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

NCT00198978 | Completed Phase 4

• 1 other identifier: GMALL02
• Study Type: interventional
• Target: 377
• Locations: 1 country
• Sites: 1

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.

Conditions

Adult Acute Lymphocytic Leukemia

Keywords

ALL; Treatment; Elderly; De novo

Outcome Measures

Primary Outcomes (3)

• 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

Study Arms (1)

Interventional arm

EXPERIMENTAL

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

Interventions

Cyclophosphamide DRUG

Interventional arm

Dexamethasone / Prednisolone DRUG

Interventional arm

Cytarabine DRUG

Interventional arm

Idarubicin DRUG

Interventional arm

Granulocyte-Colony-Stimulating Factor DRUG

Interventional arm

Mercaptopurine DRUG

Interventional arm

Methotrexate DRUG

Interventional arm

Rituximab DRUG

Interventional arm

HDARAC DRUG

Interventional arm

Vincristine DRUG

Interventional arm

Depocyte DRUG

Interventional arm

Asparaginase DRUG

Interventional arm

Eligibility Criteria

• Age: 55 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Goethe University: lead

Study Sites (1)

University of Frankfurt, Medical Dept. II

Frankfurt, 60590, Germany

Location

Related Publications (1)

• Topp MS, Gokbuget N, Zugmaier G, Degenhard E, Goebeler ME, Klinger M, Neumann SA, Horst HA, Raff T, Viardot A, Stelljes M, Schaich M, Kohne-Volland R, Bruggemann M, Ottmann OG, Burmeister T, Baeuerle PA, Nagorsen D, Schmidt M, Einsele H, Riethmuller G, Kneba M, Hoelzer D, Kufer P, Bargou RC. Long-term follow-up of hematologic relapse-free survival in a phase 2 study of blinatumomab in patients with MRD in B-lineage ALL. Blood. 2012 Dec 20;120(26):5185-7. doi: 10.1182/blood-2012-07-441030. Epub 2012 Sep 28.

  PMID: 23024237 DERIVED

MeSH Terms

Conditions

Precursor Cell Lymphoblastic Leukemia-Lymphoma

Interventions

Cyclophosphamide; Dexamethasone; Prednisolone; Cytarabine; Idarubicin; Granulocyte Colony-Stimulating Factor; Mercaptopurine; Methotrexate; Rituximab; Vincristine; Asparaginase

Condition Hierarchy (Ancestors)

Leukemia, Lymphoid; Leukemia; Neoplasms by Histologic Type; Neoplasms; Hematologic Diseases; Hemic and Lymphatic Diseases; Lymphoproliferative Disorders; Lymphatic Diseases; Immunoproliferative Disorders; Immune System Diseases

Intervention Hierarchy (Ancestors)

Phosphoramide Mustards; Nitrogen Mustard Compounds; Mustard Compounds; Hydrocarbons, Halogenated; Hydrocarbons; Organic Chemicals; Phosphoramides; Organophosphorus Compounds; Pregnadienetriols; Pregnadienes; Pregnanes; Steroids; Fused-Ring Compounds; Polycyclic Compounds; Steroids, Fluorinated; Cytidine; Pyrimidine Nucleosides; Pyrimidines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Arabinonucleosides; Nucleosides; Nucleic Acids, Nucleotides, and Nucleosides; Daunorubicin; Anthracyclines; Naphthacenes; Polycyclic Aromatic Hydrocarbons; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Aminoglycosides; Glycosides; Carbohydrates; Colony-Stimulating Factors; Glycoproteins; Glycoconjugates; Hematopoietic Cell Growth Factors; Cytokines; Intercellular Signaling Peptides and Proteins; Peptides; Amino Acids, Peptides, and Proteins; Proteins; Biological Factors; Sulfhydryl Compounds; Sulfur Compounds; Purines; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Aminopterin; Pterins; Pteridines; Antibodies, Monoclonal, Murine-Derived; Antibodies, Monoclonal; Antibodies; Immunoglobulins; Immunoproteins; Blood Proteins; Serum Globulins; Globulins; Vinca Alkaloids; Secologanin Tryptamine Alkaloids; Indole Alkaloids; Alkaloids; Indoles; Indolizidines; Indolizines; Amidohydrolases; Hydrolases; Enzymes; Enzymes and Coenzymes

Study Officials

• Dieter Hoelzer, MD,PhD

  University of Frankfurt, Medical Dept. II

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Head of GMALL

Study Record Dates

• First Submitted: September 12, 2005
• First Posted: September 20, 2005
• Study Start: January 1, 2003
• Primary Completion: June 1, 2011
• Study Completion: June 1, 2014
• Last Updated: March 20, 2023

Record last verified: 2023-03

Locations

DE (1)