Vodobatinib for Chronic Myeloid Leukemia

Recruiting at 58 trial locations

Overseen By Jayasree sreenivasan

Age: 18+

Sex: Any

Trial Phase: Phase 1 & 2

Sponsor: Sun Pharma Advanced Research Company Limited

Must be taking: TKIs

Disqualifiers: T315I, HIV, Hepatitis B, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: Unknown

Duration: Ongoing

122 Participants Needed

Trial Summary

What is the purpose of this trial?

Phase 1/2 study to determine safety, tolerability, pharmacokinetics, and anti-leukemic activity of Vodobatinib (K0706) in treatment-refractory/intolerant CML

Do I have to stop taking my current medications for the Vodobatinib trial?

The trial protocol does not specify if you must stop taking your current medications, but it mentions a washout period (time without taking certain medications) of at least 30 days or 5 half-lives for any other investigational agent. It's best to discuss your specific medications with the trial team.

What data supports the effectiveness of the drug Vodobatinib for Chronic Myeloid Leukemia?

While there is no direct data on Vodobatinib, similar drugs like Imatinib, Dasatinib, and Nilotinib, which are also tyrosine kinase inhibitors (a type of drug that blocks certain proteins involved in cancer cell growth), have shown effectiveness in treating Chronic Myeloid Leukemia by improving patient outcomes and reducing cancer markers. ^{1 2 3 4 5}

Eligibility Criteria

This trial is for adults over 18 with chronic myelogenous leukemia (CML) who haven't responded to at least three prior treatments, including ponatinib. They should be in a condition where they can perform daily activities with ease or have some limitation (ECOG status of 0-2). People ineligible include those unable to undergo blood draws, recent major surgery patients, candidates for curative therapy like stem cell transplant, other cancer diagnoses within 3 years, drug abuse history, T315I mutation presence in CML (Part C), and positive tests for pregnancy or certain infections.

Inclusion Criteria

I can take care of myself and perform daily activities.

Willing and able to comply with the scheduled visits

I am 18 years old or older.

Exclusion Criteria

Positive exclusion tests: urine pregnancy tests (if applicable), HIV, hepatitis B surface antigen, or hepatitis C virus

You have a history of serious drug abuse according to the investigator's assessment.

I am eligible for a treatment that could potentially cure my condition, including a stem cell transplant.

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive Vodobatinib (K0706) to assess safety, tolerability, pharmacokinetics, and anti-leukemic activity

Ongoing

Follow-up

Participants are monitored for safety and effectiveness after treatment

60 months

Treatment Details

Interventions

• Vodobatinib (K0706)

Trial Overview The study is testing Vodobatinib capsules' safety and effectiveness against resistant/intolerant chronic myelogenous leukemia. It's a Phase 1/2 trial which means it's early in the clinical research process focusing on how safe the treatment is (Phase 1) and starting to look at how well it works (Phase 2).

Participant Groups

Group I: Vodobatinib (K0706) capsules Experimental Treatment 1 Intervention

Who Is Running the Clinical Trial?

Sun Pharma Advanced Research Company Limited

Lead Sponsor

Trials

33

Recruited

4,600+

Findings from Research

In a study of 163 newly diagnosed patients with chronic-phase chronic myeloid leukemia (CML), dasatinib and nilotinib showed significantly higher rates of complete cytogenetic response (CCyR) and major molecular response (MMR) compared to imatinib after 3 and 12 months of treatment.

The safety profiles of dasatinib, nilotinib, and imatinib were similar, indicating that while dasatinib and nilotinib are more effective, they do not present additional safety concerns compared to imatinib.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

[Clinical Efficacy of Dasatinib, Nilotinib and Imatinib in Newly Diagnosed Patients with Chronic-Phase Chronic Myeloid Leukemia: A Three-year Retrospective Analysis]. Wang, YY., Zhao, HG., Cui, ZG., et al.[2022]

Imatinib Mesylate has significantly improved outcomes for chronic myeloid leukemia (CML) patients in the chronic phase, leading to high rates of complete hematologic and cytogenetic responses.

Long-term studies indicate that while Imatinib is effective, there is a need for early molecular markers to identify which patients will benefit most from this treatment, especially with the availability of generic options and newer therapies.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Imatinib mesylate in chronic myeloid leukemia: frontline treatment and long-term outcomes. Stagno, F., Stella, S., Spitaleri, A., et al.[2016]

In a study of 26 chronic myelogenous leukemia (CML) patients treated with nilotinib for nearly 5 years, 61.5% achieved a complete hematologic response, demonstrating its efficacy for patients resistant or intolerant to imatinib.

Nilotinib was generally safe, with most adverse events being mild (grade 1 or 2), though some patients experienced significant hematologic side effects, particularly those in advanced stages of the disease.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

[Long-term outcomes of nilotinib treatment for chronic myelogenous leukemia patients with imatinib resistance or intolerance]. Wei, Y., Zhang, X., Chen, W., et al.[2022]

In a study of 35 chronic myelogenous leukemia (CML) patients who were resistant or intolerant to imatinib, nilotinib demonstrated a high overall survival rate of 93.5% at 18 months, indicating its efficacy as a treatment option.

Nilotinib was well-tolerated, with most adverse events being mild (grade 1-2), although some patients experienced more serious hematologic issues, particularly in advanced CML, highlighting the importance of monitoring during treatment.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

[Nilotinib treatment for imatinib resistant or intolerant chronic myelogenous leukemia.]. Wang, AH., Zhou, L., You, JH., et al.[2018]

References

1. China pubmed.ncbi.nlm.nih.gov

[Clinical Efficacy of Dasatinib, Nilotinib and Imatinib in Newly Diagnosed Patients with Chronic-Phase Chronic Myeloid Leukemia: A Three-year Retrospective Analysis]. [2022]

2. England pubmed.ncbi.nlm.nih.gov

Imatinib mesylate in chronic myeloid leukemia: frontline treatment and long-term outcomes. [2016]

3. China pubmed.ncbi.nlm.nih.gov

[Long-term outcomes of nilotinib treatment for chronic myelogenous leukemia patients with imatinib resistance or intolerance]. [2022]

4. China pubmed.ncbi.nlm.nih.gov

[Nilotinib treatment for imatinib resistant or intolerant chronic myelogenous leukemia.]. [2018]

5. United States pubmed.ncbi.nlm.nih.gov

Activity and tolerability of nilotinib: a retrospective multicenter analysis of chronic myeloid leukemia patients who are imatinib resistant or intolerant. [2022]