German Multicenter Trial for Treatment of Elderly Patients With Newly Diagnosed Acute Lymphoblastic Leukemia
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ClinicalTrials.gov Identifier: NCT00198978 |
Recruitment Status : Unknown
Verified June 2008 by Johann Wolfgang Goethe University Hospital.
Recruitment status was: Recruiting
First Posted : September 20, 2005
Last Update Posted : June 5, 2008
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Condition or disease | Intervention/treatment | Phase |
---|---|---|
Adult Acute Lymphocytic Leukemia | 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 | Phase 4 |
Study Type : | Interventional (Clinical Trial) |
Estimated Enrollment : | 200 participants |
Allocation: | Non-Randomized |
Intervention Model: | Parallel Assignment |
Masking: | None (Open Label) |
Primary Purpose: | Treatment |
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) |
Study Start Date : | January 2003 |
Estimated Primary Completion Date : | June 2008 |

- Remission rate (cytologic, Remission rate (molecular), Survival time, Duration of Remission, Toxicity (CTC, Treatment realization

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Ages Eligible for Study: | 55 Years and older (Adult, Older Adult) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
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

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00198978
Contact: Dieter Hoelzer, MD,PhD | ++49(0)69 6301 5194 | hoelzer@em.uni-frankfurt.de | |
Contact: Nicola Goekbuget, MD | ++49(0)69 6301 6365 | goekbuget@em.uni-frankfurt.de |
Germany | |
University of Frankfurt, Medical Dept. II | Recruiting |
Frankfurt, Germany, 60590 | |
Contact: Dieter Hoelzer, MD,PhD ++49(0)6963015194 hoelzer@em.uni-frankfurt.de | |
Contact: Nicola Goekbuget, MD ++49(0)6963016365 goekbuget@em.uni-frankfurt.de | |
Principal Investigator: Dieter Hoelzer, MD,PhD | |
Sub-Investigator: Nicola Goekbuget, MD |
Study Chair: | Dieter Hoelzer, MD,PhD | University of Frankfurt, Medical Dept. II |
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
ClinicalTrials.gov Identifier: | NCT00198978 |
Other Study ID Numbers: |
GMALL02 |
First Posted: | September 20, 2005 Key Record Dates |
Last Update Posted: | June 5, 2008 |
Last Verified: | June 2008 |
ALL Treatment Elderly De novo |
Leukemia Precursor Cell Lymphoblastic Leukemia-Lymphoma Leukemia, Lymphoid Neoplasms by Histologic Type Neoplasms Lymphoproliferative Disorders Lymphatic Diseases Immunoproliferative Disorders Immune System Diseases Cytarabine Dexamethasone Prednisolone Cyclophosphamide Rituximab Methotrexate |
Vincristine Asparaginase Mercaptopurine Idarubicin Lenograstim Immunosuppressive Agents Immunologic Factors Physiological Effects of Drugs Antirheumatic Agents Antineoplastic Agents, Alkylating Alkylating Agents Molecular Mechanisms of Pharmacological Action Antineoplastic Agents Myeloablative Agonists Antineoplastic Agents, Immunological |