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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ClinicalTrials.gov Identifier: NCT00199082 |
Recruitment Status
:
Completed
First Posted
: September 20, 2005
Last Update Posted
: August 5, 2016
|
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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 |

- Remission rate
- Remission duration
- Disease free survival
- Overall survival
- 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

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.
Ages Eligible for Study: | 15 Years to 65 Years (Child, Adult) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
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

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
Germany | |
University Hospital, Medical Dept. II | |
Frankfurt, Germany, 60590 |
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:
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 |