Sustained treatment-free period in the course of a disease when symptoms become less severe in BCR-ABL+ chronic myeloid leukemia: a prospective study comparing a drug called Nilotinib versus another called Imatinib with switch to Nilotinib in absence of optimal response.

Phase 1

• Conditions: Chronic Myeloid Leukemia (CML) in Chronic Phase (CP); MedDRA version: 21.1Level: PTClassification code 10009013Term: Chronic myeloid leukaemiaSystem Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps); Therapeutic area: Diseases [C] - Blood and lymphatic diseases [C15]

• Registration Number: EUCTR2015-005248-33-IT
• Lead Sponsor: FONDAZIONE GIMEMA (GRUPPO ITALIANO MALATTIE EMATOLOGICHE DELL' ADULTO) FRANCO MANDELLI ONLUS

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2021-06-15
• Last Update Posted: 24 August 2021

Recruitment & Eligibility

• Status: Authorised-recruitment may be ongoing or finished
• Sex: All
• Target Recruitment: 600

Inclusion Criteria

Patients eligible for inclusion in this study have to meet all of the following criteria:
•Patients with a confirmed diagnosis of BCR/ABL+ CML in chronic phase
oDocumented chronic phase CML must meet all the following criteria:
¿< 15% blasts in peripheral blood
¿< 30% blasts plus promyelocytes in peripheral blood
¿< 20% basophils in the peripheral blood
¿= 100 x 109/L (= 100,000/mm3) platelets
•Age =18
•ECOG performance status of 0-2
•Evidence of typical BCR-ABL transcripts which are amenable to standardized RQ-PCR
•Adequate end organ function as defined by:
oTotal bilirubin < 1.5 x ULN (ULN = upper limit of normal in a local institution lab).
Does not apply to patients with isolated hyperbilirubinemia (e.g., Gilbert’s disease) grade < 3
oSGOT (AST) and SGPT (ALT) = 3 x ULN
oSerum amylase and lipase = 2 x ULN
oAlkaline phosphatase = 2.5 x ULN
oSerum creatinine < 1.5 x ULN
•Written informed consent prior to any study procedures.
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 350
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 250

Exclusion Criteria

Previous treatment with BCR-ABL inhibitors for more than 30 days.
Expression of any atypical BCR-ABL transcripts, instead of the classical P210-encoding type with the e13a2 or the e14a2 junction at screening.
Previous anticancer agents (hydroxyurea, anagrelide, interferon) for CML for more than three months.
Poorly controlled diabetes mellitus (defined as HbA1c >8%)
Prior documented history of coronary heart disease, including myocardial infarction, coronary bypass, coronary stent, and symptomatic angina as defined at page 30 in Exclusion Criteria.
Uncontrolled hypertension
History of peripheral arterial occlusive disease.
History of acute pancreatitis within 12 months of study entry, or a past medical history of chronic pancreatitis.
Patients actively receiving therapy with strong CYP3A4 inhibitors and/or inducers which 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 for which cannot be either safely discontinued or switched to a different medication prior to starting study drug.
Women of childbearing potential, defined as all women physiologically capable of becoming pregnant, unless they are using effective methods of contraception during dosing of study treatment.
Patients unable to understand and to comply with study instructions and requirements.
Refusal to give informed consent.

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified