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

August 17, 2022 updated by: Nicola Goekbuget

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Anticipated)

650

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Germany
      • Frankfurt, Germany, 60590
        • University Hospital, Medical Dept. II

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

11 years to 61 years (Child, Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Experimental
This is a single arm trial with complex chemotherapy (6 cycles) stratified by age, subtype (Burkitt-leukemia vs Burkitt-lymphoma) and initial involvement
Drug: Methotrexate
Drug: Cyclophosphamide
Drug: Rituximab
Drug: Cytarabine
Drug: G-CSF
Drug: Ifosfamide
Drug: VP16
Drug: Adriamycin
Drug: Dexamethasone/Prednisolone
Drug: Vincristine/Vindesine
Procedure: Irradiation (in specific conditions)

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Overall survival
Disease free survival
Remission rate
Remission duration

Secondary Outcome Measures

Outcome Measure
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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Nicola Goekbuget

Investigators

  • Principal Investigator: Nicola Goekbuget, Dr. med., University Hospital of Frankfurt (Main)

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

July 1, 2002

Primary Completion (Actual)

June 1, 2010

Study Completion (Actual)

June 1, 2010

Study Registration Dates

First Submitted

September 12, 2005

First Submitted That Met QC Criteria

September 12, 2005

First Posted (Estimate)

September 20, 2005

Study Record Updates

Last Update Posted (Actual)

August 19, 2022

Last Update Submitted That Met QC Criteria

August 17, 2022

Last Verified

August 1, 2022

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • GMALL05

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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