Back to resultsTrial for Treatment of Adult Patients With Standard Risk Acute Lymphoblastic Leukemia With Chemotherapy and Rituximab
Primary Purpose
Adult Acute Lymphocytic Leukemia
Status
Completed
Phase
Phase 4
Locations
Germany
Study Type
Interventional
Intervention
Cyclophosphamide
Dexamethasone / Prednisolone
Vincristine
Daunorubicin
Asparaginase
Methotrexate
Cytarabine
Mercaptopurine
G-CSF
Vindesine
VP16
Adriamycin
Thioguanine
VM26
Rituximab
CNS irradiation
Mediastinal irradiation (if residual TU)
Stem cell transplantation
Sponsored by
About this trial
This is an interventional treatment trial for Adult Acute Lymphocytic Leukemia focused on measuring ALL, Treatment, De novo, Minimal residual disease, Rituximab, Adult
Eligibility Criteria
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
Sites / Locations
- University Hospital of Frankfurt, Medical Dept. II
Outcomes
Primary Outcome Measures
Remission rate (cytologic, Remission rate (molecular), Remission duration, Disease free survival, Overall survival
Secondary Outcome Measures
Dose and time compliance, Toxicity according to WHO, Death in induction and CR, Course of MRD
Full Information
NCT ID
NCT00199004
First Posted
September 12, 2005
Last Updated
August 20, 2010
Sponsor
Johann Wolfgang Goethe University Hospital
1. Study Identification
Unique Protocol Identification Number
NCT00199004
Brief Title
Trial for Treatment of Adult Patients With Standard Risk Acute Lymphoblastic Leukemia With Chemotherapy and Rituximab
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)
Study Type
Interventional
2. Study Status
Record Verification Date
May 2008
Overall Recruitment Status
Completed
Study Start Date
April 2004 (undefined)
Primary Completion Date
March 2009 (Actual)
Study Completion Date
March 2009 (Actual)
3. Sponsor/Collaborators
Name of the Sponsor
Johann Wolfgang Goethe University Hospital
4. Oversight
5. Study Description
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
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Adult Acute Lymphocytic Leukemia
Keywords
ALL, Treatment, De novo, Minimal residual disease, Rituximab, Adult
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
60 (Anticipated)
8. Arms, Groups, and Interventions
Intervention Type
Drug
Intervention Name(s)
Cyclophosphamide
Intervention Type
Drug
Intervention Name(s)
Dexamethasone / Prednisolone
Intervention Type
Drug
Intervention Name(s)
Vincristine
Intervention Type
Drug
Intervention Name(s)
Daunorubicin
Intervention Type
Drug
Intervention Name(s)
Asparaginase
Intervention Type
Drug
Intervention Name(s)
Methotrexate
Intervention Type
Drug
Intervention Name(s)
Cytarabine
Intervention Type
Drug
Intervention Name(s)
Mercaptopurine
Intervention Type
Drug
Intervention Name(s)
G-CSF
Intervention Type
Drug
Intervention Name(s)
Vindesine
Intervention Type
Drug
Intervention Name(s)
VP16
Intervention Type
Drug
Intervention Name(s)
Adriamycin
Intervention Type
Drug
Intervention Name(s)
Thioguanine
Intervention Type
Drug
Intervention Name(s)
VM26
Intervention Type
Drug
Intervention Name(s)
Rituximab
Intervention Type
Procedure
Intervention Name(s)
CNS irradiation
Intervention Type
Procedure
Intervention Name(s)
Mediastinal irradiation (if residual TU)
Intervention Type
Procedure
Intervention Name(s)
Stem cell transplantation
Primary Outcome Measure Information:
Title
Remission rate (cytologic, Remission rate (molecular), Remission duration, Disease free survival, Overall survival
Secondary Outcome Measure Information:
Title
Dose and time compliance, Toxicity according to WHO, Death in induction and CR, Course of MRD
10. Eligibility
Sex
All
Minimum Age & Unit of Time
15 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Dieter Hoelzer, MD,PhD
Organizational Affiliation
University Hospital, Medical Dept. II
Official's Role
Study Chair
Facility Information:
Facility Name
University Hospital of Frankfurt, Medical Dept. II
City
Frankfurt
ZIP/Postal Code
60590
Country
Germany
12. IPD Sharing Statement
Links:
URL
http://www.leukemia-trials.eu
Description
European Leukemia Trial Registry
Learn more about this trial
Trial for Treatment of Adult Patients With Standard Risk Acute Lymphoblastic Leukemia With Chemotherapy and Rituximab
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