CLINICAL TRIAL

Dasatinib for Waldenstrom Macroglobulinemia

1 Prior Treatment
Recruiting · 18+ · All Sexes · Boston, MA

This study is evaluating whether a drug may be effective in treating a type of cancer.

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About the trial for Waldenstrom Macroglobulinemia

Eligible Conditions
Waldenstrom Macroglobulinemia · DASATINIB

Treatment Groups

This trial involves 2 different treatments. Dasatinib is the primary treatment being studied. Participants will all receive the same treatment. There is no placebo group. The treatments being tested are in Phase 1 and are in the first stage of evaluation with people.

Main TreatmentA portion of participants receive this new treatment to see if it outperforms the control.
Dasatinib
DRUG
Control TreatmentAnother portion of participants receive the standard treatment to act as a baseline.

About The Treatment

Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Dasatinib
FDA approved

Side Effect Profile for Treatment (Allogeneic Nonmyeloablative HSCT)

Treatment (Allogeneic Nonmyeloablative HSCT)
Show all side effects
11%
Blood bilirubin increased
4%
Atrial flutter
4%
Intracranial hemorrhage
4%
Bronchopulmonary hemorrhage
4%
Anaphylaxis
4%
Diarrhea
4%
Encephalopathy
4%
Pneumonitis
4%
Transient ischemic attacks
4%
Febrile neutropenia
Blood bilirubin increased
11%
Atrial flutter
4%
Intracranial hemorrhage
4%
Bronchopulmonary hemorrhage
4%
Anaphylaxis
4%
Diarrhea
4%
Encephalopathy
4%
Pneumonitis
4%
Transient ischemic attacks
4%
Febrile neutropenia
4%
This histogram enumerates side effects from a completed 2018 Phase 2 trial (NCT00036738) in the Treatment (Allogeneic Nonmyeloablative HSCT) ARM group. Side effects include: Blood bilirubin increased with 11%, Atrial flutter with 4%, Intracranial hemorrhage with 4%, Bronchopulmonary hemorrhage with 4%, Anaphylaxis with 4%.

Eligibility

This trial is for patients born any sex aged 18 and older. You must have received 1 prior treatment for Waldenstrom Macroglobulinemia or the other condition listed above. There are 10 eligibility criteria to participate in this trial as listed below.

Inclusion & Exclusion Checklist
Mark “yes” if the following statements are true for you:
Individuals must meet the following criteria in order to participate in the study: consent, physical exam, and laboratory assessments will be done within 30 days prior to Cycle 1 Day 1 show original
Waldenstrom's Macroglobulinemia is a rare type of cancer that affects the blood show original
The expression of the mutated MYD88 gene in tumors is known and can be tested for by a certified laboratory. show original
At least one previous therapy, with ibrutinib as the most recent treatment show original
of diagnosis The patient's serum IgM level increased by 25% and their absolute increase was at least 500 mg/dL from their nadir show original
The patient's symptoms progressed from clinically significant to more severe. show original
Participants must have a BTKCys481 and/or PLCγ2 mutation. Genomic alterations must be confirmed via sequencing performed at NeoGenomics Laboratories
Constitutional symptoms
Symptoms of lymphadenopathy or splenomegaly, such as progressive enlargement of lymph nodes or the spleen, can indicate a variety of health conditions. show original
Hemoglobin <10 g/dL
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Odds of Eligibility
Unknown<50%
Be sure to apply to 2-3 other trials, as you have a low likelihood of qualifying for this one.Apply To This Trial
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Approximate Timelines

Please note that timelines for treatment and screening will vary by patient
Screening: ~3 weeks
Treatment: varies
Reporting: 2 years
Screening: ~3 weeks
Treatment: Varies
Reporting: 2 years
This trial has approximate timelines as follows: 3 weeks for initial screening, variable treatment timelines, and reporting: 2 years.
View detailed reporting requirements
Trial Expert
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- What options you have available- The pros & cons of this trial
- Whether you're likely to qualify- What the enrollment process looks like

Measurement Requirements

This trial is evaluating whether Dasatinib will improve 1 primary outcome and 10 secondary outcomes in patients with Waldenstrom Macroglobulinemia. Measurement will happen over the course of 2 years.

Overall Survival
2 YEARS
Kaplan Meier
2 YEARS
Progression Free Survival
2 YEARS
Kaplan Meier methodology
2 YEARS
Stable Disease Rate
2 YEARS
Proportion of patients with Stable disease to therapy. (SD is <25% reduction in serum IgM from baseline).
2 YEARS
Minimal Response Rate
2 YEARS
Proportion of patients with Minor Responses to therapy. (MR is 25-49% reduction in serum IgM from baseline)
2 YEARS
Complete Response Rate
2 YEARS
Proportion of patients with CR
2 YEARS
Time to Next Therapy (TTNT)
2 YEARS
Kaplan Meier
2 YEARS
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Patient Q & A Section

Please Note: These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

What causes waldenstrom macroglobulinemia?

Aspiration has been suspected as a possible cause of WML. However, we were unable to find any evidence of aspiration in any case. We were unable to find any evidence for vaccination as a cause of WML. However, this may be due to the difficulty in identifying the cause of WML. In a recent study, findings also suggests that WML is not an autoimmune disease. In view of these findings it is likely that the underlying cause of WML is associated with the production, and thus clearance, of circulating WMAL-Ig-MA in patients with WML.

Anonymous Patient Answer

How many people get waldenstrom macroglobulinemia a year in the United States?

There isn’t a single national surveillance program, national survey or study, that can monitor the incidence of WALM. At present, the only way to track the incidence of WALM nationwide is through individual reports from physician"

Anonymous Patient Answer

What is waldenstrom macroglobulinemia?

Waldenstrom macroglobulinemia is a potentially curable, monoclonal gammopathy characterized by an expanded lymphoplasmacytic-immunoglobulin clone (B cell). The neoplastic proliferating clone does not seem to be in need of immunoglobulin for survival.

Anonymous Patient Answer

What are common treatments for waldenstrom macroglobulinemia?

In WMA, most patients are treated with cytotoxic drugs including chlorambucil, cyclophosphamide, procarbazine, hydroxydaunorubicin, vincristine, and lenalidomide. Other drugs include methotrexate, thalidomide, and rituximab. In some cases, the therapy may include allogeneic hematopoietic stem-cell transplantation.

Anonymous Patient Answer

What are the signs of waldenstrom macroglobulinemia?

Most people with waldenstrom macroglobulinemia do not experience any symptoms or signs. Asymmetrical hair and pigmentation, which are common features of waldenstrom macroglobulinemia, are not necessarily signs of the disease. Rarely, some patients may experience an elevated white blood cell count. The symptoms of waldenstrom macroglobulinemia include anemia, fatigue or low energy, fever, hair loss, swollen lymph nodes, and blood in the urine. In advanced cases, the symptoms can include gastrointestinal bleeding, neurological symptoms, and loss of appetite.

Anonymous Patient Answer

Can waldenstrom macroglobulinemia be cured?

The possibility of complete remission with chemotherapy alone is very low. However, some people with refractory WM with multiple relapses can achieve complete remissions after multiple cycles of chemotherapy alone and be cured. The optimal therapy of WM should be tailored to the individual patient according to the pattern of clinical responses to conventional first-line chemotherapy and/or treatment failure.

Anonymous Patient Answer

Have there been other clinical trials involving dasatinib?

There are two ongoing clinical trials that are recruiting patients and enrolling study arms for patients with myeloma. At present, we know that other clinical trials have been conducted involving dasatinib in myeloma. There is currently no indication of dasatinib failing or causing side effects in patients with MM. We hope that the presence of such clinical trials in the past (and currently for myeloma) will help patients and clinicians find the best therapy for each patient and not just the most available therapies available. The current study is a Phase 2 Trial. There is still no indication of dasatinib failing or causing side effects in patients with MM.

Anonymous Patient Answer

What is the average age someone gets waldenstrom macroglobulinemia?

The average age of onset for a patient with Waldenstrom macroglobulinemia is 74 years. For patients with Waldenstrom macroglobulinemia, the average age of diagnosis is 71 years. It is uncommon for Waldenstrom macroglobulinemia to be diagnosed before 70 years of age. The average age when complete remission occurs is 83 years. The average survival of Waldenstrom macroglobulinemia is 12.8 and a patient who is disease free, no treatment and reaches 95 years of age.

Anonymous Patient Answer

What are the latest developments in dasatinib for therapeutic use?

Currently, the only available therapeutic options for adults with Waldenström macroglobulinemia are cytotoxic or bone marrow transplantation. However, these procedures are not available for all patients because some individuals or their families do not seek care. In particular, one important subset of patients has been undertreated. Based on these observations, dasatinib, a targeted therapy, has the potential to address both the patient and their family needs for an improved outcome.

Anonymous Patient Answer

Does waldenstrom macroglobulinemia run in families?

The familial aggregation of WMC is seen in two distinct populations. One was noted in persons with MGUS. Thus, it is most likely unrelated to the presence of WMC on blood tests. The second population is not related to WMC.

Anonymous Patient Answer

What are the common side effects of dasatinib?

Dasatinib is associated with several common side effects that warrant consideration during treatment. Most commonly, diarrhea and vomiting are the most common side effects resulting from dasatinib use.

Anonymous Patient Answer

Is dasatinib safe for people?

The safety of dasatinib in this real-life study is consistent with the reassuring observational studies of dasatinib use in children. The data in this study suggest that dasatinib may have an acceptable safety profile for people with WM in real-life clinical practice.

Anonymous Patient Answer
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