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Completed

NCT Number: NCT00388193

Rituximab Combined With Chemotherapy in Burkitt's Lymphoma

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

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Key information

About this study

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

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Rituximab

Drug

375 mg/m2/d day 1

Primary outcomes

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

    Time frame: 1 year

Secondary outcomes

  1. Combined treatment with high doses of methotrexate and high doses of cytarabine with conventional cytostatics (block C)

    Time frame: 1 year

  2. Prophylactic administration of G-CSF after all chemotherapy cycles

    Time frame: 1 year

  3. local irradiation after 6 cycle if CNS was affected or if there are residual tumour

    Time frame: 1 year

Sponsors and collaborators

Lead sponsor

PETHEMA Foundation

Other

Registry information

Official study title

Burkimab:Study Multicenter of Optimization of the Treatment of LLA-B and the Burkitt's Lymphoma in Adult Patients (From 15 Years Old)

Important dates

Study start
2006
Primary completion
2013
Study completion
2013
First posted
Oct 16, 2006
Registry last updated
Oct 28, 2014

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.