Dasatinib In Waldenström Macroglobulinemia
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|ClinicalTrials.gov Identifier: NCT04115059|
Recruitment Status : Recruiting
First Posted : October 3, 2019
Last Update Posted : December 11, 2019
|Condition or disease||Intervention/treatment||Phase|
|Waldenstrom Macroglobulinemia DASATINIB||Drug: Dasatinib||Phase 1|
This research study is a Pilot Study, which is the first time investigators are examining this drug in patients with Waldenström Macroglobulinemia who have progressed on ibrutinib.
Patients who fulfill eligibility criteria will be entered into the trial to receive Dasatinib
After the screening procedures confirm participation in the research study:
The participant will be given a study drug-dosing calendar for each treatment cycle. In this research study, the investigators are planning to give Dasatinib, which is a targeted therapy intended to treat cancer by binding to the target protein called BTK.
- BTK is believed to be an important target for treatment of patients with specific gene mutations. Some patients who have disease progression after taking ibrutinib have these gene mutations.
- Making treatment decisions based on genetic testing is investigational, and the FDA has not approved this genetic testing.
The U.S. Food and Drug Administration (FDA) has not approved Dasatinib for Waldenström Macroglobulinemia but it has been approved for other uses.
Dasatinib is produced by Bristol-Myers Squibb.
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||6 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||Dasatinib in Patients With Waldenström Macroglobulinemia (WM) Progressing on Ibrutinib|
|Actual Study Start Date :||November 4, 2019|
|Estimated Primary Completion Date :||March 1, 2022|
|Estimated Study Completion Date :||March 1, 2024|
-- 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):
Oral, daily, dosing per protocol, once a day for cycle
Other Name: Sprycel
- To evaluate the toxicity profile of dasatinib in WM patients who progressed on ibrutinib with BTK or PLCG2 mutations. [ Time Frame: 2 years ]Number and type of toxicities experienced by patients related to dasatinib.
- Overall Response Rate [ Time Frame: 2 years ]Proportion of patients with MR, PR, VGPR, or CR to therapy.
- Complete Response Rate [ Time Frame: 2 years ]Proportion of patients with CR
- Very good partial response rate [ Time Frame: 2 years ]Proportion of patients with VGPR to therapy. (VGPR is >90% reduction in serum IgM from baseline)
- Partial Response Rate [ Time Frame: 2 years ]Proportion of patients with PR to therapy. (PR is 50-89% reduction in serum IgM from baseline)
- Minimal Response Rate [ Time Frame: 2 years ]Proportion of patients with Minor Responses to therapy. (MR is 25-49% reduction in serum IgM from baseline)
- Stable Disease Rate [ Time Frame: 2 years ]Proportion of patients with Stable disease to therapy. (SD is <25% reduction in serum IgM from baseline).
- Progressive Disease Rate [ Time Frame: 2 years ]Proportion of patients with a best response of PD to therapy. (PD is >25% increase in serum IgM from baseline).
- Progression Free Survival [ Time Frame: 2 years ]Kaplan Meier methodology
- Time to Next Therapy (TTNT) [ Time Frame: 2 years ]Kaplan Meier
- Overall Survival [ Time Frame: 2 years ]Kaplan Meier
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04115059
|Contact: Jorge Castillo, MD||(617) firstname.lastname@example.org|
|United States, Massachusetts|
|Dana Farber Cancer Institute||Recruiting|
|Boston, Massachusetts, United States, 02215|
|Contact: Jorge J Castillo, MD 617-632-6045 Jorgej_castillo@dfci.harvard.edu|
|Principal Investigator: Jorge J Castillo, MD|
|Principal Investigator:||Jorge Castillo, MD||Dana-Farber Cancer Institute|