ClinicalTrials.Veeva

Menu

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

N

Nicola Goekbuget

Status and phase

Completed
Phase 4

Conditions

Burkitt's Leukemia
Large Cell Anaplastic Lymphoma
Lymphoblastic Lymphoma
Mediastinal Neoplasms
Burkitt's Lymphoma

Treatments

Drug: Rituximab
Drug: VP16
Drug: Vincristine/Vindesine
Drug: Cytarabine
Drug: Adriamycin
Drug: Ifosfamide
Drug: Methotrexate
Procedure: Irradiation (in specific conditions)
Drug: Cyclophosphamide
Drug: Dexamethasone/Prednisolone
Drug: G-CSF

Study type

Interventional

Funder types

Other

Identifiers

NCT00199082
GMALL05

Details and patient eligibility

About

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.

Enrollment

650 estimated patients

Sex

All

Ages

15 to 65 years old

Volunteers

No 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

Trial design

Primary purpose

Treatment

Allocation

N/A

Interventional model

Single Group Assignment

Masking

None (Open label)

650 participants in 1 patient group

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

Trial contacts and locations

1

Loading...

Data sourced from clinicaltrials.gov

Clinical trials

Find clinical trialsTrials by location
© Copyright 2025 Veeva Systems