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

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
Genentech
ClinicalTrials.gov Identifier:
NCT01691898
First received: September 16, 2012
Last updated: September 2, 2014
Last verified: September 2014
  Purpose

This randomized, multicenter, open-label study will evaluate the safety and the efficacy of DCDT2980S in combination with MabThera/Rituxan (rituximab) or DCDS45

01A 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:


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 ]

Enrollment: 124
Study Start Date: September 2012
Estimated Study Completion Date: September 2017
Estimated Primary Completion Date: September 2017 (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
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: NCT01691898

  Hide Study Locations
Locations
United States, California
Los Angeles, California, United States, 90048
Stanford, California, United States, 94305-5820
United States, Colorado
Denver, Colorado, United States, 80218
United States, District of Columbia
Washington, District of Columbia, United States, 20057
United States, Florida
Fort Myers, Florida, United States, 33905
Sarasota, Florida, United States, 34232
United States, Michigan
Ann Arbor, Michigan, United States, 48109
United States, Nevada
Las Vegas, Nevada, United States, 89169
United States, New Jersey
Morristown, New Jersey, United States, 07960
United States, New York
Buffalo, New York, United States, 14263
New York, New York, United States, 10016
United States, Ohio
Cincinnati, Ohio, United States, 45242
United States, Oregon
Eugene, Oregon, United States, 97401-8122
Portland, Oregon, United States, 97239
United States, Tennessee
Nashville, Tennessee, United States, 37203
United States, Texas
Dallas, Texas, United States, 75246
San Antonio, Texas, United States, 78217
Tyler, Texas, United States, 75702
United States, Virginia
Fairfax, Virginia, United States, 22031
Roanoke, Virginia, United States, 24014
United States, Washington
Seattle, Washington, United States, 98109
Vancouver, Washington, United States, 98684
Yakima, Washington, United States, 98902
United States, Wisconsin
Madison, Wisconsin, United States, 53705
Canada, Alberta
Edmonton, Alberta, Canada, T6G 1Z2
Canada, British Columbia
Vancouver, British Columbia, Canada, V5Z 1H6
Canada, Quebec
Montreal, Quebec, Canada, H3T 1E2
France
Lille, France, 59037
Montpellier, France, 34295
Paris, France, 75475
Pierre Benite, France, 69495
Rouen, France, 76038
Germany
Heidelberg, Germany, 69120
Mainz, Germany, 55131
München, Germany, 81377
Italy
Bologna, Emilia-Romagna, Italy, 40138
Milano, Lombardia, Italy, 20133
Torino, Piemonte, Italy, 10126
Netherlands
Amsterdam, Netherlands, 1105 AZ
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: September 2, 2014
Health Authority: United States: Food and Drug Administration

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

ClinicalTrials.gov processed this record on September 18, 2014