Clinical trial NCT00388193: Rituximab Combined With Chemotherapy in Burkitt's Lymphoma
Official title: Burkimab:Study Multicenter of Optimization of the Treatment of LLA-B and the Burkitt's Lymphoma in Adult Patients (From 15 Years Old)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Acute Lymphoblastic Leukemia
Burkitt's Lymphoma
Keywords: ALL (L3)
BURKITT's LYMPHOMA
RITUXIMAB
Lead sponsor: PETHEMA Foundation
Sponsor class: OTHER
First posted: 2006-10-16
Enrollment: 20
Sex: ALL
Minimum age (years): 15
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: 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

Detailed description: Clinical Trial with a pharmaceutical speciality in new conditions to use.

Eligibility criteria: 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.

Primary outcomes:
measure: Determinate the efficacy of the administration of anti-CD20 (RITUXIMAB) combined with chemotherapy.
timeFrame: 1 year
Secondary outcomes:
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
measure: local irradiation after 6 cycle if CNS was affected or if there are residual tumour
timeFrame: 1 year
Other outcomes:
Locations:
city: Alicante
country: Spain
facility: Hospital General de Alicante
city: Barcelona
country: Spain
facility: Hospital "Santa Creu i Sant Pau"
city: Barcelona
country: Spain
facility: Hospital Clínico y Provincial de Barcelona
city: Cáceres
country: Spain
facility: Complejo Hospitalario de Cáceres
city: Jerez de la Frontera
country: Spain
facility: Hospital general de Jerez de la Frontera
city: La Coruña
country: Spain
facility: Hospital Juan Canalejo
city: Madrid
country: Spain
facility: Hospital Clínico San Carlos de Madrid
city: Madrid
country: Spain
facility: Hospital Doce de Octubre
city: Murcia
country: Spain
facility: Hospital Universitario Morales Meseguer, Murcia
city: Málaga
country: Spain
facility: Hospital Carlos Haya
city: Palma de Mallorca
country: Spain
facility: Hospital Son Dureta
city: Salamanca
country: Spain
facility: Hospital Clínico Universitario de Salamanca
city: Sevilla
country: Spain
facility: Hospital Universitario Virgen del Rocío
city: Valencia
country: Spain
facility: Hospital La Fe
city: Vitoria
country: Spain
facility: Hospital Txagorritxu
Study officials:
affiliation: Germans Trias i Pujol Hospital
name: Ribera Josep Mª, Dr
role: STUDY_CHAIR
References:
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citation: Lee 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.
citation: Zinzani PL, Martelli M, Magagnoli M, Pescarmona E, Scaramucci L, Palombi F, Bendandi M, Martelli MP, Ascani S, Orcioni GF, Pileri SA, Mandelli F, Tura S. Treatment and clinical management of primary mediastinal large B-cell lymphoma with sclerosis: MACOP-B regimen and mediastinal radiotherapy monitored by (67)Gallium scan in 50 patients. Blood. 1999 Nov 15;94(10):3289-93.
citation: Oriol A, Ribera JM, Esteve J, Sanz MA, Brunet S, Garcia-Boyero R, Fernandez-Abellan P, Marti JM, Abella E, Sanchez-Delgado M, Penarrubia MJ, Besalduch J, Moreno MJ, Borrego D, Feliu E, Ortega JJ; PETHEMA Group, Spanish Society of Hematology. Lack of influence of human immunodeficiency virus infection status in the response to therapy and survival of adult patients with mature B-cell lymphoma or leukemia. Results of the PETHEMA-LAL3/97 study. Haematologica. 2003 Apr;88(4):445-53.