Non Hodgkin Lymphoma Clinical Trial

Maintenance Obinutuzumab in Treating Patients With Central Nervous System Lymphoma Who Have Achieved a Complete or Partial Response

Summary

This randomized phase II trial studies how well obinutuzumab works as maintenance treatment in patients with central nervous system lymphoma who have achieved the disappearance of all signs of cancer in response to treatment (complete response) or a decrease in the size of a tumor, or in the extent of cancer in the body, in response to treatment (partial response). Immunotherapy with obinutuzumab, may induce changes in body's immune system and may interfere with the ability of tumor cells to grow and spread.

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Full Description

PRIMARY OBJECTIVE:

I. To determine the effect of maintenance obinutuzumab on duration of response (partial response [PR] or complete response [CR]) in patients with CD20+ B-cell primary central nervous system lymphoma (PCNSL) who attain PR or CR to first-line treatment with high-dose methotrexate-based chemotherapy.

SECONDARY OBJECTIVES:

I. To evaluate overall survival after PR or CR (overall survival [OS]-PRCR). II. To evaluate neurocognitive function, quality of life, and neuroimaging as indicators of neurotoxicity.

III. Progression-free survival (PFS) and overall survival (OS) will be calculated.

OUTLINE: Patients are randomized to 1 of 2 treatment arms.

ARM I (MAINTENANCE THERAPY): Patients receive obinutuzumab intravenously (IV) on days 1 and 2 for the first cycle, and on day 1 for the subsequent cycles. Cycles repeat every 60 days for 2 years in the absence of disease progression or unacceptable toxicity.

ARM II (OBSERVATION): Patients undergo observation for a total of 2 years.

View Eligibility Criteria

Eligibility Criteria

Inclusion Criteria:

CD20+ B-cell primary central nervous system lymphoma (PCNSL) confirmed at the time of diagnosis by histology, cytology, or immunocytochemistry from cerebrospinal fluid (CSF); diagnosis must be documented by pathology report
Must have undergone first-line treatment with a high-dose methotrexate-based chemotherapy regimen with or without brain radiotherapy; high-dose methotrexate is defined as >= 3 grams/m^2; methotrexate dose reduction for creatinine clearance < 100 ml/min is permitted
Must be within 75 days of completion of first-line treatment regimen; must have achieved objective response (PR or CR/unconfirmed complete response [CRu]) to first-line treatment
Brain magnetic resonance imaging (MRI) documenting objective response must be obtained within 30 days of study enrollment
If CSF was positive for lymphoma cells at diagnosis or during first-line treatment and/or a slit lamp examination was positive at diagnosis or during first-line treatment, then the CSF and vitreal studies must have been repeated and must have indicated CR; Note: CR requires complete disappearance of all enhancing abnormalities on gadolinium-enhanced MRI; if CSF was positive for lymphoma cells at diagnosis or during first-line treatment and/or slit lamp examination was positive at diagnosis or during first-line treatment, then the CSF and vitreal studies must have been repeated and must have indicated CR; for CRu, some patients will have a small but persistent enhancing abnormality on MRI related to biopsy or focal hemorrhage; it is often difficult to ascertain whether this represents a residual nidus of tumor or scar tissue; if the abnormality does not change or slowly involutes without therapy and corticosteroids, it is reasonable to categorize as a CRu; at the time CR/CRu is determined, the patient should not have used corticosteroids for at least two weeks
Karnofsky performance status (KPS) >= 60; Eastern Cooperative Oncology Group (ECOG) 0, 1, or 2
Signed informed consent form (ICF)
Ability and willingness to comply with the requirements of the study protocol
Total bilirubin < 3 x the upper limit of normal (ULN), +/- 7 days from date of ICF signing
Creatinine clearance > 30 mL/min (calculated according to institutional standards or using Cockcroft-Gault formula), +/- 7 days from date of ICF signing
Aspartate aminotransferase (AST) or alanine aminotransferase (ALT) =< 5 x ULN, +/- 7 days from date of ICF signing
Platelet >= 75,000 cells/mm^3, +/- 7 days from date of ICF signing
Hemoglobin > 9 g/dL, +/- 7 days from date of ICF signing
Absolute neutrophil count > 1.5 x 10^3 cells/mm^3, +/- 7 days from date of ICF signing
Surgically sterile or agree to use effective contraception using an adequate measure of contraception such as oral contraceptives, intrauterine device, or barrier method of contraception in conjunction with spermicidal jelly while receiving obinutuzumab and >= 18 months after the last dose of obinutuzumab for women, and 180 days after the last dose of obinutuzumab for men

Exclusion Criteria:

History of severe allergic or anaphylactic reactions to monoclonal antibody therapy
Clinical evidence of extra-central nervous system (CNS) (systemic) non-Hodgkin lymphoma
Known hypersensitivity to any of the study drugs

History of other malignancy that could affect compliance with the protocol or interpretation of results

Patients with a history of curatively treated basal or squamous cell carcinoma of the skin or in situ carcinoma of the cervix are generally eligible; patients with a malignancy that has been treated, but not with curative intent, will also be excluded, unless the malignancy has been in remission without treatment for >= 2 years prior to enrollment
Known active bacterial, viral, fungal, mycobacterial, or other infection (excluding fungal infections of nail beds) or any major episode of infection requiring treatment with IV antibiotics or hospitalization (related to the completion of the course of antibiotics) within 4 weeks prior to study enrollment
Major surgery within 4 weeks prior to study enrollment
Known infection with human immunodeficiency virus (HIV)

Known positive hepatitis serologies:

Hepatitis B (HBV): patients with positive serology for hepatitis B defined as positivity for hepatitis B surface antigen (HBsAg) or hepatitis B core antibody (anti-HBc); patients who are positive for anti-HBc may be considered for inclusion in the study on a case-by-case basis if they are hepatitis B viral deoxyribonucleic acid (DNA) negative and are willing to undergo ongoing HBV DNA testing by real-time polymerase chain reaction (PCR); patients with positive serology may be referred to a hepatologist or gastroenterologist for appropriate monitoring and management
Hepatitis C (HCV): patients with positive hepatitis C serology unless HCV ribonucleic acid (RNA) is confirmed negative and may be considered for inclusion in the study on a case-by-case basis
Women who are pregnant or lactating
Vaccination with a live vaccine a minimum of 4 weeks prior to study enrollment

Study is for people with:

Non Hodgkin Lymphoma

Phase:

Phase 2

Estimated Enrollment:

60

Study ID:

NCT02498951

Recruitment Status:

Recruiting

Sponsor:

OHSU Knight Cancer Institute

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There are 12 Locations for this study

See Locations Near You

University of Colorado
Denver Colorado, 80217, United States More Info
Douglas E. Ney
Contact
720-848-0650
Douglas E. Ney
Principal Investigator
Piedmont Hospital
Atlanta Georgia, 30309, United States More Info
Erin M. Dunbar
Contact
470-572-3111
[email protected]
Erin M. Dunbar
Principal Investigator
University of Michigan Comprehensive Cancer Center
Ann Arbor Michigan, 48109, United States More Info
Yoshie Umemura
Contact
800-865-1125
[email protected]
Yoshie Umemura
Principal Investigator
Wake Forest University Health Sciences
Winston-Salem North Carolina, 27157, United States More Info
Roy E. Strowd
Contact
336-713-5440
[email protected]
Roy E. Strowd
Principal Investigator
Cleveland Clinic Cancer Center/Fairview Hospital
Cleveland Ohio, 44111, United States More Info
David M. Peereboom
Contact
216-445-6068
[email protected]
David M. Peereboom
Principal Investigator
Providence Portland Medical Center
Portland Oregon, 97213, United States More Info
Prakash Ambady
Contact
503-216-1150
[email protected]
Prakash Ambady
Principal Investigator
OHSU Knight Cancer Institute
Portland Oregon, 97239, United States More Info
Edward Neuwelt
Contact
503-494-5626
[email protected]
Edward Neuwelt
Principal Investigator
Penn State Milton S Hershey Medical Center
Hershey Pennsylvania, 17033, United States More Info
Michael J. Glantz
Contact
[email protected]
Michael J. Glantz
Principal Investigator
Rhode Island Hospital
Providence Rhode Island, 02903, United States More Info
Peter Barth
Contact
401-444-8559
[email protected]
Peter Barth
Principal Investigator
UT Southwestern/Simmons Cancer Center-Dallas
Dallas Texas, 75390, United States
University of Vermont Medical Center
Burlington Vermont, 05401, United States More Info
Alissa A. Thomas
Contact
802-656-9427
[email protected]
Alissa A. Thomas
Principal Investigator
University of Virginia Cancer Center
Charlottesville Virginia, 22908, United States More Info
David Schiff
Contact
434-924-5610
[email protected]
David Schiff
Principal Investigator

How clear is this clinincal trial information?

Study is for people with:

Non Hodgkin Lymphoma

Phase:

Phase 2

Estimated Enrollment:

60

Study ID:

NCT02498951

Recruitment Status:

Recruiting

Sponsor:


OHSU Knight Cancer Institute

How clear is this clinincal trial information?

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