A Study of RO5072759 in Combination With Chemotherapy in Patients With CD20+ B-Cell Follicular Non-Hodgkin's Lymphoma (GAUDI)

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
Hoffmann-La Roche
ClinicalTrials.gov Identifier:
NCT00825149
First received: January 16, 2009
Last updated: August 26, 2014
Last verified: August 2014
  Purpose

This 6 arm study will assess the safety and efficacy of RO5072759 given in combi nation with CHOP (cyclophosphamide, doxorubicin, vincristine, prednisone), FC (f ludarabine, cyclophosphamide) or bendamustine chemotherapy in patients with CD20

+ B-cell follicular non-Hodgkin's lymphoma. Patients with relapsed or refractory disease will be assigned by physician choice to either the CHOP treatment arm, to receive a maximum of 8x3weekly cycles of treatment, or the FC treatment arm, to receive a maximum of 6x4weekly cycles of treatment, and will then be randomiz ed to receive combination treatment with RO5072759 either at a dose of 400 mg iv for all infusions, or at a dose of 1600 mg iv for the first 2 infusions, follow ed by 800 mg for all subsequent infusions. Previously untreated patients will re ceive first-line treatment with RO5072759 at a dose of 1000 mg for either a maxi mum of 8x3 weekly cycles in combination with CHOP or for a maximum of 6x4 weekly cycles in combination with bendamustine. The anticipated time on study treatmen t is 3-27 months. Patients with complete response or partial response after fir st line RO5072759 + chemotherapy may receive maintenance treatment with RO507275 9 every 3 months for 2 years or until disease progression, whichever comes first


Condition Intervention Phase
Non-Hodgkin's Lymphoma
Drug: CHOP(cyclophosphamide,doxorubicin,vincristine,prednisone)
Drug: FC(fludarabine,cyclophosphamide)
Drug: RO5072759
Drug: bendamustine
Phase 1

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-centre, Randomized, Phase Ib Study to Investigate the Safety and Efficacy of RO5072759 Given in Combination With CHOP, FC or Bendamustine Chemotherapy in Patients With CD20+ B-cell Follicular Non-Hodgkin's Lymphoma

Resource links provided by NLM:


Further study details as provided by Hoffmann-La Roche:

Primary Outcome Measures:
  • Safety: Incidence of adverse events [ Time Frame: up to 6 years ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Overall response rate :assessments according to the Criteria for evaluation of response in Non-Hodgkin's Lymphoma (International Workshop to Standardize Response criteria for NHL) [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]
  • Complete response rate: assessments according to the Criteria for evaluation of response in Non-Hodgkin's Lymphoma (International Workshop to Standardize Response criteria for NHL) [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]
  • Progression- and event-free survival [ Time Frame: up to 6 years ] [ Designated as safety issue: No ]
  • Pharmacokinetics of RO5072759 (AUC, Cmax, CL) [ Time Frame: 26 weeks ] [ Designated as safety issue: No ]
  • Pharmacodynamics: peripheral blood B-cell depletion and recovery [ Time Frame: up to 27 months ] [ Designated as safety issue: No ]

Enrollment: 137
Study Start Date: February 2009
Estimated Study Completion Date: October 2015
Estimated Primary Completion Date: October 2015 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 1 Drug: CHOP(cyclophosphamide,doxorubicin,vincristine,prednisone)
As prescribed, for 8x3week cycles
Drug: RO5072759
400mg iv on days 1 and 8 of first cycle, and on day 1 of each subsequent cycle
Experimental: 2 Drug: FC(fludarabine,cyclophosphamide)
As prescribed, for 6x4week cycles
Drug: RO5072759
400mg iv on days 1 and 8 of first cycle, and on day 1 of each subsequent cycle
Experimental: 3 Drug: CHOP(cyclophosphamide,doxorubicin,vincristine,prednisone)
As prescribed, for 8x3week cycles
Drug: RO5072759
1600mg iv on days 1 and 8 of first cycle, followed by 800mg iv on day 1 of each subsequent cycle
Experimental: 4 Drug: FC(fludarabine,cyclophosphamide)
As prescribed, for 6x4week cycles
Drug: RO5072759
1600mg iv on days 1 and 8 of first cycle, followed by 800mg iv on day 1 of each subsequent cycle
Experimental: 5 Drug: CHOP(cyclophosphamide,doxorubicin,vincristine,prednisone)
As prescribed, for 8x3week cycles
Drug: RO5072759
1000 mg iv on days 1 and 8 of first cycle, and on day 1 of each subsequent cycle
Experimental: 6 Drug: RO5072759
1000 mg iv on days 1 and 8 of first cycle, and on day 1 of each subsequent cycle
Drug: bendamustine
As prescribed, for 6x4 weekly cycles
Experimental: Maintenance Drug: RO5072759
Patients with complete response or partial response after completion of 1st line RO5072759 + chemotherapy may receive mainentance treatment with RO5072759 every 3 month for 2 years or until disease progression, whichever comes first

  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
  • Either CD20+ relapsed or refractory B-cell follicular non-Hodgkin's lymphoma (after a maximum of 2 prior chemotherapy regimens) or CD20+ B-cell follicular non-Hodgkin's lymphoma with no prior systemic therapy
  • ECOG performance status of 0-2

Exclusion Criteria:

  • Prior administration of rituximab within 8 weeks of study entry, or 3 months for any radioimmunotherapy
  • Central nervous lymphoma
  • History of other malignancies within 2 years of study entry which could affect compliance with the protocol or interpretation of results
  • Active infection, or any major episode of infection requiring hospitalization or treatment with iv antibiotics within 4 weeks of dosing
  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: NCT00825149

  Show 34 Study Locations
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: NCT00825149     History of Changes
Other Study ID Numbers: BO21000, 2008-001643-19
Study First Received: January 16, 2009
Last Updated: August 26, 2014
Health Authority: France:AFSSAPS

Additional relevant MeSH terms:
Lymphoma
Lymphoma, Follicular
Lymphoma, Non-Hodgkin
Neoplasms by Histologic Type
Neoplasms
Lymphoproliferative Disorders
Lymphatic Diseases
Immunoproliferative Disorders
Immune System Diseases
Cyclophosphamide
Bendamustine
Fludarabine
Obinutuzumab
Doxorubicin
Prednisone
Vincristine
Immunosuppressive Agents
Immunologic Factors
Physiological Effects of Drugs
Pharmacologic Actions
Antirheumatic Agents
Therapeutic Uses
Antineoplastic Agents, Alkylating
Alkylating Agents
Molecular Mechanisms of Pharmacological Action
Antineoplastic Agents
Myeloablative Agonists
Antibiotics, Antineoplastic
Topoisomerase II Inhibitors
Topoisomerase Inhibitors

ClinicalTrials.gov processed this record on September 14, 2014