Dasatinib for Blood Cancer

Recruiting in Palo Alto (17 mi)

Overseen byJorge Castillo, MD

Age: 18+

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Phase 1

Waitlist Available

Sponsor: Jorge J. Castillo, MD

No Placebo Group

Approved in 3 Jurisdictions

Trial Summary

What is the purpose of this trial?

This is Phase I pilot, single center study designed to explore the safety of Dasatinib in symptomatic Waldenström Macroglobulinemia participants who are progressing on ibrutinib therapy with BTK Cys481 or PLCG2 mutations

Research Team

Jorge Castillo, MD

Principal Investigator

Dana-Farber Cancer Institute

Eligibility Criteria

This trial is for adults over 18 with Waldenström Macroglobulinemia who are not responding to ibrutinib therapy and have specific mutations (BTK Cys481 or PLCG2). Participants must be able to take pills, follow the study schedule, use reliable contraception if of childbearing potential, and have a certain level of IgM paraprotein. They should not be pregnant, on other investigational drugs, have uncontrolled illnesses or infections, or taking certain medications.

Inclusion Criteria

I agree to use a condom during sex if my partner can get pregnant.

Women of childbearing potential must agree to use two reliable forms of contraception simultaneously or have complete abstinence from heterosexual intercourse

I am 18 years old or older.

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Exclusion Criteria

I do not have active HIV, HBV, or HCV infections.

I am not on active treatment for any cancer, except skin cancer treated with creams.

You have a history of not following your doctor's instructions for taking medication or following medical advice.

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Treatment Details

Interventions

Dasatinib (Tyrosine Kinase Inhibitor)

Trial OverviewThe trial is testing Dasatinib's safety in patients with symptomatic Waldenström Macroglobulinemia progressing on ibrutinib therapy. It's a Phase I pilot study at a single center focusing on those with BTK Cys481 or PLCG2 mutations. The goal is to see how well these patients tolerate Dasatinib after failing previous treatments.

Participant Groups

1Treatment groups

Experimental Treatment

Group I: DasatinibExperimental Treatment1 Intervention

-- After the screening procedures confirm participation in the research study: The participant will be given a study drug-dosing calendar for each treatment cycle. Dasatinib: Oral Study Drug(s): * Each study treatment cycle lasts 4 weeks during which time you will be taking the study drug one time per day. * This will continue for up to 24 cycles.

Dasatinib is already approved in Canada for the following indications: