European Leukemia Trial Registry
Trial: ALL ProphyALL

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Public Title Liposomales Amphotericin B in antifungal primary prophylaxis in ALL
Scientific Title ProphyALL - Pilot study on safety of four weekly administrations of 7 mg/kg of liposomal amphotericin B (AmBisome?) in antifungal primary prophylaxis treatment of elderly patients with acute lymphoblastic leukemia undergoing induction chemotherapy within the GMALL-Elderly protocol
Short Title ALL ProphyALL
Id KN/ELN LN_GMALL_2007_238
Trialgroup GMALL
Type of Trial multicentric, single-group, open-label
Phase Phase II
Disease Miscellaneous(Miscellaneous) Supportive Care
Acute lymphoblastic leukemia(ALL) All subtypes
Stage of Disease de novo/non-treated
Category Supportive Care
Aim
  • Safety of phophylactic 4-weekly intravenous doses of liposomal amphotericine B (AmBisome) à 7 mg/kg
Inclusion Criteria
  • male or female patients with acute lymphoblastic leukemia during the two first induction cycles - according to the GMALL Elderly 1/2003 study-protocol
Exclusion Criteria
  • acitve or estimated fungal infection
  • previous systemic fungal infection
  • patient without sufficient renal- and liver-function
Age >=55 years
Status Closed
Start of Recruitment 01.05.2007
Recruiting Countries Germany
Target Sample Size 20
Leader Böhme, PD Dr. med., Angelika
Scientific Contact Böhme, PD Dr. med., Angelika (Affliliation)
Contact Person

General Contact Person
Müller, Dr., Monika
Tel: +49 (0)89 98 90 25
Fax: +49 (0)89 98 90 62
Email: monika.mueller@gilead.com

Centre of Trial Onkologikum Frankfurt am Museumsufer
Shortprotocol Shortprotocol
Sponsors GILEAD Sciences GmbH (Main Sponsor)
Supporters GILEAD Sciences GmbH
Other Registers ClinicalTrials.gov NCT00386997
Deutsches Leukämie Studienregister - Kompetenzenetz LN_GMALL_2007_238 (primary Register)
Outcomes
  • incidence of fungal infections according to EORTC within 12 weeka after onset of phophylaxis (Primary Outcome)
Interventions
  • Amphotericin B: weekly administrations of 7 mg/kg
Remark Complementary study to the GMALL Elderly 01/2003 protocol
created 05.06.2007 Anja Hellenbrecht
changed 06.05.2008 Anja Hellenbrecht
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