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

Adult Acute Lymphocytic Leukemia Clinical Trial

Official title:

German Multicenter Trial for Treatment Optimisation in Acute Lymphoblastic Leukemia in Adults and Adolescents Above 15 Years With Rituximab for Improvement of Prognosis in CD20 Positive Standard Risk ALL (Amend 2)

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00199004
• Other study ID #: GMALL03
• Status: Completed
• Phase: Phase 4
• First received: September 12, 2005
• Last updated: August 20, 2010
• Start date: April 2004
• Est. completion date: March 2009

Study information

• Verified date: May 2008
• Source: Johann Wolfgang Goethe University Hospitals
• Contact: n/a
• Is FDA regulated: No
• Health authority: Germany: Federal Institute for Drugs and Medical Devices
• Study type: Interventional

Clinical Trial 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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 60
• Est. completion date: March 2009
• Est. primary completion date: March 2009
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 15 Years to 65 Years

Eligibility

Inclusion Criteria:

• 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

Exclusion Criteria:

• 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

Study Design

Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

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

Intervention

Drug:
• Cyclophosphamide

• Dexamethasone / Prednisolone

• Vincristine

• Daunorubicin

• Asparaginase

• Methotrexate

• Cytarabine

• Mercaptopurine

• G-CSF

• Vindesine

• VP16

• Adriamycin

• Thioguanine

• VM26

• Rituximab

Procedure:
• CNS irradiation

• Mediastinal irradiation (if residual TU)

• Stem cell transplantation

Locations

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

Sponsors (1)

Lead Sponsor	Collaborator
Johann Wolfgang Goethe University Hospitals

Country where clinical trial is conducted

Germany, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Remission rate (cytologic, Remission rate (molecular), Remission duration, Disease free survival, Overall survival
Secondary	Dose and time compliance, Toxicity according to WHO, Death in induction and CR, Course of MRD

External Links

•   European Leukemia Trial Registry
•   German Leukemia Trial Registry