Acute Lymphoblastic Leukemia, Burkitt's Lymphoma
Conditions
Keywords
ALL (L3), BURKITT's LYMPHOMA, RITUXIMAB
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.
Interventions
DRUGRITUXIMAB
375 mg/m2/d day 1
Sponsors
PETHEMA Foundation
Study design
Allocation
NON_RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
15 Years to No maximum
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Determinate the efficacy of the administration of anti-CD20 (RITUXIMAB) combined with chemotherapy. | 1 year |
Secondary
| Measure | Time frame |
|---|---|
| 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 |
Countries
Spain
Outcome results
None listed