AML96 - Risk-Adapted and Randomized Postremission-Therapy for Adult Acute Myeloid Leukemia Patients

Conditions

Leukemia, Nonlymphoblastic, Acute

Keywords

acute myeloid leukemia, cytarabine postremission dosage, risk adapted treatment strategy, allogeneic stem cell transplantation, autologous stem cell transplantation

Brief summary

The AML96 study examines the feasibility of a risk-adapted postremission treatment strategy including related and unrelated allogeneic stem cell transplantation for high risk AML patients and related allogeneic and autologous stem cell transplantation for standard risk AML patients in a multi-center setting. Furthermore it randomizes patients between intermediate-dose Cytarabine vs high-dose Cytarabine within the first postremission-course.

Detailed description

The AML96 study examines the feasibility of a risk-adapted postremission treatment strategy including related and unrelated allogeneic stem cell transplantation for high risk AML patients and related allogeneic and autologous stem cell transplantation for standard risk AML patients in a multi-center setting. Furthermore it randomizes patients between intermediate-dose Cytarabine vs high-dose Cytarabine within the first postremission-course.

Heidrich K, Thiede C, Schäfer-Eckart K, Schmitz N, Aulitzky WE, Krämer A, Rösler W, Hänel M, Einsele H, Baldus CD, Trappe RU, Stölzel F, Middeke JM, Röllig C, Taube F, Kramer M, Serve H, Berdel WE, Ehninger G, Bornhäuser M, Schetelig J, Study Alliance Leukemia (SAL).

2017-11-0114 citations

10.1093/annonc/mdx500

Marker Chromosomes Can Arise from Chromothripsis and Predict Adverse Prognosis in Acute Myeloid Leukemia

Tilmann Bochtler, Martin Granzow, Friedrich Stölzel, Christina Kunz, Brigitte Mohr et al. (16 authors)

Blood2016-12-025 citations

10.1182/blood.v128.22.2869.2869

Isolated trisomy 13 defines a homogeneous AML subgroup with high frequency of mutations in spliceosome genes and poor prognosis

Tobias Herold, Klaus H. Metzeler, Sebastian Vosberg, Luise Hartmann, Christoph Röllig et al. (28 authors)

Blood2014-06-13104 citations

10.1182/blood-2013-12-540716

Prediction of post-remission survival in acute myeloid leukaemia: a post-hoc analysis of the AML96 trial.

Pfirrmann M, Ehninger G, Thiede C, Bornhäuser M, Kramer M, Röllig C, Hasford J, Schaich M, Study Alliance Leukaemia (SAL).

2011-12-2252 citations

10.1016/s1470-2045(11)70326-6

MLD according to the WHO classification in AML has no correlation with age and no independent prognostic relevance as analyzed in 1766 patients.

Wandt H, Schäkel U, Kroschinsky F, Prange-Krex G, Mohr B, Thiede C, Pascheberg U, Soucek S, Schaich M, Ehninger G.

2007-12-0444 citations

10.1182/blood-2007-08-101162

Interventions

DRUGCytarabine Dosage

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

16 Years to No maximum

Healthy volunteers

No

Inclusion criteria

* de novo or secondary acute myeloid leukemia of the FAB subtypes M0-M2 and M4-M7 * de novo or secondary myelodysplastic syndrome FAB subtypes RAEB and RAEB-T * written informed consent

Exclusion criteria

* severe comorbidities * severe uncontrolled complications of the leukemia * previous therapy of leukemia/MDS * HIV-Infection * known relevant allergy against study medication * pregnancy * missing written informed consent

Design outcomes

Primary

Measure	Time frame
- rate of complete remission	—
- overall survival	—
- relapse-free survival	—

Secondary

Measure	Time frame
- frequencies and grade of treatment side effects	—
- feasibility according to dosages and time-intervals	—
- deaths within induction therapy	—
- deaths within postremission therapy	—

Countries

Germany

Outcome results

None listed