Your session is about to expire
← Back to Search
Tyrosine Kinase Inhibitor
Dasatinib for Blood Cancer
Phase 1
Waitlist Available
Led By Jorge Castillo, MD
Research Sponsored by Jorge J. Castillo, MD
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Clinicopathological diagnosis of Waldenstrom's Macroglobulinemia
Known tumor expression of mutated MYD88 performed by a CLIA certified laboratory
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 2 years
Awards & highlights
Study Summary
This trial is exploring whether a different cancer drug is safe for people with a specific type of blood cancer who are already taking a different drug.
Who is the study for?
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.Check my eligibility
What is being tested?
The 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.See study design
What are the potential side effects?
Potential side effects of Dasatinib may include risks like fluid retention leading to swelling around the heart or lungs, changes in blood counts that could lead to increased risk of infection or bleeding problems, digestive issues such as nausea and diarrhea, muscle pain and skin rashes.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I have been diagnosed with Waldenstrom's Macroglobulinemia.
Select...
My tumor has a MYD88 mutation as confirmed by a certified lab.
Select...
My cancer has a BTKCys481 or PLCγ2 mutation confirmed by NeoGenomics.
Select...
My condition worsened after my last treatment with ibrutinib.
Select...
I am 18 years old or older.
Select...
My blood tests show high levels of IgM, more than twice the normal limit.
Select...
I can take care of myself but might not be able to do heavy physical work.
Select...
I agree to use a condom during sex if my partner can get pregnant.
Select...
My organs and bone marrow are functioning normally.
Select...
I can swallow pills.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 2 years
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~2 years
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Number of Participants With at Least One Treatment-Emergent Adverse Event
Secondary outcome measures
Complete Response Rate
Minimal Response Rate
Overall Response Rate
+7 moreSide effects data
From 2022 Phase 2 trial • 54 Patients • NCT0302304626%
Febrile neutropenia
17%
Sepsis
9%
Mucositis oral
4%
Upper gastrointestinal hemorrhage
4%
Intracranial hemorrhage
4%
Hypotension
4%
Hypertension
4%
Enterocolitis
2%
Lower gastrointestinal hemorrhage
2%
Delirium
2%
Oropharyngeal pain
2%
Gastric hemorrhage
2%
Abdominal pain
2%
Diarrhea
2%
Fungemia
2%
Typhlitis
2%
Myocardial infarction
2%
Fibrinogen decreased
2%
Endophthalmitis
2%
Multi-organ failure
2%
Kidney infection
2%
Peripheral motor neuropathy
2%
Hypoxia
2%
Sinus bradycardia
2%
Edema limbs
2%
Small intestinal obstruction
2%
Atrial fibrillation
2%
Aspiration
100%
80%
60%
40%
20%
0%
Study treatment Arm
Treatment (Chemotherapy)
Trial Design
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.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Dasatinib
2012
Completed Phase 3
~2320
Find a Location
Who is running the clinical trial?
Jorge J. Castillo, MDLead Sponsor
1 Previous Clinical Trials
33 Total Patients Enrolled
1 Trials studying Waldenstrom Macroglobulinemia
33 Patients Enrolled for Waldenstrom Macroglobulinemia
Bristol-Myers SquibbIndustry Sponsor
2,638 Previous Clinical Trials
4,128,511 Total Patients Enrolled
2 Trials studying Waldenstrom Macroglobulinemia
49 Patients Enrolled for Waldenstrom Macroglobulinemia
Jorge Castillo, MDPrincipal InvestigatorDana-Farber Cancer Institute
2 Previous Clinical Trials
52 Total Patients Enrolled
1 Trials studying Waldenstrom Macroglobulinemia
42 Patients Enrolled for Waldenstrom Macroglobulinemia
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I agree to use a condom during sex if my partner can get pregnant.I am 18 years old or older.I can take care of myself but might not be able to do heavy physical work.I have been treated with ibrutinib as my latest therapy for my condition.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.I am not taking strong CYP3A4/5 inhibitors or inducers.My condition requires treatment according to specific expert guidelines.I do not have any serious illnesses that could interfere with the study.I can swallow pills.I will stop taking St. John's Wort 5 days before starting dasatinib.My blood tests show high levels of IgM, more than twice the normal limit.My tumor has a MYD88 mutation as confirmed by a certified lab.My organs and bone marrow are functioning normally.I am taking medications for stomach acid.I have been diagnosed with Waldenstrom's Macroglobulinemia.My cancer has a BTKCys481 or PLCγ2 mutation confirmed by NeoGenomics.I need urgent treatment for my thickened blood causing symptoms.I have been treated with BCR-ABL inhibitors before.I have been diagnosed with lymphoma in my central nervous system.My condition worsened after my last treatment with ibrutinib.Your heart's electrical activity takes too long to reset between beats, as shown on a test called an electrocardiogram.You have a history of alcohol or drug abuse.I have had serious heart rhythm problems.
Research Study Groups:
This trial has the following groups:- Group 1: Dasatinib
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
What is the participant quota for this experiment?
"Affirmative. Clinicaltrials.gov provides information that this medical research project, which commenced on November 4th 2019, is presently looking for volunteers to participate in the study. 6 participants are sought at one site."
Answered by AI
To what extent does Dasatinib pose a health risk to patients?
"Due to the limited efficacy and safety data associated with Dasatinib, our team has rated its safety a 1 on a scale of 1-3."
Answered by AI
Are there any prior investigations into Dasatinib's efficacy?
"Currently, 64 Dasatinib-based trials are in progress with 9 studies at the Phase 3 stage. While New york City has a high concentration of these clinical tests, there are 4258 sites conducting research on this drug across the US."
Answered by AI
Is recruitment still open for volunteers to participate in this experiment?
"Currently, this research project is open to recruitment. It was initially published on November 4th 2019 and had a recent update as of March 22nd 2022 according to clinicaltrials.gov."
Answered by AI
Other Trials to Consider
Popular Categories
Share this study with friends
Copy Link
Messenger