Ofatumumab in Treating Patients With Previously Untreated Stage II, Stage III, or Stage IV Follicular Non-Hodgkin Lymphoma

NCT01190449 | Completed Phase 2 Results

• 3 other identifiers: CALGB-50901GSK-CALGB-50901CDR0000683083
• Study Type: interventional
• Target: 51
• Locations: 1 country
• Sites: 48

Brief Summary

RATIONALE: Monoclonal antibodies, such as ofatumumab, can block cancer growth in different ways. Some block the ability of cancer cells to grow and spread. Others find cancer cells and help kill them or carry cancer-killing substances to them. PURPOSE: This randomized phase II trial is studying ofatumumab to see how well it works in treating patients with previously untreated stage II, stage III, or stage IV follicular non-Hodgkin lymphoma.

Conditions

Lymphoma

Keywords

stage III grade 1 follicular lymphoma; stage III grade 2 follicular lymphoma; stage III grade 3 follicular lymphoma; stage IV grade 1 follicular lymphoma; stage IV grade 2 follicular lymphoma; stage IV grade 3 follicular lymphoma; contiguous stage II grade 1 follicular lymphoma; contiguous stage II grade 2 follicular lymphoma; contiguous stage II grade 3 follicular lymphoma; noncontiguous stage II grade 1 follicular lymphoma; noncontiguous stage II grade 2 follicular lymphoma; noncontiguous stage II grade 3 follicular lymphoma

Outcome Measures

Primary Outcomes (1)

• Overall Response Rate (Complete or Partial Response) by Month 12

  The primary endpoint of this trial is overall response rate (OR=complete response (CR) or partial response (PR)) to 500 mg or 1000 mg dose of ofatumumab in previously untreated patients with CD20+ follicular NHL. The response outcome is defined as the best response during the 12 months of first-line and extended induction treatment. A CR is defined as complete disappearance of all detectable clinical evidence of disease and disease-related symptoms if present before therapy. A PR is defined as at least a 50% decrease in the sum of the product of the diameters (SPD) of up to six of the largest dominant nodes or nodal masses, with no increase observed in the size of other nodes, liver, or spleen and no new sites of disease should be observed. The ORR (percentage of patients) reported below by arm is the percentage of patients whose best response during the 12 months of treatment was CR or PR.

  From baseline to month 12

Secondary Outcomes (1)

• Median Progression-free Survival Time

  From date of study entry until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 4 years

Study Arms (2)

Arm I

EXPERIMENTAL

Patients receive high-dose ofatumumab IV over 2-8 hours on days 1, 8, 15, and 22 and then once monthly in months 3-9.

Biological: ofatumumab

Arm II

EXPERIMENTAL

Patients receive a lower dose of ofatumumab IV over 2-8 hours on days 1, 8, 15, and 22 and then once monthly in months 3-9.

Biological: ofatumumab

Interventions

ofatumumab BIOLOGICAL

Given IV

Arm I; Arm II

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

DISEASE CHARACTERISTICS: * Histologically confirmed follicular non-Hodgkin lymphoma (NHL) meeting 1 of the following criteria: * Bulky (i.e., single mass ≥ 7cm in any uni-dimensional measurement) stage II disease * Stage III or IV disease * WHO grade 1, 2, or 3a disease * Bone marrow biopsies allowed provided they are submitted in conjunction with nodal biopsies * No fine-needle aspirates for diagnosis * Tumor tissue must express the CD20-positive antigen by flow cytometry or IHC * At least 1 site of measurable disease that is \> 1 cm in diameter in ≥ 1 dimension present either on physical exam or imaging studies * Non-measurable disease alone not allowed, including the following: * Bone lesions (lesions if present should be noted) * Ascites * Pleural/pericardial effusion * Lymphangitis cutis/pulmonis * Bone marrow (involvement by NHL should be noted) * Low- or intermediate-risk disease by the Follicular Lymphoma International Prognostic Index (FLIPI) * FLIPI score meeting 1 or 2 of the following risk factors: * Age \> 60 years * Involvement of \> 4 nodal sites * Stage III-IV disease * Hemoglobin \< 12.0 g/dL * LDH normal * Risk determined by the following: * Low Risk: 0-1 of the above risk factors * Intermediate Risk: 2 risk factors * Poor Risk: ≥ 3 risk factors * No known CNS involvement PATIENT CHARACTERISTICS: * ECOG performance status 0-2 * ANC ≥ 1,000/μL * Platelet count ≥ 75,000/μL * Creatinine clearance ≥ 30 mL/min * Bilirubin ≤ 2 times upper limit of normal (unless secondary to Gilbert syndrome or hepatic involvement of NHL) * Not pregnant or nursing * Negative pregnancy test * Fertile patients must use effective contraception during and for 3 months after completion of study treatment * Patients with HIV infection allowed provided the following criteria are met: * No evidence of coinfection with hepatitis B or C * CD4+ cell count ≥ 400/mm³ * No evidence of resistant strains of HIV * HIV viral load \< 10,000 copies HIV RNA/mL if not on anti-HIV therapy OR HIV viral load \< 50 copies if on anti-HIV therapy * No history of AIDS-defining conditions * No evidence of active hepatitis B (HBV) or C (HCV) infection (i.e., no positive serology for anti-HBc or anti-HCV antibodies) * HBV seropositivity allowed (HBsAg+) provided they are closely monitored for evidence of active HBV infection by HBV DNA testing * After completing treatment, HBsAg + patients must be monitored by HBV DNA testing every 2 months for 6 months post-treatment, while continuing lamivudine (required) PRIOR CONCURRENT THERAPY: * No prior chemotherapy or immunotherapy (e.g., monoclonal antibody-based therapy) for NHL * Prior involved-field radiation therapy allowed * More than 2 weeks since prior corticosteroids except for maintenance therapy for a non-malignant disease * No concurrent dexamethasone or other steroids as antiemetics * No live virus vaccination within 6 weeks prior to study entry * No concurrent zidvoudine or stavudine

Contact the study team to discuss eligibility requirements. They can help determine if this study is right for you.

Sponsors & Collaborators

• Alliance for Clinical Trials in Oncology: lead
• National Cancer Institute (NCI): collaborator

Study Sites (48)

Tunnell Cancer Center at Beebe Medical Center

Lewes, Delaware, 19958, United States

Location

CCOP - Christiana Care Health Services

Newark, Delaware, 19713, United States

Location

Cleveland Clinic Florida - Weston

Weston, Florida, 33331, United States

Location

Illinois CancerCare - Bloomington

Bloomington, Illinois, 61701, United States

Location

Illinois CancerCare - Canton

Canton, Illinois, 61520, United States

Location

Eureka Community Hospital

Eureka, Illinois, 61530, United States

Location

Illinois CancerCare - Eureka

Eureka, Illinois, 61530, United States

Location

Galesburg Clinic, PC

Galesburg, Illinois, 61401, United States

Location

Illinois CancerCare - Macomb

Macomb, Illinois, 61455, United States

Location

BroMenn Regional Medical Center

Normal, Illinois, 61761, United States

Location

Community Cancer Center

Normal, Illinois, 61761, United States

Location

Illinois CancerCare - Community Cancer Center

Normal, Illinois, 61761, United States

Location

Community Hospital of Ottawa

Ottawa, Illinois, 61350, United States

Location

Oncology Hematology Associates of Central Illinois, PC - Ottawa

Ottawa, Illinois, 61350, United States

Location

Cancer Treatment Center at Pekin Hospital

Pekin, Illinois, 61554, United States

Location

Illinois CancerCare - Pekin

Pekin, Illinois, 61603, United States

Location

Proctor Hospital

Peoria, Illinois, 61614, United States

Location

CCOP - Illinois Oncology Research Association

Peoria, Illinois, 61615, United States

Location

Oncology Hematology Associates of Central Illinois, PC - Peoria

Peoria, Illinois, 61615, United States

Location

Methodist Medical Center of Illinois

Peoria, Illinois, 61636, United States

Location

Illinois CancerCare - Peru

Peru, Illinois, 61354, United States

Location

Illinois Valley Community Hospital

Peru, Illinois, 61354, United States

Location

Illinois CancerCare - Spring Valley

Spring Valley, Illinois, 61362, United States

Location

Iowa Blood and Cancer Care

Cedar Rapids, Iowa, 52402, United States

Location

Union Hospital of Cecil County

Elkton, Maryland, 21921, United States

Location

Battle Creek Health System Cancer Care Center

Battle Creek, Michigan, 49017, United States

Location

Mecosta County Medical Center

Big Rapids, Michigan, 49307, United States

Location

Butterworth Hospital at Spectrum Health

Grand Rapids, Michigan, 49503, United States

Location

CCOP - Grand Rapids

Grand Rapids, Michigan, 49503, United States

Location

Lacks Cancer Center at Saint Mary's Health Care

Grand Rapids, Michigan, 49503, United States

Location

Mercy General Health Partners

Muskegon, Michigan, 49444, United States

Location

Spectrum Health Reed City Hospital

Reed City, Michigan, 49677, United States

Location

Munson Medical Center

Traverse City, Michigan, 49684, United States

Location

Siteman Cancer Center at Barnes-Jewish Hospital - Saint Louis

St Louis, Missouri, 63110, United States

Location

New Hampshire Oncology - Hematology, PA at Payson Center for Cancer Care

Concord, New Hampshire, 03301, United States

Location

New Hampshire Oncology - Hematology, PA - Hooksett

Hooksett, New Hampshire, 03106, United States

Location

Lakes Region General Hospital

Laconia, New Hampshire, 03246, United States

Location

Cancer Institute of New Jersey at Cooper - Voorhees

Voorhees Township, New Jersey, 08043, United States

Location

Monter Cancer Center of the North Shore-LIJ Health System

Lake Success, New York, 11042, United States

Location

Don Monti Comprehensive Cancer Center at North Shore University Hospital

Manhasset, New York, 11030, United States

Location

Mount Kisco Medical Group, PC

Mount Kisco, New York, 10549-3417, United States

Location

Long Island Jewish Medical Center

New Hyde Park, New York, 11040, United States

Location

New York Weill Cornell Cancer Center at Cornell University

New York, New York, 10021, United States

Location

SUNY Upstate Medical University Hospital

Syracuse, New York, 13210, United States

Location

Kinston Medical Specialists

Kinston, North Carolina, 28501, United States

Location

Wake Forest University Comprehensive Cancer Center

Winston-Salem, North Carolina, 27157-1096, United States

Location

Arthur G. James Cancer Hospital and Richard J. Solove Research Institute at Ohio State University Comprehensive Cancer Center

Columbus, Ohio, 43210-1240, United States

Location

Virginia Commonwealth University Massey Cancer Center

Richmond, Virginia, 23298-0037, United States

Location

Related Publications (1)

• Rutherford SC, Yin J, Pederson L, Perez Burbano G, LaPlant B, Shadman M, Li H, LeBlanc ML, Kenkre VP, Hong F, Blum KA, Dockter T, Martin P, Jung SH, Grant B, Rosenbaum C, Ujjani C, Barr PM, Unger JM, Cheson BD, Bartlett NL, Kahl B, Friedberg JW, Mandrekar SJ, Leonard JP. Relevance of Bone Marrow Biopsies for Response Assessment in US National Cancer Institute National Clinical Trials Network Follicular Lymphoma Clinical Trials. J Clin Oncol. 2023 Jan 10;41(2):336-342. doi: 10.1200/JCO.21.02301. Epub 2022 Jul 5.

  PMID: 35787017 DERIVED

MeSH Terms

Conditions

Lymphoma; Lymphoma, Follicular

Interventions

ofatumumab

Condition Hierarchy (Ancestors)

Neoplasms by Histologic Type; Neoplasms; Lymphoproliferative Disorders; Lymphatic Diseases; Hemic and Lymphatic Diseases; Immunoproliferative Disorders; Immune System Diseases; Lymphoma, Non-Hodgkin

Results Point of Contact

• Title: Cara Rosenbaum, MD
• Organization: Weill Cornell Medicine Cornell University

car9156@med.cornell.edu

(646) 962-6500

Study Officials

• Cara A. Rosenbaum, MD

  University of Chicago

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 26, 2010
• First Posted: August 27, 2010
• Study Start: August 1, 2011
• Primary Completion: March 1, 2015
• Study Completion: October 15, 2020
• Last Updated: August 18, 2021
• Results First Posted: July 26, 2018

Record last verified: 2021-08

Locations

US (48)