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| Sponsor: | Seattle Genetics, Inc. |
|---|---|
| Collaborator: |
Millennium Pharmaceuticals, Inc. |
| Information provided by: | Seattle Genetics, Inc. |
| ClinicalTrials.gov Identifier: | NCT01060904 |
Purpose
The purpose of this study is to assess the safety profile of brentuximab vedotin in combination with ABVD in treatment-naive Stage IIa or IIb-IV Hodgkin lymphoma. It is a phase 1, single-arm, open-label dose escalation study designed to define the MTD, PK, immunogenicity and anti-tumor activity of brentuximab vedotin in combination with frontline therapy.
| Condition | Intervention | Phase |
|---|---|---|
|
Disease, Hodgkin |
Drug: brentuximab vedotin Drug: doxorubicin Drug: vinblastine Drug: dacarbazine Drug: bleomycin |
Phase I |
| Study Type: | Interventional |
| Study Design: | Allocation: Non-Randomized Endpoint Classification: Safety Study Intervention Model: Single Group Assignment Masking: Open Label Primary Purpose: Treatment |
| Official Title: | A Phase 1 Dose-Escalation Safety Study of Brentuximab Vedotin in Combination With ABVD as Frontline Therapy in Patients With Hodgkin Lymphoma |
| Estimated Enrollment: | 40 |
| Study Start Date: | January 2010 |
| Estimated Primary Completion Date: | January 2012 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
1: Experimental
brentuximab vedotin combined with ABVD (doxorubicin, bleomycin, vinblastine, dacarbazine)
|
Drug: brentuximab vedotin
0.6-1.2 mg/kg IV every 2 weeks
Drug: doxorubicin
25 mg/m2 IV every 2 weeks
Drug: vinblastine
6 mg/m2 IV every 2 weeks
Drug: dacarbazine
375 mg/m2 IV every 2 weeks
Drug: bleomycin
10 units/m2 IV every 2 weeks
|
Eligibility| Ages Eligible for Study: | 18 Years to 60 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Contacts and Locations| Contact: Terri Lowe | 866-333-7436 | clinicaltrials@seagen.com |
| United States, Minnesota | |
| Mayo Clinic Rochester | Recruiting |
| Rochester, Minnesota, United States, 55905 | |
| Contact: Tami Simmons 507-284-4740 simmons.tamera@mayo.edu | |
| Principal Investigator: Stephen Ansell, M.D. Ph.D | |
| United States, Texas | |
| MD Anderson Cancer Center / University of Texas | Recruiting |
| Houston, Texas, United States, 77030-4009 | |
| Contact: Amanda Copeland 713-792-9455 arcopeland@mdanderson.org | |
| Principal Investigator: Anas Younes, MD | |
| Canada, British Columbia | |
| BC Cancer Agency | Recruiting |
| Vancouver, British Columbia, Canada, V5Z 4E6 | |
| Contact: Daphne Brockington 604-877-6000 X2631 dbrockington@bccancer.bc.ca | |
| Principal Investigator: Joseph Connors, M.D. | |
| Study Director: | Muriel Siadak, PA-C | Seattle Genetics, Inc. |
More Information
| Responsible Party: | Seattle Genetics, Inc. ( Muriel Siadak, PA-C ) |
| ClinicalTrials.gov Identifier: | NCT01060904 History of Changes |
| Other Study ID Numbers: | SGN35-009 |
| Study First Received: | January 29, 2010 |
| Last Updated: | August 24, 2010 |
| Health Authority: | United States: Food and Drug Administration |
|
Antibodies, Monoclonal Antibody-Drug Conjugate Antigens, CD30 Disease, Hodgkin |
Hematologic Diseases Immunotherapy Lymphoma monomethyl auristatin E |
|
Hodgkin Disease Lymphoma Neoplasms by Histologic Type Neoplasms Lymphoproliferative Disorders Lymphatic Diseases Immunoproliferative Disorders Immune System Diseases Antibodies, Monoclonal Bleomycin Doxorubicin Dacarbazine Vinblastine |
Immunologic Factors Physiological Effects of Drugs Pharmacologic Actions Antibiotics, Antineoplastic Antineoplastic Agents Therapeutic Uses Antineoplastic Agents, Alkylating Alkylating Agents Molecular Mechanisms of Pharmacological Action Antineoplastic Agents, Phytogenic Tubulin Modulators Antimitotic Agents Mitosis Modulators |
