Rituximab Combined With Chemotherapy in Burkitt's Lymphoma

Sponsor

PETHEMA Foundation (Other)

Overall Status

Completed

CT.gov ID

NCT00388193

Collaborator

(none)

Enrollment

Locations

Arm

Duration (Months)

1.3

Patients Per Site

Patients Per Site Per Month

Study Details

Study Description

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

Condition or Disease	Intervention/Treatment	Phase
Acute Lymphoblastic Leukemia Burkitt's Lymphoma	Drug: RITUXIMAB	Phase 2

Detailed Description

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

Study Design

Study Type:

Interventional

Anticipated Enrollment :

20 participants

Allocation:

Non-Randomized

Intervention Model:

Single Group Assignment

Masking:

None (Open Label)

Primary Purpose:

Treatment

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 Start Date :

Aug 1, 2006

Actual Primary Completion Date :

Dec 1, 2013

Actual Study Completion Date :

Dec 1, 2013

Arms and Interventions

Arm	Intervention/Treatment
Experimental: 1	Drug: RITUXIMAB 375 mg/m2/d day 1

Arm

Intervention/Treatment

Experimental: 1

Drug: RITUXIMAB

375 mg/m2/d day 1

Outcome Measures

Primary Outcome Measures

Determinate the efficacy of the administration of anti-CD20 (RITUXIMAB) combined with chemotherapy. [1 year]

Secondary Outcome Measures

Combined treatment with high doses of methotrexate and high doses of cytarabine with conventional cytostatics (block C) [1 year]
Prophylactic administration of G-CSF after all chemotherapy cycles [1 year]
local irradiation after 6 cycle if CNS was affected or if there are residual tumour [1 year]

Eligibility Criteria

Criteria

Ages Eligible for Study:

15 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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.

Contacts and Locations

Locations

	Site	City	Country
1	Hospital General de Alicante	Alicante	Spain
2	Hospital "Santa Creu i Sant Pau"	Barcelona	Spain
3	Hospital Clínico y Provincial de Barcelona	Barcelona	Spain
4	Complejo Hospitalario de Cáceres	Cáceres	Spain
5	Hospital general de Jerez de la Frontera	Jerez de la Frontera	Spain
6	Hospital Juan Canalejo	La Coruña	Spain
7	Hospital Clínico San Carlos de Madrid	Madrid	Spain
8	Hospital Doce de Octubre	Madrid	Spain
9	Hospital Universitario Morales Meseguer, Murcia	Murcia	Spain
10	Hospital Carlos Haya	Málaga	Spain
11	Hospital Son Dureta	Palma de Mallorca	Spain
12	Hospital Clínico Universitario de Salamanca	Salamanca	Spain
13	Hospital Universitario Virgen del Rocío	Sevilla	Spain
14	Hospital La Fe	Valencia	Spain
15	Hospital Txagorritxu	Vitoria	Spain