CALGB 50901 Eligibility Checklist Form Ofatumumab in Treating Patients With Previously Untreated Stage II, Stage III, or Stage IV Follicular Non-Hodgkin Lymphoma Source Form: NCI FormBuilder:

  1. 4/19/12 4/19/12 -
  2. 1/9/15 1/9/15 - Martin Dugas
  3. 9/20/21 9/20/21 -
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September 20, 2021

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Eligibility NCT01190449 Lymphoma - CALGB 50901 Eligibility Checklist Form 3211939_v1_0

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  1. StudyEvent: CALGB 50901 Eligibility Checklist Form
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Eligibility Checklist
Hematopoietic Diagnosis (Mark one with an X. see Section 4.1.1 Histologically confirmed follicular lymphoma, WHO classification grade 1, 2, or 3a without histologic transformation that is stage III, IV or bulky stage II i.e., single mass >= 7 cm in any uni-dimensional measurement)
Modified Ann Arbor Stage (Mark one with an X. see Section 4.1.1)
Does institutional flow cytometry or immunohistochemistry confirm CD20 antigen expression (Tumor tissue must be confirmed to express the CD20 antigen by institutional flow cytometry or immunohistochemistry. see Section 4.1.2)
Any prior systemic therapy for NHL other than involved field radiation therapy (No prior therapy for NHL including chemotherapy or immunotherapy e.g., monoclonal antibody-based therapy. Patients may have received involved field radiation therapy. see Section 4.2.1)
Any corticosteroid use within two weeks prior to study entry (except for maintenance therapy of non-malignant disease No corticosteroids within two weeks prior to study entry, except for maintenance therapy for a non-malignant disease. see Section 4.2.2)
Number of nodal sites (Mark one with an X. Low or intermediate-risk disease by the follicular lymphoma international prognostic index FLIPI score see Section 4.3)
FLIPI score (Mark one with an X)
Performance Status (ECOG) (Mark one with an X ECOG performance status <= 2 see Section 4.4)
Any known CNS involvement (No known CNS involvement by lymphoma see Section 4.6)
Does the patient have HIV infection (HIV+ patients are eligible, provided they meet the parameters in Section 4.8)
Evidence of coinfection with hepatitis B or C or evidence of a resistant strain of HIV
Patient on anti-HIV therapy
Is the patient HBV seropositive (HBsAg + HBV seropositive patients HBsAg + are eligible, provided they meet the parameters in Section 4.9)
If HBsAg+, was HBV DNA testing performed
Was evidence of active HBV infection detected
Serum or urine Beta-HCG (Non-pregnant and non-nursing see Section 4.10)

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