RECRUITING

Daratumumab for Relapsed/Refractory Primary Effusion Lymphoma, Plasmablastic Lymphoma, and Multicentric Castleman Disease

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Conditions

Lymphoma, Primary EffusionNon-Hodgkin LymphomaKaposi Sarcoma HerpesvirusHIVCD38B cell lymphoproliferative diseasesMulticentric Castleman Disease

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Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

Background: Primary effusion lymphoma (PEL), plasmablastic lymphoma (PBL), and Multicentric Castleman Disease (MCD) are aggressive forms of cancer that affects cells in the immune system and lymph nodes. How they develop is not well understood, and these diseases do not respond well to standard treatments for other types of lymphomas. Objective: To test a drug treatment (daratumumab SC) in people with PEL, PBL, or MCD. Eligibility: People aged 18 and older with PEL, PBL, or MCD who must have failed to respond to therapy or they must be unable to receive standard treatment for the disease. Design: Participants will be screened. They will have a physical exam with blood tests. They will have imaging scans and tests of their heart and lung function. They may need to have a biopsy: tissue or fluid will be collected. They will have an eye exam. Daratumumab SC is given as an injection into the fat under the skin in the abdomen. This takes 3 to 5 minutes. Participants will receive the treatment once a week for 8 weeks; then every 2 weeks for 16 weeks; then every 4 weeks for up to 24 months. Participants will have other tests during the study period. These may include lumbar punctures: A needle will be inserted between the bones of the spine to draw some fluid from the area around the spinal cord. Participants may also have a thoracentesis: A needle or plastic tube will be inserted into the space around the lungs to withdraw fluid. Participants will have more imaging scans and blood tests. Follow-up visits will continue after treatment ends. Participants will be in the study for up to 5 years.

Official Title

A Phase II Study of Daratumumab for Relapsed/Refractory Primary Effusion Lymphoma, Plasmablastic Lymphoma, and Multicentric Castleman Disease

Quick Facts

Study Start:2024-07-10
Study Completion:2035-12-01
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:RECRUITING

Study ID

NCT05907759

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:18 Years to 120 Years
Sexes Eligible for Study:ALL
Accepts Healthy Volunteers:No
Standard Ages:ADULT, OLDER_ADULT
Inclusion CriteriaExclusion Criteria
  1. * Participants must have primary effusion lymphoma (PEL), including extracavitary variant and KSHV-associated large cell lymphoma, plasmablastic lymphoma (PBL), and/or KSHV-associated multicentric Castleman disease pathologically that relapsed and/or is refractory after front-line chemotherapy or be ineligible for front-line chemotherapy
  2. * Age \>= 18 years.
  3. * Any HIV status
  4. * Participants with HIV must be receiving or will initiate an effective combination antiretroviral therapy (ART) regimen and must have an undetectable HIV VL which is defined as \<200 copies/mL.
  5. * Participants with PEL or PBL must meet the following criteria:
  6. * Must have measurable or assessable lymphoma
  7. * ECOG performance status 0-2 or 3 if secondary to PEL or PBL
  8. * Adequate hematological and renal functions as defined below:
  9. * Hemoglobin (Hgb) \> 7 g/dL
  10. * Creatinine clearance (CrCl) \>= 15 mL/min/1.73 m\^2
  11. * Must have received first-line curative-intent therapy (anthracycline-containing chemotherapy) for PEL or PBL, unless such therapy is contraindicated due to infection that precludes combination chemotherapy (such as progressive multifocal leukoencephalopathy) or if there is a contraindication to receiving CHOP or EPOCH (such as multi-organ failure).
  12. * Participants with KSHV-MCD must meet the following criteria:
  13. * ECOG performance status 0-2 or 3 if secondary to MCD
  14. * Adequate hematological and renal functions as defined below:
  15. * Hemoglobin (Hgb) \> 7 g/dL
  16. * Creatinine clearance (CrCl) \>= 15 mL/min/1.73 m\^2
  17. * At least one clinical symptom attributed to KSHV-MCD
  18. * Fever (\>38 degrees Celsius)
  19. * Fatigue
  20. * Gastrointestinal symptoms
  21. * Respiratory/sinus symptoms
  22. * Rash
  23. * At least one laboratory abnormality attributed to KSHV-MCD
  24. * Anemia (Hgb \[men\] \< 12.5 g/dL, Hgb \[women\] \< 11 g/dL)
  25. * Thrombocytopenia (\< 150 K/microL)
  26. * Hypoalbuminemia (\< 3.4 g/dL)
  27. * Hyponatremia (\< 135 mmol/L)
  28. * Elevated C-reactive protein (CRP) (\> 3 mg/L)
  29. * For participants with evidence of chronic hepatitis B virus (HBV) infection, participants must be on suppressive therapy with an undetectable VL.
  30. * Participants who are seropositive for hepatitis C virus (HCV)are eligible only in the setting of a sustained virologic response \[SVR\], defined as aviremia, at least 12 weeks after completion of antiviral therapy.
  31. * Participants that have received investigational agents on other clinical trials must have had a washout period of 2 weeks or 5 drug half-lives, whichever is longer.
  32. * Women of child-bearing potential (WOCBP) must agree to use an effective (dual) form of contraception (barrier, surgical sterilization, abstinence) prior to study entry and for the duration of study participation and for 3 months after the last dose of study drug. WOCBP must refrain from egg donations during the study and for 3 months after the last dose of daratumumab.
  33. * Men must agree to use an effective method of contraception (barrier, surgical sterilization, abstinence) for the duration of the study treatment and up to 3 months after the last dose of the study drug(s). We also will recommend men with female partners of childbearing potential to ask female partners to be on an effective birth control (hormonal, intrauterine device \[IUD\], surgical sterilization).
  34. * Breastfeeding participants must be willing to discontinue breastfeeding from study treatment initiation through 3 months after the last dose of the study drug.
  35. * Participants must understand and sign a written informed consent document.
  1. * Participants who have had anticancer treatment within the last 2 weeks unless the cancer treatment is for a malignancy whose natural history or treatment does not have the potential to interfere with the safety or efficacy assessment of the investigational regimen are eligible for this trial, such as local treatment for carcinoma in situ or hormonal therapy for prostate or breast carcinoma. Toxicity related to prior therapies other than hair loss and neuropathy must have resolved to grade 1.
  2. * KS requiring urgent treatment with cytotoxic chemotherapy.
  3. * Bilirubin (total) \> 1.5 times the upper limit of normal; aspartate aminotransferase (AST) and/or alanine aminotransferase (ALT) \> 3 times the upper limit of normal (ULN);
  4. * Total bilirubin \>= 5 mg/dL in participants with Gilbert's syndrome as defined by \> 80% unconjugated
  5. * If the elevated total bilirubin or AST/ALT are due to ART or lymphoma
  6. * ANC \< 1000/mm\^3 and platelets \< 75,000/mm\^3 unless related to lymphoma and/or KSHV-MCD or prior therapy.
  7. * No life-threatening or organ-threatening manifestations of KSHV-MCD.
  8. * Clinically significant cardiac disease, including:
  9. * Myocardial infarction within 6 months of randomization, or an unstable or uncontrolled disease/condition related to or affecting cardiac function (e.g., unstable angina, congestive heart failure, New York Heart Association Class IIIIV).
  10. * Uncontrolled cardiac arrhythmia
  11. * Chronic obstructive pulmonary disease (COPD) with a forced expiratory volume in 1 second (FEV1) \< 50% of predicted normal.
  12. * Moderate or severe persistent asthma within the past 2 years, or uncontrolled asthma of any classification. Note that participants who currently have controlled intermittent asthma or controlled mild persistent asthma are allowed to participate in the study.
  13. * Pregnant people as evaluated by a positive serum or urine beta-human chorionic gonadotropin (Beta-hCG) test
  14. * Participants with severe uncontrolled intercurrent illness, evaluated by history, physical exam and chemistry panel. Participants with severe intercurrent illnesses attributed to lymphoma may be eligible per PI s or designee s discretion.

Contacts and Locations

Study Contact

Anaida Widell
CONTACT
(240) 760-6074
anaida.widell@nih.gov
Kathryn A Lurain, M.D.
CONTACT
(301) 250-5156
kathryn.lurain@nih.gov

Principal Investigator

Kathryn A Lurain, M.D.
PRINCIPAL_INVESTIGATOR
National Cancer Institute (NCI)

Study Locations (Sites)

National Institutes of Health Clinical Center
Bethesda, Maryland, 20892
United States

Collaborators and Investigators

Sponsor: National Cancer Institute (NCI)

  • Kathryn A Lurain, M.D., PRINCIPAL_INVESTIGATOR, National Cancer Institute (NCI)

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2024-07-10
Study Completion Date2035-12-01

Study Record Updates

Study Start Date2024-07-10
Study Completion Date2035-12-01

Terms related to this study

Keywords Provided by Researchers

  • Non-Hodgkin Lymphoma
  • Kaposi Sarcoma Herpesvirus
  • HIV
  • CD38
  • B cell lymphoproliferative diseases
  • Multicentric Castleman Disease

Additional Relevant MeSH Terms

  • Lymphoma, Primary Effusion