Clinical trial NCT00198978: 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
Overall status: COMPLETED
Phase: PHASE4
Conditions: Adult Acute Lymphocytic Leukemia
Keywords: ALL
Treatment
Elderly
De novo
Lead sponsor: Goethe University
Sponsor class: OTHER
First posted: 2005-09-20
Enrollment: 377
Sex: ALL
Minimum age (years): 55
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.


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

Primary outcomes:
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
measure: Survival time, Duration of Remission
timeFrame: at 3 and 5 years
Secondary outcomes:
Other outcomes:
Locations:
city: Frankfurt
country: Germany
facility: University of Frankfurt, Medical Dept. II
Study officials:
affiliation: University of Frankfurt, Medical Dept. II
name: Dieter Hoelzer, MD,PhD
role: STUDY_CHAIR
References:
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.