German Multicenter Trial for the Treatment of Newly Diagnosed T-lymphoblastic Lymphoma in Adults
This study has been completed.
Sponsor:
Johann Wolfgang Goethe University Hospitals
Information provided by:
Johann Wolfgang Goethe University Hospitals
ClinicalTrials.gov Identifier:
NCT00199017
First received: September 12, 2005
Last updated: August 20, 2010
Last verified: May 2008
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Purpose
This study evaluates the efficacy and tolerability of treatment for T-lymphoblastic lymphoma (T-LBL) according to a protocol for acute lymphoblastic leukemia. Patients receive one year of intensive cyclical chemotherapy with additional prophylaxis for central nervous system (CNS) relapse by intrathecal therapy and cranial irradiation and mediastinal irradiation after induction chemotherapy.
| Condition | Intervention | Phase |
|---|---|---|
|
Lymphoma, Lymphoblastic |
Drug: Dexamethasone/Prednisolone Drug: Cyclophosphamide Drug: Vincristine Drug: Daunorubicin Drug: Asparaginase Drug: G-CSF Drug: Mercaptopurine Drug: Cytarabine Drug: Methotrexate Drug: VP16 Drug: Vindesine Drug: Adriamycin Drug: Thioguanine Drug: HDARAC Procedure: CNS irradiation Procedure: Mediastinal irradiation Drug: Cladribine |
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: | Multicenter Trial for Treatment Optimization in T-lymphoblastic Lymphoma in Adults and Adolescents Older Than 15 Years (GMALL T-LBL 1/2004) (Amend 1) |
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
Cladribine
Asparaginase
Methotrexate sodium
Daunorubicin
Doxorubicin
Daunorubicin hydrochloride
Doxorubicin hydrochloride
Etoposide
Etoposide phosphate
Daunorubicin citrate
U.S. FDA Resources
Further study details as provided by Johann Wolfgang Goethe University Hospitals:
Primary Outcome Measures:
- remission rate, remission duration, disease free survival, overall survival
Secondary Outcome Measures:
- time and dose compliance, toxicity according to World Health Organization (WHO)
| Estimated Enrollment: | 75 |
| Study Start Date: | April 2004 |
| 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:
- T-lymphoblastic lymphoma (bone marrow [BM] involvement < 25%)
- Aged 15-65 years (55-65 years if biologically younger)
- Written informed consent
Exclusion Criteria:
- Severe complications due to lymphoma or secondary disease
- T-LBL as second malignancy or other active second malignancy
- Cytostatic pretreatment of LBL (exception of emergency treatments)
- Pregnancy
- Severe psychiatric illness or other circumstances which may compromise cooperation of the patient or informed consent
- Participation in other study interfering with study treatment
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00199017
Locations
| Germany | |
| University Hospital, Medical Dept. II | |
| Frankfurt, Germany, 60590 | |
Sponsors and Collaborators
Johann Wolfgang Goethe University Hospitals
Investigators
| Study Chair: | Dieter Hoelzer, MD, PhD | University Hospital Frankfurt, Medical Dept. II |
More Information
Additional Information:
No publications provided
| ClinicalTrials.gov Identifier: | NCT00199017 History of Changes |
| Other Study ID Numbers: | GMALL04 |
| 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:
|
T-LBL Treatment De novo |
Chemotherapy Adult Lymphoma, lymphoblastic, T-cell |
Additional relevant MeSH terms:
|
Lymphoma Precursor Cell Lymphoblastic Leukemia-Lymphoma Lymphoma, Non-Hodgkin Neoplasms by Histologic Type Neoplasms Lymphoproliferative Disorders Lymphatic Diseases Immunoproliferative Disorders Immune System Diseases Leukemia, Lymphoid Leukemia 6-Mercaptopurine Cytarabine Methotrexate Thioguanine |
Cyclophosphamide Cladribine Asparaginase Daunorubicin Dexamethasone Doxorubicin Prednisolone Methylprednisolone Hemisuccinate Vincristine Vindesine BB 1101 Dexamethasone acetate Methylprednisolone acetate Prednisolone acetate Methylprednisolone |
ClinicalTrials.gov processed this record on May 23, 2013