A Study of RO5072759 in Combination With Chemotherapy in Patients With CD20+ B-Cell Follicular Non-Hodgkin's Lymphoma (GAUDI)
This study is currently recruiting participants.
Verified May 2013 by Hoffmann-La Roche
Sponsor:
Hoffmann-La Roche
Information provided by (Responsible Party):
Hoffmann-La Roche
ClinicalTrials.gov Identifier:
NCT00825149
First received: January 16, 2009
Last updated: May 7, 2013
Last verified: May 2013
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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 combination 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 | Intervention | Phase |
|---|---|---|
|
Non-Hodgkin's Lymphoma |
Drug: RO5072759 Drug: CHOP(cyclophosphamide,doxorubicin,vincristine,prednisone) Drug: FC(fludarabine,cyclophosphamide) 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:
Drug Information available for:
Cyclophosphamide
Prednisone
Vincristine sulfate
Bendamustine hydrochloride
Bendamustine
Fludarabine
Doxorubicin
Doxorubicin hydrochloride
Fludarabine phosphate
U.S. FDA Resources
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 ]
| Estimated Enrollment: | 136 |
| Study Start Date: | February 2009 |
| Estimated Study Completion Date: | March 2016 |
| Estimated Primary Completion Date: | March 2016 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
| Experimental: 1 |
Drug: RO5072759
400mg iv on days 1 and 8 of first cycle, and on day 1 of each subsequent cycle
Drug: CHOP(cyclophosphamide,doxorubicin,vincristine,prednisone)
As prescribed, for 8x3week cycles
|
| Experimental: 2 |
Drug: RO5072759
400mg iv on days 1 and 8 of first cycle, and on day 1 of each subsequent cycle
Drug: FC(fludarabine,cyclophosphamide)
As prescribed, for 6x4week cycles
|
| Experimental: 3 |
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
|
| Experimental: 4 |
Drug: RO5072759
1600mg iv on days 1 and 8 of first cycle, followed by 800mg iv on day 1 of each subsequent cycle
Drug: FC(fludarabine,cyclophosphamide)
As prescribed, for 6x4week cycles
|
| 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
Please refer to this study by its ClinicalTrials.gov identifier: NCT00825149
Contacts
| Contact: Please reference Study ID Number: BO21000 www.roche.com/about_roche/roche_worldwide.htm | 888-662-6728 (U.S. Only) | genentechclinicaltrials@druginfo.com |
Locations
| Australia | |
| Active, not recruiting | |
| Frankston, Australia, 3199 | |
| Active, not recruiting | |
| Greenslopes, Australia, 4120 | |
| Active, not recruiting | |
| Kogarah, Australia, 2217 | |
| Active, not recruiting | |
| Melbourne, Australia, 3002 | |
| Active, not recruiting | |
| Melbourne, Australia, 3084 | |
| Active, not recruiting | |
| Sydney, Australia, 2145 | |
| Active, not recruiting | |
| Woolloongabba, Australia, 4102 | |
| France | |
| Active, not recruiting | |
| Lille, France, 59037 | |
| Active, not recruiting | |
| Montpellier, France, 34295 | |
| Active, not recruiting | |
| Pierre Benite, France, 69495 | |
| Germany | |
| Active, not recruiting | |
| Aschaffenburg, Germany, 63739 | |
| Active, not recruiting | |
| Freiburg, Germany, 79106 | |
| Terminated | |
| Göttingen, Germany, 37075 | |
| Active, not recruiting | |
| Heidelberg, Germany, 69120 | |
| Completed | |
| Kiel, Germany, 24116 | |
| Completed | |
| Köln, Germany, 50924 | |
| Active, not recruiting | |
| Muenchen, Germany, 81377 | |
| Terminated | |
| ULM, Germany, 89081 | |
| Active, not recruiting | |
| Würzburg, Germany, 97070 | |
| Italy | |
| Completed | |
| Milano, Italy, 20132 | |
| Recruiting | |
| Roma, Italy, 00161 | |
| Active, not recruiting | |
| Torino, Italy, 10126 | |
| Spain | |
| Active, not recruiting | |
| Barcelona, Spain, 08036 | |
| Active, not recruiting | |
| Barcelona, Spain, 08003 | |
| Active, not recruiting | |
| Barcelona, Spain, 08035 | |
| Active, not recruiting | |
| Salamanca, Spain, 37007 | |
| Active, not recruiting | |
| Valencia, Spain, 46009 | |
| United Kingdom | |
| Active, not recruiting | |
| Leicester, United Kingdom, LE1 5WW | |
| Active, not recruiting | |
| London, United Kingdom, SE5 9RS | |
| Active, not recruiting | |
| Manchester, United Kingdom, M20 4BX | |
| Active, not recruiting | |
| Plymouth, United Kingdom, PL6 8DH | |
| Active, not recruiting | |
| Southampton, United Kingdom, SO16 6YD | |
| Active, not recruiting | |
| Truro, United Kingdom, TR1 3LJ | |
Sponsors and Collaborators
Hoffmann-La Roche
Investigators
| Study Director: | Clinical Trials | Hoffmann-La Roche |
More Information
No publications provided
| 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: | May 7, 2013 |
| 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 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 Glucocorticoids Hormones Hormones, Hormone Substitutes, and Hormone Antagonists |
ClinicalTrials.gov processed this record on May 21, 2013