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KISS Study: Kinase Inhibition With Sprycel Start up

NCT03193281 · Status: ACTIVE_NOT_RECRUITING · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 91

Last updated 2023-11-29

No results posted yet for this study

Summary

Chronic myeloid leukaemia (CML) is due to a chromosomal abnormality in white blood cells which results in abnormal multiplication. CML in its earlier, slower growing chronic phase (CP) is well controlled by the tyrosine kinase inhibitor (TKI) drug imatinib, which targets the consequences of the chromosomal abnormality, inducing a response and subsequent remission (as measured using molecular techniques on patient blood or bone marrow samples in the lab). Dasatinib, a newer TKI drug, similar in design to imatinib, gives a more rapid molecular response, however the long term side-effects are less known than imatinib.

This study will investigate the efficacy and safety of a treatment plan for patients with newly diagnosed CML-CP, where dasatinib will be used to more rapidly induce a molecular response (MR3.0) within 12 months, after which imatinib will be used to maintain the CML in that remission. It is hypothesised that imatinib is safe and effective in maintaining MR3.0 in patients with CML who achieve MR3.0 at 12 months following initial induction therapy with dasatinib.

Conditions

  • Chronic Myeloid Leukemia

Interventions

DRUG

Dasatinib

In order to test the study hypothesis patients need to stay on dasatinib (Sprycel) treatment for the first 12 months of the study (Stage 1). Patients who do not reach MR3.0 at 12 months will remain on dasatinib treatment.

DRUG

Imatinib

Patients who reach MR3.0 at 12 months (and the result is confirmed at 13 months) will switch to imatinib (Imatinib-AFT) treatment.

Sponsors & Collaborators

  • Leukaemia & Blood Cancer New Zealand

    collaborator UNKNOWN

  • University of Auckland, New Zealand

    lead OTHER

Principal Investigators

  • Peter Browett, MBChB · University of Auckland, New Zealand

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2017-07-17
Primary Completion
2025-12-31
Completion
2025-12-31
FDA Drug
Yes

Countries

  • New Zealand

Study Locations

More Related Trials

Entities

Drugs

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03193281 on ClinicalTrials.gov