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A Randomized Phase II Study of Concurrent Fludarabine + Chimeric Anti-CD20 Monoclonal Antibody IDEC-C2B8 (Rituximab) [NSC# 687451] Induction Followed By Rituximab Consolidation In Untreated Patients With B-Cell Chronic Lymphocytic Leukemia


Phase 2
18 Years
N/A
Not Enrolling
Both
Leukemia

Thank you

Trial Information

A Randomized Phase II Study of Concurrent Fludarabine + Chimeric Anti-CD20 Monoclonal Antibody IDEC-C2B8 (Rituximab) [NSC# 687451] Induction Followed By Rituximab Consolidation In Untreated Patients With B-Cell Chronic Lymphocytic Leukemia


OBJECTIVES: I. Determine the response rate and toxicity profile of concurrent and
consolidative chimeric anti-CD20 monoclonal antibody IDEC-C2B8 (rituximab) therapy compared
to consolidative rituximab therapy in patients with chronic lymphocytic leukemia treated
with fludarabine. II. Assess the complete response (CR) rate in patients receiving
concurrent therapy with rituximab and fludarabine. III. Assess the frequency of conversion
of a partial response (PR) to a CR or stable disease to either PR or CR in patients
receiving consolidative therapy with rituximab. IV. Follow the effects of rituximab and
fludarabine on the immunologic markers CD4, CD8, IgG, IgA, and IgM. V. Assess the
progression-free and overall survival of these patients.

OUTLINE: This is a randomized study. Patients are stratified according to stage (I and II vs
III and IV). Patients are assigned to 1 of 2 treatment arms. Arm I consists of fludarabine
and chimeric anti-CD20 monoclonal antibody IDEC-C2B8 (rituximab) induction, and arm II
consists of fludarabine induction. Arm I: Rituximab is administered IV over 4 hours on day
1, on day 3, and over 1 hour on day 5 of week 1. Subsequent doses are given over 1 hour on
day 1 every 4 weeks for a total of 6 courses. Fludarabine IV is administered over 10-30
minutes daily for 5 days during weeks 1, 5, 9, 13, 17, and 21 for a total of 6 courses.
Following the sixth course of fludarabine, patients undergo clinical staging and are then
observed for an additional 2 months, after which they undergo repeat clinical staging,
including bone marrow aspiration. Patients achieving a complete or partial response or
stable disease then proceed to consolidation therapy consisting of weekly intravenous
infusions of rituximab once weekly for 4 weeks. Arm II (Fludarabine Induction): Patients
receive fludarabine IV over 10-30 minutes daily for 5 days during weeks 1, 5, 9, 13, 17, and
21 for a total of 6 courses. Patients then proceed as in arm I. Patients are followed every
3 months for 1 year, and then every 6 months thereafter.

PROJECTED ACCRUAL: A maximum of 100 patients will be accrued for this study within 12
months.

Inclusion Criteria


DISEASE CHARACTERISTICS: Histologically proven B-cell chronic lymphocytic leukemia Stage I
or II with evidence of active disease as defined by: Massive or progressive splenomegaly
and/or lymphadenopathy Weight loss of greater than 10% within 6 months CALGB grade 2 or 3
fatigue Fevers of greater than 100.5 C or night sweats for over 2 weeks and no evidence of
infection Progressive lymphocytosis Stage III or IV Patient registration on CALGB 9665
required

PATIENT CHARACTERISTICS: Age: 18 and over Performance status: CALGB 0-3 Life expectancy:
Not specified Hematopoietic: Not specified Hepatic: Not specified Renal: Creatinine no
greater than 1.5 times upper limit of normal Other: No medical condition requiring chronic
use of oral corticosteroids Direct antiglobulin test or direct Coombs test negative Not
pregnant Effective contraception required of all fertile patients

PRIOR CONCURRENT THERAPY: Biologic: No prior biologic therapy for disease No concurrent
erythropoietin Chemotherapy: No concurrent chemotherapy No prior chemotherapy for disease
Endocrine: No concurrent chronic oral corticosteroids No prior corticosteroids for
autoimmune complications developing since diagnosis No concurrent hormone therapy for
disease related conditions No concurrent dexamethasone or other corticosteroid-based
antiemetics Radiotherapy: No concurrent palliative radiotherapy Surgery: Not specified
Other: No prophylactic therapy for viral, bacterial, or fungal infections

Type of Study:

Interventional

Study Design:

Allocation: Randomized, Primary Purpose: Treatment

Principal Investigator

John C. Byrd, MD

Investigator Role:

Study Chair

Investigator Affiliation:

Ohio State University Comprehensive Cancer Center

Authority:

United States: Federal Government

Study ID:

CDR0000066128

NCT ID:

NCT00003248

Start Date:

March 1998

Completion Date:

June 2010

Related Keywords:

  • Leukemia
  • stage I chronic lymphocytic leukemia
  • stage II chronic lymphocytic leukemia
  • stage III chronic lymphocytic leukemia
  • stage IV chronic lymphocytic leukemia
  • B-cell chronic lymphocytic leukemia
  • Leukemia
  • Leukemia, Lymphocytic, Chronic, B-Cell
  • Leukemia, Lymphoid

Name

Location

Roswell Park Cancer InstituteBuffalo, New York  14263
Memorial Sloan-Kettering Cancer CenterNew York, New York  10021
Walter Reed Army Medical CenterWashington, District of Columbia  20307-5000
University of Chicago Cancer Research CenterChicago, Illinois  60637
University of Iowa Hospitals and ClinicsIowa City, Iowa  52242
University of Massachusetts Memorial Medical CenterWorcester, Massachusetts  01655
Lineberger Comprehensive Cancer Center, UNCChapel Hill, North Carolina  27599-7295
Duke Comprehensive Cancer CenterDurham, North Carolina  27710
Comprehensive Cancer Center of Wake Forest University Baptist Medical CenterWinston-Salem, North Carolina  27157-1082
Medical University of South CarolinaCharleston, South Carolina  29425-0721
Rhode Island HospitalProvidence, Rhode Island  02903
Vermont Cancer CenterBurlington, Vermont  05401-3498
CCOP - Southern Nevada Cancer Research FoundationLas Vegas, Nevada  89106
University of California San Diego Cancer CenterLa Jolla, California  92093-0658
UCSF Cancer Center and Cancer Research InstituteSan Francisco, California  94115-0128
CCOP - Christiana Care Health ServicesWilmington, Delaware  19899
CCOP - Mount Sinai Medical CenterMiami Beach, Florida  33140
Marlene & Stewart Greenebaum Cancer Center, University of MarylandBaltimore, Maryland  21201
Ellis Fischel Cancer Center - ColumbiaColumbia, Missouri  65203
Barnes-Jewish HospitalSaint Louis, Missouri  63110
Norris Cotton Cancer CenterLebanon, New Hampshire  03756
CCOP - North Shore University HospitalManhasset, New York  11030
State University of New York - Upstate Medical UniversitySyracuse, New York  13210
CCOP - Southeast Cancer Control ConsortiumWinston-Salem, North Carolina  27104-4241
University of Tennessee, Memphis Cancer CenterMemphis, Tennessee  38103
MBCCOP - Massey Cancer CenterRichmond, Virginia  23298-0037
Mount Sinai Medical Center, NYNew York, New York  10029
Massachusetts General Hospital Cancer CenterBoston, Massachusetts  02114
New York Presbyterian Hospital - Cornell CampusNew York, New York  10021
Dana-Farber Cancer InstituteBoston, Massachusetts  02115
North Shore University HospitalManhasset, New York  11030
CCOP - Syracuse Hematology-Oncology Associates of Central New York, P.C.Syracuse, New York  13217
University of Illinois at Chicago Health Sciences CenterChicago, Illinois  60612
University of Nebraska Medical CenterOmaha, Nebraska  68198-3330