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A Safety and Efficacy Study of Adding Low Dose Pegylated IFN-alpha 2B to Standard Dose Dasatinib in Patients With Newly Diagnosed Chronic Phase Myeloid Leukemia


Phase 2
18 Years
70 Years
Open (Enrolling)
Both
Leukemia, Myeloid, Chronic-Phase

Thank you

Trial Information

A Safety and Efficacy Study of Adding Low Dose Pegylated IFN-alpha 2B to Standard Dose Dasatinib in Patients With Newly Diagnosed Chronic Phase Myeloid Leukemia


Inclusion Criteria:



- Diagnosis of chronic myeloid leukemia in chronic phase (CML-CP) associated with
BCR-ABL1 quantifiable by RQ-PCR (IS)

- No other current or planned anti-leukemia therapies excluding hydroxyurea treatment
for up to two months.

- ECOG Performance status 0,1, or 2

- Adequate organ function as defined by: Total bilirubin < 1.5 x ULN (ULN = upper limit
of normal in a local institution lab) in absence of Gilbert genotype; ASAT and ALAT <
2.5 x ULN. Creatinine < 2x ULN. Potassium, magnesium and phosphate not below LLN
(LLN= lower level of normal)

- Life expectancy of more than 12 months in the absence of any intervention

- Patient has given written informed consent to participate in the study

Exclusion Criteria:

- Prior accelerated phase or blast crisis

- Uncontrolled or significant cardiovascular disease, including any of the following:

- A myocardial infarction within 6 months

- Uncontrolled angina within 3 months

- Congestive heart failure within 3 months

- Diagnosed or suspected congenital long QT syndrome

- Any history of clinically significant ventricular arrhythmias (such as
ventricular tachycardia, ventricular fibrillation, or Torsades de Pointe)

- Prolonged QTcF interval > 450 msec on pre-entry ECG

- Atypical BCR-ABL1 transcript not quantifiable by RQ-PCR.

- Another primary malignant disease, which requires systemic treatment (chemotherapy or
radiation) Severe and/or life-threatening medical disease including acute liver
disease

- History of significant congenital or acquired bleeding disorder unrelated to cancer

- Impairment of gastrointestinal (GI) function or GI disease that may significantly
alter the absorption of dasatinib

- Patients actively receiving therapy with strong CYP3A4 inhibitors and the treatment
cannot be either discontinued or switched to a different medication prior to starting
study drug

- Patients who are currently receiving treatment with any medications that have the
potential to prolong the QT interval and the treatment cannot be either discontinued
or switched to a different medication prior to starting study drug

- Female patients who are: pregnant, breast feeding or potentially fertile without a
negative pregnancy test prior to baseline or unwilling to use contraception on trial

- Previous history of pericarditis or pleuritis

- History of non-compliance, abuse of alcohol, illicit drugs, severe psychiatric
disorders or other inability to grant informed consent.

- Current treatment for depression.

- Hypersensitivity to any interferon preparation;

- Autoimmune hepatitis or a history of autoimmune disease;

- Pre-existing thyroid disease unless it can be controlled with conventional treatment;

- Epilepsy and/or compromised central nervous system (CNS) function;

- HCV/HIV patients

Type of Study:

Interventional

Study Design:

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

Outcome Measure:

major molecular response rates

Outcome Description:

defined as ≤0.1% BCR-ABL1 on the MMR International Scale

Outcome Time Frame:

1 year

Safety Issue:

Yes

Principal Investigator

Henrik Hjorth-Hansen, MD PhD

Investigator Role:

Study Chair

Investigator Affiliation:

Norwegian University of Science and Technology

Authority:

Norway:National Committee for Medical and Health Research Ethics

Study ID:

NordCML007

NCT ID:

NCT01725204

Start Date:

September 2012

Completion Date:

September 2018

Related Keywords:

  • Leukemia, Myeloid, Chronic-Phase
  • dasatinib
  • Protein Kinase Inhibitors
  • pegylated IFN-alpha 2B
  • Interferon-alpha
  • Leukemia
  • Leukemia, Myeloid
  • Leukemia, Myelogenous, Chronic, BCR-ABL Positive
  • Leukemia, Myeloid, Chronic-Phase

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