Know Cancer

or
forgot password

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


Phase 2
18 Years
N/A
Open (Enrolling)
Both
Lymphoma, B-Cell, Lymphoma, Follicular

Thank you

Trial Information

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


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
- 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

Type of Study:

Interventional

Study Design:

Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

Safety: Incidence of adverse events

Outcome Time Frame:

Up to approximately 1 year

Safety Issue:

No

Principal Investigator

Clinical Trials

Investigator Role:

Study Director

Investigator Affiliation:

Genentech

Authority:

United States: Food and Drug Administration

Study ID:

GO27834

NCT ID:

NCT01691898

Start Date:

September 2012

Completion Date:

December 2014

Related Keywords:

  • Lymphoma, B-Cell, Lymphoma, Follicular
  • Lymphoma
  • Lymphoma, Follicular
  • Lymphoma, Non-Hodgkin
  • Lymphoma, B-Cell

Name

Location

Fountain Valley, California  92708
Miami, Florida  33176
Albany, New York  12208
Cleveland, Ohio  44195
Nashville, Tennessee  37203-1632
Austin, Texas  78705
Seattle, Washington  98195
Flint, Michigan  48532
McLean, Virginia  22101
Hackensack, New Jersey  07601
Denver, Colorado  
Boston, Massachusetts  
Eugene, Oregon  
Milwaukee, Wisconsin  
Washington, District of Columbia  
Las Vegas, Nevada  89109