Nilotinib Plus Pegylated Interferon-α2b in CML

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

TERMINATED

Clinical Phase

PHASE2

Total Enrollment

20 participants

Study Classification

INTERVENTIONAL

Study Start Date

2013-04-30

Study Completion Date

2016-05-01

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

The purpose of this trial is to assess the effect of switching CML patients, who have been treated with imatinib ≥ 2 years and who have stable detectable molecular residual disease between 0.01-1.0% (IS), to the combination of Nilotinib and PegIFN, in terms of the proportion of patients who achieve confirmed MR4.0.

Related Clinical Trials

Explore similar clinical trials based on study characteristics and research focus.

Pegylated Interferon Alfa-2b and Nilotinib for Augmentation of Complete Molecular Response in Chronic Myeloid Leukaemia

NCT02001818

Chronic Myeloid Leukaemia

COMPLETED PHASE2

Nilotinib + Pegylated Interferon Alpha 2a for Untreated Chronic Phase Chronic Myelogenous Leukemia

NCT01294618

Chronic Myelogenous Leukemia

COMPLETED PHASE2

Nilotinib ± Peg-IFN for First Line Chronic Phase CML Patients

NCT02201459

Chronic Myeloid Leukemia

COMPLETED PHASE3

Study Assessing Deep Molecular Response in Adult Patients With CML in Chronic Phase Treated With Nilotinib Firstline.

NCT02546674

Chronic Myeloid Leukemia

COMPLETED PHASE4

Phase II Nilotinib With Newly Diagnosed Chronic Phase Chronic Myelogenous Leukemia (CML)

NCT00129740

Leukemia, Myelogenous, Chronic

COMPLETED PHASE2

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

Study phase: Phase II.

Patient population:

Patients with suboptimal molecular response or stable detectable molecular residual disease after ≥ 2 years of treatment with imatinib (i.e. BCR ABL level between 0.01% and 1% IS).

Study objective:

To assess the effect of switching CML patients, who have been treated with imatinib ≥ 2 years and who have stable detectable molecular residual disease between 0.01-1.0% (IS), to the combination of Nilotinib and PegIFN, in terms of the proportion of patients who achieve confirmed MR4.0.

Study design:

Single arm, open label, multicenter study to assess the efficacy, safety and tolerability of nilotinib 300 mg BID, alone and in combination with PegIFN 25 - 40 μg/week in patients not in CMR. Patients will be treated with nilotinib 300 mg BID at the beginning of the study to establish the tolerability before adding PegIFN. Combination treatment will be continued until Month 12, which is followed by monotherapy phase of nilotinib 300 mg BID. Overall study duration for the individual patient is 24 months.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Chronic Myeloid Leukemia

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

Nilotinib, Pegylated interferon α2b

Patients will be treated with nilotinib 300 mg BID during the first 3 months. Then the "combination phase" ensues with continued daily nilotinib 300 mg BID combined with PegIFN 25 ug/week for 3 months up to the Month 6 time point. If the patient has no more than grade 1 non-hematological toxicity or grade 2 hematological toxicity, the dose will be increased to 40 μg/w until Month 12. The "follow-up phase" with daily nilotinib 300 mg BID covers the next 12 months period (Month 12 to 24). until Month 12, which is followed by monotherapy phase of nilotinib 300 mg BID. Overall study duration for the individual patient is 24 months.

Group Type EXPERIMENTAL

Nilotinib

Intervention Type DRUG

300 mg capsule BID oral use

Pegylated interferon α-2b

Intervention Type DRUG

25 - 40 microgram per week for subcutaneous use

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

Nilotinib

300 mg capsule BID oral use

Intervention Type DRUG

Pegylated interferon α-2b

25 - 40 microgram per week for subcutaneous use

Intervention Type DRUG

Other Intervention Names

Discover alternative or legacy names that may be used to describe the listed interventions across different sources.

Tasigna PegIFN PegIntron Pegylated interferon alfa-2b Peginterferon alfa-2b

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

Inclusion Criteria

1. Patients ≥ 18 years
2. At diagnosis CML in chronic phase
3. Documented complete cytogenetic response by bone marrow (standard cytogenetics) or peripheral blood BCR ABL \<1% IS
4. Persistent disease demonstrated by two PCR positive tests (i.e. BCR ABL level between 0.01% and 1% IS) which have been performed during the past 9 months and more than 10 weeks apart. One of these should be performed within 1 month of registration
5. Treatment with imatinib for at least 2 years with 400 mg and at a stable dose (i.e. the dose has not changed in the previous 6 months)
6. No other current or planned anti leukemia therapies
7. ECOG Performance status 0,1, or 2
8. Adequate organ function as defined by:

1. Total bilirubin \<1.5 x ULN. Does not apply to patients with isolated hyperbilirubinemia (e.g. Gilbert's disease) grade \<3.
2. ASAT and ALAT \<2.5 x ULN.
3. Serum amylase and lipase ≤1.5 x ULN.
4. Alkaline phosphatase ≤2.5 x ULN.
5. Creatinine clearance \>30 ml/min.
6. Mg++, K+ ≥LLN.
9. Life expectancy \> 12 months in the absence of any intervention
10. Patient has given written informed consent

Exclusion Criteria

1. Prior accelerated phase or blast crisis.
2. Patient has received another investigational agent within last 6 months.
3. Previous treatment with nilotinib or dasatinib.
4. Prior stem cell transplantation.
5. Impaired cardiac function including any one of the following:

1. Inability to monitor the QT/QTc interval on ECG.
2. Long QT syndrome or a known family history of long QT syndrome.
3. Clinically significant resting brachycardia (\<50 bpm).
4. QTc \>450 msec on baseline ECG (using the QTcF formula). If QTcF \>450 msec and electrolytes are not within normal ranges, electrolytes should be corrected and then the patient re screened for QTc.
5. Myocardial infarction within 12 months prior to starting study.
6. Other clinically significant uncontrolled heart disease (e.g. unstable angina, congestive heart failure or uncontrolled hypertension).
7. History of or presence of clinically significant ventricular or atrial tachyarrhythmias.
6. Known atypical BCR ABL transcript not quantifiable by standard RQ PCR
7. History of active malignancy during the past 5 years with the exception of basal carcinoma of the skin or carcinoma in situ of cervix uteri or breast.
8. Acute liver disease or cirrhosis.
9. Previous or active acute or chronic pancreatic disease.
10. Another severe and/or life threatening medical disease.
11. History of significant congenital or acquired bleeding disorder unrelated to cancer.
12. Impairment of gastrointestinal (GI) function or GI disease that may significantly alter the absorption of study drug.
13. 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.
14. 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.
15. Patients who are pregnant, breast feeding, of childbearing potential without a negative pregnancy test prior to baseline; male or female of childbearing potential unwilling to use contraceptive precautions throughout the trial (post menopausal women must be amenorrheic for at least 12 months to be considered of non childbearing potential).
16. Interruption of imatinib therapy for a cumulative period in excess of 21 days in the preceding 3 months.
17. Major toxicity on imatinib in past 3 months.
18. History of non compliance, or other inability to grant informed consent.
19. Past or present history of alcohol abuse, use of illicit drugs, or severe psychiatric disorders, including depression.
20. Known hypersensitivity to any interferon preparation.
21. Autoimmune hepatitis or a history of autoimmune disease.
22. Pre existing thyroid disease unless it can be controlled with conventional treatment.
23. Epilepsy and/or compromised central nervous system (CNS)function.
24. HCV/HIV patients.
25. Poorly controlled diabetes mellitus(i.e. HbA1c \>9.0) or clinically relevant diabetic complications such as neuropathy, retinopathy, nephropathy, coronary or peripheral vascular disease.

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No