Know Cancer

or
forgot password

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


Phase 4
55 Years
N/A
Not Enrolling
Both
Fungal Infection

Thank you

Trial Information

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


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®.


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

Type of Study:

Interventional

Study Design:

Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Prevention

Outcome Measure:

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

Principal Investigator

Mark Sampson

Investigator Role:

Study Director

Investigator Affiliation:

Gilead Sciences GmbH

Authority:

Germany: Federal Institute for Drugs and Medical Devices

Study ID:

GS-MC-131-0165

NCT ID:

NCT00386997

Start Date:

November 2006

Completion Date:

September 2007

Related Keywords:

  • Fungal Infection
  • Leukemia
  • Leukemia, Lymphoid
  • Precursor Cell Lymphoblastic Leukemia-Lymphoma
  • Mycoses

Name

Location