Study on the Safety and Effectiveness of Vodobatinib for Treating Resistant Chronic Myeloid Leukemia (CML)
Sponsor: Sun Pharma Advanced Research Company Limited
ClinicalTrials ID:NCT02629692
This clinical trial is testing a new drug, Vodobatinib, to see if it is safe and effective for patients with a type of leukemia called Philadelphia chromosome-positive Chronic Myeloid Leukemia (Ph+ CML) that has not responded to at least three previous treatments.
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Program Overview
The purpose of this study is to evaluate the safety and effectiveness of Vodobatinib, a new medication, in patients with Ph+ Chronic Myeloid Leukemia (CML) who have not responded to or cannot tolerate at least three other treatments, including ponatinib. The study is currently in progress for patients who meet these criteria.
Description
The study is divided into different parts:
- Part A, which involved healthy volunteers, has been completed.
- Part B, which tested different doses of Vodobatinib, has also been completed.
- Part C is ongoing and focuses on patients with Ph+ CML who have not responded to or cannot tolerate previous treatments. This part is still accepting patients who meet the study criteria.
Eligibility Criteria
Inclusion Criteria
- Must be willing and able to provide written consent to participate.
- Must be 18 years or older.
- Must be willing and able to attend scheduled study visits.
- Must have a performance status score of 0, 1, or 2, indicating full activity or some restriction in strenuous activities.
- Must have been diagnosed with Ph+ CML in chronic, accelerated, or blast phase and have not responded to or cannot tolerate at least three previous treatments, including ponatinib.
Exclusion Criteria
- Cannot have a specific genetic mutation known as T315I.
- Cannot have had major surgery within four weeks before starting the study treatment.
- Cannot have difficulty with blood draws or maintaining a venous access line.
- Cannot be pregnant or have certain infections like HIV or hepatitis B or C.
- Cannot have a history of significant drug abuse.
- Cannot have taken another experimental drug within 30 days before starting the study treatment.
- Cannot be eligible for other potentially curative treatments, like a stem cell transplant.
- Cannot have had another primary cancer within the past three years, except for certain skin or cervical cancers that have been treated.
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