Trial record 1 of 1 for:    NCT01691898
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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: April 7, 2014
Last verified: April 2014
  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:


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: December 2015
Estimated Primary Completion Date: December 2015 (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

  Show 39 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: April 7, 2014
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 April 16, 2014