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Phase II Study of Intensive Chemotherapy and Rituximab in Burkitt Lymphoma

Phase 2
18 Years
Not Enrolling
Burkitt Lymphoma, Non-Hodgkins Lymphoma, Atypical Burkitt Lymphoma

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Trial Information

Phase II Study of Intensive Chemotherapy and Rituximab in Burkitt Lymphoma

- Patients will be placed into one of two groups, "low risk" and "high risk". "Low risk"
disease is defined as one area of disease measuring less than 10cm and a normal blood
test called LDH (lactate hydrogenase). Patients not fitting the "low risk" criteria
are considered "high risk".

- If the patient has "low risk" disease their treatment cycle consist of three cycles of

- If the patient has "high risk" disease they will receive Cycle A followed by cycle B
which will then repeat.

- Cycle A consists of the drugs: rituximab, cyclophosphamide, oncovin, doxorubicin and
methotrexate (R-CODOX-M). The treatment cycle is approximately 14 days. A spinal tap
is performed on day 1 and day 3 of the cycle and the patient will be hospitalized until
between day 11 and day 13. After the patient's blood counts return to normal(usually
around day 21),the next round of treatment will occur.

- Cycle B consists of the drugs: rituximab, ifosfamide, VP-16 and ara-c (IVAC). The
treatment cycle is approximately 5 days. A spinal tap is performed on day 4 and once
blood counts return to normal the patient will start cycle A again.

- After the patient has finished the treatments, they will be re-evaluated with CT scans
and PET scans to determine whether or not they are in remission. Every three months
for two years, blood tests and CT and PET scans will be performed. Follow up after
that will be every 6 months for two years.

Inclusion Criteria:

- Histologically documented Burkitt or atypical Burkitt according to World Health
Organization (WHO) criteria.

- Pathology must be reviewed at the Brigham and Women's Hospital (BWH).

- Measurable or evaluable disease: Disease reproducibly measurable in two perpendicular
dimensions on exam, computed tomography (CT), radiograph, or magnetic resonance
imaging (MRI). Disease present on bone marrow biopsy will be considered as evaluable

- The following may not be used as the sole site of measurable or evaluable disease:
*ascites, *pleural effusion, *bone lesion or *central nervous system (CNS) disease.

- Age > 18

- Laboratory data (within 2 weeks of study registration):

- ANC > 1500/ul;

- platelet > 100,000/ul;

- creatinine < 1.5 X normal;

- creatinine clearance > 60 ml/min;

- bilirubin < 1.5 X normal;

- AST and ALT < 2.5 X normal;

- alkaline phosphates < 3 X normal;

- HIV negative;

- cardiac ejection fraction > 50%.

Exclusion Criteria:

- Previous chemotherapy or radiation therapy. Steroids of less than 72 hours duration
for impending oncologic emergency are allowed.

- Uncontrolled bacterial, fungal, or viral infection.

- Concomitant malignancy excluding carcinoma in situ of the cervix and basal cell
carcinoma of the skin.

- Serious comorbid disease. Clinically significant pulmonary symptomatology. In
patients with a history of symptomatic pulmonary disease, pulmonary function tests
(PFTs) should document an forced expiratory volume at 1 second (FeV1), forced vital
capacity (FVC), and total lung capacity (TLC) of > 60% predicted and carbon monoxide
diffusing capacity of the lung (DLCO) of > 50% predicted. No clinically significant
cardiac symptomatology. The cardiac ejection fraction must be > 50%.

- Pregnancy. All males and females with reproductive potential must consent to use an
effective form of contraception while on study.

- Major surgery within the previous 2 weeks.

Type of Study:


Study Design:

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

Outcome Measure:

Response Rates (CR and PR) in Adults With Burkitt/Atypical Burkitt

Outcome Description:

Complete Response (CR): Disappearance of all measurable or evaluable disease confirmed. Partial Response (PR): Reduction of 50% or greater in the sum of the products of the perpendicular diameters of all measurable. Of 8 High Risk participants, 7 met the primary response outcome. 1 High Risk participant did not meet protocol defined primary outcome response and died two months following enrollment.

Outcome Time Frame:

3 years

Safety Issue:


Principal Investigator

Ann S. La Casce, MD

Investigator Role:

Principal Investigator

Investigator Affiliation:

Dana-Farber Cancer Institute


United States: Institutional Review Board

Study ID:




Start Date:

July 2005

Completion Date:

June 2011

Related Keywords:

  • Burkitt Lymphoma
  • Non-Hodgkins Lymphoma
  • Atypical Burkitt Lymphoma
  • Burkitt Lymphoma
  • atypical Burkitt lymphoma
  • Non-Hodgkin's Lymphoma
  • rituximab
  • Burkitt Lymphoma
  • Lymphoma
  • Lymphoma, Non-Hodgkin



Beth Israel Deaconess Medical Center Boston, Massachusetts  02215
Dana-Farber Cancer Institute Boston, Massachusetts  02115