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Phase II Randomized Trial Comparing GA101 and Rituximab in Untreated Low Tumor Burden Indolent Non-Hodgkin's Lymphoma (PrE0401)

Primary Purpose

Indolent Non-Hodgkin's Lymphoma

Status
Terminated
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
Arm A: Rituximab
Arm B: GA101
Sponsored by
PrECOG, LLC.
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Indolent Non-Hodgkin's Lymphoma focused on measuring Untreated Non-Hodgkin's Lymphoma, Low Tumor Burden Non-Hodgkin's Lymphoma, NHL, Indolent, Rituximab, Rituxan, GA101, Obinutuzumab

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • University of South Alabama
  • Marin Cancer Care
  • St. Joseph's/Candler Health System
  • Decatur Memorial Hospital
  • Carle Cancer Center
  • Indiana University
  • Siouxland Hematology Oncology Associates
  • Ochsner Cancer Institute
  • Greater Baltimore Medical Center
  • Tufts Medical Center
  • St. Joseph Mercy Health System
  • Mayo Clinic
  • Metro MN CCOP
  • Missouri Valley Cancer Consortium
  • Montefiore Medical Center
  • Aultman Hospital
  • University Hospitals Case Medical Center
  • Toledo Community Oncology Program
  • Geisinger Medical Center
  • Fox Chase Cancer Center
  • Reading Hospital
  • Susquehanna Health Cancer Center
  • University of Virginia
  • Charleston Area Medical Center (CAMC)
  • Gundersen Health System
  • Dean Clinic
  • ProHealth Care, Inc.
  • Aurora Health Care

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Experimental

Arm Label

Arm A: Rituximab

Arm B: GA101

Arm Description

Rituximab 375 mg/m² IV weekly for 4 weeks.

GA101 1,000 mg IV weekly for 4 weeks.

Outcomes

Primary Outcome Measures

Complete Response (CR) Rate
Positron Emission Tomography (PET)-documented CR rates after induction therapy (weekly treatment x 4 weeks with GA101 or rituximab) Definitions for clinical response are modified from the Revised Response Criteria for Malignant Lymphoma (Cheson BD, et al. Revised Response Criteria for Malignant Lymphoma. J Clin Oncol 2007; 25(5): 579-86). Lymph node measurements were taken from CT, CT portion of the PET/CT, or MRI scans where applicable. CR is defined as complete disappearance of all evidence of disease; PR as a >50% decrease in the sum of the products of the maximal perpendicular diameters of measured lesions (SPD) and no new sites; SD as failure to attain CR/PR or PD; and PD as any new lesion >1.5cm in any axis or ≥50% increase in previously involved sites.

Secondary Outcome Measures

PET Response Rate
PET response rate [PET-documented CR + Partial Response (PR)] based on PET scan results. Patients with unevaluable disease were included in the denominator.
Overall Response Rate
Overall response rate (CR + PR by Cheson criteria) at re-staging (including bone marrow biopsy if CR suspected) by PET and Neck, Chest, Abdomen and Pelvic Computed Tomography (CT) scan. Patients with unevaluable disease were included in the denominator.
Progression Free Survival (PFS)
CT scan every 3 months for 2 years, then every 6 months until progression. Compare PFS in each treatment arm. Progressive disease (PD) was defined using Cheson criteria as described in the Primary Outcome section above. Progression-free survival (PFS) was defined as the time from start of treatment to the documentation of PD or death, whichever occurs first. Patients alive and without PD were censored at the date of last disease assessment.

Full Information

First Posted
June 26, 2013
Last Updated
March 23, 2017
Sponsor
PrECOG, LLC.
Collaborators
Genentech, Inc.
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1. Study Identification

Unique Protocol Identification Number
NCT01889797
Brief Title
Phase II Randomized Trial Comparing GA101 and Rituximab in Untreated Low Tumor Burden Indolent Non-Hodgkin's Lymphoma
Acronym
PrE0401
Official Title
Phase II Randomized Trial Comparing GA101 (Obinutuzumab) and Rituximab in Patients With Previously Untreated Low Tumor Burden Indolent Non-Hodgkin's Lymphoma
Study Type
Interventional

2. Study Status

Record Verification Date
March 2017
Overall Recruitment Status
Terminated
Why Stopped
Closed due prolonged enrollment timelines
Study Start Date
December 2013 (undefined)
Primary Completion Date
April 2016 (Actual)
Study Completion Date
August 2016 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
PrECOG, LLC.
Collaborators
Genentech, Inc.

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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. Rituximab, an anti-CD20 chimeric antibody, was approved by the United States Food and Drug Administration in 1998 for the treatment of patients with relapsed low-grade B-cell lymphomas. Clinically, four weekly doses of rituximab have proven to be well tolerated and effective in previously untreated as well as relapsed patients with low-grade lymphoma. GA101 is an anti-CD20 humanized and glyco-engineered monoclonal antibody. GA101 has been shown to have increased antibody-dependent cellular cytotoxicity (ADCC) and direct cell-death induction compared to Rituximab. It is possible that GA101 may have greater efficacy than rituximab. PrE0401 Sub-Study Evaluation of Corrected QT (QTc) Interval and Pharmacokinetic Parameters in Patients Participating in GA101 (Obinutuzumab) Approximately twenty-five patients randomized to GA101 may participate in the sub-study. Electrocardiograms and blood samples will be obtained.
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 disease in 2014. The survival rates for patients with indolent NHL remained unchanged from the 1950s through the early 1990s, but recent evidence suggests that outcomes are improving. Indolent NHL is a particular challenge because it is an incurable disease requiring multiple treatments; yet relatively long survivals elevate the importance of quality of life associated with treatment. Agents such as rituximab are active in patients with a low burden of disease and result in high response rates and durable remissions for most patients. However, the optimal therapeutic approach to patients with low-grade lymphoma with a low disease burden is controversial as conventional chemotherapy also results in high rates of response. Regardless of whether patients receive immunotherapy, chemotherapy, or a combination thereof, they unfortunately exhibit a continuing pattern of disease relapse and the median survival for newly diagnosed patients is between 7-10 years. Rituximab and GA101 both target the CD20 antigen. The CD20 antigen is located on the surface of normal and malignant B-cell lymphocytes. An attractive feature of this target is that CD20 is not on hematopoietic stem cells, nor is it expressed in any great extent on other normal body tissues. Studies in vitro have shown that rituximab predominantly induces antibody dependent cellular cytotoxicity (ADCC), but also binds complement and directly induces apoptosis in lymphoma cells. GA101 shows increased ADCC related to an improved binding of the GA101 to the different allotypes expressed by natural killer cells and monocytes. It also has increased direct cell-death related to an elbow hinge amino acid exchange and Type II binding of the CD20 epitope. The safety of GA101 in NHL so far appears to be similar to that observed with rituximab in patients with NHL, except for a higher incidence of infusion-related reactions. Depletion of malignant B-cells using anti-CD20 monoclonal antibodies has an acceptable safety profile, particularly in patients with low-grade B-cell lymphomas with a low disease burden. To determine whether treatment with GA101 results in better outcomes than that seen with rituximab and to determine which anti-CD20 antibody to utilize in future studies, we will conduct a randomized Phase II trial of rituximab and GA101 in patients with previously untreated low-grade lymphoma. Patients will receive either rituximab or GA101 weekly for 4 weeks followed by re-staging. The endpoints of the study will be the Complete Response (CR), Overall Response Rate (ORR), time to next treatment, progression free survival (PFS), and safety of each treatment arm. PrE0401 Sub-Study Evaluation of Corrected QT (QTc) Interval and Pharmacokinetic Parameters in Patients Participating in GA101 (Obinutuzumab) Patients randomized to GA101 and who consent to the sub-study will have electrocardiograms obtained pre and post Week 1 and Week 4 to investigate the effect of GA101 on QTc interval. Pharmacokinetic blood samples will also be done to evaluate serum concentrations of GA101 at the same time-points.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Indolent Non-Hodgkin's Lymphoma
Keywords
Untreated Non-Hodgkin's Lymphoma, Low Tumor Burden Non-Hodgkin's Lymphoma, NHL, Indolent, Rituximab, Rituxan, GA101, Obinutuzumab

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
32 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Arm A: Rituximab
Arm Type
Active Comparator
Arm Description
Rituximab 375 mg/m² IV weekly for 4 weeks.
Arm Title
Arm B: GA101
Arm Type
Experimental
Arm Description
GA101 1,000 mg IV weekly for 4 weeks.
Intervention Type
Biological
Intervention Name(s)
Arm A: Rituximab
Other Intervention Name(s)
IDEC-C2B8, Chimeric anti-CD20 monoclonal antibody, Rituxan, NSC# 687451
Intervention Description
Rituximab 375 mg/m² IV x 4 weekly doses.
Intervention Type
Biological
Intervention Name(s)
Arm B: GA101
Other Intervention Name(s)
Obinutuzumab, RO5072759, huMAB<CD20>
Intervention Description
GA101 1,000 mg (flat dose) IV x 4 weekly doses.
Primary Outcome Measure Information:
Title
Complete Response (CR) Rate
Description
Positron Emission Tomography (PET)-documented CR rates after induction therapy (weekly treatment x 4 weeks with GA101 or rituximab) Definitions for clinical response are modified from the Revised Response Criteria for Malignant Lymphoma (Cheson BD, et al. Revised Response Criteria for Malignant Lymphoma. J Clin Oncol 2007; 25(5): 579-86). Lymph node measurements were taken from CT, CT portion of the PET/CT, or MRI scans where applicable. CR is defined as complete disappearance of all evidence of disease; PR as a >50% decrease in the sum of the products of the maximal perpendicular diameters of measured lesions (SPD) and no new sites; SD as failure to attain CR/PR or PD; and PD as any new lesion >1.5cm in any axis or ≥50% increase in previously involved sites.
Time Frame
Re-staging (week 12, 13 or 14) and during follow-up if physician feels patient is subsequently in CR for up to 4 years
Secondary Outcome Measure Information:
Title
PET Response Rate
Description
PET response rate [PET-documented CR + Partial Response (PR)] based on PET scan results. Patients with unevaluable disease were included in the denominator.
Time Frame
Re-staging (week 12, 13 or 14)
Title
Overall Response Rate
Description
Overall response rate (CR + PR by Cheson criteria) at re-staging (including bone marrow biopsy if CR suspected) by PET and Neck, Chest, Abdomen and Pelvic Computed Tomography (CT) scan. Patients with unevaluable disease were included in the denominator.
Time Frame
Baseline and Re-staging (week 12, 13 or 14)
Title
Progression Free Survival (PFS)
Description
CT scan every 3 months for 2 years, then every 6 months until progression. Compare PFS in each treatment arm. Progressive disease (PD) was defined using Cheson criteria as described in the Primary Outcome section above. Progression-free survival (PFS) was defined as the time from start of treatment to the documentation of PD or death, whichever occurs first. Patients alive and without PD were censored at the date of last disease assessment.
Time Frame
Percent of participants alive and progression-free at 1 year

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Stephen Ansell, MD
Organizational Affiliation
Mayo Clinic in Minnesota
Official's Role
Study Chair
Facility Information:
Facility Name
University of South Alabama
City
Mobile
State/Province
Alabama
ZIP/Postal Code
36604
Country
United States
Facility Name
Marin Cancer Care
City
Greenbrae
State/Province
California
ZIP/Postal Code
94904
Country
United States
Facility Name
St. Joseph's/Candler Health System
City
Savannah
State/Province
Georgia
ZIP/Postal Code
31405
Country
United States
Facility Name
Decatur Memorial Hospital
City
Decatur
State/Province
Illinois
ZIP/Postal Code
62526
Country
United States
Facility Name
Carle Cancer Center
City
Urbana
State/Province
Illinois
ZIP/Postal Code
61801
Country
United States
Facility Name
Indiana University
City
Indianapolis
State/Province
Indiana
ZIP/Postal Code
46202
Country
United States
Facility Name
Siouxland Hematology Oncology Associates
City
Sioux City
State/Province
Iowa
ZIP/Postal Code
51101
Country
United States
Facility Name
Ochsner Cancer Institute
City
New Orleans
State/Province
Louisiana
ZIP/Postal Code
70121
Country
United States
Facility Name
Greater Baltimore Medical Center
City
Baltimore
State/Province
Maryland
ZIP/Postal Code
21204
Country
United States
Facility Name
Tufts Medical Center
City
Boston
State/Province
Massachusetts
ZIP/Postal Code
02111
Country
United States
Facility Name
St. Joseph Mercy Health System
City
Ann Arbor
State/Province
Michigan
ZIP/Postal Code
48106
Country
United States
Facility Name
Mayo Clinic
City
Rochester
State/Province
Minnesota
ZIP/Postal Code
55905
Country
United States
Facility Name
Metro MN CCOP
City
St. Louis Park
State/Province
Minnesota
ZIP/Postal Code
55416
Country
United States
Facility Name
Missouri Valley Cancer Consortium
City
Omaha
State/Province
Nebraska
ZIP/Postal Code
68106
Country
United States
Facility Name
Montefiore Medical Center
City
Bronx
State/Province
New York
ZIP/Postal Code
10467
Country
United States
Facility Name
Aultman Hospital
City
Canton
State/Province
Ohio
ZIP/Postal Code
44710
Country
United States
Facility Name
University Hospitals Case Medical Center
City
Cleveland
State/Province
Ohio
ZIP/Postal Code
44106
Country
United States
Facility Name
Toledo Community Oncology Program
City
Toledo
State/Province
Ohio
ZIP/Postal Code
43617
Country
United States
Facility Name
Geisinger Medical Center
City
Danville
State/Province
Pennsylvania
ZIP/Postal Code
17822
Country
United States
Facility Name
Fox Chase Cancer Center
City
Philadelphia
State/Province
Pennsylvania
ZIP/Postal Code
19111
Country
United States
Facility Name
Reading Hospital
City
West Reading
State/Province
Pennsylvania
ZIP/Postal Code
19611
Country
United States
Facility Name
Susquehanna Health Cancer Center
City
Williamsport
State/Province
Pennsylvania
ZIP/Postal Code
17701
Country
United States
Facility Name
University of Virginia
City
Charlottesburg
State/Province
Virginia
ZIP/Postal Code
22908
Country
United States
Facility Name
Charleston Area Medical Center (CAMC)
City
Charleston
State/Province
West Virginia
ZIP/Postal Code
25304
Country
United States
Facility Name
Gundersen Health System
City
La Crosse
State/Province
Wisconsin
ZIP/Postal Code
54601
Country
United States
Facility Name
Dean Clinic
City
Madison
State/Province
Wisconsin
ZIP/Postal Code
53717
Country
United States
Facility Name
ProHealth Care, Inc.
City
Waukesha
State/Province
Wisconsin
ZIP/Postal Code
53188
Country
United States
Facility Name
Aurora Health Care
City
Wauwatosa
State/Province
Wisconsin
ZIP/Postal Code
53266
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
No
IPD Sharing Plan Description
Data is proprietary.
Citations:
PubMed Identifier
12377971
Citation
Hainsworth JD, Litchy S, Burris HA 3rd, Scullin DC Jr, Corso SW, Yardley DA, Morrissey L, Greco FA. Rituximab as first-line and maintenance therapy for patients with indolent non-hodgkin's lymphoma. J Clin Oncol. 2002 Oct 15;20(20):4261-7. doi: 10.1200/JCO.2002.08.674.
Results Reference
background
PubMed Identifier
20350657
Citation
Beers SA, Chan CH, French RR, Cragg MS, Glennie MJ. CD20 as a target for therapeutic type I and II monoclonal antibodies. Semin Hematol. 2010 Apr;47(2):107-14. doi: 10.1053/j.seminhematol.2010.01.001.
Results Reference
background
PubMed Identifier
20194898
Citation
Mossner E, Brunker P, Moser S, Puntener U, Schmidt C, Herter S, Grau R, Gerdes C, Nopora A, van Puijenbroek E, Ferrara C, Sondermann P, Jager C, Strein P, Fertig G, Friess T, Schull C, Bauer S, Dal Porto J, Del Nagro C, Dabbagh K, Dyer MJ, Poppema S, Klein C, Umana P. Increasing the efficacy of CD20 antibody therapy through the engineering of a new type II anti-CD20 antibody with enhanced direct and immune effector cell-mediated B-cell cytotoxicity. Blood. 2010 Jun 3;115(22):4393-402. doi: 10.1182/blood-2009-06-225979. Epub 2010 Mar 1.
Results Reference
background
Citation
Salles GA, et al. Efficacy and Safety of Obinutuzumab (GA101) Monotherapy in Relapsed/Refractory Indolent Non-Hodgkin's Lymphoma: Results from a Phase I/II Study (BO20999) American Society of Hematology Annual meeting 2011 Abstract 268.
Results Reference
background
PubMed Identifier
26282650
Citation
Sehn LH, Goy A, Offner FC, Martinelli G, Caballero MD, Gadeberg O, Baetz T, Zelenetz AD, Gaidano G, Fayad LE, Buckstein R, Friedberg JW, Crump M, Jaksic B, Zinzani PL, Padmanabhan Iyer S, Sahin D, Chai A, Fingerle-Rowson G, Press OW. Randomized Phase II Trial Comparing Obinutuzumab (GA101) With Rituximab in Patients With Relapsed CD20+ Indolent B-Cell Non-Hodgkin Lymphoma: Final Analysis of the GAUSS Study. J Clin Oncol. 2015 Oct 20;33(30):3467-74. doi: 10.1200/JCO.2014.59.2139. Epub 2015 Aug 17.
Results Reference
background

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

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