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Randomized Phase II/III-Study on All-Trans Retinoic Acid in Combination With Induction and Consolidation Therapy as Well as Pegfilgrastim After Consolidation Therapy in Younger Patients With Newly Diagnosed Acute Myeloid Leukemia


Phase 2/Phase 3
18 Years
60 Years
Open (Enrolling)
Both
Acute Myeloid Leukemia

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Trial Information

Randomized Phase II/III-Study on All-Trans Retinoic Acid in Combination With Induction and Consolidation Therapy as Well as Pegfilgrastim After Consolidation Therapy in Younger Patients With Newly Diagnosed Acute Myeloid Leukemia


First Induction Therapy:

- Cytarabine 100 mg/m² cont. i.v. days 1-7

- Idarubicin 12 mg/m² i.v. days 1,3,5

- Etoposide 100 mg/m² i.v. days 1-3

- ± ATRA 45 mg/m² p.o. days 6-8

- ATRA 15 mg/m² p.o. days 9-21

Second Induction Therapy:

- Cytarabine 100 mg/m² cont. i.v. days 1-7

- Idarubicin 12 mg/m² i.v. days 1 and 3

- Etoposide 100 mg/m² i.v. days 1-3

- ± ATRA 45 mg/m² p.o. days 6-8

- ATRA 15 mg/m² p.o. days 9-21

Consolidation Therapy:

cohort 1 (<= ID 336)

- Cytarabine 3 g/m² 2x/die i.v. Tag 1,3,5

- ± ATRA 15 mg/m² p.o. Tag 6-21

- Pegfilgrastim 6 mg s.c day 10

cohort 2 (> ID 336)

- Cytarabine 3 g/m² 2x/die i.v. Tag 1,2,3

- ± ATRA 15 mg/m² p.o. Tag 4-21

- Pegfilgrastim 6 mg s.c day 8


Inclusion Criteria:



- Newly diagnosed AML defined according to the World Health Organization
(WHO)-classification (excluding acute promyelocytic leukemia [APL])

- Ages 18-60 years

- Written informed consent of each patient at study entry.

- Molecular and cytogenetical diagnostics on initial bone marrow and peripheral blood
specimen at the central reference laboratories

Exclusion Criteria:

- Bleeding independent of the AML

- Acute promyelocytic leukemia

- Uncontrollable infection

- Participation in a concurrent clinical study

- Insufficiency of the kidneys (creatinine > 1.5x upper normal serum level), of the
liver (bilirubin, AST or AP > 2x upper normal serum level), severe obstructive or
restrictive ventilation disorder, heart failure New York Heart Association (NYHA)
III/IV

- Severe neurological or psychiatric disorder interfering with ability to give an
informed consent.

- No consent for registration, storage and processing of the individual
disease-characteristics and course.

- Performance status WHO > 2

- Pregnancy

Type of Study:

Interventional

Study Design:

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

Complete remission (CR)-rate after induction therapy

Outcome Time Frame:

after the second induction cycle

Safety Issue:

No

Principal Investigator

Richard F Schlenk, Dr.

Investigator Role:

Principal Investigator

Investigator Affiliation:

Department of Internal Medicine III, University of Ulm

Authority:

Germany: Federal Institute for Drugs and Medical Devices

Study ID:

AMLSG07-04

NCT ID:

NCT00151242

Start Date:

July 2004

Completion Date:

August 2013

Related Keywords:

  • Acute Myeloid Leukemia
  • Leukemia
  • Leukemia, Myeloid, Acute
  • Leukemia, Myeloid

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