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Phase II Study Of Rituximab And Short Duration, High Intensity Chemotherapy With G-CSF Support In Previously Untreated Patients With Burkitt Lymphoma/Leukemia


Phase 2
16 Years
N/A
Open (Enrolling)
Both
Leukemia, Lymphoma

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Trial Information

Phase II Study Of Rituximab And Short Duration, High Intensity Chemotherapy With G-CSF Support In Previously Untreated Patients With Burkitt Lymphoma/Leukemia


OBJECTIVES:

- Determine the complete response rate in patients with previously untreated Burkitt's
lymphoma or Burkitt's leukemia treated with rituximab and high-intensity chemotherapy
with filgrastim (G-CSF) support.

- Determine the progression-free and overall survival of patients treated with this
regimen.

- Determine the feasibility and toxicity of this regimen in these patients.

OUTLINE: This is a multicenter study. Patients are stratified according to disease (leukemia
vs lymphoma).

- Course 1: Patients receive cyclophosphamide IV over 5-15 minutes daily on days 1-5 and
oral prednisone on days 1-7. Allopurinol PO will be given on days 1-14.

- Courses 2, 4, and 6: Patients receive ifosfamide IV over 1 hour daily on days 1-5;
vincristine IV over 10 minutes and methotrexate IV over 24 hours on day 1; leucovorin
calcium IV over 15 minutes every 6 hours on day 2; cytarabine IV over 2 hours on days 4
and 5 and etoposide IV over 1 hour daily on days 4 and 5; oral dexamethasone daily on
days 1-5; and methotrexate and cytarabine intrathecally (IT) on day 1. During course 2,
patients receive rituximab IV over 1-4 hours on days 8, 10, and 12. During courses 4
and 6, patients receive rituximab IV over 1 hour on day 8. Patients also receive
filgrastim (G-CSF) subcutaneously (SC) beginning on day 7 and continuing until blood
counts recover.

- Courses 3, 5, and 7: Patients receive cyclophosphamide IV over 5-15 minutes daily on
days 1-5; vincristine IV over 10 minutes and methotrexate IV over 24 hours on day 1;
leucovorin calcium IV every 6 hours on day 2; doxorubicin IV daily on days 4 and 5;
oral dexamethasone daily on days 1-5; methotrexate and cytarabine IT on day 1; and
rituximab IV over 1 hour on day 8. Patients also receive G-CSF as in courses 2, 4, and
6. After course 3, treatment continues in the absence of disease progression or
unacceptable toxicity.

Patients are followed every 3 months for 2 years, every 6 months for 3 years, and then
annually for 5 years.

PROJECTED ACCRUAL: A total of 100 patients (50 per stratum) will be accrued for this study
within 3 years.

Inclusion Criteria


DISEASE CHARACTERISTICS:

- Histologically, cytogenetically, or immunophenotypically confirmed Burkitt's leukemia
or Burkitt's or Burkitt-like lymphoma

- L3 morphology surface IgG expression

- Cytogenetic evidence for t(8;14), t(8;22), or t(2;8)

- Previously untreated disease except hydroxyurea for leukocytosis

- CNS involvement allowed

- Patients with Burkitt's leukemia or Burkitt's lymphoma with bone marrow involvement
must also be enrolled on CALGB-8461

- Patients with Burkitt's leukemia must also be enrolled on CALGB-9665

PATIENT CHARACTERISTICS:

Age:

- 16 and over

Performance status:

- Not specified

Life expectancy:

- Not specified

Hematopoietic:

- Not specified

Hepatic:

- Bilirubin no greater than 1.5 times upper limit of normal (ULN)

Renal:

- Creatinine no greater than 1.5 times ULN

Other:

- HIV negative

- Not pregnant or nursing

- Fertile patients must use effective contraception

PRIOR CONCURRENT THERAPY:

Biologic therapy:

- No concurrent interleukin-11

Chemotherapy:

- See Disease Characteristics

- No other concurrent chemotherapy

Endocrine therapy:

- No concurrent hormonal therapy except for non-disease-related conditions (e.g.,
insulin for diabetes)

- No concurrent steroids except for adrenal failure

Radiotherapy:

- No concurrent palliative radiotherapy except whole-brain irradiation for documented
CNS disease

Surgery:

- Not specified

Type of Study:

Interventional

Study Design:

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

Outcome Measure:

Complete response rate

Outcome Time Frame:

6 months post tx

Safety Issue:

No

Principal Investigator

David Rizzieri, MD

Investigator Role:

Study Chair

Investigator Affiliation:

Duke University Medical Center Bone Marrow Transplant

Authority:

United States: Federal Government

Study ID:

CDR0000069354

NCT ID:

NCT00039130

Start Date:

May 2002

Completion Date:

October 2019

Related Keywords:

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

Name

Location

Roswell Park Cancer InstituteBuffalo, New York  14263
Walter Reed Army Medical CenterWashington, District of Columbia  20307-5000
University of Chicago Cancer Research CenterChicago, Illinois  60637
Duke Comprehensive Cancer CenterDurham, North Carolina  27710
CCOP - Christiana Care Health ServicesWilmington, Delaware  19899
CCOP - North Shore University HospitalManhasset, New York  11030
Holden Comprehensive Cancer Center at University of IowaIowa City, Iowa  52242-1002
Ellis Fischel Cancer Center at University of Missouri - ColumbiaColumbia, Missouri  65203
Norris Cotton Cancer Center at Dartmouth-Hitchcock Medical CenterLebanon, New Hampshire  03756-0002
Naval Medical Center - San DiegoSan Diego, California  92134-3202
Fletcher Allen Health Care - University Health Center CampusBurlington, Vermont  05401
Long Island Jewish Medical CenterNew Hyde Park, New York  11040
Stony Brook University Cancer CenterStony Brook, New York  11794-8174
Presbyterian Cancer Center at Presbyterian HospitalCharlotte, North Carolina  28233-3549
Wake Forest University Comprehensive Cancer CenterWinston-Salem, North Carolina  27157-1096
Rhode Island Hospital Comprehensive Cancer CenterProvidence, Rhode Island  02903
Hematology Oncology Associates of the Quad CitiesBettendorf, Iowa  52722
Wayne Memorial Hospital, IncorporatedGoldsboro, North Carolina  27534
Greenebaum Cancer Center at University of Maryland Medical CenterBaltimore, Maryland  21201
University of Illinois Cancer CenterChicago, Illinois  60612-7243
Masonic Cancer Center at University of MinnesotaMinneapolis, Minnesota  55455
Don Monti Comprehensive Cancer Center at North Shore University HospitalManhasset, New York  11030
Virginia Commonwealth University Massey Cancer CenterRichmond, Virginia  23298-0037
Arthur G. James Cancer Hospital and Solove Research Institute at Ohio State University Medical CenterColumbus, Ohio  43210-1240
Fort Wayne Medical Oncology and HematologyFort Wayne, Indiana  46815
Cancer Institute of New Jersey at Cooper - VoorheesVoorhees, New Jersey  08043
Mountainview MedicalBerlin, Vermont  05602
Tunnell Cancer Center at Beebe Medical CenterLewes, Delaware  19958
Union Hospital Cancer Program at Union HospitalElkton MD, Maryland  21921
Monter Cancer Center of the North Shore-LIJ Health SystemLake Success, New York  11042
Miriam HospitalProvidence, Rhode Island  02906