Treatment of Elderly Patients (>65 Years) With Acute Lymphoblastic Leukemia

Adult Acute Lymphocytic Leukemia Clinical Trial

Official title:

Pilot Study for Treatment of Elderly Patients (>65 Years) With Acute Lymphoblastic Leukemia

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00199095
• Other study ID #: GMALL11
• Status: Completed
• Phase: Phase 4
• Start date: February 1997
• Est. completion date: June 2003

Study information

• Verified date: March 2023
• Source: Goethe University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

The aim of this study is to test feasibility and efficacy of a dose reduced chemotherapy in elderly patients with newly diagnosed acute lymphoblastic leukemia. The regimen consists of induction phase I and II followed by cyclic consolidation cycles, reinduction and maintenance therapy

Recruitment information / eligibility

• Status: Completed
• Enrollment: 40
• Est. completion date: June 2003
• Est. primary completion date: June 2003
• Accepts healthy volunteers: No
• Gender: All
• Age group: 65 Years and older

Eligibility

Inclusion Criteria:

• diagnosis of acute lymphoblastic leukemia (pro-B,common,pre-B,pre-T,Thy-,mature T, B-ALL)
• age > 65 years
• written informed consent
• Karnofsky > 50% (if not mainly caused by leukemia)
• laboratory at diagnosis or after supportive pre-treatment Creatinine < 2 mg/dl Uric Acid < 8 mg/dl Bilirubin < 1.5 mg/dl ALA, ASA,AP < 2.5 x ULN

Exclusion Criteria:

• severe second diseases (e.g. renal failure, cardiomyopathy etc., not caused by leukemia) that exclude treatment according to the protocol
• severe psychiatric illness or other circumstances which may compromise cooperation
• active second neoplasia
• clinical signs of life threatening infections or bleeding, uncontrollable prior to chemotherapy

Related Conditions & MeSH terms

• Adult Acute Lymphocytic Leukemia
• Leukemia
• Leukemia, Lymphoid
• Precursor Cell Lymphoblastic Leukemia-Lymphoma

Intervention

Drug:
• Adriamycin

• Cyclophosphamide

• Cytarabine

• Dexamethasone

• Idarubicin

• Ifosfamide

• Methotrexate

• Mercaptopurine

• VM26

• Vincristine

Locations

Country	Name	City	State
Germany	University Hospital, Medical Dept. II	Frankfurt

Sponsors (1)

Lead Sponsor	Collaborator
Goethe University

Country where clinical trial is conducted

Germany, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Results of induction therapy,Distribution of entry criteria,Treatment feasibility,Relapse rate and localisation,Death in CR,Remission duration, survival and leukemia free survival,Prognostic factors,Quality of life

External Links

•   European Leukemia Trial Registry