Clinical trial · Interventional
Rituximab Combined With Chemotherapy in Burkitt's Lymphoma
Burkimab:Study Multicenter of Optimization of the Treatment of LLA-B and the Burkitt's Lymphoma in Adult Patients (From 15 Years Old)
NCT00388193CI-TRIAL-00015918completedPhase 2ClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
The purpose of this clinical trial is to prove the efficacy of the following new regimen treatment: * Administration of anti-CD20 (Rituximab) combined with chemotherapy. * Combined treatment with high doses of methotrexate and high doses of cytarabine with conventional cytostatics (block C) * Prophylactic administration of G-CSF after all chemotherapy cycles * local irradiation after 6 cycle if CNS was affected or if there are residual tumour
Conditions
Conditions (2)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Acute Lymphoblastic Leukemia | Acute Lymphoblastic Leukemia | ONTOLOGY_EXACT | 0.98 |
| Burkitt's Lymphoma | Burkitt Lymphoma | ALIAS | 0.90 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| RITUXIMAB | Drug | Rituximab | ALIAS |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- 1
- interventionNames
- Drug: RITUXIMAB
Primary outcomes (1)
- measure
- Determinate the efficacy of the administration of anti-CD20 (RITUXIMAB) combined with chemotherapy.
- timeFrame
- 1 year
Secondary outcomes (3)
- measure
- Combined treatment with high doses of methotrexate and high doses of cytarabine with conventional cytostatics (block C)
- timeFrame
- 1 year
- measure
- Prophylactic administration of G-CSF after all chemotherapy cycles
- timeFrame
- 1 year
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 15 Years
Show eligibility criteria text
Inclusion Criteria: * Patients diagnosed with mature LLA-B cell (LLA-L3) * Patients diagnosed with Burkitt´s and Burkitt´s Like Lymphoma * Patients 15 years old or up * Written Informed Consent signed Exclusion Criteria: * Serious complications related with LAL3/LB or Secondary illness: Serious complications, uncontrollable, for example, sepsis, pneumonia with hypoxia, shock, haemorrhage at diagnosis. * Renal failure unconditional for the Lymphoma/Leukemia * Heart failure or serious liver. * Pulmonary obstructive disease or serious restrictive that not allow to treat the patient with intensive chemotherapy. * Secondary Lymphoma after chemotherapy or previous radiotherapy or second malignant tumour. * Known hypersensitivity to any foreign protein. * Previous treatment with cytostatics of the LLA-B or Burkitt´s Lymphoma (exception: administration on short time of glucocorticoids ≤ 7 days, one administration of vincristine or cyclophosphamide, one cycle of CHOP, urgent administration of the another cytostatics). * With another malignant tumour in the last 5 year. * Women in fertile age must give positive in the pregnancy test or nursing mother. * Mental disability or emotional or psychiatric significant disorder were the patient can't understand nor cooperate with treatment. * Patients is enrolled in another clinical research study.
References
Publications (8)
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- BACKGROUNDReiter A, Schrappe M, Tiemann M, Ludwig WD, Yakisan E, Zimmermann M, Mann G, Chott A, Ebell W, Klingebiel T, Graf N, Kremens B, Muller-Weihrich S, Pluss HJ, Zintl F, Henze G, Riehm H. Improved treatment results in childhood B-cell neoplasms with tailored intensification of therapy: A report of the Berlin-Frankfurt-Munster Group Trial NHL-BFM 90. Blood. 1999 Nov 15;94(10):3294-306. PMID 10552938
- BACKGROUNDThomas DA, Cortes J, O'Brien S, Pierce S, Faderl S, Albitar M, Hagemeister FB, Cabanillas FF, Murphy S, Keating MJ, Kantarjian H. Hyper-CVAD program in Burkitt's-type adult acute lymphoblastic leukemia. J Clin Oncol. 1999 Aug;17(8):2461-70. doi: 10.1200/JCO.1999.17.8.2461. PMID 10561310
- BACKGROUNDAdde M, Shad A, Venzon D, Arndt C, Gootenberg J, Neely J, Nieder M, Owen W, Seibel N, Wilson W, Horak ID, Magrath I. Additional chemotherapy agents improve treatment outcome for children and adults with advanced B-cell lymphomas. Semin Oncol. 1998 Apr;25(2 Suppl 4):33-9; discussion 45-8. PMID 9578060
- BACKGROUNDMounier N, Briere J, Gisselbrecht C, Emile JF, Lederlin P, Sebban C, Berger F, Bosly A, Morel P, Tilly H, Bouabdallah R, Reyes F, Gaulard P, Coiffier B. Rituximab plus CHOP (R-CHOP) overcomes bcl-2--associated resistance to chemotherapy in elderly patients with diffuse large B-cell lymphoma (DLBCL). Blood. 2003 Jun 1;101(11):4279-84. doi: 10.1182/blood-2002-11-3442. Epub 2003 Feb 6. PMID 12576316
- BACKGROUNDLee EJ, Petroni GR, Schiffer CA, Freter CE, Johnson JL, Barcos M, Frizzera G, Bloomfield CD, Peterson BA. Brief-duration high-intensity chemotherapy for patients with small noncleaved-cell lymphoma or FAB L3 acute lymphocytic leukemia: results of cancer and leukemia group B study 9251. J Clin Oncol. 2001 Oct 15;19(20):4014-22. doi: 10.1200/JCO.2001.19.20.4014.