NCT00049413

Brief Summary

RATIONALE: Drugs used in chemotherapy use different ways to stop cancer cells from dividing so they stop growing or die. Monoclonal antibodies can locate cancer cells and either kill them or deliver cancer-killing substances to them without harming normal cells. Combining chemotherapy with monoclonal antibody therapy may kill more cancer cells. PURPOSE: Phase II trial to study the effectiveness of combining pentostatin and cyclophosphamide with rituximab in treating patients who have chronic lymphocytic leukemia or lymphocytic lymphoma.

Trial Health

87
On Track

Trial Health Score

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

Timeline
Completed

Started Jun 2002

Geographic Reach
1 country

1 active site

Status
completed

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

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

June 1, 2002

Completed
5 months until next milestone

First Submitted

Initial submission to the registry

November 12, 2002

Completed
3 months until next milestone

First Posted

Study publicly available on registry

January 27, 2003

Completed
1.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2004

Completed
1 year until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2005

Completed
Last Updated

May 12, 2011

Status Verified

May 1, 2011

Enrollment Period

2.5 years

First QC Date

November 12, 2002

Last Update Submit

May 10, 2011

Conditions

LeukemiaLymphoma

Keywords

B-cell chronic lymphocytic leukemiarefractory chronic lymphocytic leukemiastage I chronic lymphocytic leukemiastage II chronic lymphocytic leukemiastage III chronic lymphocytic leukemiastage IV chronic lymphocytic leukemiacontiguous stage II small lymphocytic lymphomanoncontiguous stage II small lymphocytic lymphomarecurrent small lymphocytic lymphomastage I small lymphocytic lymphomastage III small lymphocytic lymphomastage IV small lymphocytic lymphoma

Interventions

rituximabBIOLOGICAL
cyclophosphamideDRUG
pentostatinDRUG

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
DISEASE CHARACTERISTICS: * Diagnosis of B-cell chronic lymphocytic leukemia (CLL) or small B-cell lymphocytic lymphoma (SLL) with the following: * Lymph node biopsy interpreted as SLL or consistent with CLL or all of the following: * Peripheral lymphocyte count greater than 5,000/mm\^3 with small to moderate peripheral lymphocytes and no more than 55% prolymphocytes * Bone marrow aspirate containing at least 30% lymphoid cells * Immunophenotypic evaluation of peripheral blood lymphocytes demonstrating monoclonality of B lymphocytes with all of the following: * CD19 or CD20 coexpressed with CD5 antigen in the absence of other pan-T- cell markers (e.g., CD2 or CD3) * Expression of CD23 on CLL cells or Dim B-cell expression of kappa or lambda light chains * Measurable disease with any of the following: * 1 or more lymph nodes at least 1.5 cm by CT scan * Splenomegaly by CT scan * Peripheral lymphocyte count greater than 5,000/mm3 with coexpression of CD5 and B-cell markers * Bone marrow aspirate with at least 30% lymphoid cells * No mantle cell lymphoma PATIENT CHARACTERISTICS: Age * 18 and over Performance status * ECOG 0-2 Life expectancy * At least 2 years Hematopoietic * See Disease Characteristics * No immune thrombocytopenia * No hemolytic anemia Hepatic * Bilirubin no greater than 3 times upper limit of normal (ULN) * SGOT no greater than 3 times ULN (unless due to hemolysis or CLL) * No hepatitis Renal * Creatinine no greater than 1.5 times ULN Cardiovascular * No cardiac dysfunction * No New York Heart Association class III or IV heart disease * No myocardial infarction within the past month Other * HIV negative * No active acute or chronic infection * No immunosuppressive diseases * No autoimmune disorder * No secondary malignancy that is projected to limit life expectancy * Not pregnant or nursing * Negative pregnancy test * Fertile patients must use effective contraception PRIOR CONCURRENT THERAPY: Biologic therapy * See Chemotherapy * No prior rituximab * At least 4 weeks since prior biologic therapy Chemotherapy * At least 4 weeks since prior chemotherapy * No prior combination chemotherapy and rituximab or other antibody therapy * No prior combination chemotherapy comprising an alkylating agent and a purine nucleoside analog (i.e., cyclophosphamide or chlorambucil in combination with fludarabine, cladribine, or pentostatin) * No prior pentostatin Endocrine therapy * At least 4 weeks since prior corticosteroids * No concurrent supra-physiologic doses of corticosteroids Radiotherapy * At least 4 weeks since prior radiotherapy Surgery * At least 4 weeks since prior major surgery Other * No concurrent immunosuppressive therapy (e.g., cyclosporine)

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

Sponsors & Collaborators

Study Sites (1)

Hoag Cancer Center at Hoag Memorial Hospital Presbyterian

Newport Beach, California, 92658, United States

Location

MeSH Terms

Conditions

LeukemiaLymphomaLeukemia, Lymphocytic, Chronic, B-Cell

Interventions

RituximabCyclophosphamidePentostatin

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Antibodies, Monoclonal, Murine-DerivedAntibodies, MonoclonalAntibodiesImmunoglobulinsImmunoproteinsBlood ProteinsProteinsAmino Acids, Peptides, and ProteinsSerum GlobulinsGlobulinsPhosphoramide MustardsNitrogen Mustard CompoundsMustard CompoundsHydrocarbons, HalogenatedHydrocarbonsOrganic ChemicalsPhosphoramidesOrganophosphorus CompoundsCoformycinFormycinsPyrimidine NucleosidesPyrimidinesHeterocyclic Compounds, 1-RingHeterocyclic CompoundsDeoxyribonucleosidesNucleosidesNucleic Acids, Nucleotides, and Nucleosides

Study Officials

  • Robert O. Dillman, MD, FACP

    Hoag Memorial Hospital Presbyterian

    STUDY CHAIR

Study Design

Study Type
interventional
Phase
phase 2
Masking
NONE
Purpose
TREATMENT
Sponsor Type
OTHER

Study Record Dates

First Submitted

November 12, 2002

First Posted

January 27, 2003

Study Start

June 1, 2002

Primary Completion

December 1, 2004

Study Completion

December 1, 2005

Last Updated

May 12, 2011

Record last verified: 2011-05

Locations

US(1)