Lomustine and Intermediate Dose Cytarabine in Older Patients With AML

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE3

Total Enrollment

360 participants

Study Classification

INTERVENTIONAL

Study Start Date

1995-07-31

Study Completion Date

2007-05-31

Brief Summary

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A multicenter randomized trial was performed comparing induction therapy (IC: Idarubicin and Cytarabine, 5+7) to ICL (the same drugs plus lomustine (CCNU), 200mg\\m2 orally at day 1). Patients in complete remission (CR) were then randomized to receive either maintenance therapy or intensification with intermediate-dose cytarabine and idarubicin followed by maintenance therapy.

Detailed Description

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Induction therapy: Patients were randomized to receive idarubicin plus cytarabine (IC) or the same drugs plus lomustine (ICL), the latter given at the dose of 200 mg/m2 orally at day 1. Patients with persistent leukemia in the bone marrow, defined by at least 20% marrow cellularity with more than 5% blasts on day 14 or at a subsequent time point following initiation of induction therapy, received a second course of induction chemotherapy identical to the initial induction course. Non-responders to the second induction course were taken off the protocol.

Consolidation therapy: After completing induction treatment, patients who were in complete remission after 1 or 2 induction courses received a course of consolidation (IC') therapy with idarubicin and subcutaneous cytarabine. Subsequently, if stable remission persisted, the patients received maintenance therapy or maintenance therapy preceded by a second consolidation (IIC) with intermediate-dose cytarabine. Randomization was performed as soon as CR was achieved.

Maintenance therapy: This was conducted in all patients with persisting CR one month after completing the first (IC) or second (IIC) consolidation and consisted of the following: five courses of combination chemotherapy at 1, 3, 6, 9 and 13 months from the last consolidation, namely cytarabine (subcutaneously) and idarubicin and between these courses for one year: a continuous regimen of methotrexate and 6-mercaptopurine, as alternating 10 day-courses .

Conditions

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Acute Myeloid Leukemia

Keywords

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AML older patients lomustine

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Interventions

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Lomustine, intermediate dose cytarabine

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

* Patients aged 60 years and older with de novo AML according to FAB criteria
* With normal cardiac function with left ventricular ejection fraction \>= 50%, absence of unstable cardiac arrhythmia or unstable angina.
* Unimpaired renal (creatinin \<180µmol\\L)
* Unimpaired liver (bilirubin \<35µmol\\L) functions.
* Performance status \<3
* Signed and dated informed consent.

Exclusion Criteria

* Acute promyelocytic leukemia
* Patients with myeloproliferative syndromes prior to diagnosis of AML
* Patients who previously had myelodysplastic syndrome
* Patients pretreated with chemo- or radiotherapy
* Performance status \<2
* Positive serology for HIV

Minimum Eligible Age

60 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Principal Investigators

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JOSY REIFFERS, MD

Role: PRINCIPAL_INVESTIGATOR

CHU Haut-Leveque Pessac 33604 France

Locations

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Josy REIFFERS, MD MS

Pessac, , France

Site Status

Countries

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France

Other Identifiers

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BGMT95-V

Identifier Type: -

Identifier Source: org_study_id