Treatment Modification Based on Early Assessment of CML Patients

NCT01762969 | Unknown Phase 2

• 1 other identifier: CML-IS001
• Study Type: interventional
• Target: 300
• Locations: 1 country
• Sites: 1

Brief Summary

The investigators will check the feasibility of using early molecular response for making treatment decisions. Patients diagnosed with chronic myeloid leukemia will commence imatinib treatment. After 3 months of treatment their response will be assessed. If molecular response would be less the 10% (BCR-ABL1/ABL ISI \>10%)imatinib therapy will be stopped and patients will start a different TKI (as nilotinib, dasatinib). The investigators will follow on lab and clinical outcomes.

Conditions

CML

Outcome Measures

Primary Outcomes (1)

• Rate of complete cytogenetic response

  12 months

Secondary Outcomes (4)

• Overall survival

  12 months

• Rate of major molecular response

  12, 24 months

• PFS

  12 months

• Severe Adverse events

  12 months

Study Arms (1)

Modified by molecular response

EXPERIMENTAL

Patients will be treated with imatinib upon diagnosis of CML. Molecular response will be assessed at 3 months of therapy. Based on molecular response imatinib will be continued or changed to another TKI

Other: Treatment modification based on molecular response at 3 months

Interventions

Treatment modification based on molecular response at 3 months OTHER

Patients will be treated with imatinib upon diagnosis of CML. Molecular response will be assessed at 3 months of therapy. Based on molecular response imatinib will be continued or changed to another TKI

Modified by molecular response

Eligibility Criteria

• Age: 16 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• \. Adult patients within 6 months after the diagnosis of Philadelphia chromosome-positive CML in the chronic phase
• who were not previously treated (with the exception of hydroyurea) for CML or
• who were treated with imatinib for CML for up to 3 months, and prior to 3 months assessment (patients will be excluded if they received treatment with a tyrosine kinase inhibitor other than imatinib).
• \. Age \> 18 years Diagnosis of CML will be made by conventional cytogenetic (chromosome banding analysis) and/or interphase fluorescent in situ hybridization (FISH) analysis of bone marrow containing at least one Philadelphia chromosome-positive metaphase cell. If BCR-ABL1 fusion gene (Philadelphia chromosome) is not detected by conventional cytogenetic analysis, the diagnosis of CML can be confirmed based on FISH analysis or molecular analysis (demonstration of bcr-abl by polymerase chain reaction (PCR)).

You may not qualify if:

• Patients will be excluded if they received treatment with a tyrosine kinase inhibitor other than imatinib (i.e., nilotinib, dasatinib) before study entry. Patients may take hydroxyurea or anagrelide for up to 4 weeks prior to imatinib treatment.

Sponsors & Collaborators

• Rabin Medical Center: lead
• Rambam Health Care Campus: collaborator
• Wolfson Medical Center: collaborator
• Bnai Zion Medical Center: collaborator
• HaEmek Medical Center, Israel: collaborator
• Hadassah Medical Organization: collaborator

Study Sites (1)

Rabin Medical Center

Petah Tikva, 49100, Israel

RECRUITING

Central Study Contacts

Liat vidal, MD MSc

CONTACT

vidallit@yahoo.com

Ofer Shpilberg, MD MPH

CONTACT

+972-3-9377906

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: Dr.

Study Record Dates

• First Submitted: January 6, 2013
• First Posted: January 8, 2013
• Study Start: January 1, 2013
• Primary Completion: January 1, 2019
• Study Completion: January 1, 2020
• Last Updated: January 8, 2013

Record last verified: 2013-01

Locations

IL (1)