SUSPENDED

Testing the Combination of Venetoclax and Rituximab, in Comparison to the Usual Treatment (Ibrutinib and Rituximab) for Waldenstrom's Macroglobulinemia/Lymphoplasmacytic Lymphoma

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

This phase II trial studies the effects of venetoclax and rituximab in comparison to ibrutinib and rituximab in treating patients with previously untreated Waldenstrom's macroglobulinemia/lymphoplasmacytic lymphoma. Ibrutinib may stop the growth of cancer cells by blocking some of the enzymes needed for cell growth. Rituximab is a monoclonal antibody. It binds to a protein called CD20, which is found on B cells (a type of white blood cell) and some types of cancer cells. This may help the immune system kill cancer cells. Venetoclax is in a class of medications called B-cell lymphoma-2 (BCL-2) inhibitors. It may stop the growth of cancer cells by blocking Bcl-2, a protein needed for cancer cell survival. Giving venetoclax and rituximab may work better in treating patients with previously untreated Waldenstrom's macroglobulinemia than ibrutinib and rituximab alone.

Official Title

A Phase II Randomized Study Comparing Ibrutinib and Rituximab vs. Venetoclax and Rituximab in Previously Untreated Waldenström's Macroglobulinemia (WM) / Lymphoplasmacytic Lymphoma (LPL)

Quick Facts

Study Start:2022-01-05
Study Completion:2028-03-31
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:SUSPENDED

Study ID

NCT04840602

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
Sexes Eligible for Study:ALL
Accepts Healthy Volunteers:No
Standard Ages:ADULT, OLDER_ADULT
Inclusion CriteriaExclusion Criteria
  1. * Participants must have had a confirmed diagnosis of Waldenstrom's macroglobulinemia (WM)/lymphoplasmacytic lymphoma (LPL). Participants must have measurable disease as determined by IgM protein quantification.
  2. * IgM Spike: ≥ 500 mg/dL (≥ 5 g/L)
  3. * Extramedullary disease: The manifestation of a lymphoid mass outside of the bone marrow, resulting in enlargement in extramedullary organs such as the lymph nodes or spleen. Note: all participants must have measurable IgM spike, but are not required to have extramedullary disease
  4. * Testing to establish baseline disease status must be performed within 28 days prior to registration
  5. * Participants must have at least one of the criteria to require therapy for WM including anemia, thrombocytopenia, neuropathy related to WM, symptomatic hyperviscosity or serum viscosity levels greater than 4.0 centipoises, WM associated glomerulonephritis or renal disease, bulky disease, or constitutional symptoms. Constitutional symptoms can be described as unintentional weight loss \>= 10% within the previous 6 months prior to screening; Fevers higher than 100.5 degrees Fahrenheit (F) or 38.0 degrees Celsius (C) for 2 or more weeks prior to screening without evidence of infection; Night sweats for more than 1 month prior to screening without evidence of infection; Clinically relevant fatigue which is not relieved by rest due to WM
  6. * Participants who require ongoing use or received a moderate or strong CYP3A inducer, moderate or strong CYP3A inhibitor, P-gp inhibitor within 7 days prior to the first dose of study drug will be excluded from the study. If such participants can be safely switched to an alternative agent, then the participants will be eligible to enroll
  7. * Participants must not have had prior systemic therapy. Prior therapy with rituximab will be allowed as long as the last rituximab dose was at least 6 months prior to registration
  8. * Participants must be \>= 18 years of age
  9. * Participants must have history and physical exam within 28 days prior to registration
  10. * Participants must have Zubrod performance status =\< 2
  11. * Participants must have evidence of adequate renal function, as defined by creatinine clearance (CrCl) \>= 30 mL/min. Values must be obtained within 14 days prior to registration
  12. * Total bilirubin =\< 1.5 x IULN (institutional upper limit of the norm) (within 14 days prior to registration)
  13. * Aspartate aminotransferase (AST), alanine aminotransferase (ALT) =\< 3 x IULN (within 14 days prior to registration)
  14. * Alkaline phosphatase =\< 3 x IULN (within 14 days prior to registration)
  15. * Platelet count \>= 50,000 cells/mm\^3 (within 14 days prior to registration)
  16. * NOTE: Transfusion and/or growth factor support is allowed up to 7 days prior to registration
  17. * Hemoglobin \>= 7.5 g/dL (within 14 days prior to registration)
  18. * NOTE: Transfusion and/or growth factor support is allowed up to 7 days prior to registration
  19. * Absolute neutrophil count (ANC) \>= 1,000 cells/mm\^3 (within 14 days prior to registration)
  20. * NOTE: Transfusion and/or growth factor support is allowed up to 7 days prior to registration
  21. * Participants with known human immunodeficiency virus (HIV)-infection are eligible providing they are on effective anti-retroviral therapy and have undetectable viral load at their most recent viral load test and within 6 months prior to registration
  22. * Participants must be able to take and swallow oral medication (capsules) whole. Participants may not have any known impairment of gastrointestinal function or gastrointestinal disease that may significantly alter the absorption of the study drug (e.g. ulcerative disease, uncontrolled nausea, vomiting, diarrhea, malabsorption syndrome, or small bowel resection)
  23. * Participants must not be intolerant to rituximab
  24. * Participants must not have known active bacterial, viral, fungal, mycobacterial, parasitic, or other infection (excluding localized skin and nail bed fungal infections) at study enrollment, or any major episode of infection requiring treatment with IV antibiotics or hospitalization (relating to the completion of the course of antibiotics) 4 weeks prior to registration
  25. * Participants must not be seropositive for hepatitis C (except in the setting of sustained virologic response, defined as undetectable viral load at least 12 weeks after completion of antiviral therapy). Hepatitis C virus (HCV) testing is only required if clinically indicated or if the participant has a history of HCV
  26. * Participants must not consume grapefruit, Seville oranges or starfruit within 3 days prior to the first dose of venetoclax
  27. * Participants must not be pregnant or nursing because venetoclax has not been studied in pregnant or nursing women and the mechanism of action is expected to cause fetal harm. A woman is considered to be of "reproductive potential" if she has had menses at any time in the preceding 12 consecutive months. In addition to routine contraceptive methods, "effective contraception" e.g., implants, injectables, combined oral contraceptives, some intrauterine devices \[IUDs\], complete abstinence, or sterilized partner) and a barrier method (e.g., condom, cervical ring, sponge, etc.). This also includes heterosexual celibacy and surgery intended to prevent pregnancy (or with a side-effect of pregnancy prevention) defined as a hysterectomy, bilateral oophorectomy or bilateral tubal ligation. However, if at any point a previously celibate participant chooses to become heterosexually active during the time period for use of contraceptive measures outlined in the protocol, he/she is responsible for beginning contraceptive measures throughout the study and for at least 30 days after competition of therapy
  28. * No other prior malignancy is allowed except for the following: adequately treated basal cell or squamous cell skin cancer, in situ cervical cancer, adequately treated stage I or II cancer from which the participant is currently in complete remission, or any other cancer from which the participant has been disease free for two years or watchful waiting is appropriate in the opinion of the treating physician. Also, malignancy that in the opinion of the investigator, is considered cured with minimal risk of recurrence within 5 years, is permissible consideration of eligibility for this trial
  29. * Participants must be offered the opportunity to participate in specimen banking
  30. * Participants must be informed of the investigational nature of this study and must sign and give informed consent in accordance with institutional and federal guidelines. For participants with impaired decision-making capabilities, legally authorized representatives may sign and give informed consent on behalf of study participants in accordance with applicable federal, local, and Central Institutional Review Board (CIRB) regulations
  31. * As a part of the Oncology Participant Enrollment Network (OPEN) registration process the treating institution's identity is provided in order to ensure that the current (within 365 days) date of institutional review board approval for this study has been entered in the system
  32. * CROSSOVER CRITERIA: Participants must have been registered and received treatment in the IR or VR arm and must show progression of disease at any time during cycles 3-24
  33. * CROSSOVER CRITERIA: In case of transformation to intermediate or high-grade lymphoma or development of Bing-Neel syndrome the participants will not undergo registration step 2 crossover and will be taken off the study
  34. * CROSSOVER CRITERIA: Participants must have Zubrod performance status =\< 2
  35. * CROSSOVER CRITERIA: Participants must have evidence of adequate renal function, as defined by creatinine clearance (CrCl) \>= 30 mL/min. Values must be obtained within 14 days prior to registration
  36. * CROSSOVER CRITERIA: Participants must have no evidence of marked hepatic dysfunction on any recent liver function tests within 14 days prior to registration
  37. * CROSSOVER CRITERIA: Platelet count \>= 50,000 cells/mm\^3 (without within 14 days prior to registration)
  38. * NOTE: Transfusion and/or growth factor support is allowed up to 7 days prior to registration
  39. * CROSSOVER CRITERIA: Hemoglobin \>= 7.5 g/dL (without within 14 days prior to registration)
  40. * NOTE: Transfusion and/or growth factor support is allowed up to 7 days prior to registration
  41. * CROSSOVER CRITERIA: Absolute neutrophil count (ANC) \>= 1,000 cells/mm\^3 (without within 14 days prior to registration)
  42. * NOTE: Transfusion and/or growth factor support is allowed up to 7 days prior to registration
  1. Pregnancy or breastfeeding
  2. Severe psychiatric disorders
  3. Active substance abuse
  4. Unstable medical conditions
  5. Inability to comply with study requirements

Contacts and Locations

Principal Investigator

Sikander Ailawadhi
PRINCIPAL_INVESTIGATOR
SWOG Cancer Research Network

Study Locations (Sites)

Banner University Medical Center - Tucson
Tucson, Arizona, 85719
United States
University of Arizona Cancer Center-North Campus
Tucson, Arizona, 85719
United States
Mayo Clinic in Florida
Jacksonville, Florida, 32224-9980
United States
Centralia Oncology Clinic
Centralia, Illinois, 62801
United States
Carle at The Riverfront
Danville, Illinois, 61832
United States
Cancer Care Specialists of Illinois - Decatur
Decatur, Illinois, 62526
United States
Carle Physician Group-Effingham
Effingham, Illinois, 62401
United States
Crossroads Cancer Center
Effingham, Illinois, 62401
United States
Carle Physician Group-Mattoon/Charleston
Mattoon, Illinois, 61938
United States
Cancer Care Center of O'Fallon
O'Fallon, Illinois, 62269
United States
Southern Illinois University School of Medicine
Springfield, Illinois, 62702
United States
Springfield Clinic
Springfield, Illinois, 62702
United States
Springfield Memorial Hospital
Springfield, Illinois, 62781
United States
Carle Cancer Center
Urbana, Illinois, 61801
United States
Mary Greeley Medical Center
Ames, Iowa, 50010
United States
McFarland Clinic - Ames
Ames, Iowa, 50010
United States
McFarland Clinic - Boone
Boone, Iowa, 50036
United States
McFarland Clinic - Trinity Cancer Center
Fort Dodge, Iowa, 50501
United States
McFarland Clinic - Jefferson
Jefferson, Iowa, 50129
United States
McFarland Clinic - Marshalltown
Marshalltown, Iowa, 50158
United States
Trinity Health Saint Joseph Mercy Hospital Ann Arbor
Ann Arbor, Michigan, 48106
United States
Trinity Health IHA Medical Group Hematology Oncology - Brighton
Brighton, Michigan, 48114
United States
Trinity Health Medical Center - Brighton
Brighton, Michigan, 48114
United States
Trinity Health IHA Medical Group Hematology Oncology - Canton
Canton, Michigan, 48188
United States
Trinity Health Medical Center - Canton
Canton, Michigan, 48188
United States
Chelsea Hospital
Chelsea, Michigan, 48118
United States
Trinity Health IHA Medical Group Hematology Oncology - Chelsea Hospital
Chelsea, Michigan, 48118
United States
Hematology Oncology Consultants-Clarkston
Clarkston, Michigan, 48346
United States
Newland Medical Associates-Clarkston
Clarkston, Michigan, 48346
United States
Henry Ford Hospital
Detroit, Michigan, 48202
United States
Cancer Hematology Centers - Flint
Flint, Michigan, 48503
United States
Genesee Hematology Oncology PC
Flint, Michigan, 48503
United States
Genesys Hurley Cancer Institute
Flint, Michigan, 48503
United States
Hurley Medical Center
Flint, Michigan, 48503
United States
University of Michigan Health - Sparrow Lansing
Lansing, Michigan, 48912
United States
Trinity Health Saint Mary Mercy Livonia Hospital
Livonia, Michigan, 48154
United States
Michigan Healthcare Professionals Pontiac
Pontiac, Michigan, 48341
United States
Newland Medical Associates-Pontiac
Pontiac, Michigan, 48341
United States
Trinity Health Saint Joseph Mercy Oakland Hospital
Pontiac, Michigan, 48341
United States
MyMichigan Medical Center Saginaw
Saginaw, Michigan, 48601
United States
Oncology Hematology Associates of Saginaw Valley PC
Saginaw, Michigan, 48604
United States
MyMichigan Medical Center Tawas
Tawas City, Michigan, 48764
United States
Huron Gastroenterology PC
Ypsilanti, Michigan, 48106
United States
Trinity Health IHA Medical Group Hematology Oncology Ann Arbor Campus
Ypsilanti, Michigan, 48197
United States
Mayo Clinic in Rochester
Rochester, Minnesota, 55905
United States
Saint Francis Medical Center
Cape Girardeau, Missouri, 63703
United States
Siteman Cancer Center at Saint Peters Hospital
City of Saint Peters, Missouri, 63376
United States
Siteman Cancer Center at West County Hospital
Creve Coeur, Missouri, 63141
United States
Heartland Regional Medical Center
Saint Joseph, Missouri, 64506
United States
Washington University School of Medicine
St Louis, Missouri, 63110
United States
Mercy Hospital South
St Louis, Missouri, 63128
United States
Siteman Cancer Center-South County
St Louis, Missouri, 63129
United States
Siteman Cancer Center at Christian Hospital
St Louis, Missouri, 63136
United States
Saint Vincent Frontier Cancer Center
Billings, Montana, 59102
United States
Memorial Sloan Kettering Basking Ridge
Basking Ridge, New Jersey, 07920
United States
Memorial Sloan Kettering Monmouth
Middletown, New Jersey, 07748
United States
Memorial Sloan Kettering Bergen
Montvale, New Jersey, 07645
United States
Memorial Sloan Kettering Commack
Commack, New York, 11725
United States
Glens Falls Hospital
Glens Falls, New York, 12801
United States
Memorial Sloan Kettering Westchester
Harrison, New York, 10604
United States
NYP/Columbia University Medical Center/Herbert Irving Comprehensive Cancer Center
New York, New York, 10032
United States
Memorial Sloan Kettering Cancer Center
New York, New York, 10065
United States
University of Rochester
Rochester, New York, 14642
United States
Memorial Sloan Kettering Nassau
Uniondale, New York, 11553
United States
Carolinas Medical Center/Levine Cancer Institute
Charlotte, North Carolina, 28203
United States
Southeastern Medical Oncology Center-Clinton
Clinton, North Carolina, 28328
United States
Levine Cancer Institute-Gaston
Gastonia, North Carolina, 28054
United States
Southeastern Medical Oncology Center-Goldsboro
Goldsboro, North Carolina, 27534
United States
Southeastern Medical Oncology Center-Jacksonville
Jacksonville, North Carolina, 28546
United States
Strecker Cancer Center-Belpre
Belpre, Ohio, 45714
United States
Adena Regional Medical Center
Chillicothe, Ohio, 45601
United States
Mount Carmel East Hospital
Columbus, Ohio, 43213
United States
Columbus Oncology and Hematology Associates Inc
Columbus, Ohio, 43214
United States
Riverside Methodist Hospital
Columbus, Ohio, 43214
United States
Grant Medical Center
Columbus, Ohio, 43215
United States
The Mark H Zangmeister Center
Columbus, Ohio, 43219
United States
Mount Carmel Health Center West
Columbus, Ohio, 43222
United States
Doctors Hospital
Columbus, Ohio, 43228
United States
Delaware Health Center-Grady Cancer Center
Delaware, Ohio, 43015
United States
Grady Memorial Hospital
Delaware, Ohio, 43015
United States
Dublin Methodist Hospital
Dublin, Ohio, 43016
United States
Central Ohio Breast and Endocrine Surgery
Gahanna, Ohio, 43230
United States
Mount Carmel Grove City Hospital
Grove City, Ohio, 43123
United States
Fairfield Medical Center
Lancaster, Ohio, 43130
United States
Saint Rita's Medical Center
Lima, Ohio, 45801
United States
OhioHealth Mansfield Hospital
Mansfield, Ohio, 44903
United States
Marietta Memorial Hospital
Marietta, Ohio, 45750
United States
OhioHealth Marion General Hospital
Marion, Ohio, 43302
United States
Knox Community Hospital
Mount Vernon, Ohio, 43050
United States
Licking Memorial Hospital
Newark, Ohio, 43055
United States
Newark Radiation Oncology
Newark, Ohio, 43055
United States
Mercy Health - Perrysburg Hospital
Perrysburg, Ohio, 43551
United States
Southern Ohio Medical Center
Portsmouth, Ohio, 45662
United States
Mercy Health - Saint Vincent Hospital
Toledo, Ohio, 43608
United States
Mercy Health - Saint Anne Hospital
Toledo, Ohio, 43623
United States
Saint Ann's Hospital
Westerville, Ohio, 43081
United States
Genesis Healthcare System Cancer Care Center
Zanesville, Ohio, 43701
United States
Providence Cancer Institute Clackamas Clinic
Clackamas, Oregon, 97015
United States
Providence Newberg Medical Center
Newberg, Oregon, 97132
United States
Providence Willamette Falls Medical Center
Oregon City, Oregon, 97045
United States
Providence Portland Medical Center
Portland, Oregon, 97213
United States
Providence Saint Vincent Medical Center
Portland, Oregon, 97225
United States
VCU Massey Comprehensive Cancer Center
Richmond, Virginia, 23298
United States
Swedish Cancer Institute-Edmonds
Edmonds, Washington, 98026
United States
Swedish Cancer Institute-Issaquah
Issaquah, Washington, 98029
United States
Swedish Medical Center-First Hill
Seattle, Washington, 98122
United States
Marshfield Medical Center-EC Cancer Center
Eau Claire, Wisconsin, 54701
United States
Gundersen Lutheran Medical Center
La Crosse, Wisconsin, 54601
United States
Marshfield Medical Center-Marshfield
Marshfield, Wisconsin, 54449
United States
Marshfield Medical Center - Minocqua
Minocqua, Wisconsin, 54548
United States
Marshfield Medical Center-Rice Lake
Rice Lake, Wisconsin, 54868
United States
Marshfield Medical Center-River Region at Stevens Point
Stevens Point, Wisconsin, 54482
United States
Marshfield Medical Center - Weston
Weston, Wisconsin, 54476
United States

Collaborators and Investigators

Sponsor: National Cancer Institute (NCI)

  • Sikander Ailawadhi, PRINCIPAL_INVESTIGATOR, SWOG Cancer Research Network

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 Date2022-01-05
Study Completion Date2028-03-31

Study Record Updates

Study Start Date2022-01-05
Study Completion Date2028-03-31

Terms related to this study

Additional Relevant MeSH Terms

  • Lymphoplasmacytic Lymphoma
  • Waldenstrom Macroglobulinemia