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

Use our guide to learn which trials are right for you!

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
sites
Laconia, New Hampshire 03246
?
mi
from
Laconia, NH
Click here to add this to my saved trials
701 Doctors Dr
Kinston, North Carolina 28504
(252) 559-2200
Kinston Medical Specialists offers comprehensive medical services for all ages. Whether it’s a case of...
?
mi
from
Kinston, NC
Click here to add this to my saved trials
902 Savannah Road
Lewes, Delaware 19958
(302) 645-3770
Tunnell Cancer Center at Beebe Medical Center The Robert & Eolyne Tunnell Cancer Center at...
?
mi
from
Lewes, DE
Click here to add this to my saved trials
?
mi
from
Manhasset, NY
Click here to add this to my saved trials
1300 York Avenue # A421
New York, New York 10065
New York Weill Cornell Cancer Center at Cornell University Welcome to the Division of Hematology...
?
mi
from
New York, NY
Click here to add this to my saved trials
401 College Street
Richmond, Virginia 23298
(804) 828-0450
Virginia Commonwealth University Massey Cancer Center Founded in 1974, VCU Massey Cancer Center is a...
?
mi
from
Richmond, VA
Click here to add this to my saved trials
750 E Adams St
Syracuse, New York 13210
(315) 464-5540
SUNY Upstate Medical University Hospital SUNY Upstate Medical University in Syracuse, NY, is the only...
?
mi
from
Syracuse, NY
Click here to add this to my saved trials
42 E Laurel Rd # 2545
Voorhees, New Jersey 08043
(800) 826-6737
Cancer Institute of New Jersey at Cooper - Voorhees Cooper University Health Care, the clinical...
?
mi
from
Voorhees, NJ
Click here to add this to my saved trials
1 Medical Center Blvd
Winston-Salem, North Carolina 27103
(336) 716-2011
Wake Forest University Comprehensive Cancer Center Our newly expanded Comprehensive Cancer Center is the region’s...
?
mi
from
Winston-Salem, NC
Click here to add this to my saved trials
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...
?
mi
from
Battle Creek, MI
Click here to add this to my saved trials
605 Oak St
Big Rapids, Michigan 49307
(231) 796-8691
Mecosta County Medical Center Spectrum Health is a not-for-profit system of care dedicated to improving...
?
mi
from
Big Rapids, MI
Click here to add this to my saved trials
1505 Eastland Drive
Bloomington, Illinois 61701
309-662-2102
Illinois CancerCare-Bloomington Illinois CancerCare, P.C. is a comprehensive practice treating patients withcancer andblood diseases. Our...
?
mi
from
Bloomington, IL
Click here to add this to my saved trials
210 W Walnut St
Canton, Illinois 61520
309-647-5240
Illinois CancerCare - Canton Illinois CancerCare is one of the largest private oncology and hematology...
?
mi
from
Canton, IL
Click here to add this to my saved trials
Cedar Rapids, Iowa 52402
?
mi
from
Cedar Rapids, IA
Click here to add this to my saved trials
?
mi
from
Columbus, OH
Click here to add this to my saved trials
250 Pleasant Street
Concord, New Hampshire 03301
603-224-2556
New Hampshire Oncology - Hematology, PA at Payson Center for Cancer Care Our Concord office...
?
mi
from
Concord, NH
Click here to add this to my saved trials
Elkton, Maryland 21921
?
mi
from
Elkton, MD
Click here to add this to my saved trials
101 S Major St
Eureka, Illinois 61530
(309) 467-2371
Eureka Community Hospital Eureka Community Hospital, established in 1901, offers a wide range of emergency,...
?
mi
from
Eureka, IL
Click here to add this to my saved trials
101 S Major St
Eureka, Illinois 61530
309-467-2371
Illinois CancerCare - Eureka Illinois CancerCare is one of the largest private oncology and hematology...
?
mi
from
Eureka, IL
Click here to add this to my saved trials
3315 N. Seminary Street
Galesburg, Illinois 61401
(309) 344-1000
Galesburg Clinic, PC OSF Galesburg Clinic, located on the OSF St. Mary Medical Center campus,...
?
mi
from
Galesburg, IL
Click here to add this to my saved trials
250 Cherry St SE
Grand Rapids, Michigan 49503
(616) 685-5225
Lacks Cancer Center at Saint Mary's Health Care Mercy Health Lacks Cancer Center was one...
?
mi
from
Grand Rapids, MI
Click here to add this to my saved trials
Grand Rapids, Michigan 49503
?
mi
from
Grand Rapids, MI
Click here to add this to my saved trials
100 Michigan Street, NE, MC012
Grand Rapids, Michigan 49503
(616) 391-1230
CCOP - Grand Rapids The Grand Rapids Clinical Oncology Program (GRCOP) is a community cancer...
?
mi
from
Grand Rapids, MI
Click here to add this to my saved trials
200 Technology Drive
Hooksett, New Hampshire 03106
603-622-6484
New Hampshire Oncology - Hematology, PA - Hooksett New Hampshire Oncology-Hematology, PA (NHOH) was founded...
?
mi
from
Hooksett, NH
Click here to add this to my saved trials
?
mi
from
Lake Success, NY
Click here to add this to my saved trials
501 E Grant
Macomb, Illinois 61455
309-833-3503
Illinois CancerCare - Macomb Illinois CancerCare is one of the largest private oncology and hematology...
?
mi
from
Macomb, IL
Click here to add this to my saved trials
Mount Kisco, New York 10549
?
mi
from
Mount Kisco, NY
Click here to add this to my saved trials
1700 Oak Ave.
Muskegon, Michigan 49444
231-672-2000
Mercy General Health Partners Mercy Health Muskegon is part of Mercy Health
?
mi
from
Muskegon, MI
Click here to add this to my saved trials
270-05 76th Ave
New Hyde Park, New York 11040
(718) 470-7480
Long Island Jewish Medical Center Serving North Shore LIJ Health System employees and their families....
?
mi
from
New Hyde Park, NY
Click here to add this to my saved trials
4701 Ogletown-Stanton Road
Newark, Delaware 19713
302-623-4450
CCOP - Christiana Care Health Services Christiana Care's Cancer Research Program is part of a...
?
mi
from
Newark, DE
Click here to add this to my saved trials
Normal, Illinois 61761
?
mi
from
Normal, IL
Click here to add this to my saved trials
1304 Franklin Avenue
Normal, Illinois 61761
309.454.1400
BroMenn Regional Medical Center Advocate BroMenn Medical Center is a general medical and surgical hospital...
?
mi
from
Normal, IL
Click here to add this to my saved trials
407 East Vernon Ave.
Normal, Illinois 61761
(309) 451-8500
Illinois CancerCare - Community Cancer Center At the Community Cancer Center, we are committed to...
?
mi
from
Normal, IL
Click here to add this to my saved trials
407 East Vernon Ave.
Normal, Illinois 61761
(309) 451-8500
Illinois CancerCare - Community Cancer Center At the Community Cancer Center, we are committed to...
?
mi
from
Normal, IL
Click here to add this to my saved trials
?
mi
from
Ottawa, IL
Click here to add this to my saved trials
1100 East Norris Drive
Ottawa, Illinois 61350
(815) 433-3100
Community Hospital of Ottawa Ottawa Regional Hospital, an acute care medical facility, is located on...
?
mi
from
Ottawa, IL
Click here to add this to my saved trials
603 S 13th St
Pekin, Illinois 61554
(309) 353-0214
Illinois CancerCare - Pekin Illinois CancerCare is one of the largest private oncology and hematology...
?
mi
from
Pekin, IL
Click here to add this to my saved trials
603 S 13th St
Pekin, Illinois 61554
(309) 353-0512
Cancer Treatment Center at Pekin Hospital Since 1913, Pekin Hospital has been dedicated to improving...
?
mi
from
Pekin, IL
Click here to add this to my saved trials
?
mi
from
Peoria, IL
Click here to add this to my saved trials
?
mi
from
Peoria, IL
Click here to add this to my saved trials
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...
?
mi
from
Peoria, IL
Click here to add this to my saved trials
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...
?
mi
from
Peoria, IL
Click here to add this to my saved trials
925 West St
Peru, Illinois 61354
(815) 223-3300
Illinois Valley Community Hospital People
?
mi
from
Peru, IL
Click here to add this to my saved trials
4391 Venture Dr.
Peru, Illinois 61354
815-223-7010
Illinois CancerCare - Peru Illinois CancerCare, P.C. is a comprehensive practice treating patients withcancer andblood...
?
mi
from
Peru, IL
Click here to add this to my saved trials
300 N Patterson Rd
Reed City, Michigan 49677
(231) 832-3271
Spectrum Health Reed City Hospital At Spectrum Health Reed City Hospital, you have access to...
?
mi
from
Reed City, MI
Click here to add this to my saved trials
?
mi
from
Saint Louis, MO
Click here to add this to my saved trials
600 First Street
Spring Valley, Illinois 61362
815-664-1487
Illinois CancerCare - Spring Valley Illinois CancerCare, P.C. is a comprehensive practice treating patients withcancer...
?
mi
from
Spring Valley, IL
Click here to add this to my saved trials
105 Sixth St
Traverse City, Michigan 49684
(231) 935-5000
Munson Medical Center There’s no place quite like northern Michigan, and there is no other...
?
mi
from
Traverse City, MI
Click here to add this to my saved trials
Weston, Florida 33331
?
mi
from
Weston, FL
Click here to add this to my saved trials