/L).
- Patients must have an Eastern Cooperative Oncology Group (ECOG) performance
status of =2.
- Patients must be =18 years old.
- Male, or female patients who are post-menopausal (amenorrhagic for at least 12
months), or surgically or biologically sterile. Females of childbearing potential
must have a negative serum pregnancy test within 72 hours prior to the 1st
infusion in the study and using adequate forms of contraception for the duration of
the study, including 30 days after the last treatment. Males should avoid fathering
children during the course of the study. Patients and their partners with
reproductive potential must use an effective contraceptive method while the
patient is on the study treatment and for 30 days after the last treatment.
Adequate methods of contraception are double barrier methods (condoms with
spermicidal jelly or foam, and diaphragm with spermicidal jelly or foam), oral, depot
and injectable contraceptives, IUD, and surgical sterilization. Single barrier
methods, rhythm methods, abstinence or sterility of a partner will not be
considered adequate contraception.
- Patients must have adequate organ and immune function as indicated by the
following laboratory values:
Parameter Laboratory Values
Serum creatinine; =2.0 mg/dL (=177 µmol/L)
Total Bilirubin =2.0 mg/dL (=34 µmol/L)
AST (SGOT) and ALT (SGPT) =3 X ULN *
*ULN: Institution’s upper limit of normal.
- The patient must understand, be able and willing and likely to fully comply with
study procedures, including scheduled follow-up, and restrictions.
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range
- Clinical evidence of ongoing grade 3 or 4 non-hematological toxicities from the
initial standard dose cytarabine-based induction chemotherapy.
- Patients with a prior history of peripheral neuropathy of grade 2 or higher.
- Clinical evidence of active CNS leukemic involvement.
- Active and uncontrolled infection. Patients with an infection who are under active
treatment with antibiotics and whose infections are controlled may be entered to
the study.
- Current evidence of invasive fungal infection (blood or tissue culture).
- Current evidence of an active second malignancy except for non-melanoma skin
cancer.
- Uncontrolled medical problems, unrelated to the malignancy, or of sufficient severity
that in the opinion of the investigator, impair a patient’s ability to give informed
consent or unacceptably reduce the safety of the proposed treatment.
- Neurological or psychiatric disorders that would interfere with consent or study
follow-up.
- Known or suspected intolerance or hypersensitivity to the study drugs [or closely
related compounds] or any of their stated ingredients. Study drugs being the
antisense, cytarabine and idarubicin.
- History of alcohol or other substance abuse within the last year.
- Use of another investigational agent within the last 14 days prior to enrolment.
Patients who have received a previous antisense agent in the last 90 days will be
excluded.
- Female patients who are pregnant, lactating, or with a positive pregnancy test at
screening must be excluded.
- Patients who have previously been enrolled into this study and subsequently
withdrawn must also be excluded.
Both men and women and members of all races and ethnic groups are eligible for
this trial.
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method