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GAUSS: A Study of Obinutuzumab (RO5072759) in Patients With Indolent Non-Hodgkin's Lymphoma

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Hoffmann-La Roche
ClinicalTrials.gov Identifier:
NCT00576758
First received: December 18, 2007
Last updated: August 15, 2014
Last verified: August 2014
  Purpose

This study will investigate the efficacy of weekly intravenous obinutuzumab [GA101 (RO5072759)] monotherapy, in patients with relapsed CD20+ indolent Non-Hodgkin's Lymphoma. Patients will be randomized to receive either GA101 or rituximab, given as four weekly infusions. At the conclusion of the initial trial patients may be eligible to continue therapy up to 24 months. The anticipated time on study treatment is 3- 24 months, and the target sample size is 100-500 individuals.


Condition Intervention Phase
Non-Hodgkin's Lymphoma
Drug: obinutuzumab (RO5072759)
Drug: rituximab
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: An Open-label, Multi-center, Randomized Study to Evaluate the Efficacy on Tumor Response of GA101 (RO5072759) Monotherapy Versus Rituximab Monotherapy in Patients With Relapsed CD20+ Indolent Non-Hodgkin's Lymphoma

Resource links provided by NLM:


Further study details as provided by Hoffmann-La Roche:

Primary Outcome Measures:
  • Percentage of Participants With Overall Response At the End of Induction Period [ Time Frame: Randomization to clinical cutoff: 01 September 2011 (Up to 70 days) ] [ Designated as safety issue: No ]

    Overall response was defined as Complete Response (CR), Complete Response/Unconfirmed (CRu) or Partial Response (PR) as assessed by investigator at end of induction treatment. Computed tomography imaging was used for the primary assessment of tumor response per 1999 criteria by Cheson.

    CR was defined as the disappearance of all clinical and radiographic evidence of disease, disease-related symptoms and normalization of biochemical abnormalities of NHL.

    CRu was CR plus one or more of the following: A residual lymph node mass greater than 1.5 cm in greatest transverse diameter that has regressed by more than 75% in the sum of the products of the greatest diameter (tumors)(SPD) and/or indeterminate bone marrow.

    PR was defined as 50% decrease in SPD of the 6 largest dominant nodes or nodal masses. No increase in the size of the other nodes, liver, or spleen. Splenic and hepatic nodules must regress by at least 50% in the SPD. No new sites of disease.



Secondary Outcome Measures:
  • Percentage of Participants With Complete Response at the End of the Induction Period [ Time Frame: Randomization to clinical cutoff : 01 September 2011 (Up to 70 days) ] [ Designated as safety issue: No ]
    Computed tomography imaging was used for the primary assessment of tumor response per 1999 criteria by Cheson. CR is defined as the disappearance of all clinical and radiographic evidence of disease, disease-related symptoms and normalization of biochemical abnormalities of NHL. All lymph nodes and nodal masses must have regressed to normal size. The spleen, if considered to be enlarged before therapy on the basis of a CT scan, must have regressed in size and must not be palpable on physical examination. Any macroscopic nodules in any organs detectable on imaging techniques should no longer be present. Other organs considered to be enlarged before therapy due to involvement by lymphoma, such as liver and kidneys, must have decreased in size. If the bone marrow was involved by lymphoma before treatment, the infiltrate must be cleared on repeat bone marrow aspirate and biopsy of the same site.

  • Percentage of Participants With Partial Response (PR) at the End of the Induction Period [ Time Frame: Randomization to clinical cutoff : 01 September 2011 (Up to 70 days) ] [ Designated as safety issue: No ]
    Computed tomography imaging was used for the primary assessment of tumor response per 1999 criteria by Cheson. PR was defined as 50% decrease in SPD of the 6 largest dominant nodes or nodal masses. No increase in the size of the other nodes, liver, or spleen. Splenic and hepatic nodules must regress by at least 50% in the SPD. No new sites of disease.

  • Percentage of Participants With Best Overall Response Achieved at Any Time During the Study Treatment [ Time Frame: Randomization to clinical cutoff : 01 September 2011 (Up to 70 days) ] [ Designated as safety issue: No ]

    Overall response was defined as Complete Response (CR), Complete Response/Unconfirmed (CRu) or Partial Response (PR) as assessed by investigators during study treatment (induction or extended treatment phase). Computed tomography imaging was used for the primary assessment of tumor response per 1999 criteria by Cheson.

    CR was defined as the disappearance of all clinical and radiographic evidence of disease, disease-related symptoms and normalization of biochemical abnormalities of NHL.

    CRu was CR plus one or more of the following: A residual lymph node mass greater than 1.5 cm in greatest transverse diameter that has regressed by more than 75% in the sum of the products of the greatest diameter (tumors)(SPD) and/or indeterminate bone marrow.

    PR was defined as 50% decrease in SPD of the 6 largest dominant nodes or nodal masses. No increase in the size of the other nodes, liver, or spleen. Splenic and hepatic nodules must regress by at least 50% in the SPD. No new sites of disease.


  • Number of Participants With Improved Overall Response During the Extended Treatment Period [ Time Frame: Randomization to Clinical cutoff: 07 March 2013 (Up to 43.2 months) ] [ Designated as safety issue: No ]
    Overall response was defined as Complete Response (CR), Complete Response/Unconfirmed (CRu) or Partial Response (PR) as assessed by investigators at end of induction treatment. Computed tomography imaging was used for the primary assessment of tumor response per 1999 criteria by Cheson.

  • Percentage of Participants With Best Overall Response Achieved at Any Time During the Study Treatment [ Time Frame: Randomization to Clinical cutoff: 07 March 2013 (Up to 43.2 months) ] [ Designated as safety issue: No ]

    Overall response was defined as Complete Response (CR), Complete Response/Unconfirmed (CRu) or Partial Response (PR) as assessed by investigators during study treatment (induction or extended treatment phase). Computed tomography imaging was used for the primary assessment of tumor response per 1999 criteria by Cheson.

    CR was defined as the disappearance of all clinical and radiographic evidence of disease, disease-related symptoms and normalization of biochemical abnormalities of NHL.

    CRu was CR plus one or more of the following: A residual lymph node mass greater than 1.5 cm in greatest transverse diameter that has regressed by more than 75% in the sum of the products of the greatest diameter (tumors)(SPD) and/or indeterminate bone marrow.

    PR was defined as 50% decrease in SPD of the 6 largest dominant nodes or nodal masses. No increase in the size of the other nodes, liver, or spleen. Splenic and hepatic nodules must regress by at least 50% in the SPD. No new sites of disease.


  • Progression-Free Survival (PFS) [ Time Frame: Randomization to Clinical cutoff: 07 March 2013 (Up to 43.2 months) ] [ Designated as safety issue: No ]

    PFS was defined as the time from randomization to the first occurrence of progression, relapse, or death from any cause as assessed by the Investigator.

    Progression was defined as a ≥ 50% increase from nadir in the SPD of any previously identified abnormal node and/or the appearance of any new lesion during or at the end of therapy.

    Relapse was defined as the appearance of any new lesion or increase by ≥ 50% in the size of previously involved sites and/or a ≥ 50% increase in greatest diameter of any previously identified node greater than 1 cm in its short axis or in the SPD of more than one node.


  • Percentage of Participants With Progression-Free Survival (PFS) Events [ Time Frame: Randomization to Clinical cutoff: 07 March 2013 (Up to 43.2 months) ] [ Designated as safety issue: No ]

    The percentage of participants with progression, relapse, or death events from any cause as assessed by the Investigator.

    Progression was defined as a ≥ 50% increase from nadir in the SPD of any previously identified abnormal node and/or the appearance of any new lesion during or at the end of therapy.

    Relapse was defined as the appearance of any new lesion or increase by ≥ 50% in the size of previously involved sites and/or a ≥ 50% increase in greatest diameter of any previously identified node greater than 1 cm in its short axis or in the SPD of more than one node.


  • Event Free Survival [ Time Frame: Randomization to Clinical cutoff: 07 March 2013 (Up to 43.2 months) ] [ Designated as safety issue: No ]

    Event-free survival (EFS) was defined as the time between date of randomization and the date of disease progression/relapse, death, or start of a new anti-leukemic therapy.

    Progression was defined as a ≥ 50% increase from nadir in the SPD of any previously identified abnormal node and/or the appearance of any new lesion during or at the end of therapy.

    Relapse was defined as the appearance of any new lesion or increase by ≥ 50% in the size of previously involved sites and/or a ≥ 50% increase in greatest diameter of any previously identified node greater than 1 cm in its short axis or in the SPD of more than one node.


  • Percentage of Participants With Event Free Survival (EFS) Events [ Time Frame: Randomization to Clinical cutoff: 07 March 2013 (Up to 43.2 months) ] [ Designated as safety issue: No ]

    Percentage of participants with Event Free Events: disease progression/relapse, death, or start of a new anti-leukemic therapy.

    Progression was defined as a ≥ 50% increase from nadir in the SPD of any previously identified abnormal node and/or the appearance of any new lesion during or at the end of therapy.

    Relapse was defined as the appearance of any new lesion or increase by ≥ 50% in the size of previously involved sites and/or a ≥ 50% increase in greatest diameter of any previously identified node greater than 1 cm in its short axis or in the SPD of more than one node.


  • Duration of Response [ Time Frame: Randomization to Clinical cutoff: 07 March 2013 (Up to 43.2 months) ] [ Designated as safety issue: No ]

    Duration of Response was defined as the date the response, either Complete Response (CR) or Partial Response (PR), was first recorded until the date of Disease Progression or death due to any cause. Computed tomography imaging was used for the primary assessment of tumor response per 1999 criteria by Cheson.

    CR was defined as the disappearance of all clinical and radiographic evidence of disease, disease-related symptoms and normalization of biochemical abnormalities of NHL.

    PR was defined as 50% decrease in SPD of the 6 largest dominant nodes or nodal masses. No increase in the size of the other nodes, liver, or spleen. Splenic and hepatic nodules must regress by at least 50% in the SPD. No new sites of disease.

    Disease Progression was defined as a ≥ 50% increase from nadir in the SPD of any previously identified abnormal node and/or the appearance of any new lesion during or at the end of therapy.


  • Obinutuzumab Serum PK Parameter: Terminal Half-Life (t1/2) [ Time Frame: Day 22 (pre-infusion, at end of infusion, 3-6, 20-28, 66-80 hours, 6-8, 12-16, 18-24, 28-56 days post-infusion) ] [ Designated as safety issue: No ]
    Blood was collected for Pharmacokinetic (PK) Parameters before and after dose administration of obinutuzumab in Induction Phase Cycle 4. Serum samples were sent to a central lab and were analyzed for obinutuzumab using a validated enzyme-linked immunosorbent assay (ELISA). Terminal Half-Life was calculated in days.

  • Obinutuzumab Serum PK Parameter: Maximum Serum Concentration (Cmax) [ Time Frame: Day 1 (pre-infusion, at end of infusion, 3-6, 20-28, 66-80 hours post-infusion), Days 8 and 15 (pre-infusion, at end of infusion), Day 22 (pre-infusion, at end of infusion, 3-6, 20-28, 66-80 hours, 6-8, 12-16, 18-24, 28-56 days post-infusion) ] [ Designated as safety issue: No ]
    Blood was collected for PK Parameters before and after dose administration of obinutuzumab in Induction Phase Cycles 1, 2, 3 and 4. Serum samples were sent to a central lab and were analyzed for obinutuzumab using a validated enzyme-linked immunosorbent assay (ELISA). Cmax was calculated in micrograms/milliliter (μg/mL).

  • Obinutuzumab Serum PK Parameter: Area Under the Concentration Curve (AUClast) [ Time Frame: Day 22 (pre-infusion, at end of infusion, 3-6, 20-28, 66-80 hours, 6-8, 12-16, 18-24, 28-56 days post-infusion) ] [ Designated as safety issue: No ]
    Blood was collected for PK Parameters before and after dose administration of obinutuzumab in Induction Phase Cycle 4. Serum samples were sent to a central lab and were analyzed for obinutuzumab using a validated enzyme-linked immunosorbent assay (ELISA). AUClast was calculated in days* micrograms/milliliter (μg/mL)

  • Obinutuzumab Serum PK Parameter: Clearance at Steady-State (CLss) [ Time Frame: Day 22 (pre-infusion, at end of infusion, 3-6, 20-28, 66-80 hours, 6-8, 12-16, 18-24, 28-56 days post-infusion) ] [ Designated as safety issue: No ]
    Blood was collected for PK Parameters before and after dose administration of obinutuzumab in Induction Phase Cycle 4. Serum samples were sent to a central lab and were analyzed for obinutuzumab using a validated enzyme-linked immunosorbent assay (ELISA). CLsst was calculated in milliliter/day (mL/day)

  • Obinutuzumab Serum PK Parameter: Volume of Distribution at Steady-State (Vss) [ Time Frame: Day 22 (pre-infusion, at end of infusion, 3-6, 20-28, 66-80 hours, 6-8, 12-16, 18-24, 28-56 days post-infusion) ] [ Designated as safety issue: No ]
    Blood was collected for PK Parameters before and after dose administration of obinutuzumab in Induction Phase Cycle 4. Serum samples were sent to a central lab and were analyzed for obinutuzumab using a validated enzyme-linked immunosorbent assay (ELISA). Vss was calculated in liters (L).

  • Obinutuzumab Serum PK Parameter: Area Under the Concentration Curve Between Dosing Interval (AUCtau) [ Time Frame: Day 22 (pre-infusion, at end of infusion, 3-6, 20-28, 66-80 hours, 6-8, 12-16, 18-24, 28-56 days post-infusion) ] [ Designated as safety issue: No ]
    Blood was collected for PK Parameters before and after dose administration of obinutuzumab in Induction Phase Cycle 4. Serum samples were sent to a central lab and were analyzed for obinutuzumab using a validated enzyme-linked immunosorbent assay (ELISA). AUCtau was calculated in days* micrograms/milliliter (μg/mL)

  • Obinutuzumab Trough Serum Concentration (Ctrough) [ Time Frame: Days 8 and 15 (pre-infusion, at end of infusion), Day 22 (pre-infusion, at end of infusion, 3-6, 20-28, 66-80 hours, 6-8, 12-16, 18-24, 28-56 days post-infusion) ] [ Designated as safety issue: No ]
    Blood was collected for PK Parameters before and after dose administration of obinutuzumab in Induction Phase Cycles 2, 3 and 4. Serum samples were sent to a central lab and were analyzed for obinutuzumab using a validated enzyme-linked immunosorbent assay (ELISA). Ctrough was calculated in micrograms/milliliter (μg/mL).

  • Number of Participants With Peripheral Blood B-Cell Depletion [ Time Frame: Day 22 ] [ Designated as safety issue: No ]
    Blood was collected and sent to a central laboratory for the evaluation of cluster of differentiation 19 (CD19) by flow cytometry at the end of the induction period. B-cell depletion was defined as a CD19 result 5 % of the Baseline value after at least one dose of study drug was administered.

  • Number of Participants With Peripheral Blood B-Cell Recovery [ Time Frame: End of last dose + 6 Months Follow-Up ] [ Designated as safety issue: No ]
    Blood was sent to a central laboratory for the evaluation of cluster of differentiation 19 (CD19) by flow cytometry. B-cell recovery was defined as the time point when the CD-19 values return to ≥ 50% of baseline levels. The number of participants with B-cell recovery from End of Induction (treatment) Phase to 6 months of Follow-up is reported in two categories: Recovery with Progressive Disease (PD) or Recovery without PD. PD required one of the following: 50 % increase in the absolute number of circulating lymphocytes, Appearance of new palpable lymph nodes, 50 % increase in the longest diameter of any previous site of lymphadenopathy, 50 % increase in the enlargement of the liver and/or spleen or Transformation to a more aggressive histology.

  • Number of Participants With Adverse Events (AE) and Serious Adverse Events (SAE) [ Time Frame: Randomization to Clinical cutoff: 07 March 2013 (Up to 43.2 months) [Includes all AEs reported 28 days after last dose and all Related SAEs regardless of time of last dose.] ] [ Designated as safety issue: No ]
    An AE was defined as any unfavorable and unintended sign (including an abnormal laboratory result), symptom, or disease temporally associated with the use of an investigational medicinal product (IMP) or other protocol-imposed intervention, regardless of attribution. A SAE was any AE that was one of the following: fatal, life-threatening, required or prolonged inpatient hospitalization, resulted in persistent or significant disability/incapacity, a congenital anomaly/birth defect in a neonate/infant born to a mother exposed to the investigational product or considered a significant medical event by the investigator. Additional information about AEs can be found in the Adverse Event Section.

  • Number of Participants With Infusion Related Reactions [ Time Frame: Randomization to Clinical cutoff: 07 March 2013 (Up to 43.2 months) ] [ Designated as safety issue: No ]
    Infusion Related Reactions were AEs that occurred during the infusion or within 24 hours of the infusion.

  • Number of Participants With Human Anti-Chimeric Antibodies (HACA) [ Time Frame: Day 1 ] [ Designated as safety issue: No ]
    Blood was collected on Day 1 and was sent to a central laboratory for analysis of human anti-chimeric antibodies (anti-rituximab antibodies) using a validated enzyme-linked immunosorbent assay (ELISA). HACA samples were not collected for participants randomized to the rituximab arm.

  • Number of Participants With Human Anti-Human Antibodies (HAHA) [ Time Frame: Randomization to Clinical cutoff: 07 March 2013 (Up to 43.2 months) ] [ Designated as safety issue: No ]
    Blood was collected on Day 1 pre-infusion, during the safety follow-up for those patients who did not enter the Extension period and 6 months after the last infusion of the Extension Period if applicable. Blood was sent to a central laboratory and was tested for anti-obinutuzumab antibodies using a validated enzyme-linked immunosorbent assay (ELISA). HAHA samples were not collected for participants randomized to the rituximab arm.


Enrollment: 175
Study Start Date: January 2008
Study Completion Date: March 2013
Primary Completion Date: September 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Obinutuzumab
Participants received 1000 mg obinutuzumab intravenous (IV) infusion once a week on Days 1, 8, 15, and 22 in the Induction Period. 2 months following the last infusion, participants without disease progression, were eligible to receive a 1000 mg IV infusion every two months for 2 years in the Extension Period. All participants received oral acetaminophen/ paracetamol (1000 mg) and an antihistamine such as diphenhydramine (50-100 mg), 30-60 minutes prior to each infusion.
Drug: obinutuzumab (RO5072759)
1000 mg obinutuzumab intravenous (IV) infusion once a week for 4 weeks.
Other Names:
  • RO5072759
  • GA101
  • GAZYVA®
Active Comparator: Rituximab
Participants received 375 mg/m^2 rituximab IV infusion once a week on Days 1, 8, 15 and 22 in the Induction Period. 2 months following the last infusion, participants without disease progression were eligible to receive a 375 mg/m^2 rituximab IV infusion once every two months for 2 years in the Extension Period. All participants received oral acetaminophen/ paracetamol (1000 mg) and an antihistamine such as diphenhydramine (50-100 mg), 30-60 minutes prior to each infusion.
Drug: rituximab
375 mg/m^2 rituximab IV infusion once a week for 4 weeks.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • adult patients, >=18 years of age
  • relapsed CD20+ indolent B-cell non-Hodgkin's lymphoma
  • documented history of response of >/= 6 months duration from last rituximab-containing regimen
  • clinical indication for treatment as determined by the investigator
  • Eastern Cooperative Oncology Group (ECOG) performance status 0-2

Exclusion Criteria:

  • prior use of any investigational monoclonal antibody within 6 months of study start
  • prior use of any anti-cancer vaccine
  • prior use of rituximab within 8 weeks of study entry
  • radioimmunotherapy within 3 months prior to study entry
  • Central Nervous System (CNS) lymphoma or evidence of transformation to high-grade or diffuse large B-cell lymphoma
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00576758

  Hide Study Locations
Locations
United States, California
Los angeles, California, United States, 90024
United States, Colorado
Denver, Colorado, United States, 80220
United States, Florida
Gainesville, Florida, United States, 32610
Tampa, Florida, United States, 33612
United States, Georgia
Augusta, Georgia, United States, 30912
United States, Maryland
Cumberland, Maryland, United States, 21502
United States, New Jersey
Hackensack, New Jersey, United States, 07601
United States, New York
New York, New York, United States, 10065
Rochester, New York, United States, 14642
United States, North Carolina
Concord, North Carolina, United States, 28025
United States, Ohio
Columbus, Ohio, United States, 43219
United States, Texas
Houston, Texas, United States, 77030
United States, Washington
Seattle, Washington, United States, 98109
Argentina
Buenos Aires, Argentina, C1431FWO
Buenos Aires, Argentina, C1221ADC
Buenos Aires, Argentina, 1406
Austria
Innsbruck, Austria, 6020
Salzburg, Austria, 5020
Wien, Austria, 1090
Belgium
Bruxelles, Belgium, 1200
Gent, Belgium, 9000
Mont-godinne, Belgium, 5530
Brazil
Goiania, GO, Brazil, 74140-050
Porto Alegre, RS, Brazil, 90035-903
Piracicaba, SP, Brazil, 13419-155
Sao Paulo, SP, Brazil, 04029-000
Sao Paulo, SP, Brazil, 01323-020
Canada, Alberta
Calgary, Alberta, Canada, T2N 4N2
Canada, British Columbia
Vancouver, British Columbia, Canada, V5Z 4E6
Canada, Ontario
Kingston, Ontario, Canada, K7L 5P9
Toronto, Ontario, Canada, M4N 3M5
Toronto, Ontario, Canada, M5G 2M9
Canada, Quebec
Montreal, Quebec, Canada, H3T 1E2
Montreal, Quebec, Canada, H3A 1A1
Croatia
Rijeka, Croatia, 51000
Zagreb, Croatia, 10000
Denmark
København, Denmark, 2100
Vejle, Denmark, 7100
Århus, Denmark, 8000
Greece
Athens, Greece, 115 27
Thessaloniki, Greece, 570 10
Italy
Bologna, Italy, 40138
Brescia, Italy, 25123
Milano, Italy, 20162
Milano, Italy, 20141
Novara, Italy, 28100
Pisa, Italy, 56100
Reggio Calabria, Italy, 89100
Rozzano, Italy, 20089
Netherlands
Amsterdam, Netherlands, 1105 AZ
Groningen, Netherlands, 9713 GZ
Rotterdam, Netherlands, 3075EA
Rotterdam, Netherlands, 3015 CE
Poland
Warszawa, Poland, 02-097
Warszawa, Poland, 02-781
Spain
Palma de Mallorca, Islas Baleares, Spain, 07198
La Coruna, La Coruña, Spain, 15006
Barcelona, Spain, 08025
Barcelona, Spain, 08035
Madrid, Spain, 28046
Salamanca, Spain, 37007
Sevilla, Spain, 41013
Valencia, Spain, 46010
Zaragoza, Spain, 50009
Sweden
Huddinge, Sweden, 14186
Malmo, Sweden, 205 02
Switzerland
St. Gallen, Switzerland, 9007
Zürich, Switzerland, 8091
Turkey
Istanbul, Turkey, 34365
Izmir, Turkey, 35100
United Kingdom
London, United Kingdom, N6A 4L6
Sponsors and Collaborators
Hoffmann-La Roche
Investigators
Study Director: Clinical Trials Hoffmann-La Roche
  More Information

No publications provided by Hoffmann-La Roche

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Hoffmann-La Roche
ClinicalTrials.gov Identifier: NCT00576758     History of Changes
Other Study ID Numbers: BO21003
Study First Received: December 18, 2007
Results First Received: November 27, 2013
Last Updated: August 15, 2014
Health Authority: Canada: Health Canada

Additional relevant MeSH terms:
Lymphoma
Lymphoma, Non-Hodgkin
Immune System Diseases
Immunoproliferative Disorders
Lymphatic Diseases
Lymphoproliferative Disorders
Neoplasms
Neoplasms by Histologic Type
Obinutuzumab
Rituximab
Antineoplastic Agents
Antirheumatic Agents
Immunologic Factors
Pharmacologic Actions
Physiological Effects of Drugs
Therapeutic Uses

ClinicalTrials.gov processed this record on November 25, 2014