German Multicenter Trial for Treatment of Newly Diagnosed Acute Lymphoblastic Leukemia in Adults (06/99)

Conditions

Adult Acute Lymphocytic Leukemia

Keywords

ALL, Treatment, De Novo, Adult

Brief summary

The study evaluates the efficacy and tolerability of an intensified induction and consolidation therapy. Thereafter patients receive individualised treatment stratified according to relapse risk with stem cell transplantation for patients with high and very high risk of relapse. Patients with standard risk receive further consolidation and reinduction chemotherapy. In parallel minimal residual disease (MRD) is evaluated. A MRD based risk stratification and treatment decision is developed.

Tobias Herold, Stephanie Schneider, Klaus H. Metzeler, Martín Neumann, Luise Hartmann et al. (24 authors)

Haematologica2016-08-25161 citations

10.3324/haematol.2015.136366

Adult patients with acute lymphoblastic leukemia and molecular failure display a poor prognosis and are candidates for stem cell transplantation and targeted therapies.

Gökbuget N, Kneba M, Raff T, Trautmann H, Bartram CR, Arnold R, Fietkau R, Freund M, Ganser A, Ludwig WD, Maschmeyer G, Rieder H, Schwartz S, Serve H, Thiel E, Brüggemann M, Hoelzer D, German Multicenter Study Group for Adult Acute Lymphoblastic Leukemia.

2012-03-22349 citations

10.1182/blood-2011-09-377713

Interventions

DRUGDexamethasone / Prednisolone

DRUGCyclophosphamide

DRUGMethotrexate

DRUGVincristine / Vindesine

DRUGDaunorubicin

DRUGAsparaginase

DRUGG-CSF

DRUGCytarabine

DRUG6-Mercaptopurine

DRUGVP16

DRUGAdriamycin

DRUGThioguanine

DRUGVM26

DRUGIdarubicin

DRUGFludarabine

DRUGIfosfamide

PROCEDURECNS irradiation

PROCEDUREMediastinal irradiation (if residual tumor)

PROCEDUREstem cell transplantation

Study design

Allocation

NON_RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

15 Years to 65 Years

Healthy volunteers

No

Inclusion criteria

* Acute lymphoblastic leukemia (pro-B, common, pre-B, early T, T) * Age 15-65 yrs (\*55-65 years if biologically younger according to general condition)

Exclusion criteria

* Severe comorbidity * Cytostatic pre-treatment * Pregnancy * Missing written informed consent

Design outcomes

Primary

Measure	Time frame
Remission rate,Remission duration,Disease free survival,Overall survival	—

Secondary

Measure	Time frame
Time and dose compliance,Realisation of SCT,Toxicity according to WHO,Course of MRD	—

Countries

Germany

Outcome results

None listed