search
Back to results

German Multicenter Trial for Treatment of Newly Diagnosed Acute Lymphoblastic Leukemia in Adults (05/93)

Primary Purpose

Adult Acute Lymphocytic Leukemia

Status
Completed
Phase
Phase 4
Locations
Germany
Study Type
Interventional
Intervention
Asparaginase
Vincristine
Daunorubicin, Adriamycin
Cyclophosphamide
Ifosfamide
Cytarabine
Mitoxantrone
Methotrexate
6-Mercaptopurine
6-Thioguanine
VM26
Dexamethasone / Prednisolone
CNS Irradiation
Mediastinal Irradiation
Stem Cell Transplantation
Sponsored by
Goethe University
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an interventional treatment trial for Adult Acute Lymphocytic Leukemia focused on measuring ALL, Treatment, De Novo, Adult

Eligibility Criteria

15 Years - 65 Years (Child, Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria: Acute Lymphocytic Leukemia Age 15 - 65 years Exclusion Criteria: Serious secondary diseases which may compromise intensified chemotherapeutical treatment Serious psychiatric diseases, which may compromise compliance with therapy HIV-1 or HIV-2 Infection Pretreatment > 2 weeks or chemotherapy other than Vincristine and Steroids Patients without central diagnosis who cannot be allocated to a risk group

Sites / Locations

  • University Hospital, Medical Dept. II

Outcomes

Primary Outcome Measures

remission rate, disease free survival, overall survival

Secondary Outcome Measures

death in induction, toxicity, time and dose compliance

Full Information

First Posted
September 12, 2005
Last Updated
March 15, 2023
Sponsor
Goethe University
Collaborators
Deutsche Krebshilfe e.V., Bonn (Germany)
search

1. Study Identification

Unique Protocol Identification Number
NCT00199069
Brief Title
German Multicenter Trial for Treatment of Newly Diagnosed Acute Lymphoblastic Leukemia in Adults (05/93)
Official Title
Multicenter Trial for Treatment of Acute Lymphoblastic Leukemia in Adults (05/93)
Study Type
Interventional

2. Study Status

Record Verification Date
March 2023
Overall Recruitment Status
Completed
Study Start Date
April 1993 (Actual)
Primary Completion Date
January 1999 (Actual)
Study Completion Date
May 2001 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Goethe University
Collaborators
Deutsche Krebshilfe e.V., Bonn (Germany)

4. Oversight

5. Study Description

Brief Summary
The study evaluates the efficacy and tolerability of a risk- and subtype-adapted chemotherapy over one year, followed by randomized either intensified or conventional maintenance therapy. It includes a distinct protocol for the subgroup 'mature B-ALL',

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, Treatment, De Novo, Adult

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
720 (false)

8. Arms, Groups, and Interventions

Intervention Type
Drug
Intervention Name(s)
Asparaginase
Intervention Type
Drug
Intervention Name(s)
Vincristine
Intervention Type
Drug
Intervention Name(s)
Daunorubicin, Adriamycin
Intervention Type
Drug
Intervention Name(s)
Cyclophosphamide
Intervention Type
Drug
Intervention Name(s)
Ifosfamide
Intervention Type
Drug
Intervention Name(s)
Cytarabine
Intervention Type
Drug
Intervention Name(s)
Mitoxantrone
Intervention Type
Drug
Intervention Name(s)
Methotrexate
Intervention Type
Drug
Intervention Name(s)
6-Mercaptopurine
Intervention Type
Drug
Intervention Name(s)
6-Thioguanine
Intervention Type
Drug
Intervention Name(s)
VM26
Intervention Type
Drug
Intervention Name(s)
Dexamethasone / Prednisolone
Intervention Type
Procedure
Intervention Name(s)
CNS Irradiation
Intervention Type
Procedure
Intervention Name(s)
Mediastinal Irradiation
Intervention Type
Procedure
Intervention Name(s)
Stem Cell Transplantation
Primary Outcome Measure Information:
Title
remission rate, disease free survival, overall survival
Secondary Outcome Measure Information:
Title
death in induction, toxicity, time and dose compliance

10. Eligibility

Sex
All
Minimum Age & Unit of Time
15 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Acute Lymphocytic Leukemia Age 15 - 65 years Exclusion Criteria: Serious secondary diseases which may compromise intensified chemotherapeutical treatment Serious psychiatric diseases, which may compromise compliance with therapy HIV-1 or HIV-2 Infection Pretreatment > 2 weeks or chemotherapy other than Vincristine and Steroids Patients without central diagnosis who cannot be allocated to a risk group
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Dieter Hoelzer, MD, PhD
Organizational Affiliation
University of Frankfurt, Medical Department II
Official's Role
Study Chair
Facility Information:
Facility Name
University Hospital, Medical Dept. II
City
Frankfurt
Country
Germany

12. IPD Sharing Statement

Links:
URL
http://www.leukemia-trials.eu
Description
European Leukemia Trial Registry

Learn more about this trial

German Multicenter Trial for Treatment of Newly Diagnosed Acute Lymphoblastic Leukemia in Adults (05/93)

We'll reach out to this number within 24 hrs