A Study 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
This study is currently recruiting participants.
Verified November 2012 by Genentech
Sponsor:
Genentech
Information provided by (Responsible Party):
Genentech
ClinicalTrials.gov Identifier:
NCT01290549
First received: February 3, 2011
Last updated: November 19, 2012
Last verified: November 2012
- Full Text View
- Tabular View
- No Study Results Posted
- Disclaimer
- How to Read a Study Record
Purpose
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.
| Condition | Intervention | Phase |
|---|---|---|
|
Non-Hodgkin's Lymphoma, Chronic Lymphocytic Leukemia |
Drug: DCDS4501A Drug: rituximab |
Phase 1 |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Intervention Model: Single Group Assignment Masking: Open Label Primary Purpose: Treatment |
| Official Title: | 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 |
Resource links provided by NLM:
Further study details as provided by Genentech:
Primary Outcome Measures:
- 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 ]
Secondary Outcome Measures:
- 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 ]
| Estimated Enrollment: | 99 |
| Study Start Date: | March 2011 |
| Estimated Study Completion Date: | January 2014 |
| Estimated Primary Completion Date: | January 2013 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
| Experimental: A |
Drug: DCDS4501A
Escalating intravenous dose
|
| Experimental: Phase Ib |
Drug: DCDS4501A
Escalating intravenous dose
Drug: rituximab
375 mg/m2 iv, Day 1 of each 21-day cycle
|
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Criteria
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
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01290549
Contacts
| Contact: Please reference Study ID Number: DCS4968g www.roche.com/about_roche/roche_worldwide.htm | 888-662-6728 (U.S. Only) | genentechclinicaltrials@druginfo.com |
Locations
| United States, California | |
| Recruiting | |
| Stanford, California, United States, 94305-5820 | |
| United States, Florida | |
| Recruiting | |
| Sarasota, Florida, United States, 34232 | |
| United States, New York | |
| Recruiting | |
| Buffalo, New York, United States, 14263 | |
| United States, Tennessee | |
| Recruiting | |
| Nashville, Tennessee, United States, 37203 | |
| United States, Texas | |
| Recruiting | |
| Houston, Texas, United States, 77030 | |
| United States, Washington | |
| Recruiting | |
| Seattle, Washington, United States, 98109 | |
| Canada, Alberta | |
| Recruiting | |
| Edmonton, Alberta, Canada, T5J 3N4 | |
| Canada, British Columbia | |
| Recruiting | |
| Vancouver, British Columbia, Canada, V5Z 1H6 | |
| Canada, Quebec | |
| Recruiting | |
| Montreal, Quebec, Canada, H3T IE2 | |
| France | |
| Recruiting | |
| Dijon, France, 21000 | |
| Recruiting | |
| Lille, France | |
| Recruiting | |
| Montpellier, France, 34295 | |
| Recruiting | |
| Pierre Benite, France, 69495 | |
| Recruiting | |
| Rouen, France, 76000 | |
| Netherlands | |
| Recruiting | |
| Amsterdam, Netherlands, 1105 AZ | |
Sponsors and Collaborators
Genentech
Investigators
| Study Director: | Yu-Waye Chu, M.D. | Genentech |
More Information
No publications provided
| Responsible Party: | Genentech |
| ClinicalTrials.gov Identifier: | NCT01290549 History of Changes |
| Other Study ID Numbers: | DCS4968g, GO01294 |
| Study First Received: | February 3, 2011 |
| Last Updated: | November 19, 2012 |
| Health Authority: | United States: Food and Drug Administration |
Additional relevant MeSH terms:
|
Leukemia Leukemia, Lymphocytic, Chronic, B-Cell Leukemia, Lymphoid Lymphoma Lymphoma, Non-Hodgkin Lymphoma, B-Cell Neoplasms by Histologic Type Neoplasms Leukemia, B-Cell 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 May 23, 2013