A Study of Obinutuzumab (RO5072759) Plus Chemotherapy in Comparison With MabThera/Rituxan (Rituximab) Plus Chemotherapy Followed by GA101 or MabThera/Rituxan Maintenance in Patients With Untreated Advanced Indolent Non-Hodgkin's Lymphoma (GALLIUM)

This study is ongoing, but not recruiting participants.
Sponsor:
Collaborators:
German Low Grade Lymphoma Study Group
Institute of Cancer Research, United Kingdom
Information provided by (Responsible Party):
Hoffmann-La Roche
ClinicalTrials.gov Identifier:
NCT01332968
First received: April 8, 2011
Last updated: August 26, 2014
Last verified: August 2014
  Purpose

This open-label, randomized study will assess the efficacy and safety of obinutu zumab (RO5072759) in combination with chemotherapy compared to MabThera/Rituxan (rituximab) with chemotherapy followed by obinutuzumab or MabThera/Rituxan maint enance in patients with untreated advanced indolent non-Hodgkin's lymphoma. Afte r the end of the induction period, patients achieving response (CR or PR) will g

o on to a maintenance period thereby continuing on their randomized antibody tre atment alone every 2 months until disease progression for a total of 2 years. An ticipated time on study treatment is up to approximately 2.5 years. After mainte nance or observation patients will be followed for 5 years until progression. Af ter progression, patients will be followed for new anti-lymphoma therapy and ove rall survival until the end of the study.


Condition Intervention Phase
Non-Hodgkin's Lymphoma
Drug: RO5072759
Drug: chemotherapy
Drug: rituximab [MabThera/Rituxan]
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: A Multicentre, Phase III, Open Label, Randomized Study in Previously Untreated Patients With Advanced Indolent Non-Hodgkin's Lymphoma Evaluating the Benefit of GA101 (RO5072759) + Chemotherapy Compared to Rituximab + Chemotherapy Followed by GA101 or Rituximab Maintenance Therapy in Responders.

Resource links provided by NLM:


Further study details as provided by Hoffmann-La Roche:

Primary Outcome Measures:
  • Progression-free survival in patients with follicular lymphoma, investigator-assessed according to the Revised Response Criteria for Malignant Lymphoma [ Time Frame: up to approximately 7.5 years ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Progression-free survival in the overall study population, investigator-assessed [ Time Frame: up to approximately 7.5 years ] [ Designated as safety issue: No ]
  • Progression-free survival, Independent Review Committee - assessed [ Time Frame: up to approximately 7.5 years ] [ Designated as safety issue: No ]
  • Response (overall response and complete response), investigator-assessed [ Time Frame: 168 days ] [ Designated as safety issue: No ]
  • Response (overall response and complete response), Independent Review Committee - assessed [ Time Frame: 168 days ] [ Designated as safety issue: No ]
  • Overall survival [ Time Frame: up to approximately 10.7 years ] [ Designated as safety issue: No ]
  • Event-free survival [ Time Frame: up to approximately 7.5 years ] [ Designated as safety issue: No ]
  • Disease-free survival [ Time Frame: up to approximately 7.5 years ] [ Designated as safety issue: No ]
  • Duration of response [ Time Frame: up to approximately 7.5 years ] [ Designated as safety issue: No ]
  • Time to next anti-lymphoma treatment [ Time Frame: up to approximately 10.7 years ] [ Designated as safety issue: No ]
  • Safety: Incidence of adverse events [ Time Frame: up to approximately 10.7 years ] [ Designated as safety issue: No ]
  • Patient-reported outcomes (Functional Assessment of Cancer Therapy for Lymphoma scale, EuroQol EQ-5D questionnaire) [ Time Frame: up to approximately 7.5 years ] [ Designated as safety issue: No ]
  • Medical resource utilization (hospitalizations, subsequent drug therapies, medical and surgical procedures) [ Time Frame: up to approximately 7.5 years ] [ Designated as safety issue: No ]

Enrollment: 1401
Study Start Date: July 2011
Estimated Study Completion Date: March 2017
Estimated Primary Completion Date: February 2017 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: A Drug: chemotherapy
CHOP (6 cycles of 21 days), CVP (8 cycles of 21 days), Bendamustine (6 cycles of 28 days). Patients with follicular lymphoma are receiving either CHOP, CVP or Bendamustine as background chemotherapy as selected by each participating site at study start. Background chemotherapy for patients with non-follicular lymphoma will be chosen by the site individually for each patient.
Drug: rituximab [MabThera/Rituxan]
375 mg/m2 iv on Day 1 of Cycles 1-8 (21-day cycles) or Cycles 1-6 (28-day cycles); followed by 375 mg/m2 iv every 2 months in responders until disease progression, for up to 2 years
Experimental: B Drug: RO5072759
1000 mg iv on Days 1, 8 and 15 of Cycle 1 and on Day 1 of Cycles 2-8 (21-day cycles) or Cycles 2-6 (28-day cycles); followed by 1000 mg iv every 2 months in responders until disease progression, for up to 2 years
Other Name: GA101
Drug: chemotherapy
CHOP (6 cycles of 21 days), CVP (8 cycles of 21 days), Bendamustine (6 cycles of 28 days). Patients with follicular lymphoma are receiving either CHOP, CVP or Bendamustine as background chemotherapy as selected by each participating site at study start. Background chemotherapy for patients with non-follicular lymphoma will be chosen by the site individually for each patient.

  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
  • CD20-positive indolent B-cell non-Hodgkin's lymphoma (follicular lymphoma or splenic, nodal or extranodal marginal zone lymphoma)
  • Stage III or IV disease, or Stage II bulky disease (defined as tumour diameter >/= 7 cm), requiring treatment
  • For patients with follicular lymphoma: requirement for treatment according to GELF criteria
  • For patients with symptomatic marginal zone lymphoma: disease that is de novo or has relapsed following local therapy (i.e. surgery or radiotherapy) and requires therapy as assessed by the investigator
  • At least one bi-dimensionally measurable lesion (>2 cm in its largest dimension by CT scan or MRI)
  • Eastern Cooperative Oncology Group (ECOG) performance status 0, 1 or 2
  • Adequate hematologic function

Exclusion Criteria:

  • Central nervous system lymphoma, leptomeningeal lymphoma, or histological evidence of transformation to a high-grade or diffuse large B-cell lymphoma
  • Grade 3b follicular lymphoma, small lymphocytic lymphoma or Waldenström's macroglobulinaemia
  • Ann Arbor Stage I disease
  • History of severe allergic or anaphylactic reactions to monoclonal antibody therapy, known hypersensitivity to any of the study drugs or sensitivity to murine products, or history of sensitivity to mannitol
  • For patients with follicular lymphoma: prior treatment for non-Hodgkin's lymphoma with chemotherapy, immunotherapy, or radiotherapy
  • For patients with non-follicular lymphoma: prior treatment with chemotherapy or immunotherapy
  • Regular treatment with corticosteroids during the 4 weeks prior to the start of Cycle 1
  • Evidence of significant, uncontrolled concomitant diseases that could affect compliance with the protocol or interpretation of results
  • For patients who will be receiving CHOP: LVEF <50% by MUGA scan or echocardiogram
  • History of prior malignancy with the exception of curatively treated basal or squamous cell carcinoma of the skin and low-grade in situ carcinoma of the cervix
  • Known active infection, or major episode of infection within 4 week prior to the start of Cycle 1
  • Vaccination with a live vaccine within 28 days prior to randomization
  • Recent major surgery (within 4 weeks prior to start of Cycle 1), other than for diagnosis
  • Abnormal laboratory values as defined by protocol for creatinine, creatinine clearance, AST or ALT, total bilirubin, INR, PTT or aPPT, unless these abnormalities are due to underlying lymphoma
  • Positive as per protocol definition for HIV, HTLV1, hepatitis C or chronic hepatitis B
  • Pregnant or lactating women
  • Life expectancy < 12 months
  • Participation in another clinical trial with drug intervention within 28 days prior to start of Cycle 1 and during study
  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: NCT01332968

  Show 199 Study Locations
Sponsors and Collaborators
Hoffmann-La Roche
German Low Grade Lymphoma Study Group
Institute of Cancer Research, United Kingdom
Investigators
Study Director: Clinical Trials Hoffmann-La Roche
  More Information

No publications provided

Responsible Party: Hoffmann-La Roche
ClinicalTrials.gov Identifier: NCT01332968     History of Changes
Other Study ID Numbers: BO21223
Study First Received: April 8, 2011
Last Updated: August 26, 2014
Health Authority: United States: Food and Drug Administration

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

ClinicalTrials.gov processed this record on September 18, 2014