German Multicenter Trial for Treatment of Newly Diagnosed Acute Lymphoblastic Leukemia in Adults (07/2003)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.

ClinicalTrials.gov Identifier: NCT00198991

Recruitment Status : Unknown

Verified May 2008 by Johann Wolfgang Goethe University Hospital.
Recruitment status was: Recruiting

First Posted : September 20, 2005

Last Update Posted : May 30, 2008

Sponsor:

Collaborators:

Deutsche Krebshilfe e.V., Bonn (Germany)

German Federal Ministry of Education and Research

Information provided by:

Johann Wolfgang Goethe University Hospital

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. After six months and one year the decision on intensification or discontinuation of therapy is made based on the results of MRD evaluation.

Condition or disease	Intervention/treatment	Phase
Adult Acute Lymphocytic Leukemia	Drug: Cyclophosphamide Drug: Dexamethasone Drug: Vincristine Drug: daunorubicin Drug: Asparaginase Drug: Methotrexate Drug: Cytarabine Drug: Mercaptopurine Drug: G-CSF Drug: Vindesine Drug: VP16 Drug: Prednisolone Drug: Adriamycin Drug: Thioguanine Drug: VM26 Procedure: CNS irradiation Procedure: Mediastinal Irradiation Procedure: Stem cell transplantation Drug: Idarubicin Drug: Fludarabine Drug: Cladribine	Phase 4

Study Design

Layout table for study information

Study Type :	Interventional (Clinical Trial)
Estimated Enrollment :	1250 participants
Allocation:	Non-Randomized
Intervention Model:	Parallel Assignment
Masking:	None (Open Label)
Primary Purpose:	Treatment
Official Title:	German Multicenter Study for Treatment Optimisation in Acute Lymphoblastic Leukemia in Adults and Adolescents Above 15 Years (Amend 3) (GMALL 07/2003)
Study Start Date :	April 2003
Estimated Primary Completion Date :	December 2008

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Chronic Lymphocytic Leukemia Leukemia

Genetic and Rare Diseases Information Center resources: Acute Lymphoblastic Leukemia Lymphoblastic Lymphoma Lymphosarcoma

U.S. FDA Resources

Arms and Interventions

Outcome Measures

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

Eligibility Criteria

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.

Layout table for eligibility information

Ages Eligible for Study:	15 Years to 65 Years (Child, Adult, Older Adult)
Sexes Eligible for Study:	All
Accepts Healthy Volunteers:	No

Criteria

Inclusion Criteria:

Acute lymphoblastic leukemia (pro-B, common, pre-B, early T, thymic T, mature T)
Age 15-65 yrs (*55-65 years if biologically younger according to general condition)
Written informed consent

Exclusion Criteria:

Severe comorbidity or leukemia associated complications
Late relapse of pediatric ALL or ALL as second malignancy
Cytostatic pre-treatment
Pregnancy
Severe psychiatric illness or other circumstances which may compromise cooperation of the patient
Participation in other clinical trials interfering with the study therapy

Contacts and Locations

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00198991

Contacts

Layout table for location contacts

Contact: Dieter Hoelzer, MD, PhD	++49 (0)69 6301 5194	hoelzer@em.uni-frankfurt.de
Contact: Nicola Goekbuget, MD	++49(0)69 6301 6365	goekbuget@em.uni-frankfurt.de

Locations

Layout table for location information

Germany
University of Frankfurt, Medical Dept. II	Recruiting
Frankfurt, Germany, 60590
Contact: Dieter Hoelzer, MD,PhD ++49(0)69 6301 5194 hoelzer@em.uni-frankfurt.de
Contact: Nicola Goekbuget, MD ++49(0)69 6301 6365 goekbuget@em.uni-frankfurt.de
Principal Investigator: Dieter Hoelzer, MD,PhD
Sub-Investigator: Nicola Goekbuget, MD

Sponsors and Collaborators

Johann Wolfgang Goethe University Hospital

Deutsche Krebshilfe e.V., Bonn (Germany)

German Federal Ministry of Education and Research

Investigators

Layout table for investigator information

Study Chair:	Dieter Hoelzer, MD,PhD	University Hospital of Frankfurt, Medical Dept. II

More Information

Additional Information:

European Leukemia Trial Registry This link exits the ClinicalTrials.gov site

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

Kobitzsch B, Gökbuget N, Schwartz S, Reinhardt R, Brüggemann M, Viardot A, Wäsch 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.

Herold T, Schneider S, Metzeler KH, Neumann M, Hartmann L, Roberts KG, Konstandin NP, Greif PA, Bräundl K, Ksienzyk B, Huk N, Schneider I, Zellmeier E, Jurinovic V, Mansmann U, Hiddemann W, Mullighan CG, Bohlander SK, Spiekermann K, Hoelzer D, Brüggemann M, Baldus CD, Dreyling M, Gökbuget 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.

Topp MS, Gökbuget N, Zugmaier G, Degenhard E, Goebeler ME, Klinger M, Neumann SA, Horst HA, Raff T, Viardot A, Stelljes M, Schaich M, Köhne-Volland R, Brüggemann M, Ottmann OG, Burmeister T, Baeuerle PA, Nagorsen D, Schmidt M, Einsele H, Riethmüller 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.

Gökbuget N, Stanze D, Beck J, Diedrich H, Horst HA, Hüttmann 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. Epub 2012 Apr 4.

Gökbuget 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, Brüggemann 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. Epub 2012 Mar 22.

Burmeister T, Meyer C, Schwartz S, Hofmann J, Molkentin M, Kowarz E, Schneider B, Raff T, Reinhardt R, Gökbuget 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.

Layout table for additonal information

ClinicalTrials.gov Identifier:	NCT00198991
Other Study ID Numbers:	GMALL01
First Posted:	September 20, 2005 Key Record Dates
Last Update Posted:	May 30, 2008
Last Verified:	May 2008

Keywords provided by Johann Wolfgang Goethe University Hospital:


ALL Treatment de novo Minimal residual disease Adult

Additional relevant MeSH terms:

Layout table for MeSH terms

Leukemia Leukemia, Lymphoid Precursor Cell Lymphoblastic Leukemia-Lymphoma Neoplasms by Histologic Type Neoplasms Lymphoproliferative Disorders Lymphatic Diseases Immunoproliferative Disorders Immune System Diseases Cytarabine Dexamethasone Prednisolone Cyclophosphamide Methotrexate Fludarabine	Vincristine Doxorubicin Daunorubicin Asparaginase Mercaptopurine Idarubicin Thioguanine Cladribine Vindesine Immunosuppressive Agents Immunologic Factors Physiological Effects of Drugs Antirheumatic Agents Antineoplastic Agents, Alkylating Alkylating Agents

To Top