Randomised phase II study on the treatment with pegfilgrastim after autologous blood stem cell transplantatio

• Conditions: Patients suffering from a hematological malignancy (leukemia, lymphoma or multiple myeloma), after autologous blood stem cell transplantation; MedDRA version: 9.1Level: LLTClassification code 10024329Term: Leukemia; MedDRA version: 9.1Level: LLTClassification code 10025310Term: Lymphoma; MedDRA version: 9.1Level: LLTClassification code 10028228Term: Multiple myeloma

• Registration Number: EUCTR2006-003682-14-DE
• Lead Sponsor: GMIHO Gesellschaft für Medizinische Innovation/Hämatologie und Onkologie mbH

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2007-02-23
• Last Update Posted: 17 March 2014

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: Not specified

Inclusion Criteria

- patients with leukemia (with exceptions, cf. exclusion criteria), lymphoma or multiple myeloma (first-line or in first relapse) after autologous peripheral blood stem cell transplantation
- transfused CD34+ >= 2,0*10^6/kg body weight
- age >= 18 years
- adequate contraceptive measures in case of reproductive potential (oral contraceptives, implantable or injectable contraceptive drugs, hormonal IUDs, vasectomy of the partner, or abstinence
- negative pregnancy test
- written informed consent
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range

Exclusion Criteria

- hypersensitivity against pegfilgrastim, other proteins manufactured using E. coli, or one of the drugs other components
- patients with myelodysplastic syndrome
- patients with chronic myeloid leukemia
- patients with secondary AML
- pregnant or lactating women
- insufficient compliance anticipated

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Main Objective: To compare the effects of pegfilgrastim administered on day 1 vs. day 4 after transplantation on the time to granulocyte engraftment > 500/ml;Secondary Objective: To compare:<br>- median times to granulocyte engraftment > 1000/µl, to platelet engraftment >20000/µl and >50000/µl<br>- rate and duration of febrile episodes<br>- rate and duration of iv antibiotic treatment<br>- number of blood transfusions<br>- duration of days in hospital<br>- adverse effecst of pegfilgrastim<br>- pharmacokinetics of pegfilgrastim<br>;Primary end point(s): time to granulocyte recovery as measured from day of transplantation to day with granulocytes > 500/µl