Clinical Trials Logo

Clinical Trial Summary

This study is designed to determine the objective response rate in patients with relapsed or refractory Hodgkin's disease treated with MDX-060 in combination with gemcitabine or gemcitabine alone.


Clinical Trial Description

Secondary objectives include:

- to characterize progression-free survival

- to characterize time to progression

- to determine response duration

- to characterize the effect of study drug on health-related quality of life

- to explore the correlation of positron emission tomography (PET) scan results with objective responses observed with conventional imaging in this patient population

- to characterize the immunogenicity response of MDX-060

- to characterize the safety of MDX-060, and

- to characterize the pharmacokinetic profile of MDX-060 ;


Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment


Related Conditions & MeSH terms


NCT number NCT00284804
Study type Interventional
Source Bristol-Myers Squibb
Contact
Status Completed
Phase Phase 2
Start date November 2005
Completion date October 2009

See also
  Status Clinical Trial Phase
Completed NCT01665768 - Maintenance Rituximab With mTor Inhibition After High-dose Consolidative Therapy in Lymphoma Phase 2
Completed NCT01188798 - Methotrexate or Pentostatin for Graft-versus-host Disease Prophylaxis in Risk-adapted Allogeneic Bone Marrow Transplantation for Hematologic Malignancies Phase 3
Completed NCT00975975 - Basiliximab #2: In-Vivo Activated T-Cell Depletion to Prevent Graft-Versus_Host Disease (GVHD) After Nonmyeloablative Allotransplantation for the Treatment of Blood Cancer Phase 2
Completed NCT00150462 - Safety Study of the Proteasome Inhibitor PR-171 (Carfilzomib for Injection) in Patients With Hematological Malignancies Phase 1
Completed NCT00606437 - Total Body Irradiation With Fludarabine Followed by Combined Umbilical Cord Blood (UCB) Transplants Phase 1
Completed NCT02856646 - Hodgkin Lymphoma Molecular Profiling and Clinical Outcomes in U.S. Community Oncology Practices
Completed NCT01458288 - A Study to Evaluate the Safety, Pharmacokinetics, and Hematopoietic Stem Cell Mobilization of TG-0054 Alone or in Combination With G-CSF in Patients With Multiple Myeloma, Non-Hodgkin Lymphoma or Hodgkin Disease Phase 2
Completed NCT00990587 - Study Evaluating the Tolerance and Biologic Activity of Oral Ciclopirox Olamine in Patients With Relapsed or Refractory Hematologic Malignancy Phase 1
Completed NCT00469729 - Efficacy and Safety Study of StemEx®, to Treat Subjects With High Risk Hematologic Malignancies, Following Myeloablative Therapy Phase 2/Phase 3
Terminated NCT00594308 - In-Vivo Activated T-Cell Depletion to Prevent GVHD N/A
Completed NCT00552825 - Pulmonary Function at Presentation and Follow-up in Hemato-Oncology 3-7 Years Old Children N/A
Completed NCT00165438 - Pulmonary Function in Patients With Hodgkin's Disease Receiving Bleomycin-Based Chemotherapy N/A
Terminated NCT00176930 - Stem Cell Transplant for Hematological Malignancy N/A
Recruiting NCT02007811 - Open-label Clinical Trial to Investigate the Safety and Tolerability of Allogeneic B-cell Concentrates for Immune Reconstitution After Allogeneic Stem Cell Transplantation Measured as Response to a Antedated Single Vaccination Phase 1/Phase 2
Completed NCT01221857 - Pilot Study Evaluating Safety & Efficacy of DCBT: NiCord® & UNM CBU to Patients With Hematological Malignancies Phase 1/Phase 2
Completed NCT00569842 - Investigation of the Cylex® ImmuKnow® Assay N/A
Completed NCT00665314 - Evaluation of the Safety and Efficacy of the Addition of AMD3100 to a G-CSF Mobilization Regimen in Patients With Lymphoma (NHL and HD) and Multiple Myeloma (MM). Phase 2
Completed NCT00256191 - Study of TPI 287 Administered Every 21 Days in Patients With Advanced Malignancies Phase 1
Completed NCT00396201 - AMD3100 (Plerixafor) Added to a Mobilizing Regimen of Granulocyte-colony Stimulating Factor (G-CSF) to Increase the Number of Peripheral Blood Stem Cells (PBSCs) in Patients With Hodgkin's Disease Phase 2
Completed NCT00144677 - Sirolimus With Tacrolimus for Graft-vs-Host Disease Prophylaxis After Un-Related Stem Cell Transplantation Phase 2