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



Status:Active, not recruiting
Conditions:Lymphoma
Therapuetic Areas:Oncology
Healthy:No
Age Range:18 - Any
Updated:7/27/2018
Start Date:August 2011

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A Phase II Trial of Ofatumumab (CALGB IND #) in Previously Untreated Follicular Non-Hodgkin's Lymphoma (NHL)

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.

OBJECTIVES:

Primary

- To determine the response rate in patients with previously untreated CD20-positive bulky
stage II, or stage III or IV follicular non-Hodgkin lymphoma (NHL) treated with a lower-
or high-dose of ofatumumab.

Secondary

- To determine the progression-free survival (PFS) of patients treated with these
regimens.

- To determine the toxicity profile of these regimens in these patients.

- To establish whether the therapeutic effect of single-agent ofatumumab is sufficiently
promising to warrant evaluation in subsequent randomized, ofatumumab-based, biologic
doublet trials.

- To evaluate the two ofatumumab doses by independent comparison of response, PFS, and
toxicity to a historical control in previously untreated patients with follicular NHL.

- To prospectively validate the FLIPI2 prognostic index in low- and intermediate-risk
patients and compare to low- and intermediate-risk stratified patients by standard FLIPI
scoring to determine a more reliable indicator of response and PFS.

OUTLINE: This is a multicenter study. Patients are randomized to 1 of 2 treatment arms.

- Arm I: 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.

- Arm II: 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.

In both arms, treatment continues in the absence of disease progression or unacceptable
toxicity.

Patients may undergo blood and bone marrow sample collection for correlative studies.

After completion of study therapy, patients are followed up every 4 months for 2 years and
then every 6 months for 8 years.

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
We found this trial at
49
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BroMenn Regional Medical Center Advocate BroMenn Medical Center is a general medical and surgical hospital...
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701 Doctors Dr
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(252) 559-2200
Kinston Medical Specialists offers comprehensive medical services for all ages. Whether it’s a case of...
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902 Savannah Road
Lewes, Delaware 19958
(302) 645-3770
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1300 York Avenue # A421
New York, New York 10065
New York Weill Cornell Cancer Center at Cornell University Welcome to the Division of Hematology...
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401 College Street
Richmond, Virginia 23298
(804) 828-0450
Virginia Commonwealth University Massey Cancer Center Founded in 1974, VCU Massey Cancer Center is a...
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750 E Adams St
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(315) 464-5540
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42 E Laurel Rd # 2545
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(800) 826-6737
Cancer Institute of New Jersey at Cooper - Voorhees Cooper University Health Care, the clinical...
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1 Medical Center Blvd
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(336) 716-2011
Wake Forest University Comprehensive Cancer Center Our newly expanded Comprehensive Cancer Center is the region’s...
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300 North Ave
Battle Creek, Michigan 49017
(269) 245-8000
Battle Creek Health System Cancer Care Center As a proud member of the Battle Creek...
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605 Oak St
Big Rapids, Michigan 49307
(231) 796-8691
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1505 Eastland Drive
Bloomington, Illinois 61701
309-662-2102
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210 W Walnut St
Canton, Illinois 61520
309-647-5240
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Cedar Rapids, Iowa 52402
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250 Pleasant Street
Concord, New Hampshire 03301
603-224-2556
New Hampshire Oncology - Hematology, PA at Payson Center for Cancer Care Our Concord office...
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Elkton, Maryland 21921
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101 S Major St
Eureka, Illinois 61530
(309) 467-2371
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101 S Major St
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3315 N. Seminary Street
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250 Cherry St SE
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Grand Rapids, Michigan 49503
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100 Michigan Street, NE, MC012
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(616) 391-1230
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200 Technology Drive
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603-622-6484
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Laconia, New Hampshire 03246
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501 E Grant
Macomb, Illinois 61455
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Mount Kisco, New York 10549
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1700 Oak Ave.
Muskegon, Michigan 49444
231-672-2000
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270-05 76th Ave
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4701 Ogletown-Stanton Road
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302-623-4450
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Normal, Illinois 61761
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407 East Vernon Ave.
Normal, Illinois 61761
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603 S 13th St
Pekin, Illinois 61554
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221 NE Glen Oak Ave
Peoria, Illinois 61636
(309) 672-5522
Methodist Medical Center of Illinois UnityPoint Health is one of the nation's most integrated health...
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5409 N Knoxville Ave
Peoria, Illinois 61614
(309) 691-1000
Proctor Hospital Proctor Hospital provides unmatched healthcare experiences…every day. In fact, it’s our mission. Licensed...
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925 West St
Peru, Illinois 61354
(815) 223-3300
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4391 Venture Dr.
Peru, Illinois 61354
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300 N Patterson Rd
Reed City, Michigan 49677
(231) 832-3271
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600 First Street
Spring Valley, Illinois 61362
815-664-1487
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105 Sixth St
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(231) 935-5000
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Weston, Florida 33331
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