Empirical Versus Preemptive Antifungal Therapy
This study is currently recruiting participants.
Verified May 2012 by European Organisation for Research and Treatment of Cancer - EORTC
Sponsor:
European Organisation for Research and Treatment of Cancer - EORTC
Information provided by (Responsible Party):
European Organisation for Research and Treatment of Cancer - EORTC
ClinicalTrials.gov Identifier:
NCT01288378
First received: February 1, 2011
Last updated: May 11, 2012
Last verified: May 2012
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Purpose
RATIONALE: Caspofungin acetate may be effective in treating fungal infections in patients with acute myeloid leukemia or myelodysplastic syndrome who are receiving treatment for their cancer. It is not yet known whether caspofungin acetate is more effective when treatment starts after development of a fever or after the infection is shown in laboratory test, chest x-ray, or CT scan.
PURPOSE: This randomized phase III trial is studying the best time to start caspofungin acetate therapy in treating patients with acute myeloid leukemia or myelodysplastic syndrome that is newly diagnosed or in first relapse.
| Condition | Intervention | Phase |
|---|---|---|
|
Fungal Infection Leukemia Myelodysplastic Syndromes |
Drug: caspofungin acetate |
Phase 3 |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Intervention Model: Parallel Assignment Masking: Open Label Primary Purpose: Supportive Care |
| Official Title: | Empirical Versus Pre-emptive (Diagnostic-driven) Antifungal Therapy of Patients Treated for Haematological Malignancies or Receiving an Allogeneic Stem Cell Transplant. A Therapeutic Open Label Phase III Strategy Study of the EORTC Infectious Diseases and Leukemia Groups |
Resource links provided by NLM:
MedlinePlus related topics:
Acute Myeloid Leukemia
Cancer
Fungal Infections
Leukemia
Molds
Myelodysplastic Syndromes
Drug Information available for:
Miconazole nitrate
Miconazole
Clotrimazole
Caspofungin
Caspofungin acetate
U.S. FDA Resources
Further study details as provided by European Organisation for Research and Treatment of Cancer - EORTC:
Primary Outcome Measures:
- Overall survival at 42 days after randomization [ Time Frame: 6 weeks after randomization ] [ Designated as safety issue: No ]
Secondary Outcome Measures:
- Overall survival at 84 days after randomization [ Time Frame: 12 weeks after randomization ] [ Designated as safety issue: No ]
- Development of proven or probable invasive fungal disease (IFD) during the 42 and 84 days following randomization [ Time Frame: during 84 days after randomization ] [ Designated as safety issue: Yes ]
- Proper management according to allocated treatment arm (i.e., appropriate administration of caspofungin acetate in compliance to protocol, and compliance to the treatment strategy) during the 42 and 84 days after randomization [ Time Frame: during 84 days after randomization ] [ Designated as safety issue: No ]
- Survival-free of fungal infection during the 42 and 84 days following randomization [ Time Frame: during 84 days after randomization ] [ Designated as safety issue: No ]
- Safety (adverse event [AE] and serious adverse event [SAE]) as assessed by CTCAE criteria v4.0 [ Time Frame: during 84 days after randomization ] [ Designated as safety issue: Yes ]
- Number of days under caspofungin treatment or under another antifungal treatment administered after caspofungin (evaluation will be done at day 42 and day 84 after randomization) [ Time Frame: at day 42 and day 84 after randomization ] [ Designated as safety issue: No ]
- Costs related to the strategy for initiating and monitoring antifungal treatment during the 42 and 84 days following randomization [ Time Frame: during 84 days after randomization ] [ Designated as safety issue: No ]
| Estimated Enrollment: | 556 |
| Study Start Date: | March 2012 |
| Estimated Primary Completion Date: | August 2013 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Active Comparator: Empirical
Empirical approach (fever driven) for starting antifungal therapy
|
Drug: caspofungin acetate
intravenous route, at a 70 mg loading dose on day 1 of antifungal therapy, followed by 50 mg once a day thereafter.
|
|
Experimental: Pre-emptive
Pre-emptive approach (diagnostic driven) for starting antifungal therapy
|
Drug: caspofungin acetate
intravenous route, at a 70 mg loading dose on day 1 of antifungal therapy, followed by 50 mg once a day thereafter.
|
Show Detailed Description Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Criteria
DISEASE CHARACTERISTICS:
Diagnosis of acute myeloid leukemia (AML) or myelodysplastic syndrome (MDS)
Newly diagnosed disease or disease in first relapse after hematological remission lasting for a minimum of 6 months AND meets one of the following criteria:
- Starting remission-induction chemotherapy within 3 days prior to study randomization
- Starting myeloablative conditioning regimen to prepare for a first allogeneic hematopoietic stem cell transplantation within 3 days prior to study randomization
- Planning a hospital admission for the duration of the neutropenic phase (ANC < 0.5 x 10^9 /L)
Planning to receive oral or intravenous fluconazole for Candida prophylaxis at a dose of 400 mg/day
- Fluconazole is discontinued during caspofungin acetate administration
- No previous or current history of proven or probable invasive fungal disease (IFD)
PATIENT CHARACTERISTICS:
- See Disease Characteristics
- Not pregnant or nursing
- Negative pregnancy test
- Fertile patients muse use effective contraception during and for at least 3 months after completion of study therapy
- No current clinical diagnosis of pneumonia
- No serious, uncontrolled, concomitant disease or comorbidity that, in the opinion of the investigator, may compromise adherence to the study protocol
- No history of allergy or any adverse reaction to echinocandin drugs (i.e., caspofungin acetate, micafungin, or anidulafungin)
- No hypersensitivity to caspofungin active substance or to any of the excipients
- No inadequately treated infection
- No documented HIV infection
- No psychological, familial, sociological, or geographical condition potentially hampering compliance with the study protocol and follow-up schedule
- No history of liver cirrhosis or severe hepatic insufficiency (i.e., Child Pugh Class C, D, or E)
PRIOR CONCURRENT THERAPY:
- See Disease Characteristics
- No concurrent participation on another clinical trial using an investigational drug for infectious diseases
- No other concurrent systemic antifungal therapy (oral or intravenous)
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01288378
Contacts
| Contact: Alice Preumont, PhD | +30 2 774 15 10 | alice.preumont@eortc.be |
Locations
| Belgium | |
| A.Z. St. Jan | Recruiting |
| Brugge, Belgium | |
| Hôpitaux Universitaires Bordet-Erasme - Institut Jules Bordet | Recruiting |
| Brussels, Belgium | |
| U.Z. Gasthuisberg | Recruiting |
| Leuven, Belgium | |
| C.H.U. Sart-Tilman | Recruiting |
| Liège, Belgium | |
| France | |
| CHU de Caen - Hopital Cote de Nacre | Recruiting |
| Caen, France | |
| C.H.U. Henri Mondor AP-HP | Recruiting |
| Créteil, France | |
| Hopital Saint Antoine AP-HP | Recruiting |
| Paris, France | |
| Netherlands | |
| Radboud University Nijmegen Medical Centre | Recruiting |
| Nijmegen, Netherlands | |
Sponsors and Collaborators
European Organisation for Research and Treatment of Cancer - EORTC
Investigators
| Study Chair: | J. Peter Donnelly | Universitair Medisch Centrum St. Radboud - Nijmegen |
| Study Chair: | Johan Maertens, MD | U.Z. Gasthuisberg |
| Study Chair: | Catherine Cordonnier, MD, PhD | Centre Hospitalier Universitaire Henri Mondor |
| Study Chair: | Tom Lodewyck | AZ Sint-Jan |
More Information
Additional Information:
No publications provided
| Responsible Party: | European Organisation for Research and Treatment of Cancer - EORTC |
| ClinicalTrials.gov Identifier: | NCT01288378 History of Changes |
| Other Study ID Numbers: | EORTC-65091-06093, 2010-020814-27, MK-0991-070 |
| Study First Received: | February 1, 2011 |
| Last Updated: | May 11, 2012 |
| Health Authority: | Belgium: Federal Agency for Medicinal Products and Health Products France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis) Netherlands: The Central Committee on Research Involving Human Subjects (CCMO) Germany: Federal Institute for Drugs and Medical Devices Switzerland: Swissmedic Italy: Ethics Committee Slovakia: State Institute for Drug Control Croatia: Ministry of Health and Social Care Turkey: Ministry of Health |
Keywords provided by European Organisation for Research and Treatment of Cancer - EORTC:
|
fungal infection de novo myelodysplastic syndromes previously treated myelodysplastic syndromes secondary myelodysplastic syndromes recurrent adult acute myeloid leukemia untreated adult acute myeloid leukemia adult acute myeloid leukemia with 11q23 (MLL) abnormalities |
adult acute myeloid leukemia with del(5q) adult acute myeloid leukemia with inv(16)(p13;q22) adult acute myeloid leukemia with t(15;17)(q22;q12) adult acute myeloid leukemia with t(16;16)(p13;q22) adult acute myeloid leukemia with t(8;21)(q22;q22) secondary acute myeloid leukemia |
Additional relevant MeSH terms:
|
Leukemia Mycoses Myelodysplastic Syndromes Preleukemia Neoplasms by Histologic Type Neoplasms Bone Marrow Diseases Hematologic Diseases Precancerous Conditions Antifungal Agents Clotrimazole |
Miconazole Caspofungin Echinocandins Anti-Infective Agents Therapeutic Uses Pharmacologic Actions Anti-Infective Agents, Local 14-alpha Demethylase Inhibitors Enzyme Inhibitors Molecular Mechanisms of Pharmacological Action |
ClinicalTrials.gov processed this record on May 19, 2013