Clinical trial · Interventional
German Multicenter Trial for Treatment of Newly Diagnosed Acute Lymphoblastic Leukemia in Adults (07/2003)
German Multicenter Study for Treatment Optimisation in Acute Lymphoblastic Leukemia in Adults and Adolescents Above 15 Years (Amend 3) (GMALL 07/2003)
NCT00198991CI-TRIAL-00060412completedPhase 4ClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Adult Acute Lymphocytic Leukemia | Adult Acute Lymphoblastic Leukemia | ALIAS | 0.90 |
Interventions
Interventions (21)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Adriamycin | Drug | — | UNRESOLVED |
| Asparaginase | Drug | Asparaginase | ALIAS |
| Cladribine | Drug | Cladribine | ALIAS |
| CNS irradiation | Procedure | — | UNRESOLVED |
| Cyclophosphamide | Drug | Cyclophosphamide | ALIAS |
| Cytarabine | Drug | Cytarabine | ALIAS |
| Daunorubicin | Drug | Daunorubicin | ALIAS |
| Dexamethasone | Drug | Dexamethasone | ALIAS |
| Etoposide |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- All patients
- description
- All patients are treated upfront according to one arm
- interventionNames
- Drug: Cyclophosphamide
- Drug: Dexamethasone
- Drug: Vincristine
- Drug: Daunorubicin
- Drug: Asparaginase
- Drug: Methotrexate
- Drug: Cytarabine
- Drug: Mercaptopurine
- Drug: G-CSF
- Drug: Vindesine
- Drug: Etoposide
- Drug: Prednisolone
- Drug: Adriamycin
- Drug: Thioguanine
- Drug: Teniposide
- Procedure: CNS irradiation
- Procedure: Mediastinal Irradiation
- Procedure: Stem cell transplantation (SCT)
- Drug: Idarubicin
- Drug: Fludarabine
- Drug: Cladribine
Primary outcomes (4)
- measure
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 15 Years
- Maximum age
- 65 Years
Show eligibility criteria text
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
References
Publications (7)
- DERIVEDSzczepanowski M, Richter J, Bendig S, Bastian L, Kelm M, Beck V, Beder T, Chitadze G, Kotrova M, Duell J, Faul C, Gartner J, Hartmann A, Kehden B, Penas EMM, Neumann M, Ritgen M, Schrader W, Steffen B, Trautmann H, Viardot A, Burmeister T, Baldus CD, Schwartz S, Gokbuget N, Bruggemann M. CD20 expression dynamics in adult B-cell acute lymphoblastic leukemia and impact on anti-CD20 treatment. J Hematol Oncol. 2026 Jul 20;19(1):52. doi: 10.1186/s13045-026-01832-4. PMID 42477805
- DERIVEDKobitzsch 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. PMID 28751559
- DERIVEDHerold 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. PMID 27561722
- DERIVEDTopp 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. PMID 23024237
- DERIVEDGokbuget 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.