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

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

Status

Completed

Phases

Phase 4

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00199095

Enrollment

Registered

2005-09-20

Start date

1997-02-28

Completion date

2003-06-30

Last updated

2023-03-20

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Adult Acute Lymphocytic Leukemia

Keywords

ALL, Elderly, Chemotherapy

Brief 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

Interventions

DRUGAdriamycin

DRUGCyclophosphamide

DRUGCytarabine

DRUGDexamethasone

DRUGIdarubicin

DRUGIfosfamide

DRUGMethotrexate

DRUGMercaptopurine

DRUGVM26

DRUGVincristine

Study design

Allocation

NON_RANDOMIZED

Intervention model

SINGLE_GROUP

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

65 Years to No maximum

Healthy volunteers

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

Design outcomes

Primary

Measure	Time frame
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	—

Countries

Germany

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026