NCT00265915

Brief Summary

RATIONALE: 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. Colony-stimulating factors, such as GM-CSF, may increase the number of immune cells found in bone marrow or peripheral blood. Giving rituximab together with GM-CSF may be an effective treatment for chronic lymphocytic leukemia. PURPOSE: This phase II trial is studying how well giving rituximab together with GM-CSF works in treating patients with B-cell chronic lymphocytic leukemia.

Trial Health

55
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Timeline
Completed

Started Jul 2005

Shorter than P25 for phase_2 leukemia

Status
terminated

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

July 1, 2005

Completed
6 months until next milestone

First Submitted

Initial submission to the registry

December 14, 2005

Completed
1 day until next milestone

First Posted

Study publicly available on registry

December 15, 2005

Completed
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2006

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2006

Completed
Last Updated

August 12, 2014

Status Verified

August 1, 2014

Enrollment Period

8 months

First QC Date

December 14, 2005

Last Update Submit

August 11, 2014

Conditions

Leukemia

Keywords

B-cell chronic lymphocytic leukemiarefractory chronic lymphocytic leukemiastage 0 chronic lymphocytic leukemiastage I chronic lymphocytic leukemiastage II chronic lymphocytic leukemiastage III chronic lymphocytic leukemiastage IV chronic lymphocytic leukemia

Outcome Measures

Primary Outcomes (1)

  • Overall response rate

Interventions

rituximabBIOLOGICAL
sargramostimBIOLOGICAL

Eligibility Criteria

Age15 Years+
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
DISEASE CHARACTERISTICS: * Diagnosis of B-cell chronic lymphocytic leukemia meeting 1 of the following criteria: * Previously treated stage III or IV or earlier stage disease with evidence of active disease, as defined by ≥ 1 of the following: * Weight loss \> 10% within the past 6 months * Extreme fatigue * Fever or night sweats without evidence of infection * Worsening anemia or thrombocytopenia * Progressive lymphocytosis with a rapid lymphocyte doubling time * Marked hypogammaglobulinemia or paraproteinemia * Lymphadenopathy \> 5 cm in diameter * Previously untreated stage 0-II disease with symptoms or significant fatigue or at high risk of progression due to of B2 microglobulin \> 3.0 mg/mL * Patients who are ≥ 70 years of age with previously untreated stage III or IV or earlier stage disease requiring treatment but who refused chemotherapy are eligible PATIENT CHARACTERISTICS: Performance status * Zubrod 0-2 Life expectancy * Not specified Hematopoietic * See Disease Characteristics Hepatic * Bilirubin \< 2.0 mg/dL\* (elevated bilirubin allowed if due to of Gilbert's disease) NOTE: \*Liver dysfunction due to lymphocytic organ infiltration allowed Renal * Creatinine \< 2.5 mg/dL\* NOTE: \*Renal dysfunction due to lymphocytic organ infiltration allowed Other * Not pregnant or nursing * Negative pregnancy test * Fertile patients must use effective contraception * No active viral infection (e.g., viral hepatitis) PRIOR CONCURRENT THERAPY: Chemotherapy * See Disease Characteristics

Contact the study team to discuss eligibility requirements. They can help determine if this study is right for you.

Sponsors & Collaborators

MeSH Terms

Conditions

LeukemiaLeukemia, Lymphocytic, Chronic, B-Cell

Interventions

Rituximabsargramostim

Condition Hierarchy (Ancestors)

Neoplasms by Histologic TypeNeoplasmsHematologic DiseasesHemic and Lymphatic DiseasesLeukemia, B-CellLeukemia, LymphoidLymphoproliferative DisordersLymphatic DiseasesImmunoproliferative DisordersImmune System DiseasesChronic DiseaseDisease AttributesPathologic ProcessesPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Antibodies, Monoclonal, Murine-DerivedAntibodies, MonoclonalAntibodiesImmunoglobulinsImmunoproteinsBlood ProteinsProteinsAmino Acids, Peptides, and ProteinsSerum GlobulinsGlobulins

Study Officials

  • Ian W. Flinn, MD, PhD

    Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins

    STUDY CHAIR

Study Design

Study Type
interventional
Phase
phase 2
Purpose
TREATMENT
Sponsor Type
OTHER

Study Record Dates

First Submitted

December 14, 2005

First Posted

December 15, 2005

Study Start

July 1, 2005

Primary Completion

March 1, 2006

Study Completion

March 1, 2006

Last Updated

August 12, 2014

Record last verified: 2014-08