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Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Symptomatic disease meeting criteria for treatment using consensus panel criteria from the Second International Workshop on WM
Measurable disease, defined as presence of immunoglobulin M (IgM) paraprotein with a minimum serum IgM level of > 2 times the upper limit normal
Must not have
Be younger than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up2 years
Awards & highlights
No Placebo-Only Group
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.
Eligible Conditions
- Waldenstrom Macroglobulinemia
- Dasatinib
Eligibility Criteria
Inclusion Criteria
You will be eligible if you check “Yes” for the criteria belowSelect...
You have symptoms of a disease that need to be treated based on specific guidelines.
Select...
You have a certain type of protein in your blood called immunoglobulin M (IgM) at a high level.
Select...
You have a performance status of 2 or lower, based on how well you can carry out daily activities.
Select...
Your organs and bone marrow need to be working normally.
Select...
You have been diagnosed with Waldenstrom's Macroglobulinemia.
Select...
Your tumor has a specific gene mutation called MYD88, as confirmed by a certified laboratory test.
Select...
You need to have a specific BTKCys481 and/or PLCγ2 mutation confirmed by a certain laboratory test.
Select...
You must have received at least one treatment before, with ibrutinib being the most recent one. If you are currently taking ibrutinib, you will need to stop for one day before starting dasatinib.
Select...
Your disease got worse while you were taking ibrutinib as your last treatment, based on specific guidelines.
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
Dasatinib
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%
Intracranial hemorrhage
4%
Upper gastrointestinal hemorrhage
4%
Hypertension
4%
Hypotension
4%
Enterocolitis
2%
Fungemia
2%
Fibrinogen decreased
2%
Hypoxia
2%
Edema limbs
2%
Abdominal pain
2%
Diarrhea
2%
Aspiration
2%
Atrial fibrillation
2%
Delirium
2%
Endophthalmitis
2%
Kidney infection
2%
Lower gastrointestinal hemorrhage
2%
Myocardial infarction
2%
Peripheral motor neuropathy
2%
Sinus bradycardia
2%
Small intestinal obstruction
2%
Typhlitis
2%
Multi-organ failure
2%
Gastric hemorrhage
2%
Oropharyngeal pain
100%
80%
60%
40%
20%
0%
Study treatment Arm
Treatment (Chemotherapy)
Awards & Highlights
No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.
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 2
~2200
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
2,602 Previous Clinical Trials
4,048,245 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:- You are currently receiving treatment for any other cancer, except for skin cancer that is being treated with creams or ointments.You have a history of not following your doctor's instructions for taking medication or following medical advice.You are currently taking strong medications that can affect the way other drugs work in your body.You are taking St. John's Wort. You need to stop taking it at least 5 days before starting dasatinib.Taking medication like Zantac or Prilosec for stomach issues.You have symptoms of a disease that need to be treated based on specific guidelines.You have a certain type of protein in your blood called immunoglobulin M (IgM) at a high level.You have a performance status of 2 or lower, based on how well you can carry out daily activities.Your organs and bone marrow need to be working normally.You have been diagnosed with Waldenstrom's Macroglobulinemia.Your tumor has a specific gene mutation called MYD88, as confirmed by a certified laboratory test.You need to have a specific BTKCys481 and/or PLCγ2 mutation confirmed by a certain laboratory test.You must have received at least one treatment before, with ibrutinib being the most recent one. If you are currently taking ibrutinib, you will need to stop for one day before starting dasatinib.Your disease got worse while you were taking ibrutinib as your last treatment, based on specific guidelines.You have previously been treated with BCR-ABL inhibitors.You have been diagnosed with central nervous system (CNS) lymphoma.You have a condition that requires immediate treatment for thickened blood.You have HIV, active Hepatitis B, or active Hepatitis C.You have a history of alcohol or drug abuse.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 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
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