Clinical trial NCT00199082: 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
Overall status: COMPLETED
Phase: PHASE4
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
Lead sponsor: Goethe University
Sponsor class: OTHER
First posted: 2005-09-20
Enrollment: 650
Sex: ALL
Minimum age (years): 15
Maximum age (years): 65
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.


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

Primary outcomes:
measure: Remission rate
measure: Remission duration
measure: Disease free survival
measure: Overall survival
Secondary outcomes:
measure: Dose and time compliance
measure: Toxicity according to National Cancer Institute (NCI)-Common Toxicity Criteria (CTC)
measure: Death under therapy and in complete remission (CR)
measure: Localisations of relapse
Other outcomes:
Locations:
city: Frankfurt
country: Germany
facility: University Hospital, Medical Dept. II
Study officials:
affiliation: University Hospital of Frankfurt (Main)
name: Nicola Goekbuget, Dr. med.
role: PRINCIPAL_INVESTIGATOR
References:
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.