A Study of RO5072759 in Combination With Chemotherapy in Patients With CD20+ B-Cell Follicular Non-Hodgkin's Lymphoma (GAUDI)
Overview[ - collapse ][ - ]
| Purpose | This 6 arm study will assess the safety and efficacy of RO5072759 given in combination with CHOP (cyclophosphamide, doxorubicin, vincristine, prednisone), FC (fludarabine, 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 randomized 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, followed by 800 mg for all subsequent infusions. Previously untreated patients will receive first-line treatment with RO5072759 at a dose of 1000 mg for either a maximum of 8x3 weekly cycles in combination with CHOP or for a maximum of 6x4 weekly cycles in c! ombination with bendamustine. The anticipated time on study treatment is 3-27 months. Patients with complete response or partial response after first line RO5072759 + chemotherapy may receive maintenance treatment with RO5072759 every 3 months for 2 years or until disease progression, whichever comes first. |
|---|---|
| Condition | Non-Hodgkin's Lymphoma |
| Intervention | Drug: RO5072759 Drug: bendamustine Drug: RO5072759 Drug: RO5072759 Drug: RO5072759 Drug: CHOP(cyclophosphamide,doxorubicin,vincristine,prednisone) Drug: FC(fludarabine,cyclophosphamide) |
| Phase | Phase 1 |
| Sponsor | Hoffmann-La Roche |
| Responsible Party | Hoffmann-La Roche |
| ClinicalTrials.gov Identifier | NCT00825149 |
| First Received | January 16, 2009 |
| Last Updated | April 7, 2014 |
| Last verified | April 2014 |
Tracking Information[ + expand ][ + ]
| First Received Date | January 16, 2009 |
|---|---|
| Last Updated Date | April 7, 2014 |
| Start Date | February 2009 |
| Estimated Primary Completion Date | October 2015 |
| Current Primary Outcome Measures | Safety: Incidence of adverse events [Time Frame: up to 6 years] [Designated as safety issue: No] |
| Current Secondary Outcome Measures |
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Descriptive Information[ + expand ][ + ]
| Brief Title | A Study of RO5072759 in Combination With Chemotherapy in Patients With CD20+ B-Cell Follicular Non-Hodgkin's Lymphoma (GAUDI) |
|---|---|
| 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 |
| Brief Summary | This 6 arm study will assess the safety and efficacy of RO5072759 given in combination with CHOP (cyclophosphamide, doxorubicin, vincristine, prednisone), FC (fludarabine, 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 randomized 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, followed by 800 mg for all subsequent infusions. Previously untreated patients will receive first-line treatment with RO5072759 at a dose of 1000 mg for either a maximum of 8x3 weekly cycles in combination with CHOP or for a maximum of 6x4 weekly cycles in c! ombination with bendamustine. The anticipated time on study treatment is 3-27 months. Patients with complete response or partial response after first line RO5072759 + chemotherapy may receive maintenance treatment with RO5072759 every 3 months for 2 years or until disease progression, whichever comes first. |
| Detailed Description | Not Provided |
| Study Type | Interventional |
| Study Phase | Phase 1 |
| Study Design | Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment |
| Condition | Non-Hodgkin's Lymphoma |
| Intervention | 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 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 Drug: RO5072759 400mg iv on days 1 and 8 of first cycle, and on day 1 of each subsequent cycle Drug: RO5072759 1600mg iv on days 1 and 8 of first cycle, followed by 800mg iv on day 1 of each subsequent cycle Drug: CHOP(cyclophosphamide,doxorubicin,vincristine,prednisone) As prescribed, for 8x3week cycles Drug: FC(fludarabine,cyclophosphamide) As prescribed, for 6x4week cycles |
| Study Arm (s) |
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Recruitment Information[ + expand ][ + ]
| Recruitment Status | Active, not recruiting |
|---|---|
| Estimated Enrollment | 137 |
| Estimated Completion Date | October 2015 |
| Estimated Primary Completion Date | October 2015 |
| Eligibility 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 |
| Gender | Both |
| Ages | 18 Years |
| Accepts Healthy Volunteers | No |
| Contacts | Not Provided |
| Location Countries | Australia, France, Germany, Italy, Spain, United Kingdom |
Administrative Information[ + expand ][ + ]
| NCT Number | NCT00825149 |
|---|---|
| Other Study ID Numbers | BO21000 |
| Has Data Monitoring Committee | Not Provided |
| Information Provided By | Hoffmann-La Roche |
| Study Sponsor | Hoffmann-La Roche |
| Collaborators | Not Provided |
| Investigators | Study Director: Clinical Trials Hoffmann-La Roche |
| Verification Date | April 2014 |
Locations[ + expand ][ + ]
| Australia, New South Wales | Kogarah, New South Wales, Australia, 2217 |
|---|---|
| Australia, New South Wales | Sydney, New South Wales, Australia, 2145 |
| Australia, Queensland | Greenslopes, Queensland, Australia, 4120 |
| Australia, Queensland | Woolloongabba, Queensland, Australia, 4102 |
| Australia, South Australia | Kurralta Park, South Australia, Australia, 5037 |
| Australia, Victoria | Frankston, Victoria, Australia, 3199 |
| Australia, Victoria | Melbourne, Victoria, Australia, 3002 |
| Australia, Victoria | Melbourne, Victoria, Australia, 3084 |
| France | Lille, France, 59037 |
| France | Montpellier, France, 34295 |
| France | Pierre Benite, France, 69495 |
| Germany | Aschaffenburg, Germany, 63739 |
| Germany | Freiburg, Germany, 79106 |
| Germany | Göttingen, Germany, 37075 |
| Germany | Heidelberg, Germany, 69120 |
| Germany | Kiel, Germany, 24116 |
| Germany | Köln, Germany, 50924 |
| Germany | Muenchen, Germany, 81377 |
| Germany | Ulm, Germany, 89081 |
| Germany | Wuerzburg, Germany, 97080 |
| Italy, Lazio | Roma, Lazio, Italy, 00161 |
| Italy, Lombardia | Milano, Lombardia, Italy, 20132 |
| Italy, Piemonte | Torino, Piemonte, Italy, 10126 |
| Spain | Barcelona, Spain, 08036 |
| Spain | Barcelona, Spain, 08003 |
| Spain | Barcelona, Spain, 08035 |
| Spain | Salamanca, Spain, 37007 |
| Spain | Valencia, Spain, 46026 |
| United Kingdom | Leicester, United Kingdom, LE1 5WW |
| United Kingdom | London, United Kingdom, SE5 9RS |
| United Kingdom | Manchester, United Kingdom, M20 4BX |
| United Kingdom | Plymouth, United Kingdom, PL6 8DH |
| United Kingdom | Southampton, United Kingdom, SO16 6YD |
| United Kingdom | Truro, United Kingdom, TR1 3LJ |