3 Anthracyclines, 2 Types of Consolidation With Different ARA-C Doses and Maintenance in Adult Acute Myeloid Leukemia

National Research Center for Hematology, Russia

Status and phase: Unknown; Phase 4

Conditions: Acute Myeloid Leukemia

Treatments: Drug: high dose ARA-C; Drug: standard dose ARA-C

Study type: Interventional

Funder types: NETWORK

Identifiers

NCT01587430

AML-01.10

Details and patient eligibility

About

The goal: to evaluate the role of high dose ara-c plus idarubicin and mitoxantrone consolidation followed by maintenance in the setting of high total cumulative anthracyclines dose(720-660 mg/m2).

Full description

In previous Russian AML multicenter studies it was shown that escalation of ARA-C dose (from 5,6 g to 72 g in 4 induction/consolidation courses) in parallel with anthracyclines dose reduction (from 630 mg/m2 to 285 mg/m2)did not improve survival, but decreased feasibility. In the ongoing trial we try to learn whether anthracyclines dose escalation (up to 720-660 mg m2) will or will not equivalise the standard (5,6 g in 4 induction/consolidation courses) and high (14,8 g) ARA-C doses.

Enrollment: 245 estimated patients

Sex: All

Ages: 15 to 60 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• de novo acute myeloid leukemia - age 15-60

Exclusion criteria

• secondary acute myeloid leukemia
• acute myeloid leukemia from myelodysplastic syndrome
• Ph+ acute myeloid leukemia

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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245 participants in 2 patient groups

high dose ARA-C

Active Comparator group

Description:

High dose ARA-C will be applied after two 7+3 induction courses during the first and the second consolidation courses: ARA-C 1 g/m2 bid 1-3 days with idarubicin (8mg/m2 3-5 days)and mitoxantrone (10 mg/m2 3-5 days)

Treatment:

Drug: high dose ARA-C

standard dose ARA-C

Active Comparator group

Description:

Standard dose ARA-C will be applied after two 7+3 induction courses the first and the second consolidation courses : ARA-C 100 g/m2 bid 1-7 days with idarubicin (8mg/m2 1-3 days)and mitoxantrone (10 mg/m2 1-3 days)

Treatment:

Drug: standard dose ARA-C