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

Adult Acute Lymphocytic Leukemia Clinical Trial

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)

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00198978
• Other study ID #: GMALL02
• Status: Completed
• Phase: Phase 4
• Start date: January 2003
• Est. completion date: June 2014

Study information

• Verified date: March 2023
• Source: Goethe University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 377
• Est. completion date: June 2014
• Est. primary completion date: June 2011
• Accepts healthy volunteers: No
• Gender: All
• Age group: 55 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Adult Acute Lymphocytic Leukemia
• Leukemia
• Leukemia, Lymphoid
• Precursor Cell Lymphoblastic Leukemia-Lymphoma

Intervention

Drug:
• Cyclophosphamide

• Dexamethasone / Prednisolone

• Cytarabine

• Idarubicin

• Granulocyte-Colony-Stimulating Factor

• Mercaptopurine

• Methotrexate

• Rituximab

• HDARAC

• Vincristine

• Depocyte

• Asparaginase

Locations

Country	Name	City	State
Germany	University of Frankfurt, Medical Dept. II	Frankfurt

Sponsors (1)

Lead Sponsor	Collaborator
Goethe University

Country where clinical trial is conducted

Germany, 

Outcome

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