Home
Search
Study Topics
Glossary
|
|
|
|
|
|
Sponsors and Collaborators: |
European Group for Blood and Marrow Transplantation Amgen |
---|---|
Information provided by: | European Group for Blood and Marrow Transplantation |
ClinicalTrials.gov Identifier: | NCT00570999 |
This is a double blind, placebo controlled clinical trial, where patients with an advanced form of blood cancer are treated with haploidentical allogeneic peripheral blood progenitor cell (PBPC) transplant after which they are randomised to receive either placebo or a keratinocyte growth factor (Palifermin or Kepivance®).
The function of Kepivance® is to stimulate the growth of epithelial cells. This drug has also been suggested to have an ability to help improve the reconstitution, or development, of the immune system after the transplantation.
The hypothesis is that the patients T-cell dependent humoral immune response to recall antigen (PrevenarTM) will be higher in in palifermin treated patients than in the placebo control group
Condition | Intervention | Phase |
---|---|---|
Non-Hodgkin's Lymphoma or Hodgkin's Disease Acute Leukaemia Myelodysplastic Syndrome Chronic Myeloid Leukemia Osteomyelofibrosis |
Drug: Palifermin Other: Placebo |
Phase II |
Study Type: | Interventional |
Study Design: | Treatment, Randomized, Double Blind (Subject, Caregiver, Investigator), Placebo Control, Parallel Assignment, Efficacy Study |
Official Title: | Randomised Placebo-Controlled Double-Blind Phase II Study Applying Palifermin to Improve T-Cell Immune Reconstitution After Haploidentical Allogeneic Peripheral Blood Progenitor Cell (PBPC) Transplantation |
Estimated Enrollment: | 100 |
Study Start Date: | February 2008 |
Estimated Study Completion Date: | January 2013 |
Arms | Assigned Interventions |
---|---|
Arm A: Experimental
Palifermin once daily at a dose of 60 mg/kg/day for 3 days before the start of the conditioning regimen and then for 3 consecutive days starting on the day of transplantation (days 0 to day +2 inclusively).
|
Drug: Palifermin
60 mg/kg/day
|
Arm B: Placebo Comparator
Placebo at a dose of 1.2 mL (saline 0,9%) once daily for 3 days before the start of the conditioning regimen and then for 3 consecutive days starting on the day of transplantation (days 0 to day +2 inclusively).
|
Other: Placebo
1,2 mL once daily
|
Ages Eligible for Study: | 18 Years to 65 Years |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Recipient:
Donor:
Exclusion Criteria:
Recipient:
Donor:
Contact: Ruth Seggwiss, MD | +49 931-201-36402 | Seggewiss_R@medizin.uni-wuerzburg.de |
Contact: Georgia Bullock | +44 20 718 88404 | georgia.bullock@kcl.ac.uk |
Germany | |
Dr Ruth Seggewiss | |
Würzburg, Germany, 97080 |
Study Chair: | Ruth Seggewiss, MD | University Hospital of Würzburg |
Responsible Party: | EBMT (European Group for Blood and Marrow Transplantation) ( Kim Champion ) |
Study ID Numbers: | EudraCt: 2007-003241-32 |
Study First Received: | December 10, 2007 |
Last Updated: | December 10, 2007 |
ClinicalTrials.gov Identifier: | NCT00570999 |
Health Authority: | Germany: Federal Institute for Drugs and Medical Devices; Belgium: Federal Agency for Medicinal Products and Health Products; Italy: Ethics Committee |
Peripheral blood stem cell transplantation Palifermin Kepivance Prevenar Placebo |
Myelodysplastic syndromes Myelofibrosis Hodgkin's disease Immunoproliferative Disorders Chronic myelogenous leukemia Precancerous Conditions Hematologic Diseases Hodgkin lymphoma, adult Myelodysplasia Myelodysplastic Syndromes Lymphoma, small cleaved-cell, diffuse Myeloproliferative Disorders |
Leukemia, Myeloid Myeloid Metaplasia Leukemia Lymphatic Diseases Preleukemia Leukemia, Myelogenous, Chronic, BCR-ABL Positive Bone Marrow Diseases Lymphoma, Non-Hodgkin Lymphoproliferative Disorders Lymphoma Hodgkin Disease |
Neoplasms Pathologic Processes Disease |
Neoplasms by Histologic Type Immune System Diseases Syndrome |