Decentrialz logo
  • HIPAA Compliant
  • ISO 27001 Certified
Find Trials
About UsContact
Become a Volunteer+1 877 705 1914

Status:

COMPLETED

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

Lead Sponsor:

Alliance for Clinical Trials in Oncology

Collaborating Sponsors:

National Cancer Institute (NCI)

Conditions:

Lymphoma

Eligibility:

All Genders

18+ years

Phase:

PHASE2

Brief Summary

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 ...

Detailed Description

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...

Eligibility Criteria

Inclusion

  • 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

Exclusion

    Key Trial Info

    Start Date :

    August 1 2011

    Trial Type :

    INTERVENTIONAL

    Allocation :

    ACTUAL

    End Date :

    October 15 2020

    Estimated Enrollment :

    51 Patients enrolled

    Trial Details

    Trial ID

    NCT01190449

    Start Date

    August 1 2011

    End Date

    October 15 2020

    Last Update

    August 18 2021

    Active Locations (48)

    Enter a location and click search to find clinical trials sorted by distance.

    Page 1 of 12 (48 locations)

    1

    Tunnell Cancer Center at Beebe Medical Center

    Lewes, Delaware, United States, 19958

    2

    CCOP - Christiana Care Health Services

    Newark, Delaware, United States, 19713

    3

    Cleveland Clinic Florida - Weston

    Weston, Florida, United States, 33331

    4

    Illinois CancerCare - Bloomington

    Bloomington, Illinois, United States, 61701