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Sponsored by: |
GlaxoSmithKline |
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Information provided by: | GlaxoSmithKline |
ClinicalTrials.gov Identifier: | NCT00823719 |
The purpose of this study is to evaluate the safety and efficacy of ofatumumab used in combination with ICE or DHAP salvage chemotherapy regimens in subjects with relapsed or refractory DLBCL who are eligible for autologous stem cell transplant.
Condition | Intervention | Phase |
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Diffuse Large B Cell Lymphoma (DLBCL) Non-Hodgkin's Lymphoma Grade 3b Follicular Lymphoma Transformed Follicular Lymphoma |
Drug: ofatumumab + DHAP Drug: ofatumumab + ICE |
Phase II |
Study Type: | Interventional |
Study Design: | Treatment, Open Label, Single Group Assignment, Safety/Efficacy Study |
Official Title: | A Single Arm, Safety and Efficacy Study of Ofatumumab in Combination With ICE or DHAP Chemotherapy in Relapsed or Refractory Aggressive Lymphoma Prior to Autologous Stem Cell Transplantation |
Estimated Enrollment: | 48 |
Study Start Date: | May 2009 |
Estimated Study Completion Date: | July 2010 |
Estimated Primary Completion Date: | July 2010 (Final data collection date for primary outcome measure) |
Arms | Assigned Interventions |
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ofatumumab + DHAP or ICE chemotherapy regimen: Experimental
This study is a single arm study, but the Investigators are required to prospectively choose to treat all of their subjects with either ICE or DHAP chemotherapy regimens in combination with ofatumumab. Regardless of whether the subject receives ICE or DHAP chemotherapy, all subjects will receive the same ofatumumab regimen and dose.
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Drug: ofatumumab + DHAP
3 cycles of treatment will be administered. Each cycle will last 21 days. ofatumumab dose: cycle 1, day 1 - 300 mg; cycle 1, day 8 - 1000 mg; cycle 2, day 1 and cycle 3, day 1 - 1000 mg. DHAP regimen: dexamethasone - 40 mg on days 1, 2, 3, and 4 of dosing cycle; cisplatin - 100 mg/m2/24hrs continuous on day 1 of dosing cycle; cytarabine - 2g/m2 q12 hrs (2 doses) on day 2 of dosing cycle. 3 cycles of treatment will be administered. Each cycle will last 21 days. ofatumumab dose: cycle 1, day 1 - 300 mg; cycle 1, day 8 - 1000 mg; cycle 2, day 1 and cycle 3, day 1 - 1000 mg ICE regimen: ifosfamide + mesna - 5 g/m2/24h continuous on day 2 of dosing cycle; carboplatin - AUC 5 (800 mg maximum) on day 2 of dosing cycle; etoposide - 100 mg/m2 on days 1, 2 and 3 of dosing cycle. |
Rituximab combined with anthracycline based chemotherapy is the most common first-line treatment for subjects with diffuse large B cell lymphoma (DLBCL). Subjects requiring second-line therapy will most often receive rituximab in combination with salvage chemotherapy as an induction therapy prior to autologous stem cell transplant. With rituximab being in first-line therapy, the response rates for subjects receiving rituximab plus salvage chemotherapy has significantly decreased. Treatment with ofatumumab may be able to overcome the resistance to rituximab in the second-line setting and offer improved response rates. The objective of this study is to evaluate the overall response rate of ofatumumab in combination with ICE or DHAP chemotherapy prior to autologous stem cell transplant. Additional objectives are to evaluate the complete response rate, ability to mobilize CD34+ cells, progression-free survival (PFS) and overall survival.
Ages Eligible for Study: | 18 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Refractory to, or relapsed following, first-line treatment with rituximab combined with anthracycline-based chemotherapy as defined by the protocol.
Exclusion Criteria:
Contact: US GSK Clinical Trials Call Center | 877-379-3718 |
United States, Florida | |
GSK Investigational Site | Recruiting |
Tampa, Florida, United States, 33612-9497 | |
GSK Investigational Site | Recruiting |
Miami, Florida, United States, 33136 | |
United States, Massachusetts | |
GSK Investigational Site | Recruiting |
Boston, Massachusetts, United States, 02215 | |
United States, New York | |
GSK Investigational Site | Not yet recruiting |
Buffalo, New York, United States, 14263 | |
United States, North Carolina | |
GSK Investigational Site | Not yet recruiting |
Chapel Hill, North Carolina, United States, 27599 |
Study Director: | GSK Clinical Trials | GlaxoSmithKline |
Responsible Party: | GSK ( Study Director ) |
Study ID Numbers: | 110927 |
Study First Received: | January 8, 2009 |
Last Updated: | July 30, 2009 |
ClinicalTrials.gov Identifier: | NCT00823719 History of Changes |
Health Authority: | United States: Food and Drug Administration; United States: Institutional Review Board |
relapsed refractory Oncology safety efficacy |
ofatumumab ICE DHAP Salvage chemotherapy |
Dexamethasone Lymphoma, Large B-Cell, Diffuse Immunoproliferative Disorders Lymphoma, Follicular Carboplatin Etoposide phosphate Follicular Lymphoma Lymphoma, B-Cell Lymphoma, Small Cleaved-cell, Diffuse Lymphatic Diseases Ifosfamide Cisplatin |
B-cell Lymphomas Lymphoma, Non-Hodgkin Aggression Lymphoproliferative Disorders Lymphoma, Large-cell Mesna Etoposide Lymphoma Dexamethasone acetate Cytarabine Isophosphamide mustard |
Lymphoma, B-Cell Lymphatic Diseases Neoplasms Lymphoma, Large B-Cell, Diffuse Immunoproliferative Disorders Neoplasms by Histologic Type |
Immune System Diseases Lymphoma, Follicular Lymphoproliferative Disorders Lymphoma, Non-Hodgkin Lymphoma |