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Phase I/II Study on Cytarabine and Idarubicin Combined With Escalating Doses of Clofarabine as Induction Therapy in Patients With Acute Myeloid Leukemia and High Risk for Induction Failure (AMLSG 17-10)


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

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Trial Information

Phase I/II Study on Cytarabine and Idarubicin Combined With Escalating Doses of Clofarabine as Induction Therapy in Patients With Acute Myeloid Leukemia and High Risk for Induction Failure (AMLSG 17-10)


Inclusion Criteria:



1. Patients with newly diagnosed AML according to WHO classification and aged ≥ 18 years
eligible for an intensive induction chemotherapy with with the following
characteristics:

- absence of a t(15;17), t(8;21), inv(16)/t(16;16) and the respective fusion
transcripts PML-RARA, RUNX1-RUNX1T1 and CBFB-MYH11

- absence of an activating FLT3-mutation (FLT3-ITD or TKD-mutation)

- absence of an NPM1 exon12 mutation

2. Written informed consent

3. No previous cytotoxic chemotherapy for the treatment of AML (exception: oral
hydroxyurea for up to 5 days during screening/baseline to control hyperleukocytosis)

4. Adequate renal and hepatic functions as indicated by the following laboratory values:

- Serum creatinine > upper limit of normal (ULN) or glomerular filtration rate
(GFR) > 60 mL/min/1.73 m2, respectively

- Serum bilirubin < 1.5 x ULN

- Aspartate aminotransferase (AST/SGOT)/ alanine aminotransferase (ALT/SGPT) < 2.5
x ULN

- Alkaline phosphatase (ALP) < 2.5 x ULN

5. Capable of understanding the investigational nature, potential risks and benefits of
the study

6. Women of childbearing potential must have a negative serum pregnancy test with a
sensitivity of at least 25 MIU/ml within 72 hours prior to start of IMP treatment

7. Female patients must meet one of the following criteria:

- For female patients > 50 years of age at the day of inclusion: Menopause since
at least 1 year

- Female patients < 50 years of age at the day of inclusion who meet all of the
following criteria:

- menopause since at least 1 year

- serum FSH levels > 40 MIU/mL

- serum estrogen levels < 30 pg/ml or negative estrogen test

- 6 weeks after surgical sterilization by bilateral tubal ligation or bilateral
ovariectomy with or without hysterectomy

- Correct use of two reliable contraception methods from the time of
screening/baseline and during the study for a minimum of 90 days after the last
administration of study medication. This includes every combination of a
hormonal contraceptive (such as oral, injection, transdermal patch, implant,
cervical ring) or of an intrauterine device (IUD) with a barrier method
(diaphragm, cervical cap, Lea contraceptive, femidom or condom) or with a
spermicide. In case the patient takes hormone preparations for suppression of
menstruation during the period of aplasia, a suitable and effective method of
contraception has to be discussed with the investigator and used by the patient

- General sexual abstinence from the time of screening/baseline, during the study
until a minimum of 90 days after the last administration of study medication

- Having only female sexual partners

- Monogamous relationship with sterile male partner

8. Male patients must meet one of the following criteria:

- 6 weeks after surgical sterilization by vasectomy

- Correct use of two reliable contraception methods from the time of
screening/baseline and during the study for a minimum of 90 days after the last
administration of study medication. This includes every combination of a
hormonal contraceptive (such as oral, injection, transdermal patch, implant,
cervical ring) or of an IUD with a barrier method (diaphragm, cervical cap, Lea
contraceptive, femidom or condom) or with a spermicide.

- General sexual abstinence from the time of screening/baseline, during the study
until a minimum of 90 days after the last administration of study medication

- Having only male sexual partners

- Monogamous relationship with sterile female partner

Exclusion Criteria:

1. Current concomitant chemotherapy, radiation therapy or immunotherapy not defined in
the study protocol

2. Use of investigational agents within 30 days or any anticancer therapy within 2 weeks
before study entry with the exception of oral hydroxyurea. The patient must have
recovered from all non-hematological acute toxicities from any previous therapy

3. Participation in a clinical trial within 30 days before inclusion in this study or
concurrent to this study.

4. Bleeding disorder independent of AML

5. Patients with uncontrolled systemic fungal, bacterial, viral or other infection
(defined as persistent disease signs/symptoms without improvement despite appropriate
antibiotics or other treatment)

6. HIV Infection

7. Pregnant or lactating women

8. Any significant concurrent disease, illness, psychiatric disorder or history of
serious organ dysfunction that would compromise patient safety or compliance,
interfere with consent, study participation, follow up, or interpretation of study
results

9. Diagnosis of another malignancy, unless the patient is disease-free for at least 3
years following the completion of curative intent therapy, with the following
exceptions:

- Myelodysplastic syndrome (MDS) in patients with AML after MDS according to the
WHO classification

- Patients with treated non-melanoma skin cancer, in situ carcinoma, or cervical
intraepithelial neoplasia, regardless of the disease-free duration, are eligible
for this study if definitive treatment for the condition has been completed.

10. Known hypersensitivity to any of the investigational medical products

Type of Study:

Interventional

Study Design:

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

Outcome Measure:

maximal tolerated dose of clofarabine in combination with cytarabine and idarubicin

Outcome Description:

maximal tolerated dose of clofarabine in combination with cytarabine and idarubicin in the therapy of previously untreated AML and high risk for induction failure

Outcome Time Frame:

six weeks

Safety Issue:

Yes

Principal Investigator

Juergen Krauter, MD

Investigator Role:

Principal Investigator

Investigator Affiliation:

Hannover Medical School

Authority:

Germany: Federal Institute for Drugs and Medical Devices

Study ID:

KS-2009-003

NCT ID:

NCT01534702

Start Date:

January 2012

Completion Date:

September 2015

Related Keywords:

  • Acute Myeloid Leukemia
  • Acute Myeloid Leukemia
  • chemotherapy
  • clofarabine
  • Leukemia
  • Leukemia, Myeloid, Acute
  • Leukemia, Myeloid

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