Is NCT06561347 recruiting in Dallas, TX?

Yes, NCT06561347 is currently recruiting participants at its Dallas, TX location. This waldenstrom macroglobulinemia clinical trial is actively enrolling qualified participants.

How do I join the waldenstrom macroglobulinemia clinical trial in Dallas?

To join this clinical trial in Dallas, complete the eligibility form on this page. A study coordinator will contact you to discuss next steps and determine if you qualify.

Is participation in this Dallas clinical trial free?

Yes, all study-related care is provided at no cost to qualified participants. Many studies also offer compensation for time and travel expenses.

Waldenstrom Macroglobulinemia Clinical Trial in Dallas, TX

About This Waldenstrom Macroglobulinemia Study in Dallas

The purpose of this study is to determine the very good partial response (VGPR) or better rate in participants with Waldenström macroglobulinemia (WM). The names of the study drugs involved in this study are as follows: zanubrutinib, bendamustine, and rituximab.

Sponsor: Massachusetts General Hospital

Who Can Participate

Inclusion Criteria

Clinicopathological diagnosis of waldenström macroglobulinemia (WM) per the second international workshop on waldenström macroglobulinemia (IWWM2) criteria

Presence of any MYD88 and CXCR4 mutation status, including MYD88 L265P mutation plus CXCR4 wild type, MYD88 L265P mutation plus CXCR4 mutation, or MYD88 wild type

Meeting criteria for treatment per IWWM2 criteria. At least one of the following:

Constitutional Symptoms (at least one of the following)

Recurrent fever

Night sweats

Weight loss

Progressive or symptomatic lymphadenopathy or splenomegaly

Hemoglobin ≤ 10 g/dL

Platelet count ≤ 100 k/uL

Hyperviscosity syndrome

Symptomatic peripheral neuropathy

Systemic amyloidosis

Renal insufficiency

Symptomatic cryoglobulinemia or cold agglutinemia

Treatment naive; must have not received any prior systemic therapy for WM

Participants with suspected or symptomatic hyperviscosity (e.g. nosebleeds, headaches, blurred vision) must undergo plasmapheresis prior to treatment initiation.

Adults age ≥18

ECOG performance status ≤2 (Karnofsky ≥60%, see Appendix A)

Women of childbearing potential: Females of childbearing potential (FCBP) must agree to use two reliable forms of contraception simultaneously or practice complete abstinence1 from heterosexual intercourse during treatment and for at least 1 week after the last dose of zanubrutinib or at least 12 months after the last dose of rituximab, whichever is later. FCBP must be referred to a qualified provider of contraceptive methods if needed. Also, FCBP must have a pregnancy check with a negative serum pregnancy test obtained 28 days prior to and confirmed by C1D1.

Men must agree to use a condom during sexual contact with a female of childbearing potential (FCBP) even if they have had a successful vasectomy 1) while participating in the study; and 2) for at least 1 week following the last dose of zanubrutinib.

Participants must meet the following organ and marrow function as defined below:

Absolute neutrophil count ≥500/mcL believed to be caused by WM bone marrow involvement. Growth factors are not permitted \<14 days prior to C1D1.

Platelets ≥30,000/mcL believed to be caused by WM bone marrow involvement. Platelet transfusions are not permitted \<14 days prior to C1D1.

Hemoglobin ≥ 7 g/dL. RBC transfusions are not permitted \<14 days prior to C1D1.

Total bilirubin ≤ 1.5 X institutional ULN, or ≤3 x institutional ULN with documented liver metastases and/or Gilbert's Disease

AST(SGOT)/ALT(SGPT) ≤2.5 × institutional upper limit of normal, or ≤5 X institutional ULN with documented liver metastases

Creatinine clearance ≥30 mL/min using the Cockcroft-Gault formula

Able to adhere to the study visit schedule and other protocol requirements.

Ability to understand and the willingness to sign a written informed consent document.

Exclusion Criteria

Any serious medical condition, laboratory abnormality, uncontrolled intercurrent illness, or psychiatric illness/social condition that would prevent the participant from signing the informed consent form

Female participants who are pregnant, breastfeeding, or planning to become pregnant or breastfeed while enrolled in this study

Participants with known CNS involvement by WM

Participants with known history of Human Immunodeficiency Virus (HIV)

Known active hepatitis B virus (HBV) or hepatitis C virus (HCV) infection based on criteria below:

Hepatitis B virus (HBV): Patients with positive hepatitis B surface antigen (HBsAg) are excluded. Patients with positive hepatitis B core antibody (antiHBc) and negative HBsAg require hepatitis B polymerase chain reaction (PCR) evaluation before enrollment. Patients who are hepatitis B PCR positive will be excluded.

Hepatitis C virus (HCV): positive hepatitis C antibody. If positive hepatitis C antibody result, patient will need to have a negative result for hepatitis C ribonucleic acid (RNA) before enrollment. Patients who are hepatitis C RNA positive will be excluded.

Concurrent systemic immunosuppressant therapy. Systemic steroids at doses \<20mg prednisone per day are permitted.

Active and/or ongoing autoimmune anemia and/or autoimmune thrombocytopenia (eg, idiopathic thrombocytopenia purpura).

Concurrent administration of warfarin or warfarin derivatives.

Vaccinated with live, attenuated vaccines within 4 weeks of first dose of study drug.

Active uncontrolled systemic bacterial, viral, fungal or parasitic infection (except for fungal nail infection), or other clinically significant active disease process which in the opinion of the Investigator and the Sponsor makes it undesirable for the patient to participate in the trial. Screening for chronic conditions is not required. Active uncontrolled systemic bacterial, viral, fungal or parasitic infection (except for fungal nail infection), or other clinically significant active disease process which in the opinion of the Investigator and the Sponsor makes it undesirable for the patient to participate in the trial. Screening for chronic conditions is not required.

Major surgery within 4 weeks of first dose of study drug.

History of severe bleeding disorder such as hemophilia A, hemophilia B, or history of spontaneous bleeding requiring blood transfusion or other medical intervention. History of stroke or intracranial hemorrhage within 6 months before first dose of study drug.

Participants with inability to swallow pills.

Inability to comply with outpatient treatment, laboratory monitoring, and required clinic visits for the duration of the study participation.

Any uncontrolled or significant cardiovascular disease defined as:

Unstable angina within 3 months before screening, or

History of myocardial infarction within 6 months prior to planned start of zanubrutinib, or

Previously documented left ventricular ejection fraction (LVEF) by any method of ≤ 45% in the 12 months prior to planned start of zanubrutinib; assessment of LVEF via echocardiogram or multigated acquisition (MUGA) scan during Screening should be performed in selected patients as medically indicated, or

Any Class 3 or 4 cardiac disease as defined by the New York Heart Association Functional Classification, or

Uncontrolled or symptomatic arrhythmias (eg, sustained ventricular tachycardia, ventricular fibrillation, torsades de pointes)

Participants with a known hypersensitivity to any of the excipients of Zanubrutinib, Rituximab, or Bendamustine.

Participants with a history of non-compliance to medical regimens, which will render the administration of study drug hazardous or obscure the interpretation of toxicity or AEs.

Prior malignancy within the past 3 years, except for curatively treated basal or squamous cell skin cancer, non-muscle-invasive bladder cancer, carcinoma in situ of the cervix or breast, or localized Gleason score 6 prostate cancers.

Severe or debilitating pulmonary disease.

Ongoing alcohol or drug addiction or any psychiatric condition(s) which would compromise ability to comply with study procedures.

Ongoing use of a strong CYP3A inducer.

Not sure if you qualify? Submit your interest and a study coordinator will help determine your eligibility.

Frequently Asked Questions

Q:Is this study available in Dallas?

Yes, this clinical trial (NCT06561347) has an active research site in Dallas, TX that is currently enrolling participants.

Q:Is it safe to participate?

Clinical trials follow strict safety guidelines and ethical standards. This study has been reviewed and approved, and participants are closely monitored by medical professionals. You can withdraw at any time.

Q:Will I be compensated?

Many clinical trials offer compensation for your time and travel expenses. Specific compensation details will be discussed during the screening process. All study-related medical care is provided at no cost.

Q:Can I leave the trial if I change my mind?

Absolutely. Participation is completely voluntary. You have the right to withdraw from the study at any time, for any reason, without penalty.

Still have questions? Our study coordinators are here to help.

Waldenstrom Macroglobulinemia Treatment Options in Dallas, TX

If you're searching for waldenstrom macroglobulinemia treatment options in Dallas, TX, this clinical trial (NCT06561347) may be an excellent opportunity. Clinical trials provide access to cutting-edge treatments that aren't yet available to the general public, often at no cost to participants.

Our Dallas research site is actively enrolling participants for this phase 2 clinical trial. You'll receive care from experienced waldenstrom macroglobulinemia specialists who are at the forefront of medical research. All study-related care, including examinations, treatments, and monitoring, is provided at no cost to qualified participants.

Looking for more options? Browse all waldenstrom macroglobulinemia clinical trials near you to find additional studies recruiting in your area.

Waldenstrom Macroglobulinemia Clinical Trial in Dallas, TX

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