Rituximab Combined With Chemotherapy in Burkitt's Lymphoma

PETHEMA Foundation

Status and phase: Completed; Phase 2

Conditions: Acute Lymphoblastic Leukemia; Burkitt's Lymphoma

Treatments: Drug: RITUXIMAB

Study type: Interventional

Funder types: Other

Identifiers

NCT00388193

2005-001067-64

Details and patient eligibility

About

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

Full description

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

Enrollment: 20 estimated patients

Sex: All

Ages: 15+ years old

Volunteers: No 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.

Trial design

Primary purpose: Treatment

Allocation: Non-Randomized

Interventional model: Single Group Assignment

Masking: None (Open label)

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20 participants in 1 patient group

1

Experimental group

Treatment:

Drug: RITUXIMAB