An Open-Label, Multicenter, Phase I Trial of the Safety and Pharmacokinetics of Escalating Doses of DCDT2980S in Patients With Relapsed or Refractory B-Cell Non-Hodgkin's Lymphoma and Chronic Lymphocytic Leukemia And DCDT2980S in Combination With Rituximab in Patients With Relapsed or Refractory B-Cell Non Hodgkin's Lymphoma
Phase 1
18 Years
N/A
18 Years
N/A
Open (Enrolling)
Both
Chronic Lymphocytic Leukemia, Non-Hodgkin's Lymphoma
Both
Chronic Lymphocytic Leukemia, Non-Hodgkin's Lymphoma
Trial Information
An Open-Label, Multicenter, Phase I Trial of the Safety and Pharmacokinetics of Escalating Doses of DCDT2980S in Patients With Relapsed or Refractory B-Cell Non-Hodgkin's Lymphoma and Chronic Lymphocytic Leukemia And DCDT2980S in Combination With Rituximab in Patients With Relapsed or Refractory B-Cell Non Hodgkin's Lymphoma
Inclusion Criteria:
- Life expectancy of at least 12 weeks
- History of histologically-documented hematologic malignancy for which no effective
standard therapy exists: indolent NHL (including Grades 1-3a FL; MZL [including
splenic, nodal, and extra-nodal]; and SLL), Grade 3b FL, DLBCL, MCL, or CLL
- Must have at least one bi-dimensionally measurable lesion
Exclusion Criteria:
- Prior use of any monoclonal antibody or antibody-drug conjugate within 4 weeks prior
to study treatment
- Treatment with radiotherapy, any chemotherapeutic agent, or treatment with any other
investigational anti-cancer agent within 2 weeks prior to of study treatment
- Completion of autologous stem cell transplant within 100 days prior to study
treatment
- Prior allogeneic stem cell transplant
Type of Study:
Interventional
Study Design:
Allocation: Non-Randomized, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Outcome Measure:
Incidence and nature of dose-limiting toxicities (DLTs)
Outcome Time Frame:
Throughout study or until early discontinuation
Safety Issue:
No
Principal Investigator
Clinical Trials
Investigator Role:
Study Director
Investigator Affiliation:
Genentech
Authority:
United States: Food and Drug Administration
Study ID:
DCT4862g
NCT ID:
NCT01209130
Start Date:
October 2010
Completion Date:
September 2013
Related Keywords:
- Chronic Lymphocytic Leukemia, Non-Hodgkin's Lymphoma
- Leukemia
- Leukemia, Lymphocytic, Chronic, B-Cell
- Leukemia, Lymphoid
- Lymphoma
- Lymphoma, Non-Hodgkin
- Lymphoma, B-Cell
Name | Location |
|---|---|
| Fountain Valley, California 92708 | |
| Flint, Michigan 48532 | |
| Hackensack, New Jersey 07601 | |
| Denver, Colorado | |
| Boston, Massachusetts | |
| Eugene, Oregon | |
| Milwaukee, Wisconsin | |
| Washington, District of Columbia |
