Actively Recruiting

Phase 2
Age: 18Years +
All Genders
NCT06649812

Testing the Effectiveness of a Combination Targeted Therapy (ViPOR) for Patients With Relapsed and/or Refractory Aggressive B-cell Lymphoma

Led by National Cancer Institute (NCI) · Updated on 2026-05-13

120

Participants Needed

83

Research Sites

99 weeks

Total Duration

On this page

AI-Summary

What this Trial Is About

This phase II trial tests how well venetoclax, ibrutinib, prednisone, obinutuzumab, and Revlimid® (ViPOR) works in treating patients with CD10 negative diffuse large B-cell lymphoma (DLBCL) and high-grade lymphoma with MYC and BCL2 rearrangements that has come back after a period of improvement (relapsed) and/or that has not responded to previous treatment (refractory). 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. Ibrutinib is in a class of medications called kinase inhibitors. It blocks a protein called BTK, which is present on B-cell (a type of white blood cells) cancers at abnormal levels. This may help keep cancer cells from growing and spreading. Anti-inflammatory drugs, such as prednisone lower the body's immune response and are used with other drugs in the treatment of some types of cancer. Obinutuzumab, a monoclonal antibody, binds to a protein called CD20, which is found on B cells and some types of leukemia and lymphoma cells. Obinutuzumab may block CD20 and help the immune system kill cancer cells. Revlimid, a type of anti-angiogenesis agent and a type of immunomodulating agent, may help the immune system kill abnormal blood cells or cancer cells. It may also prevent the growth of new blood vessels that cancers need to grow. ViPOR may be an effective treatment option for patients with relapsed and/or refractory CD10 negative DLBCL and high-grade B-cell lymphoma with MYC and BCL2 rearrangements.

CONDITIONS

Official Title

Testing the Effectiveness of a Combination Targeted Therapy (ViPOR) for Patients With Relapsed and/or Refractory Aggressive B-cell Lymphoma

Who Can Participate

Age: 18Years +
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Patient must be 18 years of age or older
  • Histologically or cytologically confirmed aggressive B-cell lymphoma including CD10-negative DLBCL or CD10-positive/negative high-grade B-cell lymphoma with MYC and BCL2 rearrangements
  • Relapsed and/or refractory disease after at least one prior anthracycline and anti-CD20 antibody-containing regimen
  • No confirmed or suspected primary mediastinal large B-cell lymphoma
  • Negative pregnancy test for patients of childbearing potential within 14 days prior to registration and again before treatment
  • Use of effective contraception or abstinence throughout treatment and for 6 months after last dose for patients of childbearing potential
  • Male patients agree to use condoms during sexual contact with partners of childbearing potential and not to donate sperm during treatment and for 28 days after last lenalidomide dose
  • Agreement to abstain from breastfeeding during treatment and for 6 months after last dose
  • Agreement to abstain from blood donation during treatment and for 28 days after last lenalidomide dose
  • Ability to understand and willing to sign informed consent
  • Adequate blood counts and organ function within 7 days prior to registration
  • HIV-positive patients on effective therapy with undetectable viral load within 6 months
  • Patients with controlled hepatitis B or cured hepatitis C infection
  • No confirmed or suspected primary central nervous system lymphoma
  • Patients with prior secondary CNS lymphoma with no progression after CNS-directed therapy
  • No interfering prior or concurrent malignancies
  • No warfarin or strong CYP3A inhibitors/inducers within 7 days prior to registration
  • No uncontrolled intercurrent illness or active infection at registration
  • No recent chemotherapy, targeted therapy, or anti-cancer antibody treatments within 2 weeks prior to registration
  • No more than 3 prior lines of cytotoxic chemotherapy
  • No recent radio- or toxin-immunoconjugates within 10 weeks prior to registration
  • No prior treatment with more than one of venetoclax, ibrutinib, or lenalidomide
  • No recent stem cell or organ transplant within 3 months prior to registration
  • No active graft-versus-host disease or immunosuppressant use within 28 days prior to registration
  • Cardiac function assessed as New York Heart Association class 2B or better
  • Availability of adequate tumor tissue for molecular analysis
  • Measurable disease
  • ECOG performance status 0-2
Not Eligible

You will not qualify if you...

  • Confirmed or suspected primary mediastinal large B-cell lymphoma
  • Pregnancy
  • Use of warfarin or strong CYP3A inhibitors or inducers within 7 days prior to registration
  • Uncontrolled intercurrent illness
  • Evidence of active infection at registration
  • More than 3 prior lines of cytotoxic chemotherapy
  • Recent chemotherapy, targeted therapy, or anti-cancer antibody treatments within 2 weeks prior to registration
  • Recent radio- or toxin-immunoconjugates within 10 weeks prior to registration
  • Prior treatment with more than one of venetoclax, ibrutinib, or lenalidomide
  • Recent autologous stem cell transplant, CAR-T therapy, or allogeneic stem cell or organ transplant within 3 months prior to registration
  • Active graft-versus-host disease or requirement for immunosuppressants within 28 days prior to registration
  • Primary diffuse large B-cell lymphoma of the central nervous system
  • Not recovered from adverse events of prior treatments (except alopecia)
  • Cardiac function below New York Heart Association class 2B

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

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Trial Site Locations

Total: 83 locations

1

Banner University Medical Center - Tucson

Tucson, Arizona, United States, 85719

Suspended

2

University of Arizona Cancer Center-North Campus

Tucson, Arizona, United States, 85719

Suspended

3

Cedars-Sinai Medical Center

Los Angeles, California, United States, 90048

Actively Recruiting

4

Smilow Cancer Hospital-Derby Care Center

Derby, Connecticut, United States, 06418

Actively Recruiting

5

Smilow Cancer Hospital Care Center - Guilford

Guilford, Connecticut, United States, 06437

Actively Recruiting

6

Yale University

New Haven, Connecticut, United States, 06520

Actively Recruiting

7

Kootenai Health - Coeur d'Alene

Coeur d'Alene, Idaho, United States, 83814

Suspended

8

Kootenai Clinic Cancer Services - Post Falls

Post Falls, Idaho, United States, 83854

Suspended

9

Kootenai Clinic Cancer Services - Sandpoint

Sandpoint, Idaho, United States, 83864

Suspended

10

Northwestern University

Chicago, Illinois, United States, 60611

Actively Recruiting

11

Carle at The Riverfront

Danville, Illinois, United States, 61832

Suspended

12

Northwestern Medicine Cancer Center Kishwaukee

DeKalb, Illinois, United States, 60115

Actively Recruiting

13

Carle Physician Group-Effingham

Effingham, Illinois, United States, 62401

Suspended

14

Northwestern Medicine Cancer Center Delnor

Geneva, Illinois, United States, 60134

Actively Recruiting

15

Northwestern Medicine Glenview Outpatient Center

Glenview, Illinois, United States, 60026

Actively Recruiting

16

Northwestern Medicine Grayslake Outpatient Center

Grayslake, Illinois, United States, 60030

Actively Recruiting

17

Northwestern Medicine Lake Forest Hospital

Lake Forest, Illinois, United States, 60045

Actively Recruiting

18

Carle Physician Group-Mattoon/Charleston

Mattoon, Illinois, United States, 61938

Suspended

19

Carle BroMenn Medical Center

Normal, Illinois, United States, 61761

Suspended

20

Carle Cancer Institute Normal

Normal, Illinois, United States, 61761

Suspended

21

Northwestern Medicine Oak Brook

Oak Brook, Illinois, United States, 60523

Actively Recruiting

22

Northwestern Medicine Orland Park

Orland Park, Illinois, United States, 60462

Actively Recruiting

23

Memorial Hospital East

Shiloh, Illinois, United States, 62269

Actively Recruiting

24

Carle Cancer Center

Urbana, Illinois, United States, 61801

Suspended

25

Northwestern Medicine Cancer Center Warrenville

Warrenville, Illinois, United States, 60555

Actively Recruiting

26

Mary Greeley Medical Center

Ames, Iowa, United States, 50010

Actively Recruiting

27

McFarland Clinic - Ames

Ames, Iowa, United States, 50010

Actively Recruiting

28

McFarland Clinic - Boone

Boone, Iowa, United States, 50036

Suspended

29

Mercy Hospital

Cedar Rapids, Iowa, United States, 52403

Actively Recruiting

30

Oncology Associates at Mercy Medical Center

Cedar Rapids, Iowa, United States, 52403

Actively Recruiting

31

McFarland Clinic - Trinity Cancer Center

Fort Dodge, Iowa, United States, 50501

Actively Recruiting

32

McFarland Clinic - Jefferson

Jefferson, Iowa, United States, 50129

Suspended

33

McFarland Clinic - Marshalltown

Marshalltown, Iowa, United States, 50158

Actively Recruiting

34

Ochsner Medical Center Jefferson

New Orleans, Louisiana, United States, 70121

Actively Recruiting

35

National Institutes of Health Clinical Center

Bethesda, Maryland, United States, 20892

Actively Recruiting

36

Essentia Health Saint Joseph's Medical Center

Brainerd, Minnesota, United States, 56401

Actively Recruiting

37

Essentia Health - Deer River Clinic

Deer River, Minnesota, United States, 56636

Actively Recruiting

38

Essentia Health Cancer Center

Duluth, Minnesota, United States, 55805

Actively Recruiting

39

Essentia Health Hibbing Clinic

Hibbing, Minnesota, United States, 55746

Actively Recruiting

40

Essentia Health Sandstone

Sandstone, Minnesota, United States, 55072

Actively Recruiting

41

Essentia Health Virginia Clinic

Virginia, Minnesota, United States, 55792

Actively Recruiting

42

Siteman Cancer Center at Saint Peters Hospital

City of Saint Peters, Missouri, United States, 63376

Actively Recruiting

43

Siteman Cancer Center at West County Hospital

Creve Coeur, Missouri, United States, 63141

Actively Recruiting

44

Washington University School of Medicine

St Louis, Missouri, United States, 63110

Actively Recruiting

45

Siteman Cancer Center-South County

St Louis, Missouri, United States, 63129

Actively Recruiting

46

Siteman Cancer Center at Christian Hospital

St Louis, Missouri, United States, 63136

Actively Recruiting

47

Community Hospital of Anaconda

Anaconda, Montana, United States, 59711

Suspended

48

Billings Clinic Cancer Center

Billings, Montana, United States, 59101

Suspended

49

Bozeman Health Deaconess Hospital

Bozeman, Montana, United States, 59715

Suspended

50

Benefis Sletten Cancer Institute

Great Falls, Montana, United States, 59405

Suspended

51

Community Medical Center

Missoula, Montana, United States, 59804

Suspended

52

Nebraska Medicine-Bellevue

Bellevue, Nebraska, United States, 68123

Actively Recruiting

53

Nebraska Medicine-Village Pointe

Omaha, Nebraska, United States, 68118

Actively Recruiting

54

University of Nebraska Medical Center

Omaha, Nebraska, United States, 68198

Actively Recruiting

55

Duke University Medical Center

Durham, North Carolina, United States, 27710

Actively Recruiting

56

Essentia Health Cancer Center-South University Clinic

Fargo, North Dakota, United States, 58103

Actively Recruiting

57

University of Cincinnati Cancer Center-UC Medical Center

Cincinnati, Ohio, United States, 45219

Suspended

58

Ohio State University Comprehensive Cancer Center

Columbus, Ohio, United States, 43210

Actively Recruiting

59

University of Cincinnati Cancer Center-West Chester

West Chester, Ohio, United States, 45069

Suspended

60

University of Oklahoma Health Sciences Center

Oklahoma City, Oklahoma, United States, 73104

Actively Recruiting

61

Providence Newberg Medical Center

Newberg, Oregon, United States, 97132

Actively Recruiting

62

Providence Willamette Falls Medical Center

Oregon City, Oregon, United States, 97045

Actively Recruiting

63

Providence Portland Medical Center

Portland, Oregon, United States, 97213

Actively Recruiting

64

Providence Saint Vincent Medical Center

Portland, Oregon, United States, 97225

Actively Recruiting

65

Thomas Jefferson University Hospital

Philadelphia, Pennsylvania, United States, 19107

Actively Recruiting

66

University of Vermont Medical Center

Burlington, Vermont, United States, 05401

Actively Recruiting

67

University of Vermont and State Agricultural College

Burlington, Vermont, United States, 05405

Actively Recruiting

68

University of Virginia Cancer Center

Charlottesville, Virginia, United States, 22908

Actively Recruiting

69

VCU Massey Comprehensive Cancer Center

Richmond, Virginia, United States, 23298

Actively Recruiting

70

Swedish Medical Center-First Hill

Seattle, Washington, United States, 98122

Actively Recruiting

71

Duluth Clinic Ashland

Ashland, Wisconsin, United States, 54806

Actively Recruiting

72

Mercyhealth Hospital and Cancer Center - Janesville

Janesville, Wisconsin, United States, 53548

Actively Recruiting

73

Gundersen Lutheran Medical Center

La Crosse, Wisconsin, United States, 54601

Actively Recruiting

74

Froedtert Menomonee Falls Hospital

Menomonee Falls, Wisconsin, United States, 53051

Actively Recruiting

75

Medical College of Wisconsin

Milwaukee, Wisconsin, United States, 53226

Actively Recruiting

76

ProHealth D N Greenwald Center

Mukwonago, Wisconsin, United States, 53149

Suspended

77

Froedtert and MCW Moorland Reserve Health Center

New Berlin, Wisconsin, United States, 53151

Actively Recruiting

78

Drexel Town Square Health Center

Oak Creek, Wisconsin, United States, 53154

Actively Recruiting

79

ProHealth Oconomowoc Memorial Hospital

Oconomowoc, Wisconsin, United States, 53066

Suspended

80

Essentia Health-Spooner Clinic

Spooner, Wisconsin, United States, 54801

Actively Recruiting

81

Essentia Health Saint Mary's Hospital - Superior

Superior, Wisconsin, United States, 54880

Actively Recruiting

82

UW Cancer Center at ProHealth Care

Waukesha, Wisconsin, United States, 53188

Suspended

83

Froedtert West Bend Hospital/Kraemer Cancer Center

West Bend, Wisconsin, United States, 53095

Actively Recruiting

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How is the study designed?

Study Type

INTERVENTIONAL

Masking

NONE

Allocation

NA

Model

SINGLE_GROUP

Primary Purpose

TREATMENT

Number of Arms

1

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Testing the Effectiveness of a Combination Targeted Therapy (ViPOR) for Patients With Relapsed and/or Refractory Aggressive B-cell Lymphoma | DecenTrialz