Trial for Treatment of Adult Patients With Standard Risk Acute Lymphoblastic Leukemia With Chemotherapy and Rituximab
This study has been completed.
Sponsor:
Johann Wolfgang Goethe University Hospitals
Information provided by:
Johann Wolfgang Goethe University Hospitals
ClinicalTrials.gov Identifier:
NCT00199004
First received: September 12, 2005
Last updated: August 20, 2010
Last verified: May 2008
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Purpose
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
| Condition | Intervention | Phase |
|---|---|---|
|
Adult Acute Lymphocytic Leukemia |
Drug: 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 Procedure: CNS irradiation Procedure: Mediastinal irradiation (if residual TU) Procedure: Stem cell transplantation |
Phase 4 |
| Study Type: | Interventional |
| Study Design: | Allocation: Non-Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Single Group Assignment Masking: Open Label Primary Purpose: Treatment |
| 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) |
Resource links provided by NLM:
Drug Information available for:
Dexamethasone
Cyclophosphamide
Prednisolone
Mercaptopurine
Prednisolone acetate
Methylprednisolone acetate
Methotrexate
Methylprednisolone
Prednisolone sodium phosphate
Cytarabine
Thioguanine
Prednisolone phosphate
Dexamethasone acetate
Prednisolone sodium succinate
Vincristine sulfate
Methylprednisolone sodium succinate
Dexamethasone sodium phosphate
Asparaginase
Methotrexate sodium
Daunorubicin
Doxorubicin
Daunorubicin hydrochloride
Doxorubicin hydrochloride
Teniposide
Etoposide
Etoposide phosphate
Rituximab
Daunorubicin citrate
U.S. FDA Resources
Further study details as provided by Johann Wolfgang Goethe University Hospitals:
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
| Estimated Enrollment: | 60 |
| Study Start Date: | April 2004 |
| Study Completion Date: | March 2009 |
| Primary Completion Date: | March 2009 (Final data collection date for primary outcome measure) |
Eligibility| Ages Eligible for Study: | 15 Years to 65 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
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
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00199004
Locations
| Germany | |
| University Hospital of Frankfurt, Medical Dept. II | |
| Frankfurt, Germany, 60590 | |
Sponsors and Collaborators
Johann Wolfgang Goethe University Hospitals
Investigators
| Study Chair: | Dieter Hoelzer, MD,PhD | University Hospital, Medical Dept. II |
More Information
Additional Information:
No publications provided
| ClinicalTrials.gov Identifier: | NCT00199004 History of Changes |
| Other Study ID Numbers: | GMALL03 |
| Study First Received: | September 12, 2005 |
| Last Updated: | August 20, 2010 |
| Health Authority: | Germany: Federal Institute for Drugs and Medical Devices |
Keywords provided by Johann Wolfgang Goethe University Hospitals:
|
ALL Treatment De novo |
Minimal residual disease Rituximab Adult |
Additional relevant MeSH terms:
|
Leukemia Leukemia, Lymphoid Precursor Cell Lymphoblastic Leukemia-Lymphoma Neoplasms by Histologic Type Neoplasms Lymphoproliferative Disorders Lymphatic Diseases Immunoproliferative Disorders Immune System Diseases 6-Mercaptopurine Cytarabine Methotrexate Thioguanine Cyclophosphamide Rituximab |
Asparaginase Daunorubicin Dexamethasone Doxorubicin Prednisolone Methylprednisolone Hemisuccinate Vincristine Vindesine BB 1101 Dexamethasone acetate Methylprednisolone acetate Prednisolone acetate Methylprednisolone Dexamethasone 21-phosphate Prednisolone hemisuccinate |
ClinicalTrials.gov processed this record on May 23, 2013