ProphyALL - Study on the Safety of Liposomal Amphotericin B to Prevent Antifungal Infections in Elderly Patients With Acute Lymphoblastic Leukemia

NCT00386997 | Terminated Phase 4

• 1 other identifier: GS-MC-131-0165
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 1

Brief Summary

Due to the poor outcome of patients with invasive fungal infections (IFI), a more effective prevention of these infections in such patients is wanted. These experiences in intensively treated elderly patients with acute leukemia are especially worrying. This pilot study is designed to collect information on the safety (and efficacy) of an antifungal preventative therapy with an AmBisome® loading dose regimen of 7 mg/kg/week, in four weekly administrations, during the aplastic phase following the start of chemotherapy for acute lymphoblastic leukemia in elderly patients, which is a high risk period for severe fungal infections.

Conditions

Fungal Infection

Outcome Measures

Primary Outcomes (4)

• To characterize the safety profile of a prophylactic antifungal LAMB treatment of

• 7 mg/kg, administered as a weekly intravenous infusion over two hours, during

• induction treatment of acute lymphoblastic leukemia of elderly patients undergoing

• chemotherapy with GMALL-Elderly 1/2003 protocol for four weeks

Secondary Outcomes (5)

• Incidence and time to onset of possible, probable or proven IFI according to EORTC-MSG {3391} criteria within the 12 weeks following the initiation of prophylaxis treatment

• IFI free time as % of follow-up time

• The incidence of pulmonary infiltrates within 12 weeks following initiation of prophylaxis

• The need for additional systemic antifungal therapy within 12 weeks following initiation of prophylaxis

• The survival rate and incidence of mortality related to fungal infection at the end of prophylaxis treatment and within 12 weeks after prophylaxis treatment initiation

Interventions

liposomal amphotericin B (AmBisome®) DRUG

Eligibility Criteria

• Age: 55 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Male or female patients
• Patients with acute lymphoblastic leukemia (ALL) undergoing first induction chemotherapy within the GMALL-Elderly 1/2003 protocol
• Females of childbearing potential (less than 2 years post-menopausal) must be surgically incapable of pregnancy, or practicing an acceptable method of birth control with a negative pregnancy test (blood or urine) at baseline
• Understanding of the study's rationale and procedures documented in the patient's informed consent
• Ability and agreement to comply with all study requirements
• Patient willing to attend hospital appointments for each visit (infusions will be performed in hospital, under strict medical supervision).

You may not qualify if:

• Known hypersensitivity to amphotericin B or LAMB or any of its constituents, in particular known history of anaphylactic reaction to amphotericin B or LAMB or any of its constituents
• Signs or symptoms of IFI or previous proven or probable IFI in the medical history
• Evidence for pulmonary infiltrates in chest CT and/or x-ray of the chest (only when a chest CT/x-ray is done at baseline)
• Estimated creatinine clearance (ECC) ≤ 60 mL/min (Cockcroft-Gault); in such cases the body surface adjusted Modification Diet in Renal Disease (MDRD) glomerular filtration rate (GFRMDRD) should be calculated. If the body surface adjusted GFRMDRD is above 60 mL/min, the patient can be included.
• Patient with moderate or severe liver disease as defined by AST, ALT or alkaline phosphatase (AP) \> 5 times the upper limit of normal (ULN), or bilirubin \> 3 times ULN
• Patients who are unlikely to survive more than 1 month
• Febrile patients (≥ 38.5°C)
• Any severe co-morbidity other than the underlying hematological disease (ALL), which in the investigator's judgment may interfere with study evaluations or affect the patient's safety
• Patients previously included in this study
• Patients who participate in another clinical trial except anti-cancer trials

Sponsors & Collaborators

• Gilead Sciences: lead

Study Sites (1)

Gilead Sciences GmbH

Martinsried/Munich, 82152, Germany

Location

MeSH Terms

Conditions

Mycoses

Interventions

liposomal amphotericin B

Condition Hierarchy (Ancestors)

Bacterial Infections and Mycoses; Infections

Study Officials

• Mark Sampson

  Gilead Sciences

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY

Study Record Dates

• First Submitted: October 10, 2006
• First Posted: October 12, 2006
• Study Start: November 1, 2006
• Study Completion: September 1, 2007
• Last Updated: August 21, 2007

Record last verified: 2007-08

Locations

DE (1)