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Completed

NCT Number: NCT00199082

Newly Diagnosed Mature B-ALL, Burkitt's Lymphoma and Other High-grade Lymphoma in Adults

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.

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Key information

Conditions

Burkitt's Lymphoma Burkitt Lymphoma Burkitt's Leukemia DNA Virus Infections Epstein-Barr Virus Infections Hematologic Diseases Hemic and Lymphatic Diseases Herpesviridae Infections Immune System Diseases Immunoproliferative Disorders Infections Large Cell Anaplastic Lymphoma Leukemia Leukemia, Lymphoid Lymphatic Diseases Lymphoblastic Lymphoma Lymphoma Lymphoma, B-Cell Lymphoma, Large-Cell, Anaplastic Lymphoma, Non-Hodgkin Lymphoma, T-Cell Lymphoproliferative Disorders Mediastinal Diseases Mediastinal Neoplasms Neoplasms Neoplasms by Histologic Type Neoplasms by Site Precursor Cell Lymphoblastic Leukemia-Lymphoma Respiratory Tract Diseases Thoracic Diseases Thoracic Neoplasms Tumor Virus Infections Virus Diseases

Age range

15 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

University Hospital, Medical Dept. II

Frankfurt, 60590, Germany

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Adriamycin

Drug

Cyclophosphamide

Drug

Cytarabine

Drug

Dexamethasone/Prednisolone

Drug

VP16

Drug

ifosfamide

Drug

methotrexate

Drug

G-CSF

Drug

Rituximab

Drug

Vincristine/Vindesine

Drug

Irradiation (in specific conditions)

Procedure

Primary outcomes

  1. Remission rate

  2. Remission duration

  3. Disease free survival

  4. Overall survival

Secondary outcomes

  1. Dose and time compliance

  2. Toxicity according to National Cancer Institute (NCI)-Common Toxicity Criteria (CTC)

  3. Death under therapy and in complete remission (CR)

  4. Localisations of relapse

Sponsors and collaborators

Lead sponsor

Nicola Goekbuget

Other

Registry information

Official study title

Multicenter Study to Optimise Therapy of B-ALL, Burkitt's NHL and High-Grade Non-Hodgkin's Lymphoma in Adults (Amend 7)

Important dates

Study start
2002
Primary completion
2010
Study completion
2010
First posted
Sep 20, 2005
Registry last updated
Aug 19, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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