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

Phase 4

Completed

• Conditions: Adult Acute Lymphocytic Leukemia
• Interventions: 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

• Registration Number: NCT00198978
• Lead Sponsor: Goethe University

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2003-01
• Study First Submitted: 2005-09-12
• Study First Submitted QC: 2005-09-12
• Study First Posted: 2005-09-20
• Primary Completion: 2011-06
• Study Completion: 2014-06
• Status Verified: 2023-03
• Last Update Submitted: 2023-03-16
• Last Update Posted: 2023-03-20

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 377

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Interventional arm	HDARAC	-
Interventional arm	Dexamethasone / Prednisolone	-
Interventional arm	Depocyte	-
Interventional arm	Granulocyte-Colony-Stimulating Factor	-
Interventional arm	Cyclophosphamide	-
Interventional arm	Cytarabine	-
Interventional arm	Idarubicin	-
Interventional arm	Mercaptopurine	-
Interventional arm	Methotrexate	-
Interventional arm	Rituximab	-
Interventional arm	Vincristine	-
Interventional arm	Asparaginase	-

Primary Outcome Measures

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

Trial Locations

Locations (1)

University of Frankfurt, Medical Dept. II; 🇩🇪 Frankfurt, Germany