Multicenter Study To Optimize Treatment in Elderly Patients (> 55 Years, No Upper Age Limit) With Acute Lymphoblastic Leukemia (GMALL Elderly 1/2003)(Amend 2)
Overview
- Phase
- Phase 4
- Intervention
- Cyclophosphamide
- Conditions
- Adult Acute Lymphocytic Leukemia
- Sponsor
- Goethe University
- Enrollment
- 377
- Locations
- 1
- Primary Endpoint
- Survival time, Duration of Remission
- Status
- Completed
- Last Updated
- 3 years ago
Overview
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.
Investigators
Nicola Goekbuget
Head of GMALL
Goethe University
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
Arms & Interventions
Interventional arm
Intervention: Cyclophosphamide
Interventional arm
Intervention: Dexamethasone / Prednisolone
Interventional arm
Intervention: Cytarabine
Interventional arm
Intervention: Idarubicin
Interventional arm
Intervention: Granulocyte-Colony-Stimulating Factor
Interventional arm
Intervention: Mercaptopurine
Interventional arm
Intervention: Methotrexate
Interventional arm
Intervention: Rituximab
Interventional arm
Intervention: HDARAC
Interventional arm
Intervention: Vincristine
Interventional arm
Intervention: Depocyte
Interventional arm
Intervention: Asparaginase
Outcomes
Primary Outcomes
Survival time, Duration of Remission
Time Frame: at 3 and 5 years
Toxicity (CTC)
Time Frame: After each cycle; time-frame not specified
Remission rate (cytologic, molecular)
Time Frame: After induction; approximately 6 wks (exact time frame not specified)