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Palifermin After Haploidentical PBSCT

NCT00570999 · Status: WITHDRAWN · Phase: PHASE2 · Type: INTERVENTIONAL

Last updated 2012-05-10

No results posted yet for this study

Summary

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

Conditions

  • Non-Hodgkin's Lymphoma or Hodgkin's Disease
  • Acute Leukaemia
  • Myelodysplastic Syndrome
  • Chronic Myeloid Leukemia
  • Osteomyelofibrosis

Interventions

DRUG

Palifermin

60 mg/kg/day

OTHER

Placebo

1,2 mL once daily

Sponsors & Collaborators

  • Amgen

    collaborator INDUSTRY

  • European Society for Blood and Marrow Transplantation

    lead NETWORK

Principal Investigators

  • Ruth Seggewiss, MD · University Hospital of Würzburg

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
65 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2008-02-29
Completion
2013-01-31

Countries

  • Germany

Study Locations

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Diseases
Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00570999 on ClinicalTrials.gov