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

  • STATUS
    Recruiting
  • participants needed
    100
  • sponsor
    Australasian Leukaemia and Lymphoma Group
Updated on 7 November 2020
imatinib
tyrosine
hydroxyurea
lipase
interferon
potassium
leukemia
nilotinib
anagrelide
chronic phase chronic myeloid leukemia
basophils

Summary

The treatment of CML and the expected survival has been revolutionised since the introduction of tyrosine kinase inhibitors (TKIs) such as nilotinib. Despite their effectiveness, these drugs will never totally remove CML affected cells from the body. In order to achieve this goal, and potentially enable CML patients to live without the daily need for TKIs, other features of the patient's immune system may need to be harnessed. One possibility is using externally administered interferon (IFN) to augment the response induced by the TKI.

This study will assess the response in terms of length of survival, detection of minimal disease levels and time until disease worsens in patients with chronic phase CML who are taking nilotinib and pegylated Interferon. Patients will commence taking nilotinib for 3 months, and once tolerated, will simultaneously be treated with injected pegIFN for up to 2 years. Patients can continue taking nilotinib beyond this time providing they are receiving benefit. Options are available for patients to decrease or increase their dose or to switch to another TKI, imatinib, to ensure a balance between drug effectiveness and minimal side effects is achieved.

Details
Condition Chronic myeloid leukemia
Treatment Nilotinib, Pegylated interferon alpha-2b, Imatinib
Clinical Study IdentifierNCT02001818
SponsorAustralasian Leukaemia and Lymphoma Group
Last Modified on7 November 2020

Eligibility

Yes No Not Sure

Inclusion Criteria

All of the following criteria must be satisfied for enrolment in the study
Post-pubertal male or female patients aged 18 years or above
Newly diagnosed (within Three months of study entry) Ph+ CML-Chronic Phase with a quantifiable "breakpoint cluster region - Abelson murine leukemia" (BCR-ABL) transcript
No prior therapy for CML and no other current anti-leukaemic therapies (other than prior or current treatment with hydroxyurea or anagrelide)
No signs of extramedullary leukaemia, except for hepatosplenomegaly
Documented chronic-phase CML as defined by
<15% blasts in both the peripheral blood and bone marrow ii. <30% blasts and promyelocytes in both the peripheral blood and bone marrow iii. <20% basophils in the peripheral blood iv. Platelet count >100 109/L (Note: Patients will be considered to be in chronic phase if their platelet count is 100 x 109/L as a result of treatment with hydroxyurea or anagrelide provided that all of the other criteria for chronic phase CML are met)
Eastern Cooperative Oncology Group Performance Status score 2 (see Appendix 2)
Patients must have the following laboratory values
Potassium level > Lower Limit of Normal (LLN)
Calcium (corrected for serum albumin) > Lower Limit of Normal (LLN)
Magnesium level > Lower Limit of Normal (LLN)
Phosphorus > Lower Limit of Normal (LLN)
ALT and AST < 2.5 ULN or < 5.0 Upper limit of normal (ULN) if considered due to tumour
ALP < 2.5 Upper limit of normal (ULN) unless considered due to tumour
Bilirubin < 1.5 Upper limit of normal (ULN) unless due to Gilbert's syndrome
Creatinine < 1.5 Upper limit of normal (ULN)
Amylase and lipase < 1.5 Upper limit of normal (ULN) Note: Biochemical abnormalities that resolve after corrective measures pose no impediment to re-screening
Female patients of childbearing potential must have a negative serum pregnancy test within one week prior to study entry OR have been amenorrhoeic for at least 12 months
All patients of reproductive potential must agree to use birth control for the duration of the study. This is only required for as long as the patient has reproductive potential. The type of birth control is a decision which should be made between the treating clinician and the patient
Life expectancy of more than 12 months. 10.Patient has given written, informed consent to participate in the study (which includes consent to obtain samples for the correlative study except in a rare case where a site does not have the capacity to participate in the correlative study)
Current participation in another therapeutic clinical trial (participation in clinical trials that do not involve active interventions is not an

Exclusion Criteria

Current participation in another therapeutic clinical trial (participation in clinical trials that do not involve active interventions is not an exclusion for the study.)
Previous adverse reaction to the trial drug/s
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