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


Phase 2
18 Years
N/A
Open (Enrolling)
Both
Lymphoma

Thank you

Trial Information

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


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.

Inclusion Criteria


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

Type of Study:

Interventional

Study Design:

Allocation: Randomized, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

Overall response (complete or partial response)

Safety Issue:

No

Principal Investigator

Cara A. Rosenbaum, MD

Investigator Role:

Principal Investigator

Investigator Affiliation:

University of Chicago

Authority:

Unspecified

Study ID:

CDR0000683083

NCT ID:

NCT01190449

Start Date:

August 2011

Completion Date:

Related Keywords:

  • Lymphoma
  • 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
  • Lymphoma
  • Lymphoma, Follicular
  • Lymphoma, Non-Hodgkin

Name

Location

CCOP - Christiana Care Health ServicesWilmington, Delaware  19899
CCOP - Illinois Oncology Research AssociationPeoria, Illinois  61602
Methodist Medical Center of IllinoisPeoria, Illinois  61636
CCOP - Grand RapidsGrand Rapids, Michigan  49503
Long Island Jewish Medical CenterNew Hyde Park, New York  11040
SUNY Upstate Medical University HospitalSyracuse, New York  13210
Wake Forest University Comprehensive Cancer CenterWinston-Salem, North Carolina  27157-1096
Battle Creek Health System Cancer Care CenterBattle Creek, Michigan  49017
Munson Medical CenterTraverse City, Michigan  49684
New York Weill Cornell Cancer Center at Cornell UniversityNew York, New York  10021
Butterworth Hospital at Spectrum HealthGrand Rapids, Michigan  49503-2560
Siteman Cancer Center at Barnes-Jewish Hospital - Saint LouisSt. Louis, Missouri  63110
Don Monti Comprehensive Cancer Center at North Shore University HospitalManhasset, New York  11030
Virginia Commonwealth University Massey Cancer CenterRichmond, Virginia  23298-0037
Eureka Community HospitalEureka, Illinois  61530
BroMenn Regional Medical CenterNormal, Illinois  61761
Community Cancer CenterNormal, Illinois  61761
Community Hospital of OttawaOttawa, Illinois  61350
Oncology Hematology Associates of Central Illinois, PC - OttawaOttawa, Illinois  61350
Cancer Treatment Center at Pekin HospitalPekin, Illinois  61554
Oncology Hematology Associates of Central Illinois, PC - PeoriaPeoria, Illinois  61615
Proctor HospitalPeoria, Illinois  61614
Illinois Valley Community HospitalPeru, Illinois  61354
Mecosta County Medical CenterBig Rapids, Michigan  49307
Cancer Institute of New Jersey at Cooper - VoorheesVoorhees, New Jersey  08043
Tunnell Cancer Center at Beebe Medical CenterLewes, Delaware  19958
Monter Cancer Center of the North Shore-LIJ Health SystemLake Success, New York  11042
Arthur G. James Cancer Hospital and Richard J. Solove Research Institute at Ohio State University Comprehensive Cancer CenterColumbus, Ohio  43210-1240
Union Hospital of Cecil CountyElkton MD, Maryland  21921
Kinston Medical SpecialistsKinston, North Carolina  28501
Lacks Cancer Center at Saint Mary's Health CareGrand Rapids, Michigan  49503
Lakes Region General HospitalLaconia, New Hampshire  03246
Galesburg Clinic, PCGalesburg, Illinois  61401
Illinois CancerCare - BloomingtonBloomington%, Illinois  61701
Illinois CancerCare - CantonCanton, Illinois  61520
Illinois CancerCare - EurekaEureka, Illinois  61530
Illinois CancerCare - MacombMacomb, Illinois  61455
Illinois CancerCare - Community Cancer CenterNormal, Illinois  61761
Illinois CancerCare - PekinPekin, Illinois  61603
Illinois CancerCare - PeruPeru, Illinois  61354
Illinois CancerCare - Spring ValleySpring Valley, Illinois  61362
Iowa Blood and Cancer CareCedar Rapids, Iowa  52402
Mercy General Health PartnersMuskegon, Michigan  49443
New Hampshire Oncology - Hematology, PA at Payson Center for Cancer CareConcord, New Hampshire  03301
New Hampshire Oncology - Hematology, PA - HooksettHooksett, New Hampshire  03106
Cleveland Clinic Florida - WestonWeston, Florida  33331
Spectrum Health Reed City HospitalReed City, Michigan  49677
Mount Kisco Medical Group, PCMount Kisco, New York  10549