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Basic Trial Information
Trial Description
     Summary
     Eligibility Criteria
Trial Contact Information

Basic Trial Information

Phase Type Status Age Sponsor Protocol IDs Phase IV Treatment Active Over 55 Other GMALL02 NCT00198978

Trial Description

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

Trial Contact Information

Trial Lead Organizations/Sponsors

Klinikum der J.W. Goethe Universitaet

Dieter Hoelzer

Study Chair

Dieter Hoelzer, MD,PhD		Ph: ++49(0)69 6301 5194
		Email: hoelzer@em.uni-frankfurt.de

Nicola Goekbuget, MD		Ph: ++49(0)69 6301 6365
		Email: goekbuget@em.uni-frankfurt.de

Germany
	Frankfurt
	Universitaetsfrauenklinik Frankfurt
		Dieter Hoelzer, MD,PhD	Ph: ++49(0)6963015194
			Email: hoelzer@em.uni-frankfurt.de
		Nicola Goekbuget, MD	Ph: ++49(0)6963016365
			Email: goekbuget@em.uni-frankfurt.de
		Dieter Hoelzer, MD,PhD	Principal Investigator
		Nicola Goekbuget, MD	Sub-Investigator

Link to the current ClinicalTrials.gov record.
NLM Identifer NCT00198978
Information obtained from ClinicalTrials.gov on July 16, 2008