A Study of DCDT2980S in Combination With MabThera/Rituxan or DCDS4501A in Combination With MabThera/Rituxan in Patients With Non-Hodgkin's Lymphoma - Full Text View

Purpose

This randomized, multicenter, open-label study will evaluate the safety and the efficacy of DCDT2980S in combination with MabThera/Rituxan (rituximab) or DCDS4501A in combination with MabThera/Rituxan in patients with relapsed or refractory follicular non-Hodgkin's lymphoma and relapsed/refractory diffuse large B-cell lymphoma.

Condition	Intervention	Phase
Lymphoma, B-Cell, Lymphoma, Follicular	Drug: DCDT2980S Drug: DCDS4501A Drug: rituximab [MabThera/Rituxan]	Phase 2

Study Type:	Interventional
Study Design:	Allocation: Non-Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Single Group Assignment Masking: Open Label Primary Purpose: Treatment
Official Title:	A Randomized, Open-Label, Multicenter, Phase II Trial Evaluating the Safety and Activity of DCDT2980S in Combination With Rituximab or DCDS4501A in Combination With Rituximab in Patients With Relapsed or Refractory B-cell Non Hodgkin's Lymphoma

Resource links provided by NLM:

MedlinePlus related topics: Lymphoma

Drug Information available for: Rituximab

U.S. FDA Resources

Further study details as provided by Genentech:

Primary Outcome Measures:

Safety: Incidence of adverse events [ Time Frame: Up to approximately 1 year ] [ Designated as safety issue: No ]
Objective response according to standard criteria for non-Hodgkin's lymphoma [ Time Frame: Up to approximately 1 year ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

Incidence of antibody formation to study drug [ Time Frame: Up to approximately 1 year ] [ Designated as safety issue: No ]
Duration of objective response according to standard criteria for non-Hodgkin's lymphoma [ Time Frame: Up to approximately 1 year ] [ Designated as safety issue: No ]
Progression-free survival (PFS) according to standard criteria for non-Hodgkin's lymphoma [ Time Frame: Up to approximately 1 year ] [ Designated as safety issue: No ]
Pharmacokinetics: Area under the concentration-time curve (AUC) [ Time Frame: Up to approximately 1 year ] [ Designated as safety issue: No ]
Pharmacokinetics: Maximum plasma and serum concentration (Cmax) [ Time Frame: Up to approximately 1 year ] [ Designated as safety issue: No ]
Pharmacokinetics: Clearance (CL) [ Time Frame: Up to approximately 1 year ] [ Designated as safety issue: No ]
Pharmacokinetics: Terminal half-life (t1/2) [ Time Frame: Up to approximately 1 year ] [ Designated as safety issue: No ]
Pharmacokinetics: Steady state volume of distribution (Vss) [ Time Frame: Up to approximately 1 year ] [ Designated as safety issue: No ]

Estimated Enrollment:	120
Study Start Date:	September 2012
Estimated Study Completion Date:	December 2014
Estimated Primary Completion Date:	December 2014 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
Experimental: DCDT2980S in combination with MabThera/Rituxan	Drug: DCDT2980S Repeating intravenous dose Drug: rituximab [MabThera/Rituxan] Repeating intravenous dose
Experimental: DCDS4501A in combination with MabThera/Rituxan	Drug: DCDS4501A Repeating intravenous dose Drug: rituximab [MabThera/Rituxan] Repeating intravenous dose

Eligibility

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

Criteria

Inclusion Criteria:

Eastern Cooperative Oncology Group (ECOG) Performance Status of 0, 1, or 2
Life expectancy of at least 12 weeks
History of histologically documented relapsed or refractory Grades 1-3a follicular lymphoma, or relapsed or refractory diffuse large B-cell lymphoma
Availability of an archival or freshly biopsied tumor tissue sample must be confirmed for study enrollment
Have a clinical indication for treatment as determined by the investigator
Must have at least one bi-dimensionally measurable lesion (>1.5 cm in its largest dimension by CT scan or MRI)

Exclusion Criteria:

Prior use of any monoclonal antibody, radioimmuno-conjugate or antibody drug conjugate within 4 weeks before study start
Treatment with radiotherapy, chemotherapy, immunotherapy, immunosuppressive therapy, or any investigational anti-cancer agent within 2 weeks prior study start
Adverse events except for sensory neuropathy from any previous treatments must be resolved or stabilized to Grade </=2 prior study start
Completion of autologous stem cell transplant within 100 days prior study start
Prior allogeneic stem cell transplant
Eligibility for autologous SCT (patients with relapsed or refractory DLBCL)
History of severe allergic or anaphylactic reactions to monoclonal antibody therapy (or recombinant antibody-related fusion proteins)
History of other malignancy that could affect compliance with the protocol or interpretation of results
Current or past history of CNS lymphoma
Current Grade > 1 peripheral neuropathy

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT01691898

Contacts

Contact: Reference Study ID Number: GO27834 www.roche.com/about_roche/roche_worldwide.htm

888-662-6728 (U.S. Only)

global.rochegenentechtrials@roche.com

Show 42 Study Locations

Sponsors and Collaborators

Genentech

Investigators

Study Director:

Clinical Trials

Genentech

More Information

No publications provided

Responsible Party:	Genentech
ClinicalTrials.gov Identifier:	NCT01691898 History of Changes
Other Study ID Numbers:	GO27834, 2011-004377-84
Study First Received:	September 16, 2012
Last Updated:	June 7, 2013
Health Authority:	United States: Food and Drug Administration

Additional relevant MeSH terms:

Lymphoma
Lymphoma, Follicular
Lymphoma, Non-Hodgkin
Lymphoma, B-Cell
Neoplasms by Histologic Type
Neoplasms
Lymphoproliferative Disorders
Lymphatic Diseases
Immunoproliferative Disorders

Immune System Diseases
Rituximab
Immunologic Factors
Physiological Effects of Drugs
Pharmacologic Actions
Antirheumatic Agents
Therapeutic Uses
Antineoplastic Agents

ClinicalTrials.gov processed this record on June 18, 2013