German Multicenter Trial for Treatment of Elderly Patients With Newly Diagnosed Acute Lymphoblastic Leukemia

Study Overview
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Brief Summary
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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.

Official Title
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Multicenter Study To Optimize Treatment in Elderly Patients (> 55 Years, No Upper Age Limit) With Acute Lymphoblastic Leukemia (GMALL Elderly 1/2003)(Amend 2)

Conditions
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Adult Acute Lymphocytic Leukemia

Intervention / Treatment
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* 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


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 55 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Interventional arm<br> | Drug: Cyclophosphamide<br> <br> Drug: Dexamethasone / Prednisolone<br> <br> Drug: Cytarabine<br> <br> Drug: Idarubicin<br> <br> Drug: Granulocyte-Colony-Stimulating Factor<br> <br> Drug: Mercaptopurine<br> <br> Drug: Methotrexate<br> <br> Drug: Rituximab<br> <br> Drug: HDARAC<br> <br> Drug: Vincristine<br> <br> Drug: Depocyte<br> <br> Drug: Asparaginase<br> <br> |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Remission rate (cytologic, molecular) |  | After induction; approximately 6 wks (exact time frame not specified) | 
| Toxicity (CTC) |  | After each cycle; time-frame not specified | 
| Survival time, Duration of Remission |  | at 3 and 5 years | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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ALL, Treatment, Elderly, De novo