The Efficacy and Safety of Induction-Maintenance Protocol for Patients With Chronic Myelogenous Leukaemia

NCT03241199 | Unknown Phase 2 DMC

• 1 other identifier: QMH-CML-002
• Study Type: interventional
• Target: 15
• Locations: 1 country
• Sites: 1

Brief Summary

The purpose of this pilot study is to investigate whether some patients who were started on a 2G-TKI as first-line treatment can be safely switched to imatinib, a first-generation TKI, while maintaining or even deepening the molecular response as a cost-effective treatment. Eligible patients will be switched to imatinib 400mg daily, with regular molecular monitoring.

Conditions

Chronic Myeloid Leukemia; Philadelphia Chromosome Positive CML

Outcome Measures

Primary Outcomes (1)

• molecular progression-free survival

  Molecular progression-free survival after switch to imatinib at 6 months

  6 months

Secondary Outcomes (6)

• molecular progression-free survival

  12 months

• molecular progression-free survival

  24 months

• Molecular responses

  12 months

• Molecular responses

  24 months

• Rate of molecular progression on Imatinib

  24 months

Study Arms (1)

Imatinib Mesylate

EXPERIMENTAL

imatinib 400mg daily

Drug: Imatinib Mesylate

Interventions

Imatinib Mesylate DRUG

a first-generation tyrosine kinase inhibitors

Imatinib Mesylate

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Adult (aged 18 years or above) patients diagnosed with chronic-phase CML
• Must have received a 2G-TKI (nilotinib or dasatinib) as first-line therapy for at least 12 months (Note: Cytoreductive agents, namely hydroxyurea and anagrelide, prior to the use of TKI are allowed.)
• In sustained, good molecular response (i.e. molecular response (MR3) or below) for at least 6 months, as confirmed with at least 2 consecutive quantitative real time-polymerase chain reaction (RT-PCR) results

You may not qualify if:

• Under 18 years old
• Adults under law protection or without ability to consent
• Previous or planned autologous/allogeneic haematopoietic stem cell transplantation
• Documented kinase domain mutation
• A change to the current TKI because of unsatisfactory response to a previous TKI (Note: patients are still considered eligible if the switch in TKI was due to intolerance or side effects)
• History of disease progression (accelerated or blast phase)
• Patients who can speak neither Chinese nor English
• Any molecular result during the preceding 6 months that is higher than MR3, i.e. BCR-ABL1/ABL1 ratio \>0.1% on IS ratio

Sponsors & Collaborators

• The University of Hong Kong: lead

Study Sites (1)

The University of Hong Kong

Hong Kong, Hong Kong

RECRUITING

MeSH Terms

Conditions

Leukemia, Myelogenous, Chronic, BCR-ABL Positive

Interventions

Imatinib Mesylate

Condition Hierarchy (Ancestors)

Leukemia, Myeloid; Leukemia; Neoplasms by Histologic Type; Neoplasms; Myeloproliferative Disorders; Bone Marrow Diseases; Hematologic Diseases; Hemic and Lymphatic Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Benzamides; Amides; Organic Chemicals; Benzoates; Acids, Carbocyclic; Carboxylic Acids; Benzene Derivatives; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons; Piperazines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Pyrimidines

Study Officials

• Carol Cheung, MBBS

  Queen Mary Hospital, Hong Kong

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Carol Cheung, MBBS

CONTACT

852 22553111; drcarolcheung@gmail.com

Crosby Lu, MMedSc

CONTACT

852 22553111; khlu@hku.hk

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Chair Professor

Study Record Dates

• First Submitted: August 2, 2017
• First Posted: August 7, 2017
• Study Start: August 1, 2017
• Primary Completion: June 13, 2020
• Study Completion: January 1, 2021
• Last Updated: August 8, 2017

Record last verified: 2017-08

Locations

HK (1)