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

Primary Purpose

Adult Acute Lymphocytic Leukemia

Status
Completed
Phase
Phase 4
Locations
Germany
Study Type
Interventional
Intervention
Cyclophosphamide
Dexamethasone / Prednisolone
Cytarabine
Idarubicin
Granulocyte-Colony-Stimulating Factor
Mercaptopurine
Methotrexate
Rituximab
HDARAC
Vincristine
Depocyte
Asparaginase
Sponsored by
Goethe University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

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

Eligibility Criteria

55 Years - undefined (Adult, Older Adult)All SexesDoes not accept 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

Sites / Locations

  • University of Frankfurt, Medical Dept. II

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Interventional arm

Arm Description

Outcomes

Primary Outcome Measures

Remission rate (cytologic, molecular)
Toxicity (CTC)
Survival time, Duration of Remission

Secondary Outcome Measures

Full Information

First Posted
September 12, 2005
Last Updated
March 16, 2023
Sponsor
Goethe University
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1. Study Identification

Unique Protocol Identification Number
NCT00198978
Brief Title
German Multicenter Trial for Treatment of Elderly Patients With Newly Diagnosed Acute Lymphoblastic Leukemia
Official Title
Multicenter Study To Optimize Treatment in Elderly Patients (> 55 Years, No Upper Age Limit) With Acute Lymphoblastic Leukemia (GMALL Elderly 1/2003)(Amend 2)
Study Type
Interventional

2. Study Status

Record Verification Date
March 2023
Overall Recruitment Status
Completed
Study Start Date
January 2003 (Actual)
Primary Completion Date
June 2011 (Actual)
Study Completion Date
June 2014 (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 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.

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, Elderly, De novo

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
377 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Interventional arm
Arm Type
Experimental
Intervention Type
Drug
Intervention Name(s)
Cyclophosphamide
Intervention Type
Drug
Intervention Name(s)
Dexamethasone / Prednisolone
Intervention Type
Drug
Intervention Name(s)
Cytarabine
Intervention Type
Drug
Intervention Name(s)
Idarubicin
Intervention Type
Drug
Intervention Name(s)
Granulocyte-Colony-Stimulating Factor
Intervention Type
Drug
Intervention Name(s)
Mercaptopurine
Intervention Type
Drug
Intervention Name(s)
Methotrexate
Intervention Type
Drug
Intervention Name(s)
Rituximab
Intervention Type
Drug
Intervention Name(s)
HDARAC
Intervention Type
Drug
Intervention Name(s)
Vincristine
Intervention Type
Drug
Intervention Name(s)
Depocyte
Intervention Type
Drug
Intervention Name(s)
Asparaginase
Primary Outcome Measure Information:
Title
Remission rate (cytologic, molecular)
Time Frame
After induction; approximately 6 wks (exact time frame not specified)
Title
Toxicity (CTC)
Time Frame
After each cycle; time-frame not specified
Title
Survival time, Duration of Remission
Time Frame
at 3 and 5 years

10. Eligibility

Sex
All
Minimum Age & Unit of Time
55 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Dieter Hoelzer, MD,PhD
Organizational Affiliation
University of Frankfurt, Medical Dept. II
Official's Role
Study Chair
Facility Information:
Facility Name
University of Frankfurt, Medical Dept. II
City
Frankfurt
ZIP/Postal Code
60590
Country
Germany

12. IPD Sharing Statement

Citations:
PubMed Identifier
23024237
Citation
Topp MS, Gokbuget N, Zugmaier G, Degenhard E, Goebeler ME, Klinger M, Neumann SA, Horst HA, Raff T, Viardot A, Stelljes M, Schaich M, Kohne-Volland R, Bruggemann M, Ottmann OG, Burmeister T, Baeuerle PA, Nagorsen D, Schmidt M, Einsele H, Riethmuller G, Kneba M, Hoelzer D, Kufer P, Bargou RC. Long-term follow-up of hematologic relapse-free survival in a phase 2 study of blinatumomab in patients with MRD in B-lineage ALL. Blood. 2012 Dec 20;120(26):5185-7. doi: 10.1182/blood-2012-07-441030. Epub 2012 Sep 28.
Results Reference
derived

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

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