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

G

Goethe University

Status and phase

Completed
Phase 4

Conditions

Adult Acute Lymphocytic Leukemia

Treatments

Drug: 6-Mercaptopurine
Drug: VM26
Drug: Daunorubicin
Drug: Cytarabine
Drug: Methotrexate
Procedure: Mediastinal irradiation (if residual tumor)
Drug: VP16
Procedure: stem cell transplantation
Procedure: CNS irradiation
Drug: Ifosfamide
Drug: G-CSF
Drug: Cyclophosphamide
Drug: Adriamycin
Drug: Asparaginase
Drug: Dexamethasone / Prednisolone
Drug: Fludarabine
Drug: Vincristine / Vindesine
Drug: Idarubicin
Drug: Thioguanine

Study type

Interventional

Funder types

Other

Identifiers

NCT00199056
GMALL10

Details and patient eligibility

About

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.

Sex

All

Ages

15 to 65 years old

Volunteers

No Healthy Volunteers

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

Trial design

Primary purpose

Treatment

Allocation

Non-Randomized

Interventional model

Parallel Assignment

Masking

None (Open label)

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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