Clinical Trials Logo
  1. Home
  2. Hodgkin's Disease
  3. NCT00147875
  4. Details
NCT00147875 Clinical Trial

Study of Prednisone, Vinblastine, Doxorubicin, and Gemcitabine in Elderly Patients With Advanced Stages Hodgkin's Lymphoma

Hodgkin's Disease Clinical Trial

Official title:
PVAG - Phase I/II Dose Finding Trial in Elderly Patients (> 60 Years) With Advanced Stages Hodgkin's Lymphoma

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT00147875
Other study ID # PVAG elderly
Secondary ID
Status Completed
Phase Phase 1/Phase 2
First received September 2, 2005
Last updated September 4, 2009
Start date March 2004

Study information
Verified date September 2009
Source University of Cologne
Contact n/a
Is FDA regulated No
Health authority Germany: Federal Institute for Drugs and Medical Devices
Study type Interventional

Clinical Trial Summary

The objectives of this study are to assess the feasibility and efficacy of a combination chemotherapy (PVAG) in elderly patients with advanced stages Hodgkin's lymphoma.

Description:

Gemcitabine shows promising activity in patients with relapsed lymphoma either administered as single agent or in combination with other cytotoxic agents. No trial to date evaluated its role in patients with primary Hodgkin's lymphoma. We therefore developed a three-weekly regimen based on the standard ABVD regimen.

Recruitment information / eligibility
Status Completed
Enrollment 60
Est. completion date
Est. primary completion date July 2007
Accepts healthy volunteers No
Gender Both
Age group 60 Years to 75 Years
Eligibility Inclusion Criteria:

- Hodgkin's lymphoma (histologically proven)

- Clinical stage IIB (with risk factors bulky mediastinal mass and/or extranodal involvement), III, or IV

- No prior antitumor therapy

- Age 60 to 75 years

- WHO performance status 0-2

- Normal pulmonary function

- Written informed consent

Exclusion Criteria:

- The following histologies are excluded: lymphocyte predominant HD

- Leukocytes < 2,500/microL

- Platelets < 100,000/microL

Study Design

Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

Intervention

Drug:
• Prednisone

• Vinblastine

• Doxorubicin (Adriamycin)

• Gemcitabine

Locations
Country Name City State
Germany University of Cologne Cologne NRW

Sponsors (3)
Lead Sponsor Collaborator
University of Cologne Eli Lilly and Company, German Hodgkin's Lymphoma Study Group

Country where clinical trial is conducted

Germany, 

Outcome
Type Measure Description Time frame Safety issue
Primary Phase I: Dose-limiting toxicities and dose reductions
Primary Phase II: Treatment administration and complete response rate
Secondary Toxicities
Secondary Supportive care (RBCT need, antibiotic need)
Secondary Early progression rate
Secondary Overall survival
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 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 NCT00569842 - Investigation of the Cylex® ImmuKnow® Assay N/A
Completed NCT00256191 - Study of TPI 287 Administered Every 21 Days in Patients With Advanced Malignancies Phase 1
Completed NCT00284804 - A Phase II Study of MDX-060 in Subjects With Relapsed or Refractory Hodgkin's Disease Phase 2
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