Risk-Adapted Therapy of Acute Myeloid Leukemia of Adults (18-60 Years) According to the Cytogenetic Result

Sponsor

University of Ulm (Other)

Overall Status

Completed

CT.gov ID

NCT00146120

Collaborator

(none)

400

Enrollment

Locations

Duration (Months)

18.2

Patients Per Site

0.2

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

The concept of the investigators risk-adapted multicenter treatment trial for younger adults, AML HD98A, is based on the results of the AML HD93 trial and on published data. Definition of risk groups is different compared to the AML HD93 trial; high-risk: refractory disease after first induction therapy and/or high risk karyotype [abn(3q), -5/5q-, -7/7q-, abn(12p), abn(17p), complex]; intermediate-risk: complete remission after induction therapy and intermediate risk karyotype [normal, abn(11q23), abn(16q22), other rare aberrations]; low-risk: complete remission after induction therapy and low risk karyotype [t(8;21)]. Patients exhibiting a t(15;17) were treated in a separated trial (APL HD95). Treatment consists of a first induction therapy with ICE followed by a second cycle ICE in case of response to first induction therapy. Patients with refractory disease after first induction therapy are assigned to a salvage therapy with A-HAM (all-trans retinoic acid, high-dose cytarabine and mitoxantrone) and the search for potential hematopoietic stem cell donors is extended from the family to unrelated persons. All patients achieving a CR after induction therapy with ICE are assigned to a first consolidation therapy with HAM. For intermediate-risk patients a peripheral stem cell or a bone marrow harvest are intended during the hematological recovery after the first consolidation. Second consolidation therapy was stratified according to the risk definition. For high risk patients a allogeneic transplantation is assigned from a related or unrelated donor preferentially after a dose-intensified conditioning therapy. All patients with intermediate risk and an HLA-matched family donor are assigned to allogeneic transplantation. Intermediate-risk patients without a family donor and normal karyotype at diagnosis are randomized between an autologous stem cell transplantation and a second course of HAM. The other intermediate-risk patients are assigned to autologous transplantation. For low-risk patients a second course of HAM is assigned.

Condition or Disease	Intervention/Treatment	Phase
Acute Myeloid Leukemia	Drug: Idarubicin Drug: Cytosin-Arabinosid Drug: Etoposide Drug: All-trans Retinoid acid	Phase 3

Study Design

Study Type:

Interventional

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

None (Open Label)

Primary Purpose:

Treatment

Official Title:

Risk-Adapted Therapy of Acute Myeloid Leukemia of Adults (18-60 Years) According to the Cytogenetic Result

Study Start Date :

May 1, 1998

Actual Primary Completion Date :

May 1, 2005

Actual Study Completion Date :

May 1, 2005

Outcome Measures

Primary Outcome Measures

relapse-free survival [two years]

Secondary Outcome Measures

overall survival [two years]

Eligibility Criteria

Criteria

Ages Eligible for Study:

16 Years to 60 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Inclusion Criteria:

Patients with AML, de Novo or secondary after Myelodysplasy, or with therapy-induced AML after healed primary malignom; or refractory anemia with excess of blasts in transformation (RAEB-t); the diagnosis must be confirmed morphological, cytochemical and with immunological phenotyping
Cytogenetical tests must be performed for each patient
Age: 16 - 60 years
All patients have to be informed about the character of the study. Written informed consent of each patient at study entry.

Exclusion Criteria:

Organic insufficiency: Insufficiency of the kidneys (Crea > 1.5 x upper normal serum level), or insufficiency of the liver (bilirubin, SGOT or AP > 2 x upper normal serum level) uncaused by the AML; severe obstruction or restrictive ventilation disorder, heart failure with a ejection fraction < 0.5
Secondary malignom
Other severe diseases
Pregnancy
Participation in an concurrent clinical study

Contacts and Locations

Locations

	Site	City	Country	Postal Code
1	Department of Hematology / Oncology, University Hospital of Innsbruck	Innsbruck	Austria	6020
2	III Medical Department, Hematology and Oncology Center, Hanuschhospital Wien	Wien	Austria	1140
3	Department of General Internal Medicine, University Hospital of Bonn	Bonn	Germany	53127
4	Department of Internal Medicine Hematology, Heinrich-Heine University	Düsseldorf	Germany	40225
5	Department of Interial Medicine III, City Hospital Frankfurt Am Main - Höchst	Frankfurt	Germany	65927
6	Medical Department IV, University of Gießen	Gießen	Germany	35392
7	Department of Interial Medicine, Wilhelm-Anton-Hospital Goch	Goch	Germany	47574
8	Centre of Interial Medicine, University of Göttingen	Göttingen	Germany	37075
9	Medical Department III of Hematology and Oncology, General Hospital Altona	Hamburg	Germany	22763
10	Department of Interial Medicine V, University of Heidelberg	Heidelberg	Germany	69120
11	Department of Interial Medicine I, University Hospital of Saarland	Homburg	Germany	66421
12	Medical Department II, City Hospital Karlsruhe gGmbH	Karlsruhe	Germany	76133
13	Medical Department II, University Hospital of Kiel	Kiel	Germany	24116
14	Department of Interial Medicine /Hematology and Oncology, Caritas Hospital Lebach	Lebach	Germany	66822
15	I. Medical Department, City Hospital München-Schwabing	München	Germany	80804
16	Medical Department III, Clinical Center rechts der Isar	München	Germany	81675
17	Department of Hematology and Oncology, City Hospital Neunkirchen gGmbH	Neunkirchen	Germany	66538
18	Department of Hematology and Oncology, Clinical Center of Oldenburg gGmbH	Oldenburg	Germany	26133
19	Department of Hematologie and Oncology, Caritas Hospital St. Theresa Saarbrücken	Saarbrücken	Germany	66113
20	Clinikal Cetner of Stuttgart, Center of Oncology	Stuttgart	Germany	70174
21	Medical Department I, Clinical Center of Stuttgart	Stuttgart	Germany	70191
22	Hospital of Barmherzige Brüder, I Medical Department	Trier	Germany	54292