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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
Open (Enrolling)

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Trial Information

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



- 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.


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

- 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

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


- 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

- Stage III or IV disease

- WHO grade 1, 2, or 3a disease

- Bone marrow biopsies allowed provided they are submitted in conjunction with nodal

- 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


- 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


- No prior chemotherapy or immunotherapy (e.g., monoclonal antibody-based therapy) for

- 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:


Study Design:

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

Outcome Measure:

Overall response (complete or partial response)

Safety Issue:


Principal Investigator

Cara A. Rosenbaum, MD

Investigator Role:

Principal Investigator

Investigator Affiliation:

University of Chicago



Study ID:




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



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