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Phase II Study of Intensified CVP, Rituximab, and High Dose Cyclophosphamide for Adult Burkitt or Burkitt-Like Lymphoma


Phase 2
30 Years
N/A
Not Enrolling
Both
Leukemia, Lymphoma

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Trial Information

Phase II Study of Intensified CVP, Rituximab, and High Dose Cyclophosphamide for Adult Burkitt or Burkitt-Like Lymphoma


OBJECTIVES:

Primary

- Determine the overall response rate, 1-year event-free survival, and overall survival
of adult patients with newly diagnosed Burkitt or atypical Burkitt lymphoma or leukemia
treated with dose-intensified induction therapy comprising cyclophosphamide,
vincristine, prednisone, and rituximab followed by consolidation therapy comprising
rituximab and high-dose cyclophosphamide.

- Determine the grade 3 or higher non-hematologic toxic effects and overall tolerability
of this regimen in these patients.

Secondary

- Determine the 3-year event-free survival and overall survival of patients treated with
this regimen.

- Determine the general patterns of CNS and systemic relapse in patients treated with
this regimen.

OUTLINE: This is a multicenter study.

- Dose-intensified CVP induction therapy: Patients receive cyclophosphamide IV and
vincristine IV on day 1. Patients also receive oral prednisone on days 1-5 and
rituximab IV on days 1 and 8, and high-dose methotrexate IV with leucovorin calcium IV
rescue on day 8. Patients receive filgrastim (G-CSF) subcutaneously (SC) once daily
beginning on day 3 and continuing until blood counts recover. Treatment repeats
approximately every 14 days for 2 courses.

- CNS therapy: Patients receive cytarabine intrathecally (IT) with or without
hydrocortisone IT on days 1, 4, and 11 of each induction therapy course. Patients with
evidence of CNS involvement by lymphoma continue to receive cytarabine IT twice weekly
during any induction therapy treatment delay. Patients who demonstrate CSF clearance
receive cytarabine IT once weekly for 4 doses and then once every other week for 4
doses during consolidation therapy. Patients with disease progression during induction
therapy or persistent CNS involvement by lymphoma are removed from the study. All other
patients proceed to consolidation therapy.

- Consolidation therapy: Patients receive rituximab IV on day -4 and high-dose
cyclophosphamide IV on days -3, -2, -1, and 0. Patients receive G-CSF SC once daily
beginning on day 6 and continuing until blood counts recover OR pegfilgrastim SC once
on day 6. Patients then receive rituximab IV once weekly for 4 weeks in the absence of
disease progression or unacceptable toxicity.

After completion of study treatment, patients are followed periodically for 3 years.

PROJECTED ACCRUAL: A total of 30 patients will be accrued for this study within 3 years.

Inclusion Criteria


DISEASE CHARACTERISTICS:

- Histologically confirmed diagnosis of 1 of the following:

- Classic, sporadic Burkitt's lymphoma

- Burkitt's leukemia (FAB L3 acute lymphoblastic leukemia)

- Atypical Burkitt/Burkitt's-like lymphoma or leukemia, defined by the following
criteria:

- Characteristic morphologic features

- High proliferative index AND Ki-67 ≥ 85%

- Any stage allowed

- Newly diagnosed or untreated disease

- Steroids allowed

PATIENT CHARACTERISTICS:

Age

- 30 and over

Performance status

- Not specified

Life expectancy

- Not specified

Renal

- No known irreversible renal dysfunction that would preclude treatment with high-dose
cyclophosphamide

Cardiovascular

- No known significant cardiac dysfunction that would preclude treatment with high-dose
cyclophosphamide

Other

- Not pregnant or nursing

- No known HIV positivity

- No other malignancy within the past 3 years except basal cell or squamous cell skin
cancer or carcinoma in situ of the cervix

PRIOR CONCURRENT THERAPY:

Biologic therapy

- Not specified

Chemotherapy

- No prior chemotherapy for lymphoma

- A maximum of 2 prior doses of intrathecal chemotherapy are allowed

Endocrine therapy

- Not specified

Radiotherapy

- No prior radiation therapy for lymphoma

Surgery

- Prior complete or incomplete surgical resection of lymphoma allowed

Type of Study:

Interventional

Study Design:

Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

Overall response rate

Safety Issue:

No

Principal Investigator

Yvette L. Kasamon, MD

Investigator Role:

Study Chair

Investigator Affiliation:

Sidney Kimmel Comprehensive Cancer Center

Authority:

United States: Food and Drug Administration

Study ID:

CDR0000439521, J0409

NCT ID:

NCT00133991

Start Date:

March 2005

Completion Date:

Related Keywords:

  • Leukemia
  • Lymphoma
  • untreated adult acute lymphoblastic leukemia
  • L3 adult acute lymphoblastic leukemia
  • contiguous stage II adult Burkitt lymphoma
  • noncontiguous stage II adult Burkitt lymphoma
  • stage I adult Burkitt lymphoma
  • stage III adult Burkitt lymphoma
  • stage IV adult Burkitt lymphoma
  • Burkitt Lymphoma
  • Leukemia
  • Lymphoma

Name

Location

Drexel University College of Medicine - Center City Hahnemann CampusPhiladelphia, Pennsylvania  19102
Sidney Kimmel Comprehensive Cancer Center at Johns HopkinsBaltimore, Maryland  21231-2410