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

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

Status

Completed

Phases

Phase 4

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00199082

Enrollment

650

Registered

2005-09-20

Start date

2002-07-31

Completion date

2010-06-30

Last updated

2022-08-19

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

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

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.

Interventions

DRUGAdriamycin

DRUGCyclophosphamide

DRUGCytarabine

DRUGDexamethasone/Prednisolone

DRUGVP16

DRUGIfosfamide

DRUGMethotrexate

DRUGG-CSF

DRUGRituximab

DRUGVincristine/Vindesine

PROCEDUREIrradiation (in specific conditions)

Study design

Allocation

Intervention model

SINGLE_GROUP

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

15 Years to 65 Years

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

Design outcomes

Primary

Measure	Time frame
Overall survival	—
Remission rate	—
Remission duration	—
Disease free survival	—

Secondary

Measure	Time frame
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	—

Countries

Germany

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Mar 7, 2026