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

Primary Purpose

Burkitt's Lymphoma, Burkitt's Leukemia, Mediastinal Neoplasms

Status
Completed
Phase
Phase 4
Locations
Germany
Study Type
Interventional
Intervention
Adriamycin
Cyclophosphamide
Cytarabine
Dexamethasone/Prednisolone
VP16
Ifosfamide
Methotrexate
G-CSF
Rituximab
Vincristine/Vindesine
Irradiation (in specific conditions)
Sponsored by
Nicola Goekbuget
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Burkitt's Lymphoma focused on measuring High-grade NHL, De novo, Mature B-ALL, Burkitt'S NHL, Chemotherapy, Rituximab, Primary mediastinal diffuse large cell lymphoma, B-precursor lymphoblastic lymphoma

Eligibility Criteria

15 Years - 65 Years (Child, Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • University Hospital, Medical Dept. II

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Experimental

Arm Description

This is a single arm trial with complex chemotherapy (6 cycles) stratified by age, subtype (Burkitt-leukemia vs Burkitt-lymphoma) and initial involvement

Outcomes

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

Full Information

First Posted
September 12, 2005
Last Updated
August 17, 2022
Sponsor
Nicola Goekbuget
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1. Study Identification

Unique Protocol Identification Number
NCT00199082
Brief Title
Newly Diagnosed Mature B-ALL, Burkitt's Lymphoma and Other High-grade Lymphoma in Adults
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 Type
Interventional

2. Study Status

Record Verification Date
August 2022
Overall Recruitment Status
Completed
Study Start Date
July 2002 (undefined)
Primary Completion Date
June 2010 (Actual)
Study Completion Date
June 2010 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor-Investigator
Name of the Sponsor
Nicola Goekbuget

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Burkitt's Lymphoma, Burkitt's Leukemia, Mediastinal Neoplasms, Lymphoblastic Lymphoma, Large Cell Anaplastic Lymphoma
Keywords
High-grade NHL, De novo, Mature B-ALL, Burkitt'S NHL, Chemotherapy, Rituximab, Primary mediastinal diffuse large cell lymphoma, B-precursor lymphoblastic lymphoma

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
650 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Experimental
Arm Type
Experimental
Arm Description
This is a single arm trial with complex chemotherapy (6 cycles) stratified by age, subtype (Burkitt-leukemia vs Burkitt-lymphoma) and initial involvement
Intervention Type
Drug
Intervention Name(s)
Adriamycin
Intervention Type
Drug
Intervention Name(s)
Cyclophosphamide
Intervention Type
Drug
Intervention Name(s)
Cytarabine
Intervention Type
Drug
Intervention Name(s)
Dexamethasone/Prednisolone
Intervention Type
Drug
Intervention Name(s)
VP16
Intervention Type
Drug
Intervention Name(s)
Ifosfamide
Intervention Type
Drug
Intervention Name(s)
Methotrexate
Intervention Type
Drug
Intervention Name(s)
G-CSF
Intervention Type
Drug
Intervention Name(s)
Rituximab
Intervention Type
Drug
Intervention Name(s)
Vincristine/Vindesine
Intervention Type
Procedure
Intervention Name(s)
Irradiation (in specific conditions)
Primary Outcome Measure Information:
Title
Remission rate
Title
Remission duration
Title
Disease free survival
Title
Overall survival
Secondary Outcome Measure Information:
Title
Dose and time compliance
Title
Toxicity according to National Cancer Institute (NCI)-Common Toxicity Criteria (CTC)
Title
Death under therapy and in complete remission (CR)
Title
Localisations of relapse

10. Eligibility

Sex
All
Minimum Age & Unit of Time
15 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Nicola Goekbuget, Dr. med.
Organizational Affiliation
University Hospital of Frankfurt (Main)
Official's Role
Principal Investigator
Facility Information:
Facility Name
University Hospital, Medical Dept. II
City
Frankfurt
ZIP/Postal Code
60590
Country
Germany

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
25359988
Citation
Hoelzer D, Walewski J, Dohner H, Viardot A, Hiddemann W, Spiekermann K, Serve H, Duhrsen U, Huttmann A, Thiel E, Dengler J, Kneba M, Schaich M, Schmidt-Wolf IG, Beck J, Hertenstein B, Reichle A, Domanska-Czyz K, Fietkau R, Horst HA, Rieder H, Schwartz S, Burmeister T, Gokbuget N; German Multicenter Study Group for Adult Acute Lymphoblastic Leukemia. Improved outcome of adult Burkitt lymphoma/leukemia with rituximab and chemotherapy: report of a large prospective multicenter trial. Blood. 2014 Dec 18;124(26):3870-9. doi: 10.1182/blood-2014-03-563627. Epub 2014 Oct 30.
Results Reference
result

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

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