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Status:

TERMINATED

Phase II Randomized Trial Comparing GA101 and Rituximab in Untreated Low Tumor Burden Indolent Non-Hodgkin's Lymphoma

Lead Sponsor:

PrECOG, LLC.

Collaborating Sponsors:

Genentech, Inc.

Conditions:

Indolent Non-Hodgkin's Lymphoma

Eligibility:

All Genders

18+ years

Phase:

PHASE2

Brief Summary

Patients with previously untreated low tumor burden indolent Non-Hodgkin's Lymphoma (NHL) will receive either rituximab or GA101 weekly for 4 weeks followed by re-staging to determine response. Ritux...

Detailed Description

According to the American Cancer Society, it is estimated that approximately 70,800 individuals will be diagnosed with non-Hodgkin's lymphoma (NHL) and over 18,990 men and women will die of the diseas...

Eligibility Criteria

Inclusion

  • Inclusion Criteria:
  • Registration: Patients having both diffuse and follicular architectural elements will be considered eligible if the histology is predominantly follicular (≥ 50% of the cross-sectional area), and there is no evidence of transformation to a large cell histology.
  • Biopsy-proven diagnosis of Grade 1 or 2 follicular non-Hodgkin's lymphoma with no evidence of transformation to large cell histology.
  • Meet criteria for Low Tumor Burden:
  • No nodal or extra nodal mass ≥ 7 centimeter (cm)
  • \<3 nodal masses \>3 cm in diameter
  • No systemic symptoms or B symptoms
  • No splenomegaly \>16 cm by CT scan
  • No risk of compression of a vital organ.
  • No leukemic phase with \>5000/mm³ circulating lymphocytes.
  • No cytopenias defined as:
  • Platelets \<100,000/mm³
  • Hemoglobin (Hgb) \<10 g/dL
  • Absolute Neutrophil Count (ANC) \<1500/mm³
  • Must have Stage III or Stage IV disease.
  • Baseline measurements/evaluations obtained within 6 weeks of registration. Patient must have at least one objective measurable disease parameter.
  • Age ≥ 18 years.
  • Eastern Oncology Cooperative Group Performance Status 0-1.
  • Must not have received investigational agents within 30 days of registration.
  • Signed Institutional Review Board (IRB)-approved informed consent.
  • Willing to provide blood samples for research purposes.
  • Women must not be pregnant or breastfeeding.
  • Women of childbearing potential and sexually active males must use an accepted and effective method of contraception.
  • No prior chemotherapy, radiotherapy or immunotherapy for lymphoma.
  • No prior treatment with cytotoxic drugs or rituximab for a previous cancer or another condition (e.g. rheumatoid arthritis) or prior use of an anti-CD20 antibody.
  • No prior use of any monoclonal antibody within 3 months of randomization.
  • No history of severe allergic/anaphylactic reactions to humanized/murine monoclonal antibodies or known sensitivity/allergy to murine products.
  • No history of prior malignancy except for adequately treated basal cell or squamous cell skin cancer, in situ cervical cancer, or other cancer for which the patient has been disease-free for at least 2 years and did not require treatment with cytotoxic drugs or rituximab.
  • No major surgery within 4 weeks prior to randomization, other than for diagnosis.
  • Must be Human Immunodeficiency Virus (HIV) negative.
  • Have adequate organ function without growth factor and/or transfusion support within ≤ 2 weeks prior to registration:
  • ANC ≥ 1500/mm³
  • Hgb ≥ 10 g/dL
  • Platelets ≥ 100,000/mm³
  • Serum Creatinine ≤ 2x Upper Limit Normal (ULN)
  • Total Bilirubin ≤ 2x ULN
  • AST (aspartate aminotransferase)/ALT (alanine aminotransferase) ≤ 5x ULN
  • PTT (Partial Thromboplastin Time) or aPTT (activated Partial Thromboplastin Time) \>1.5x the ULN in the absence of a lupus anticoagulant
  • INR (International Normalized Ratio) \>1.5x the ULN in the absence of therapeutic anticoagulation
  • No active, uncontrolled infections (afebrile for ≥ 48 hours off antibiotics).
  • Must not receive immunization with attenuated live vaccines within 28 days prior to registration or during the study period.
  • Must be tested for hepatitis B surface antigen (HBsAg) and total hepatitis B core antibody (anti-HBc) within 2 weeks of registration. Patients who are chronic carriers of HBsAg and anti-HBc are excluded.
  • Must be tested for hepatitis C antibody within 2 week of registration. If this test is positive, patients are excluded unless a hepatitis C virus ribonucleic acid (HCV RNA) is negative.
  • No evidence of significant, uncontrolled concomitant diseases that could affect compliance with the protocol or interpretation of results, including significant cardiovascular disease (i.e., severe arrhythmia, myocardial infarction within the previous 6 months, unstable arrhythmias, or unstable angina) or pulmonary disease.

Exclusion

    Key Trial Info

    Start Date :

    December 1 2013

    Trial Type :

    INTERVENTIONAL

    Allocation :

    ACTUAL

    End Date :

    August 1 2016

    Estimated Enrollment :

    32 Patients enrolled

    Trial Details

    Trial ID

    NCT01889797

    Start Date

    December 1 2013

    End Date

    August 1 2016

    Last Update

    May 5 2017

    Active Locations (28)

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

    Page 1 of 7 (28 locations)

    1

    University of South Alabama

    Mobile, Alabama, United States, 36604

    2

    Marin Cancer Care

    Greenbrae, California, United States, 94904

    3

    St. Joseph's/Candler Health System

    Savannah, Georgia, United States, 31405

    4

    Decatur Memorial Hospital

    Decatur, Illinois, United States, 62526