search
Back to results

German Multicenter Trial for Treatment of Newly Diagnosed Acute Lymphoblastic Leukemia in Adults (06/99)

Primary Purpose

Adult Acute Lymphocytic Leukemia

Status
Completed
Phase
Phase 4
Locations
Germany
Study Type
Interventional
Intervention
Dexamethasone / Prednisolone
Cyclophosphamide
Methotrexate
Vincristine / Vindesine
Daunorubicin
Asparaginase
G-CSF
Cytarabine
6-Mercaptopurine
VP16
Adriamycin
Thioguanine
VM26
Idarubicin
Fludarabine
Ifosfamide
CNS irradiation
Mediastinal irradiation (if residual tumor)
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 lymphoblastic leukemia (pro-B, common, pre-B, early T, T) Age 15-65 yrs (*55-65 years if biologically younger according to general condition) Exclusion Criteria: Severe comorbidity Cytostatic pre-treatment Pregnancy Missing written informed consent

Sites / Locations

  • University Hospital, Medical Dept. II

Outcomes

Primary Outcome Measures

Remission rate,Remission duration,Disease free survival,Overall survival

Secondary Outcome Measures

Time and dose compliance,Realisation of SCT,Toxicity according to WHO,Course of MRD

Full Information

First Posted
September 12, 2005
Last Updated
March 16, 2023
Sponsor
Goethe University
search

1. Study Identification

Unique Protocol Identification Number
NCT00199056
Brief Title
German Multicenter Trial for Treatment of Newly Diagnosed Acute Lymphoblastic Leukemia in Adults (06/99)
Official Title
Multicenter Trial for Treatment of Acute Lymphocytic Leukemia in Adults (Pilot Study 06/99)
Study Type
Interventional

2. Study Status

Record Verification Date
March 2023
Overall Recruitment Status
Completed
Study Start Date
October 1999 (Actual)
Primary Completion Date
November 2003 (Actual)
Study Completion Date
December 2005 (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 an intensified induction and consolidation therapy. Thereafter patients receive individualised treatment stratified according to relapse risk with stem cell transplantation for patients with high and very high risk of relapse. Patients with standard risk receive further consolidation and reinduction chemotherapy. In parallel minimal residual disease (MRD) is evaluated. A MRD based risk stratification and treatment decision is developed.

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
Non-Randomized
Enrollment
225 (false)

8. Arms, Groups, and Interventions

Intervention Type
Drug
Intervention Name(s)
Dexamethasone / Prednisolone
Intervention Type
Drug
Intervention Name(s)
Cyclophosphamide
Intervention Type
Drug
Intervention Name(s)
Methotrexate
Intervention Type
Drug
Intervention Name(s)
Vincristine / Vindesine
Intervention Type
Drug
Intervention Name(s)
Daunorubicin
Intervention Type
Drug
Intervention Name(s)
Asparaginase
Intervention Type
Drug
Intervention Name(s)
G-CSF
Intervention Type
Drug
Intervention Name(s)
Cytarabine
Intervention Type
Drug
Intervention Name(s)
6-Mercaptopurine
Intervention Type
Drug
Intervention Name(s)
VP16
Intervention Type
Drug
Intervention Name(s)
Adriamycin
Intervention Type
Drug
Intervention Name(s)
Thioguanine
Intervention Type
Drug
Intervention Name(s)
VM26
Intervention Type
Drug
Intervention Name(s)
Idarubicin
Intervention Type
Drug
Intervention Name(s)
Fludarabine
Intervention Type
Drug
Intervention Name(s)
Ifosfamide
Intervention Type
Procedure
Intervention Name(s)
CNS irradiation
Intervention Type
Procedure
Intervention Name(s)
Mediastinal irradiation (if residual tumor)
Intervention Type
Procedure
Intervention Name(s)
stem cell transplantation
Primary Outcome Measure Information:
Title
Remission rate,Remission duration,Disease free survival,Overall survival
Secondary Outcome Measure Information:
Title
Time and dose compliance,Realisation of SCT,Toxicity according to WHO,Course of MRD

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 lymphoblastic leukemia (pro-B, common, pre-B, early T, T) Age 15-65 yrs (*55-65 years if biologically younger according to general condition) Exclusion Criteria: Severe comorbidity Cytostatic pre-treatment Pregnancy Missing written informed consent
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Dieter Hoelzer, MD,PhD
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

Citations:
PubMed Identifier
28751559
Citation
Kobitzsch B, Gokbuget N, Schwartz S, Reinhardt R, Bruggemann M, Viardot A, Wasch R, Starck M, Thiel E, Hoelzer D, Burmeister T. Loss-of-function but not dominant-negative intragenic IKZF1 deletions are associated with an adverse prognosis in adult BCR-ABL-negative acute lymphoblastic leukemia. Haematologica. 2017 Oct;102(10):1739-1747. doi: 10.3324/haematol.2016.161273. Epub 2017 Jul 27.
Results Reference
derived
PubMed Identifier
27561722
Citation
Herold T, Schneider S, Metzeler KH, Neumann M, Hartmann L, Roberts KG, Konstandin NP, Greif PA, Braundl K, Ksienzyk B, Huk N, Schneider I, Zellmeier E, Jurinovic V, Mansmann U, Hiddemann W, Mullighan CG, Bohlander SK, Spiekermann K, Hoelzer D, Bruggemann M, Baldus CD, Dreyling M, Gokbuget N. Adults with Philadelphia chromosome-like acute lymphoblastic leukemia frequently have IGH-CRLF2 and JAK2 mutations, persistence of minimal residual disease and poor prognosis. Haematologica. 2017 Jan;102(1):130-138. doi: 10.3324/haematol.2015.136366. Epub 2016 Aug 25.
Results Reference
derived
PubMed Identifier
22493293
Citation
Gokbuget N, Stanze D, Beck J, Diedrich H, Horst HA, Huttmann A, Kobbe G, Kreuzer KA, Leimer L, Reichle A, Schaich M, Schwartz S, Serve H, Starck M, Stelljes M, Stuhlmann R, Viardot A, Wendelin K, Freund M, Hoelzer D; German Multicenter Study Group for Adult Acute Lymphoblastic Leukemia. Outcome of relapsed adult lymphoblastic leukemia depends on response to salvage chemotherapy, prognostic factors, and performance of stem cell transplantation. Blood. 2012 Sep 6;120(10):2032-41. doi: 10.1182/blood-2011-12-399287. Epub 2012 Apr 4.
Results Reference
derived
PubMed Identifier
22442346
Citation
Gokbuget N, Kneba M, Raff T, Trautmann H, Bartram CR, Arnold R, Fietkau R, Freund M, Ganser A, Ludwig WD, Maschmeyer G, Rieder H, Schwartz S, Serve H, Thiel E, Bruggemann M, Hoelzer D; German Multicenter Study Group for Adult Acute Lymphoblastic Leukemia. Adult patients with acute lymphoblastic leukemia and molecular failure display a poor prognosis and are candidates for stem cell transplantation and targeted therapies. Blood. 2012 Aug 30;120(9):1868-76. doi: 10.1182/blood-2011-09-377713. Epub 2012 Mar 22.
Results Reference
derived
PubMed Identifier
19144982
Citation
Burmeister T, Meyer C, Schwartz S, Hofmann J, Molkentin M, Kowarz E, Schneider B, Raff T, Reinhardt R, Gokbuget N, Hoelzer D, Thiel E, Marschalek R. The MLL recombinome of adult CD10-negative B-cell precursor acute lymphoblastic leukemia: results from the GMALL study group. Blood. 2009 Apr 23;113(17):4011-5. doi: 10.1182/blood-2008-10-183483. Epub 2009 Jan 14.
Results Reference
derived
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 (06/99)

We'll reach out to this number within 24 hrs