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Main
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Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
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Register:
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EUCTR |
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Last refreshed on:
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4 January 2022 |
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Main ID: |
EUCTR2008-001043-19-DE |
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Date of registration:
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18/07/2008 |
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Prospective Registration:
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Yes |
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Primary sponsor: |
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Public title:
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Phase III Randomized, Double-Blind, Controlled Study Comparing Clofarabine and Cytarabine versus Cytarabine Alone in Adult Patients 55 Years and Older with Acute Myelogenous Leukemia (AML) who have Relapsed or are Refractory after Receiving up to Two Prior Induction Regimens - CLASSIC I
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Scientific title:
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Phase III Randomized, Double-Blind, Controlled Study Comparing Clofarabine and Cytarabine versus Cytarabine Alone in Adult Patients 55 Years and Older with Acute Myelogenous Leukemia (AML) who have Relapsed or are Refractory after Receiving up to Two Prior Induction Regimens - CLASSIC I |
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Date of first enrolment:
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24/09/2008 |
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Target sample size:
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325 |
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Recruitment status: |
Not Recruiting |
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URL:
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https://www.clinicaltrialsregister.eu/ctr-search/search?query=eudract_number:2008-001043-19 |
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Study type:
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Interventional clinical trial of medicinal product |
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Study design:
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Controlled: yes
Randomised: yes
Open: no
Single blind: no
Double blind: yes
Parallel group: yes
Cross over: no
Other: no
If controlled, specify comparator, Other Medicinial Product: yes
Placebo: yes
Other: no
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Phase:
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Human pharmacology (Phase I): no
Therapeutic exploratory (Phase II): no
Therapeutic confirmatory - (Phase III): yes
Therapeutic use (Phase IV): no
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Countries of recruitment
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France
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Germany
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Italy
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Key inclusion & exclusion criteria
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Inclusion criteria:
Patients must meet all of the following criteria to be eligible to participate in the study:
(1) Provide signed, written informed consent.
(2) Have a diagnosis of AML according to the WHO classification (see Appendix B of the study protocol).
(3) Have received not more than 2 prior induction regimens for treatment of AML according to the following definitions and qualifications:
• Induction regimen: a drug or combination of drugs administered for a pre-specified number of cycles (usually not exceeding 2 cycles total) to patients with AML with the intent of achieving a CR or CRi;
• At least 1 prior induction regimen must have included cytotoxic chemotherapy;
• Hematopoietic stem cell transplantation (HSCT) (administered after induction therapy) is not considered a distinct induction regimen.
• Consolidation or maintenance regimens (administered after CR or CRi documented) are not considered distinct induction regimens.
(4) Are refractory or relapsed (requiring at least 5% leukemic blasts in the bone marrow, regardless of the presence of other features such as new or recurrent dysplastic changes or extramedullary disease).
(5) Be 55 years of age or older at the time of signing the informed consent.
(6) Have an ECOG performance status (see Appendix C) score of 0, 1, or 2.
(7) Be able to comply with study procedures and follow-up examinations.
(8) Be nonfertile or agree to use birth control (ie, condom, diaphragm, cervical cap, etc) during the study and for at least 90 days after the last dose of study drug.
(9) Have adequate renal and hepatic function as indicated by the following
laboratory values:
Renal-Estimated GFR : =60 mL/min/1.73m2
Hepatic-
Serum bilirubin: =1.5 × ULN
AST and ALT: =2.5 × ULN
Alkaline phosphatase: =2.5 × ULN
GFR = Glomerular filtration rate, as estimated by the Modification of Diet
in Renal Disease (MDRD) equation (see appendix E)
ULN = Institutional Upper Limit of Normal
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range
Exclusion criteria:
(1) Received previous treatment with clofarabine.
(2) Received intermediate- or high-dose cytarabine (IDAC or HDAC, respectively) defined as a bolus administration schedule at =500 mg/m2/dose as a component of prior induction or consolidation therapy.
(3) Have received an HSCT within the previous 3 months prior to study entry.
(4) Have = grade 2 acute graft versus host disease (GvHD).
(5) Have either moderate or severe chronic GvHD, whether limited or extensive chronic GvHD. Patients with mild limited or extensive chronic GvHD may be included.
(6) Are receiving any other systemic antileukemic therapy (standard or investigational). Patients must not have received previous therapy for at least 2 weeks prior to the first dose of study drug and must have recovered from any prior drug-related non-hematologic toxicity to = grade 2, with the following exceptions:
• hydroxyurea, which must not have been received <24 hours prior to the first dose of study drug;
• monoclonal antibodies, which must not have been received for 6 weeks prior to the first dose of study drug.
(7) Have psychiatric disorders that would interfere with consent, study participation, or follow-up.
(8) Have a systemic fungal, bacterial, viral, or other infection not controlled.
(9) Have any other severe concurrent disease, or have a history of serious organ dysfunction or disease involving the heart, kidney, liver or other organ system that may place the patient at undue risk to undergo induction therapy with either or both of these agents.
(10) Have been diagnosed with another malignancy, unless the patient has been
disease free for at least 5 years following curative intent therapy.
(11) Have clinical evidence suggestive of CNS involvement with leukemia unless a lumbar puncture confirms the absence of leukemic blasts in the CSF.
(12) Known HIV positivity
(13) Are pregnant or lactating.
Age minimum:
Age maximum:
Gender:
Female: yes
Male: yes
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Health Condition(s) or Problem(s) studied
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Acute Myelogenous (Myeloid) Leukemia (AML)
MedDRA version: 9.1
Level: LLT
Classification code 10000880
Term: Acute myeloid leukaemia
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Intervention(s)
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Trade Name: Evoltra 1 mg/ml concentrate for solution for infusion
Pharmaceutical Form: Concentrate for solution for infusion
INN or Proposed INN: CLOFARABINE
CAS Number: 123318-82-1
Concentration unit: mg/ml milligram(s)/millilitre
Concentration type: equal
Concentration number: 1-
Pharmaceutical form of the placebo: Solution for infusion
Route of administration of the placebo: Intravenous use
Trade Name: Cytarabine
Product Name: CYTARABINE
Pharmaceutical Form: Powder for infusion*
INN or Proposed INN: CYTARABINE
CAS Number: 147-94-4
Concentration unit: mg/ml milligram(s)/millilitre
Concentration type: equal
Concentration number: 50-
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Primary Outcome(s)
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Main Objective: To assess the efficacy of clofarabine in combination with cytarabine compared with cytarabine alone in adult patients 55 years and older with AML who have either relapsed or are refractory after receiving up to two prior induction regimens, as measured by overall survival.
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Secondary Objective: • To determine the overall remission (OR) rate (CR + CRi) of clofarabine in combination with cytarabine compared with cytarabine alone;
• To determine the duration of remission and disease-free survival for each treatment group;
• To compare treatment groups with respect to event-free survival and 4-month event-free survival;
• To determine the safety and tolerability of clofarabine when used in combination with cytarabine compared with cytarabine alone and the duration, seriousness, severity and relationship of adverse events which occur during the treatment and follow-up period, including hospitalizations.
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Primary end point(s): Overall survival
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Secondary ID(s)
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CLO-34100405
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Source(s) of Monetary Support
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Ethics review
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Status: Approved
Approval date: 24/09/2008
Contact:
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