Is NCT06510491 recruiting in Chapel Hill, NC?

Yes, NCT06510491 is currently recruiting participants at its Chapel Hill, NC location. This waldenstrom macroglobulinemia clinical trial is actively enrolling qualified participants.

Is participation in this Chapel Hill 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 Chapel Hill, NC

Q: How do I join the waldenstrom macroglobulinemia clinical trial in Chapel Hill?

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

Who Can Participate

Inclusion Criteria

A diagnosis of lymphoplasmacytic lymphoma/WM that is CD20+ by immunophenotype or immunohistochemistry confirmed by bone marrow biopsy/aspirate (fresh or archival tissue acceptable) at time of most recent progression. All degrees of CD20 positivity will be accepted.

Serum IgM level \>2x upper limit of normal (ULN)

Meeting criteria for initiation of treatment per IWWM2 criteria \[Kyle Semin Oncol 2002\], including but not limited to hyperviscosity syndrome, peripheral neuropathy, cold agglutinin disease, cryoglobulinemia, amyloidosis, cytopenias due to bone marrow infiltration, symptomatic or bulky lymph nodes, symptomatic splenomegaly, constitutional symptoms not otherwise explained by other causes, signs of organ dysfunction secondary to WM

At least one prior line of treatment that was discontinued either due to intolerance or disease progression

Prior therapies must have included an anti-CD20 antibody (e.g. rituximab) and a BTK inhibitor (e.g. ibrutinib, zanubrutinib). Patients who received ibrutinib and rituximab in combination as first line therapy will be eligible. BTKi should be stopped to allow a washout period of no less than 4 half-lives prior to epcoritamab.

Age ≥18 years

ECOG performance status £ 2

Life expectancy of greater than 2 years

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

absolute neutrophil count ≥1000 cells/mcl (G-CSF allowed)

absolute lymphocyte count ≥200 cells/mcl

platelets ≥75,000 cells/mcl OR ≥50,000 cells/mcl in the presence of bone marrow involvement or splenomegaly (Note: no PLT transfusions within 7 days prior to screening)

hemoglobin ≥ 8 g/dL (transfusion allowed)

total bilirubin ≤ 1.5 institutional upper limit of normal (ULN). In patients with suspected/known Gilbert's disease total bilirubin up to 3x ULN will be allowed but direct bilirubin must be ≤ 2 x ULN

AST(SGOT)/ALT(SGPT) ≤3× institutional ULN

creatinine ≤ institutional ULN OR

creatinine clearance \>45 ml/min (by Cockcroft-Gault estimate or 24-hr creatinine clearance measurement)

Subject does not have an active (PCR-positive) Hepatitis B virus (HBV) or Hepatitis C virus (HCV) infection. If laboratory evidence for a chronic infection with hepatitis B, close monitoring and prophylactic therapy is required as described in Section 5.4.

Participants with a history of prior malignancy will be eligible if all treatment of that malignancy was completed at least 2 years before registration, the treatment was considered "curable-intent", and there is no evidence of disease.

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

Females of childbearing potential must agree to practice a highly effective method of birth control (as defined by the EU Clinical Trial Facilitation Group) consistent with local regulations regarding the use of birth control methods for patients participating in clinical trials:

Established use of oral, injected or implanted combined (estradiol and progesterone containing) hormonal contraception;

Placement of an intrauterine device (IUD) or intrauterine system (IUS);

Male partner sterilization (the vasectomized partner should be the sole partner for that patient)

True abstinence (when this is in line with the preferred and usual lifestyle of the patient)

Women must agree not to donate eggs (ova, oocytes) for the purposes of assisted reproduction during the trial and for 12 months after receiving the last dose of epcoritamab. Men must also not donate sperm during the trial and for 12 months after receiving the last dose of epcoritamab.

A man who is sexually active with a woman of childbearing potential must agree to use a barrier method of birth control (i.e. use of condom) during the trial and for 12 months after receiving the last dose of epcoritamab.

Patients with HIV may be enrolled if they are on stable antiretroviral therapy, have an undetectable viral load, and CD4 count \> 250 cells/mm3.

Exclusion Criteria

Participants who have disease that has transformed to aggressive lymphoma

Participants with symptomatic or suspected hyperviscosity syndrome or IgM levels greater than 4000 mg/dL who are unable to undergo plasmapheresis to decrease the risk of an IgM flare. Participants who can undergo plasmapheresis will be eligible as long as they undergo the procedure prior to first treatment dose.

Participants who are receiving any other investigational agent

Washout from prior therapy: BTKi: no less than5 half-lives prior to epcoritamab to prevent BTKi rebound and rituximab: no less than 4 weeks (28 days) from last dose.

Participants who have not recovered from adverse events due to prior anti-cancer therapy (i.e., have residual toxicities \> Grade 1) except for alopecia and peripheral neuropathy

Uncontrolled intercurrent active infection requiring hospitalization or intravenous antimicrobial agents within 4 weeks of start of treatment

Uncontrolled underlying cardiac conditions including but not limited to: congestive heart failure grade III or IV (by NYHA) or EF \< 45%, unstable angina pectoris, acute myocardial infarction \< 6 months, uncontrolled cardiac arrhythmia

History of uncontrolled neurologic condition including but not limited to: seizure disorder, stroke, psychosis, dementia, CNS vasculitis, encephalitis

Need for supplemental O2 at rest to maintain SaO2\>92%

Chronic immunosuppressive therapy for non-WM-related indication within 28 days of initiation of treatment, including systemic corticosteroids 20 mg/day or greater prednisone-equivalent

Patients with known or suspected CNS involvement or leptomeningeal disease (i.e. BingNeel Syndrome) are excluded given concern for potentially increased risk of neurologic toxicity with epcoritamab. Patients with history of CNS malignancy from separate malignancy must have completed CNS-directed therapy and must currently have no evidence of disease

Pregnant or breastfeeding women or participants unwilling to adhere to institutional guidelines for highly effective contraception for the duration of the therapy are excluded. This is because of the unknown but potential risk of teratogenic or abortifacient effects, as well as potential for adverse events in nursing infants secondary to treatment of the mother, as epcoritamab has not yet been studied in this patient population. A female can be determined to not be of childbearing potential if she meets any of the following criteria:

Premenarchal

Postmenopausal (\>45 years of age with amenorrhea for at least 12 months or any age with amenorrhea for at least 6 months and a serum follicle stimulating hormone \[FSH\] level \>40 IU/L or mIU/mL)

Permanently sterilized (e.g., bilateral tubal occlusion \[which includes tubal ligation procedures as consistent with local regulations\], hysterectomy, bilateral salpingectomy, bilateral oophorectomy) Note: If the childbearing potential changes after start of the trial (e.g., woman who is not heterosexually active becomes active, premenarchal woman experiences menarche) a woman must begin a highly effective method of birth control, as described under 3.1.13.

Known current alcohol or drug abuse, psychiatric illness, or unstable social situation that is likely to limit compliance with study requirements

History of allergic reactions attributed to compounds of similar chemical or biologic composition to epcoritamab

Exposure to a live or a live attenuated vaccine within 4 weeks

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 Chapel Hill?

Yes, this clinical trial (NCT06510491) has an active research site in Chapel Hill, NC 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 Chapel Hill, NC

If you're searching for waldenstrom macroglobulinemia treatment options in Chapel Hill, NC, this clinical trial (NCT06510491) 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 Chapel Hill 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 Chapel Hill, NC

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