Know Cancer

or
forgot password

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


Phase 2
15 Years
N/A
Open (Enrolling)
Both
Acute Lymphoblastic Leukemia, Burkitt's Lymphoma

Thank you

Trial Information

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


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


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.

Type of Study:

Interventional

Study Design:

Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

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

Outcome Time Frame:

1 year

Safety Issue:

No

Principal Investigator

Ribera Josep Mª, Dr

Investigator Role:

Study Chair

Investigator Affiliation:

HOSPITAL GERMANS TRIAS I PUJOL

Authority:

Spain: Ministry of Health

Study ID:

2005-001067-64

NCT ID:

NCT00388193

Start Date:

August 2006

Completion Date:

December 2013

Related Keywords:

  • Acute Lymphoblastic Leukemia
  • Burkitt's Lymphoma
  • ALL (L3)
  • BURKITT's LYMPHOMA
  • RITUXIMAB
  • Burkitt Lymphoma
  • Leukemia
  • Leukemia, Lymphoid
  • Precursor Cell Lymphoblastic Leukemia-Lymphoma
  • Lymphoma

Name

Location