Back to resultsTreatment of Elderly Patients (>65 Years) With Acute Lymphoblastic Leukemia
Primary Purpose
Adult Acute Lymphocytic Leukemia
Status
Completed
Phase
Phase 4
Locations
Germany
Study Type
Interventional
Intervention
Adriamycin
Cyclophosphamide
Cytarabine
Dexamethasone
Idarubicin
Ifosfamide
Methotrexate
Mercaptopurine
VM26
Vincristine
Sponsored by
About this trial
This is an interventional treatment trial for Adult Acute Lymphocytic Leukemia focused on measuring ALL, Elderly, Chemotherapy
Eligibility Criteria
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
Sites / Locations
- University Hospital, Medical Dept. II
Outcomes
Primary Outcome Measures
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
Secondary Outcome Measures
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT00199095
Brief Title
Treatment of Elderly Patients (>65 Years) With Acute Lymphoblastic Leukemia
Official Title
Pilot Study for Treatment of Elderly Patients (>65 Years) With Acute Lymphoblastic Leukemia
Study Type
Interventional
2. Study Status
Record Verification Date
March 2023
Overall Recruitment Status
Completed
Study Start Date
February 1997 (Actual)
Primary Completion Date
June 2003 (Actual)
Study Completion Date
June 2003 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Goethe University
4. Oversight
5. Study Description
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
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Adult Acute Lymphocytic Leukemia
Keywords
ALL, Elderly, Chemotherapy
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
40 (false)
8. Arms, Groups, and Interventions
Intervention Type
Drug
Intervention Name(s)
Adriamycin
Intervention Type
Drug
Intervention Name(s)
Cyclophosphamide
Intervention Type
Drug
Intervention Name(s)
Cytarabine
Intervention Type
Drug
Intervention Name(s)
Dexamethasone
Intervention Type
Drug
Intervention Name(s)
Idarubicin
Intervention Type
Drug
Intervention Name(s)
Ifosfamide
Intervention Type
Drug
Intervention Name(s)
Methotrexate
Intervention Type
Drug
Intervention Name(s)
Mercaptopurine
Intervention Type
Drug
Intervention Name(s)
VM26
Intervention Type
Drug
Intervention Name(s)
Vincristine
Primary Outcome Measure Information:
Title
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
10. Eligibility
Sex
All
Minimum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Dieter Hoelzer, MD
Organizational Affiliation
University Hospital Frankfurt, Medical Dept. II
Official's Role
Study Chair
Facility Information:
Facility Name
University Hospital, Medical Dept. II
City
Frankfurt
ZIP/Postal Code
60590
Country
Germany
12. IPD Sharing Statement
Links:
URL
http://www.leukemia-trials.eu
Description
European Leukemia Trial Registry
Learn more about this trial
Treatment of Elderly Patients (>65 Years) With Acute Lymphoblastic Leukemia
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