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
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The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. |
| ClinicalTrials.gov Identifier: NCT00199082 |
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Recruitment Status
:
Completed
First Posted
: September 20, 2005
Last Update Posted
: August 5, 2016
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Sponsor:
Nicola Goekbuget
Information provided by (Responsible Party):
Nicola Goekbuget, Johann Wolfgang Goethe University Hospital
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Brief Summary:
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 or disease | Intervention/treatment | 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 (Clinical Trial) |
| Estimated Enrollment : | 650 participants |
| Allocation: | Non-Randomized |
| Intervention Model: | Parallel Assignment |
| Masking: | None (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) |
| Study Start Date : | July 2002 |
| Actual Primary Completion Date : | June 2010 |
| Actual Study Completion Date : | June 2010 |
Resource links provided by the National Library of Medicine
MedlinePlus related topics:
Lymphoma
Genetic and Rare Diseases Information Center resources:
Lymphosarcoma
Diffuse Large B-Cell Lymphoma
Acute Lymphoblastic Leukemia
Burkitt Lymphoma
Lymphoma, Large-cell
Anaplastic Large Cell Lymphoma
Lymphoblastic Lymphoma
B-cell Lymphoma
U.S. FDA Resources
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
Information from the National Library of Medicine
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| 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
Information from the National Library of Medicine
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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) |
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 |
| First Posted: | September 20, 2005 Key Record Dates |
| Last Update Posted: | August 5, 2016 |
| Last Verified: | August 2016 |
| Individual Participant Data (IPD) Sharing Statement: | |
| Plan to Share IPD: | No |
Keywords provided by Nicola Goekbuget, Johann Wolfgang Goethe University Hospital:
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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:
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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 |