Combination Chemotherapy and Rituximab in Treating Patients With Newly Diagnosed Burkitt's Lymphoma or Leukemia

Part of paid clinical trials in Baltimore, Maryland.

Sponsor
Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins
Study ID
NCT00133991
Phase
PHASE2
Status
Completed

Conditions

Eligibility Criteria

Sex
ALL
Age
30 Years - 120 Years
Healthy Volunteers
Not accepted

Interventions

  • Filgrastim — BIOLOGICAL
    5 mcg/kg/day starting on Day 3 after each R-CVP cycle and on Day 6 after HiCy.
  • Rituximab — BIOLOGICAL
    375 mg/m\^2 on Day 1 and Day 8 of each R-CVP cycle. 375 mg/m\^2 on Day -4 of HiCy and weekly for four weeks after HiCy.
  • Cyclophosphamide — DRUG
    1500 mg/m\^2 on Day 1 of each R-CVP cycle. 50 mg/kg/day on Days -3, -2, -1, and 0 of HiCy.
  • Cytarabine — DRUG
    100 mg intrathecal on Days 1, 4, and 11 of each cycle of R-CVP.
  • Methotrexate — DRUG
    3 g/m\^2 on Day 8 of each cycle of R-CVP.
  • Prednisone — DRUG
    100 mg on Days 1-5 of each cycle of R-CVP.
  • Hydrocortisone — DRUG
    50 mg intrathecal on Days 1, 4, and 11 of each cycle of R-CVP.
  • Vincristine — DRUG
    1.4 mg/m\^2 on Day 1 of each cycle of R-CVP.
  • Leucovorin — DRUG
    25 mg four times daily after methotrexate administration. Dosing continues until adequate methotrexate levels are reached.

Study Details

RATIONALE: Drugs used in chemotherapy, work in different ways to stop the growth of cancer cells, either by killing the cells or by stopping them from dividing. Giving more than one drug (combination chemotherapy) may kill more cancer cells. Monoclonal antibodies, such as rituximab, can block cancer growth in different ways. Some block the ability of cancer cells to grow and spread. Others find cancer cells and help kill them or carry cancer-killing substances to them. Giving combination chemotherapy together with rituximab may kill more cancer cells. PURPOSE: This phase II trial is studying how well giving combination chemotherapy together with rituximab works in treating patients with newly diagnosed Burkitt's lymphoma or leukemia.

Key Dates

Start date
Jul 31, 2005
Status verified
Sep 2018
Primary completion
Aug 31, 2011
Completion
Aug 31, 2013

Study Design

Enrollment
23 participants (actual)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • Experimental: R-CVP + HiCy
    Protocol intervention consists of two fifteen-day cycles of cyclophosphamide (Cy), vincristine (V), prednisone (P), rituximab (R), with filgrastim support. CNS intervention consists of three days of cytarabine and hydrocortisone and one day of methotrexate (with leucovorin support) for each cycle. After those two cycles, rituximab and high-dose cyclophosphamide (HiCy) will be given.

Primary Outcome Measure

Overall Response Rate [ Time Frame: Up to 3 months ]

Locations (2)

FacilityCityStateZIPSite coordinators
Sidney Kimmel Comprehensive Cancer Center at Johns HopkinsBaltimoreMaryland21231-2410-
Drexel University College of Medicine - Center City Hahnemann CampusPhiladelphiaPennsylvania19102-

Find similar trials in Baltimore, MD

By condition
Leukemia (other)
By specialty
OncologyBlood cancer
By research site
Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins· Baltimore, MDDrexel University College of Medicine - Center City Hahnemann Campus· Philadelphia, PA

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