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Trial for the Treatment of Newly Diagnosed Mature B-Cell Acute Lymphoblastic Leukemia (B-ALL), Burkitt's Non-Hodgkin's Lymphoma (NHL) and Other High-grade Lymphoma in Adults
This study has been completed.
Sponsor:
Nicola Goekbuget
Information provided by (Responsible Party):
Nicola Goekbuget, Johann Wolfgang Goethe University Hospital
ClinicalTrials.gov Identifier:
NCT00199082
First received: September 12, 2005
Last updated: August 4, 2016
Last verified: August 2016
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Purpose
The study evaluates the efficacy and tolerability of alternating short cycles of high-dose and conventional chemotherapy in combination with rituximab in CD20 positive patients, followed by local radiation therapy in the case of initial mediastinal or central nervous system (CNS) involvement or a residual tumor after chemotherapy. A dose-reduced regimen is offered for patients estimated to be over 55 years, biologically.
| Condition | Intervention | Phase |
|---|---|---|
| Burkitt's Lymphoma Burkitt's Leukemia Mediastinal Neoplasms Lymphoblastic Lymphoma Large Cell Anaplastic Lymphoma | Drug: Adriamycin Drug: Cyclophosphamide Drug: Cytarabine Drug: Dexamethasone/Prednisolone Drug: VP16 Drug: Ifosfamide Drug: Methotrexate Drug: G-CSF Drug: Rituximab Drug: Vincristine/Vindesine Procedure: Irradiation (in specific conditions) | Phase 4 |
| Study Type: | Interventional |
| Study Design: | Allocation: Non-Randomized Intervention Model: Parallel Assignment Masking: Open Label Primary Purpose: Treatment |
| Official Title: | Multicenter Study to Optimise Therapy of B-ALL, Burkitt's NHL and High-Grade Non-Hodgkin's Lymphoma in Adults (Amend 7) |
Resource links provided by NLM:
MedlinePlus related topics:
Lymphoma
Genetic and Rare Diseases Information Center resources:
Lymphosarcoma
Diffuse Large B-Cell Lymphoma
Acute Lymphoblastic Leukemia
Lymphoma, Large-cell
Anaplastic Large Cell Lymphoma
Lymphoblastic Lymphoma
Burkitt Lymphoma
B-cell Lymphoma
U.S. FDA Resources
Further study details as provided by Nicola Goekbuget, Johann Wolfgang Goethe University Hospital:
Primary Outcome Measures:
- Remission rate
- Remission duration
- Disease free survival
- Overall survival
Secondary Outcome Measures:
- Dose and time compliance
- Toxicity according to National Cancer Institute (NCI)-Common Toxicity Criteria (CTC)
- Death under therapy and in complete remission (CR)
- Localisations of relapse
| Estimated Enrollment: | 650 |
| Study Start Date: | July 2002 |
| Study Completion Date: | June 2010 |
| Primary Completion Date: | June 2010 (Final data collection date for primary outcome measure) |
Eligibility| Ages Eligible for Study: | 15 Years to 65 Years (Child, Adult) |
| Sexes Eligible for Study: | All |
| Accepts Healthy Volunteers: | No |
Criteria
Inclusion Criteria:
- Burkitt's leukemia or Burkitt's lymphoma or primary mediastinal large B-cell lymphoma or B-precursor lymphoblastic lymphoma or large cell anaplastic lymphoma
- Age > 15 years
- Written informed consent
Exclusion Criteria:
- Serious secondary diseases, including psychiatric conditions, under which the required therapy compliance is not to be expected
- HIV infection
- Secondary lymphoma following prior chemotherapy/radiotherapy or active second malignancy
- Known severe allergy to foreign proteins
- Pre-treatment other than 1 cycle CHOP or similar; < 1 week of another chemotherapy.
- Pregnancy or nursing
- Participation in other studies that interfere with study therapy
Contacts and Locations
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To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below.
For general information, see Learn About Clinical Studies.
Please refer to this study by its ClinicalTrials.gov identifier: NCT00199082
Please refer to this study by its ClinicalTrials.gov identifier: NCT00199082
Locations
| Germany | |
| University Hospital, Medical Dept. II | |
| Frankfurt, Germany, 60590 | |
Sponsors and Collaborators
Nicola Goekbuget
Investigators
| Principal Investigator: | Nicola Goekbuget, Dr. med. | University Hospital of Frankfurt (Main) |
More Information
Additional Information:
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
| Responsible Party: | Nicola Goekbuget, Dr. med., Johann Wolfgang Goethe University Hospital |
| ClinicalTrials.gov Identifier: | NCT00199082 History of Changes |
| Other Study ID Numbers: |
GMALL05 |
| Study First Received: | September 12, 2005 |
| Last Updated: | August 4, 2016 |
| Individual Participant Data (IPD) Sharing Statement: | |
| Plan to Share IPD: | No |
Keywords provided by Nicola Goekbuget, Johann Wolfgang Goethe University Hospital:
|
High-grade NHL De novo Mature B-ALL Burkitt'S NHL |
Chemotherapy Rituximab Primary mediastinal diffuse large cell lymphoma B-precursor lymphoblastic lymphoma |
Additional relevant MeSH terms:
|
Lymphoma Leukemia Lymphoma, Non-Hodgkin Precursor Cell Lymphoblastic Leukemia-Lymphoma Burkitt Lymphoma Mediastinal Neoplasms Lymphoma, Large-Cell, Anaplastic Neoplasms by Histologic Type Neoplasms Lymphoproliferative Disorders Lymphatic Diseases Immunoproliferative Disorders Immune System Diseases Leukemia, Lymphoid Epstein-Barr Virus Infections |
Herpesviridae Infections DNA Virus Infections Virus Diseases Tumor Virus Infections Lymphoma, B-Cell Thoracic Neoplasms Neoplasms by Site Mediastinal Diseases Thoracic Diseases Respiratory Tract Diseases Lymphoma, T-Cell Dexamethasone Prednisolone Cyclophosphamide Rituximab |
ClinicalTrials.gov processed this record on July 19, 2017