Trial record 1 of 1 for:    NCT01290549
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A Study of Escalating Doses of DCDS4501A in Patients With Relapsed or Refractory B-Cell Non-Hodgkins Lymphoma and Chronic Lymphocytic Leukemia and DCDS4501A in Combination With Rituximab in Patients With Relapsed or Refractory B-Cell Non-Hodgkins Lymphoma

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
Genentech
ClinicalTrials.gov Identifier:
NCT01290549
First received: February 3, 2011
Last updated: April 7, 2014
Last verified: April 2014

February 3, 2011
April 7, 2014
March 2011
June 2012   (final data collection date for primary outcome measure)
  • Incidence of dose-limiting toxicities (DLTs) [ Time Frame: 21 days ] [ Designated as safety issue: No ]
  • Nature of dose-limiting toxicities (DLTs) [ Time Frame: 21 days ] [ Designated as safety issue: No ]
Same as current
Complete list of historical versions of study NCT01290549 on ClinicalTrials.gov Archive Site
  • Incidence of adverse events [ Time Frame: Up to 12 months ] [ Designated as safety issue: No ]
  • Nature of adverse events [ Time Frame: Up to 12 months ] [ Designated as safety issue: No ]
  • Severity of adverse events [ Time Frame: Up to 12 months ] [ Designated as safety issue: No ]
  • Incidence of anti-therapeutic antibodies (ATAs) against DCDS4501A [ Time Frame: Up to 12 months ] [ Designated as safety issue: No ]
Same as current
Not Provided
Not Provided
 
A Study of Escalating Doses of DCDS4501A in Patients With Relapsed or Refractory B-Cell Non-Hodgkins Lymphoma and Chronic Lymphocytic Leukemia and DCDS4501A in Combination With Rituximab in Patients With Relapsed or Refractory B-Cell Non-Hodgkins Lymphoma
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-Hodgkins Lymphoma and Chronic Lymphocytic Leukemia and DCDS4501A in Combination With Rituximab in Patients With Relapsed or Refractory B-Cell Non-Hodgkins Lymphoma

This is a Phase I, multicenter, open-label, dose-escalation study of DCDS4501A administered as a single agent by IV infusion to patients with relapsed or refractory hematologic malignancies. In Phase Ib, patients will receive DCDS4501A in combination with rituximab.

Not Provided
Interventional
Phase 1
Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Non-Hodgkin's Lymphoma, Chronic Lymphocytic Leukemia
  • Drug: rituximab
    375 mg/m2 iv, Day 1 of each 21-day cycle
  • Drug: DCDS4501A
    Escalating intravenous dose
  • Experimental: Phase Ib
    Interventions:
    • Drug: rituximab
    • Drug: DCDS4501A
  • Experimental: A
    Intervention: Drug: DCDS4501A
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Active, not recruiting
95
Not Provided
June 2012   (final data collection date for primary outcome measure)

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
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
United States,   Canada,   France,   Netherlands
 
NCT01290549
DCS4968g, GO01294
Not Provided
Genentech
Genentech
Not Provided
Study Director: Yu-Waye Chu, M.D. Genentech
Genentech
April 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP