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An Open-Label, Multicenter, Phase I Trial of the Safety and Pharmacokinetics Of Escalating Doses of DCDS4501A in Patients With Relapsed or Refractory B-Cell Non-Hodgkin's Lymphoma and Chronic Lymphocytic Leukemia and DCDS4501A in Combination With Rituximab in Patients With Relapsed or Refractory B-Cell Non-Hodgkin's Lymphoma


Phase 1
18 Years
N/A
Open (Enrolling)
Both
Non-Hodgkin's Lymphoma, Chronic Lymphocytic Leukemia

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Trial Information

An Open-Label, Multicenter, Phase I Trial of the Safety and Pharmacokinetics Of Escalating Doses of DCDS4501A in Patients With Relapsed or Refractory B-Cell Non-Hodgkin's Lymphoma and Chronic Lymphocytic Leukemia and DCDS4501A 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 one of the following histologically-documented hematologic malignancy for
which no effective standard therapy exists: indolent non Hodgkin's lymphoma (NHL),
Grade 3b FL, diffuse large B-cell lymphoma (DLBCL), mantle cell lymphoma (MCL), or
chronic lymphocytic leukemia (CLL)

- All patients (NHL and B-CLL) must have at least one bi-dimensionally measurable
lesion

- For all men or women of childbearing potential (unless surgically sterile): use of
adequate methods of contraception such as oral contraceptives, intrauterine device,
or barrier method of contraception in conjunction with spermicidal jelly

Exclusion Criteria:

- Prior use of any monoclonal antibody or antibody-drug conjugate within 4 weeks before
Cycle 1, Day 1

- Treatment with radiotherapy, any chemotherapeutic agent, or treatment with any other
investigational anti-cancer agent within 2 weeks prior to Cycle 1, Day 1. Adverse
events from any previous treatments must be resolved or stabilized prior to Cycle 1,
Day 1, except for neuropathy

- Completion of autologous stem cell transplant within 100 days prior to Cycle 1, Day 1

- Prior allogeneic stem cell transplant

Type of Study:

Interventional

Study Design:

Allocation: Randomized, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

Incidence of dose-limiting toxicities (DLTs)

Outcome Time Frame:

21 days

Safety Issue:

No

Principal Investigator

Yu-Waye Chu, M.D.

Investigator Role:

Study Director

Investigator Affiliation:

Genentech

Authority:

United States: Food and Drug Administration

Study ID:

DCS4968g

NCT ID:

NCT01290549

Start Date:

March 2011

Completion Date:

January 2014

Related Keywords:

  • Non-Hodgkin's Lymphoma, Chronic Lymphocytic Leukemia
  • Leukemia
  • Leukemia, Lymphocytic, Chronic, B-Cell
  • Leukemia, Lymphoid
  • Lymphoma
  • Lymphoma, Non-Hodgkin
  • Lymphoma, B-Cell

Name

Location

Fountain Valley, California  92708
Miami, Florida  33176
Albany, New York  12208
Nashville, Tennessee  37203-1632
Austin, Texas  78705
Seattle, Washington  98195