Back to resultsProphyALL - Study on the Safety of Liposomal Amphotericin B to Prevent Antifungal Infections in Elderly Patients With Acute Lymphoblastic Leukemia
Primary Purpose
Fungal Infection
Status
Terminated
Phase
Phase 4
Locations
Germany
Study Type
Interventional
Intervention
liposomal amphotericin B (AmBisome®)
Sponsored by
About this trial
This is an interventional prevention trial for Fungal Infection
Eligibility Criteria
Inclusion Criteria:
- 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).
Exclusion Criteria:
- 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)
- Patients who have received systemic antifungal therapy within 15 days prior to the inclusion
- 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 have taken any investigational drug within the last 30 days prior to inclusion except drugs used according to the GMALL-Elderly/2003 protocol
- Patients who participate in another clinical trial except anti-cancer trials
Sites / Locations
- Gilead Sciences GmbH
Outcomes
Primary Outcome Measures
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 Outcome Measures
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
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT00386997
Brief Title
ProphyALL - Study on the Safety of Liposomal Amphotericin B to Prevent Antifungal Infections in Elderly Patients With Acute Lymphoblastic Leukemia
Official 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
Study Type
Interventional
2. Study Status
Record Verification Date
August 2007
Overall Recruitment Status
Terminated
Why Stopped
Study closed due to recruitment challenges.
Study Start Date
November 2006 (undefined)
Primary Completion Date
undefined (undefined)
Study Completion Date
September 2007 (undefined)
3. Sponsor/Collaborators
Name of the Sponsor
Gilead Sciences
4. Oversight
5. Study Description
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.
Detailed Description
This is a multi-center, pilot, prospective, open label study. Approximately 20 patients will be recruited in 10 to 15 centers.
The patient group will be the following:
Elderly patients (≥ 55 years) with acute lymphoblastic leukemia undergoing chemotherapy with GMALL-Elderly 1/2003 protocol.
They will be treated with LAMB for four weeks after induction phase I. Patients will attend for full assessment until trial completion or withdrawal: there will be 3 assessment visits during the first week, 2 assessment visits during the second week, and 1 weekly assessment visit during the third and fourth week of the prophylaxis treatment (the first visit of each week being the infusion visit as well).
After the end of the prophylaxis period, patients will have 3 follow-up visits which will be scheduled at Weeks 6, 9, and 12.
Please note that no other systemic antifungal prophylaxis is allowed to be used concomitantly with AmBisome®.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Fungal Infection
7. Study Design
Primary Purpose
Prevention
Study Phase
Phase 4
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
20 (Anticipated)
8. Arms, Groups, and Interventions
Intervention Type
Drug
Intervention Name(s)
liposomal amphotericin B (AmBisome®)
Primary Outcome Measure Information:
Title
To characterize the safety profile of a prophylactic antifungal LAMB treatment of
Title
7 mg/kg, administered as a weekly intravenous infusion over two hours, during
Title
induction treatment of acute lymphoblastic leukemia of elderly patients undergoing
Title
chemotherapy with GMALL-Elderly 1/2003 protocol for four weeks
Secondary Outcome Measure Information:
Title
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
Title
IFI free time as % of follow-up time
Title
The incidence of pulmonary infiltrates within 12 weeks following initiation of prophylaxis
Title
The need for additional systemic antifungal therapy within 12 weeks following initiation of prophylaxis
Title
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
10. Eligibility
Sex
All
Minimum Age & Unit of Time
55 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
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).
Exclusion Criteria:
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)
Patients who have received systemic antifungal therapy within 15 days prior to the inclusion
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 have taken any investigational drug within the last 30 days prior to inclusion except drugs used according to the GMALL-Elderly/2003 protocol
Patients who participate in another clinical trial except anti-cancer trials
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Mark Sampson
Organizational Affiliation
Gilead Sciences
Official's Role
Study Director
Facility Information:
Facility Name
Gilead Sciences GmbH
City
Martinsried/Munich
ZIP/Postal Code
82152
Country
Germany
12. IPD Sharing Statement
Learn more about this trial
ProphyALL - Study on the Safety of Liposomal Amphotericin B to Prevent Antifungal Infections in Elderly Patients With Acute Lymphoblastic Leukemia
We'll reach out to this number within 24 hrs