CALLS: CML and Ph+ALL Low Level Mutation Prevalence Survey
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ClinicalTrials.gov Identifier: NCT03647215 |
Recruitment Status :
Completed
First Posted : August 27, 2018
Last Update Posted : August 16, 2021
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Tracking Information | |||||
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First Submitted Date | August 23, 2018 | ||||
First Posted Date | August 27, 2018 | ||||
Last Update Posted Date | August 16, 2021 | ||||
Actual Study Start Date | December 18, 2017 | ||||
Actual Primary Completion Date | March 31, 2021 (Final data collection date for primary outcome measure) | ||||
Current Primary Outcome Measures |
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Original Primary Outcome Measures | Same as current | ||||
Change History | |||||
Current Secondary Outcome Measures |
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Original Secondary Outcome Measures | Same as current | ||||
Current Other Pre-specified Outcome Measures | Not Provided | ||||
Original Other Pre-specified Outcome Measures | Not Provided | ||||
Descriptive Information | |||||
Brief Title | CALLS: CML and Ph+ALL Low Level Mutation Prevalence Survey | ||||
Official Title | A Cohort Study To Establish the Prevalence of Mutations in Patients With CML Who Meet the ELN Criteria for Warning or Failure and Patients With Ph+ ALL With Detectable BCR-ABL Currently Being Treated With First or Subsequent TKI Therapy in the UK, Ireland, or France Using Next-Generation Sequencing | ||||
Brief Summary | A multicenter, prospective cohort study of the mutation status of patients with chronic myeloid leukemia (CML) and Philadelphia chromosome-positive acute lymphoblastic leukemia (Ph+ ALL) who are being treated with first or subsequent tyrosine kinase inhibitor (TKI) therapy in the UK, Ireland, or France. | ||||
Detailed Description | Not Provided | ||||
Study Type | Observational | ||||
Study Design | Observational Model: Cohort Time Perspective: Prospective |
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Target Follow-Up Duration | Not Provided | ||||
Biospecimen | Not Provided | ||||
Sampling Method | Non-Probability Sample | ||||
Study Population | Approximately 50 centers in the UK, Ireland and France that treat adult patients with CML and Ph+ ALL will be selected for participation in the study. The sites selected will be a mixture of hospital and academic centers. The target study population will include adult patients with CML who meet the ELN criteria for warning or failure or have high SOKAL score > 0.8 or presence of additional chromosomal abnormalities (ACAs), all with detectable BCR-ABL levels. Ph+ ALL patients must have detectable BCR-ABL levels. Patients will be taking their first or subsequent TKI. Consecutive patients within each prescriber's practice who meet the enrollment criteria and provide informed consent will be invited to enroll into the study. Repeat NGS KD mutation testing is permitted under the protocol as deemed part of the standard management of patients. |
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Condition |
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Intervention | Not Provided | ||||
Study Groups/Cohorts | All Participants
Participants with CML and Ph+ALL who are being treated with their first or subsequent TKI therapy. CML patients must meet the ELN criteria for warning and failure ) or have high SOKAL score (>0.8) or presence of additional chromosomal abnormalities (ACAs) and have detectable BCR-ABL levels. Ph+ALL patients need detectable BCR-ABL levels only.
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Publications * | Not Provided | ||||
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
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Recruitment Information | |||||
Recruitment Status | Completed | ||||
Actual Enrollment |
427 | ||||
Original Estimated Enrollment |
400 | ||||
Actual Study Completion Date | June 30, 2021 | ||||
Actual Primary Completion Date | March 31, 2021 (Final data collection date for primary outcome measure) | ||||
Eligibility Criteria | Inclusion Criteria:
OR
Exclusion Criteria: Patients without detectable BCR-ABL and patients who have switched TKI due to intolerance but who have met the criteria for optimal response (CP-CML, ELN 2013 guidelines). |
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Sex/Gender |
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Ages | 18 Years and older (Adult, Older Adult) | ||||
Accepts Healthy Volunteers | No | ||||
Contacts | Contact information is only displayed when the study is recruiting subjects | ||||
Listed Location Countries | Ireland, United Kingdom | ||||
Removed Location Countries | |||||
Administrative Information | |||||
NCT Number | NCT03647215 | ||||
Other Study ID Numbers | INCB 84344-401 | ||||
Has Data Monitoring Committee | Not Provided | ||||
U.S. FDA-regulated Product |
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IPD Sharing Statement |
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Current Responsible Party | Incyte Corporation ( Incyte Biosciences UK ) | ||||
Original Responsible Party | Same as current | ||||
Current Study Sponsor | Incyte Biosciences UK | ||||
Original Study Sponsor | Same as current | ||||
Collaborators | Not Provided | ||||
Investigators |
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PRS Account | Incyte Corporation | ||||
Verification Date | August 2021 |