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German Multicenter Trial for Treatment of Elderly Patients With Newly Diagnosed Acute Lymphoblastic Leukemia

G

Goethe University

Status and phase

Completed
Phase 4

Conditions

Adult Acute Lymphocytic Leukemia

Treatments

Drug: Mercaptopurine
Drug: Methotrexate
Drug: Vincristine
Drug: Idarubicin
Drug: Dexamethasone / Prednisolone
Drug: Depocyte
Drug: Cyclophosphamide
Drug: Granulocyte-Colony-Stimulating Factor
Drug: Rituximab
Drug: Asparaginase
Drug: HDARAC
Drug: Cytarabine

Study type

Interventional

Funder types

Other

Identifiers

NCT00198978
GMALL02

Details and patient eligibility

About

The study evaluates the efficacy and tolerability of a dose-reduced chemotherapy for the treatment of elderly patients with acute lymphoblastic leukemia. In patients with expression of CD20 on leukemic cells the efficacy and tolerability of additional application of Rituximab together with chemotherapy is evaluated.

Enrollment

377 patients

Sex

All

Ages

55+ years old

Volunteers

No Healthy Volunteers

Inclusion criteria

  • Diagnosis of acute lymphoblastic leukemia (pro B, pre B, c-ALL or T-ALL), proved by morphology and immunophenotyping
  • Age > 55 yrs (no upper age limit)
  • Written informed consent

Exclusion criteria

  • Severe leukemia associated complications, not controllable before therapy onset e.g.
  • life threatening infections as sepsis, pneumonia, hypoxia, shock, life threatening bleeding)
  • Severe comorbidity e.g.
  • decompensated renal failure if not caused by leukemia with Creatinine > 2x ULN
  • heart failure (NYHA II/IV), instable Angina, significant coronary stenosis
  • hepatic insufficiency e.g. liver cirrhosis or chronic active hepatitis with bilirubin > 1,5 x ULN and/or ASA, ALA, AP > 2,5 ULN
  • decompensated metabolic disturbances (e.g. not controllable diabetes)
  • severe obstructive or restrictive pulmonary disease with hypoxaemia
  • Severe psychiatric illness or other circumstances which may compromise cooperation of the patient
  • Active second neoplasia
  • HIV infection
  • Severely reduced general condition
  • Cytostatic pre-treatment of ALL
  • Chemotherapy treatment of any other malignancy during the last 5 years
  • Participation in other clinical trials interfering with the study therapy

Trial design

Primary purpose

Treatment

Allocation

N/A

Interventional model

Single Group Assignment

Masking

None (Open label)

377 participants in 1 patient group

Interventional arm
Experimental group
Treatment:
Drug: Mercaptopurine
Drug: Dexamethasone / Prednisolone
Drug: Asparaginase
Drug: Depocyte
Drug: Idarubicin
Drug: Methotrexate
Drug: Granulocyte-Colony-Stimulating Factor
Drug: Vincristine
Drug: Cyclophosphamide
Drug: HDARAC
Drug: Cytarabine
Drug: Rituximab

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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