Clinical trial · Interventional
German Multicenter Trial for Treatment of Elderly Patients With Newly Diagnosed Acute Lymphoblastic Leukemia
Multicenter Study To Optimize Treatment in Elderly Patients (> 55 Years, No Upper Age Limit) With Acute Lymphoblastic Leukemia (GMALL Elderly 1/2003)(Amend 2)
NCT00198978CI-TRIAL-00064833completedPhase 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 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.
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 (12)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Asparaginase | Drug | Asparaginase | ALIAS |
| Cyclophosphamide | Drug | Cyclophosphamide | ALIAS |
| Cytarabine | Drug | Cytarabine | ALIAS |
| Depocyte | Drug | Cytarabine | ALIAS |
| Dexamethasone / Prednisolone | Drug | — | UNRESOLVED |
| Granulocyte-Colony-Stimulating Factor | Drug | — | UNRESOLVED |
| HDARAC | Drug | — | UNRESOLVED |
| Idarubicin | Drug | Idarubicin | ALIAS |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- Interventional arm
- interventionNames
- Drug: Cyclophosphamide
- Drug: Dexamethasone / Prednisolone
- Drug: Cytarabine
- Drug: Idarubicin
- Drug: Granulocyte-Colony-Stimulating Factor
- Drug: Mercaptopurine
- Drug: Methotrexate
- Drug: Rituximab
- Drug: HDARAC
- Drug: Vincristine
- Drug: Depocyte
- Drug: Asparaginase
Primary outcomes (3)
- measure
- Remission rate (cytologic, molecular)
- timeFrame
- After induction; approximately 6 wks (exact time frame not specified)
- measure
- Toxicity (CTC)
- timeFrame
- After each cycle; time-frame not specified
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 55 Years
Show eligibility criteria text
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
References
Publications (1)
- 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