Rituximab Combined With Chemotherapy in Burkitt`s Lymphoma
This study is ongoing, but not recruiting participants.
Sponsor:
PETHEMA Foundation
Information provided by (Responsible Party):
PETHEMA Foundation
ClinicalTrials.gov Identifier:
NCT00388193
First received: October 13, 2006
Last updated: February 27, 2013
Last verified: February 2013
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Purpose
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 | Intervention | Phase |
|---|---|---|
|
Acute Lymphoblastic Leukemia Burkitt's Lymphoma |
Drug: RITUXIMAB |
Phase 2 |
| Study Type: | Interventional |
| Study Design: | Allocation: Non-Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Single Group Assignment Masking: 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) |
Resource links provided by NLM:
Further study details as provided by PETHEMA Foundation:
Primary Outcome Measures:
- Determinate the efficacy of the administration of anti-CD20 (RITUXIMAB) combined with chemotherapy. [ Time Frame: 1 year ] [ Designated as safety issue: No ]
Secondary Outcome Measures:
- Combined treatment with high doses of methotrexate and high doses of cytarabine with conventional cytostatics (block C) [ Time Frame: 1 year ] [ Designated as safety issue: Yes ]
- Prophylactic administration of G-CSF after all chemotherapy cycles [ Time Frame: 1 year ] [ Designated as safety issue: Yes ]
- local irradiation after 6 cycle if CNS was affected or if there are residual tumour [ Time Frame: 1 year ] [ Designated as safety issue: No ]
| Estimated Enrollment: | 20 |
| Study Start Date: | August 2006 |
| Estimated Study Completion Date: | December 2013 |
| Estimated Primary Completion Date: | December 2013 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
| Experimental: 1 |
Drug: RITUXIMAB
375 mg/m2/d day 1
|
Detailed Description:
Clinical Trial with a pharmaceutical speciality in new conditions to use.
Eligibility| Ages Eligible for Study: | 15 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
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.
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00388193
Locations
| Spain | |
| Hospital General de Alicante | |
| Alicante, Spain | |
| Hospital "Santa Creu i Sant Pau" | |
| Barcelona, Spain | |
| Hospital Clínico y Provincial de Barcelona | |
| Barcelona, Spain | |
| Complejo Hospitalario de Cáceres | |
| Cáceres, Spain | |
| Hospital general de Jerez de la Frontera | |
| Jerez de la Frontera, Spain | |
| Hospital Juan Canalejo | |
| La Coruña, Spain | |
| Hospital Doce de Octubre | |
| Madrid, Spain | |
| Hospital Clínico San Carlos de Madrid | |
| Madrid, Spain | |
| Hospital Universitario Morales Meseguer, Murcia | |
| Murcia, Spain | |
| Hospital Carlos Haya | |
| Málaga, Spain | |
| Hospital Son Dureta | |
| Palma de Mallorca, Spain | |
| Hospital Clínico Universitario de Salamanca | |
| Salamanca, Spain | |
| Hospital Universitario Virgen del Rocío | |
| Sevilla, Spain | |
| Hospital La Fe | |
| Valencia, Spain | |
| Hospital Txagorritxu | |
| Vitoria, Spain | |
Sponsors and Collaborators
PETHEMA Foundation
Investigators
| Study Chair: | Ribera Josep Mª, Dr | HOSPITAL GERMANS TRIAS I PUJOL |
More Information
Additional Information:
Publications:
| Responsible Party: | PETHEMA Foundation |
| ClinicalTrials.gov Identifier: | NCT00388193 History of Changes |
| Other Study ID Numbers: | 2005-001067-64 |
| Study First Received: | October 13, 2006 |
| Last Updated: | February 27, 2013 |
| Health Authority: | Spain: Ministry of Health |
Keywords provided by PETHEMA Foundation:
|
ALL (L3) BURKITT's LYMPHOMA RITUXIMAB |
Additional relevant MeSH terms:
|
Burkitt Lymphoma Leukemia Leukemia, Lymphoid Precursor Cell Lymphoblastic Leukemia-Lymphoma Lymphoma Epstein-Barr Virus Infections Herpesviridae Infections DNA Virus Infections Virus Diseases Tumor Virus Infections Lymphoma, Non-Hodgkin Neoplasms by Histologic Type Neoplasms |
Lymphoma, B-Cell Neoplasms, Experimental Lymphoproliferative Disorders Lymphatic Diseases Immunoproliferative Disorders Immune System Diseases Rituximab Immunologic Factors Physiological Effects of Drugs Pharmacologic Actions Antirheumatic Agents Therapeutic Uses Antineoplastic Agents |
ClinicalTrials.gov processed this record on May 21, 2013