Trial for Treatment of Adult Patients With Standard Risk Acute Lymphoblastic Leukemia With Chemotherapy and Rituximab

NCT00199004 | Completed Phase 4

• 1 other identifier: GMALL03
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

Brief Summary

The study evaluates the efficacy and tolerability of an intensified induction and consolidation therapy in combination with rituximab in CD20 positive standard risk patients. Thereafter patients receive additional consolidation and reinduction cycles combined with rituximab. In parallel minimal residual disease is evaluated. After six months and one year the decision on intensification or discontinuation of therapy is made based on results of MRD evaluation

Conditions

Adult Acute Lymphocytic Leukemia

Keywords

ALL; Treatment; De novo; Minimal residual disease; Rituximab; Adult

Outcome Measures

Primary Outcomes (1)

• Remission rate (cytologic, Remission rate (molecular), Remission duration, Disease free survival, Overall survival

Secondary Outcomes (1)

• Dose and time compliance, Toxicity according to WHO, Death in induction and CR, Course of MRD

Interventions

Cyclophosphamide DRUG

Dexamethasone / Prednisolone DRUG

Vincristine DRUG

Daunorubicin DRUG

Asparaginase DRUG

Methotrexate DRUG

Cytarabine DRUG

Mercaptopurine DRUG

G-CSF DRUG

Vindesine DRUG

VP16 DRUG

Adriamycin DRUG

Thioguanine DRUG

VM26 DRUG

Rituximab DRUG

CNS irradiation PROCEDURE

Mediastinal irradiation (if residual TU) PROCEDURE

Stem cell transplantation PROCEDURE

Eligibility Criteria

• Age: 15 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• B-precursor ALL (common / pre B-ALL)
• Standard risk
• CD20 expression \>20%
• Ph/BCR-ABL negative
• Age 15-65 years (55-65 if biologically younger)
• Written informed consent

You may not qualify if:

• Severe complications due to leukemia or secondary illnesses
• Late relapse of childhood ALL
• Cytostatic pretreatment
• Pregnancy
• Severe psychiatric illness or other circumstances which may compromise cooperation of the patient or informed consent
• Known severe allergy to foreign proteins

Sponsors & Collaborators

• Johann Wolfgang Goethe University Hospital: lead

Study Sites (1)

University Hospital of Frankfurt, Medical Dept. II

Frankfurt, 60590, Germany

Location

Related Links

• German Leukemia Trial Registry

MeSH Terms

Conditions

Precursor Cell Lymphoblastic Leukemia-Lymphoma; Neoplasm, Residual

Interventions

Cyclophosphamide; Dexamethasone; Prednisolone; Vincristine; Daunorubicin; Asparaginase; Methotrexate; Cytarabine; Mercaptopurine; Granulocyte Colony-Stimulating Factor; Vindesine; Etoposide; Doxorubicin; Thioguanine; Teniposide; Rituximab; Stem Cell Transplantation

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; Neoplastic Processes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

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; Vinca Alkaloids; Secologanin Tryptamine Alkaloids; Indole Alkaloids; Alkaloids; Heterocyclic Compounds; Indoles; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Indolizidines; Indolizines; Anthracyclines; Naphthacenes; Polycyclic Aromatic Hydrocarbons; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Aminoglycosides; Glycosides; Carbohydrates; Amidohydrolases; Hydrolases; Enzymes; Enzymes and Coenzymes; Aminopterin; Pterins; Pteridines; Cytidine; Pyrimidine Nucleosides; Pyrimidines; Heterocyclic Compounds, 1-Ring; Arabinonucleosides; Nucleosides; Nucleic Acids, Nucleotides, and Nucleosides; Sulfhydryl Compounds; Sulfur Compounds; Purines; Colony-Stimulating Factors; Glycoproteins; Glycoconjugates; Hematopoietic Cell Growth Factors; Cytokines; Intercellular Signaling Peptides and Proteins; Peptides; Amino Acids, Peptides, and Proteins; Proteins; Biological Factors; Podophyllotoxin; Tetrahydronaphthalenes; Naphthalenes; Glucosides; Antibodies, Monoclonal, Murine-Derived; Antibodies, Monoclonal; Antibodies; Immunoglobulins; Immunoproteins; Blood Proteins; Serum Globulins; Globulins; Cell Transplantation; Cell- and Tissue-Based Therapy; Biological Therapy; Therapeutics; Transplantation; Surgical Procedures, Operative

Study Officials

• Dieter Hoelzer, MD,PhD

  University Hospital, Medical Dept. II

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: September 12, 2005
• First Posted: September 20, 2005
• Study Start: April 1, 2004
• Primary Completion: March 1, 2009
• Study Completion: March 1, 2009
• Last Updated: August 23, 2010

Record last verified: 2008-05

Locations

DE (1)