NCT00026351

Brief Summary

RATIONALE: Drugs used in chemotherapy use different ways to stop cancer cells from dividing so they stop growing or die. Monoclonal antibodies such as rituximab 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 rituximab in treating patients who have non-Hodgkin's lymphoma or chronic lymphocytic leukemia.

Trial Health

87
On Track

Trial Health Score

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

Timeline
Completed

Started Dec 2000

Shorter than P25 for phase_2 leukemia

Geographic Reach
1 country

5 active sites

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

December 1, 2000

Completed
11 months until next milestone

First Submitted

Initial submission to the registry

November 9, 2001

Completed
1.6 years until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2003

Completed
24 days until next milestone

First Posted

Study publicly available on registry

June 25, 2003

Completed
Last Updated

February 4, 2013

Status Verified

July 1, 2002

First QC Date

November 9, 2001

Last Update Submit

February 1, 2013

Conditions

LeukemiaLymphoma

Keywords

stage I chronic lymphocytic leukemiastage II chronic lymphocytic leukemiastage III chronic lymphocytic leukemiastage IV chronic lymphocytic leukemiarefractory chronic lymphocytic leukemiaB-cell chronic lymphocytic leukemiastage I grade 1 follicular lymphomastage I grade 2 follicular lymphomastage I grade 3 follicular lymphomastage III grade 1 follicular lymphomastage III grade 2 follicular lymphomastage III grade 3 follicular lymphomastage IV grade 1 follicular lymphomastage IV grade 2 follicular lymphomastage IV grade 3 follicular lymphomarecurrent grade 1 follicular lymphomarecurrent grade 2 follicular lymphomarecurrent grade 3 follicular lymphomaprolymphocytic leukemiacontiguous stage II grade 1 follicular lymphomacontiguous stage II grade 2 follicular lymphomacontiguous stage II grade 3 follicular lymphomanoncontiguous stage II grade 1 follicular lymphomanoncontiguous stage II grade 2 follicular lymphomanoncontiguous stage II grade 3 follicular lymphomanoncontiguous stage II small lymphocytic lymphomanoncontiguous stage II marginal zone lymphomarecurrent marginal zone lymphomarecurrent small lymphocytic lymphomastage I marginal zone lymphomastage I small lymphocytic lymphomastage III small lymphocytic lymphomastage III marginal zone lymphomastage IV small lymphocytic lymphomastage IV marginal zone lymphomacontiguous stage II marginal zone lymphomacontiguous stage II small lymphocytic lymphomaextranodal marginal zone B-cell lymphoma of mucosa-associated lymphoid tissue

Interventions

rituximabBIOLOGICAL
pentostatinDRUG

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
DISEASE CHARACTERISTICS: * Histologically confirmed low-grade non-Hodgkin's lymphoma * REAL classification: * B-cell chronic lymphocytic leukemia * Prolymphocytic leukemia * Small lymphocytic lymphoma * Follicular center lymphoma (grade I, II, or III) * Extranodal marginal zone B-cell lymphoma Malt type * International Working Group classification: * Small lymphocytic/chronic lymphocytic leukemia (CLL) * CLL with lymph node involvement allowed * Small lymphocytic plasmacytoid * Follicular small cleaved cell * Follicular mixed small and large cell * Follicular predominantly large cell * Measurable disease * Lymph node more than 1 cm in longest transverse diameter NOTE: A new classification scheme for adult non-Hodgkin's lymphoma has been adopted by PDQ. The terminology of "indolent" or "aggressive" lymphoma will replace the former terminology of "low", "intermediate", or "high" grade lymphoma. However, this protocol uses the former terminology. PATIENT CHARACTERISTICS: Age: * 18 and over Performance status: * ECOG 0-2 Life expectancy: * More than 6 months Hematopoietic: * Absolute neutrophil count at least 1,000/mm\^3 * Platelet count at least 75,000/mm\^3 * Hemoglobin at least 9 g/dL Hepatic: * Bilirubin no greater than 2.0 mg/dL * AST no greater than 5 times upper limit of normal Renal: * Creatinine less than 2.0 mg/dL * BUN normal * Urinalysis normal Cardiovascular: * LVEF normal in patients with history of stable heart disease for at least 2 years Other: * HIV negative * No thyroid disease with thyroid function that cannot be maintained in the normal range * No other prior malignancy unless progression free for more than 5 years * Not pregnant or nursing * Negative pregnancy test * Fertile patients must use effective contraception PRIOR CONCURRENT THERAPY: Biologic therapy: * Prior rituximab, Y2B8, or iodine I 131 tositumomab allowed provided at least 6 months have elapsed and patient has had clear disease progression * No other concurrent immunotherapy Chemotherapy: * No more than 6 prior chemotherapy drugs * No more than 3 prior treatments with pentostatin * At least 3 weeks since prior chemotherapy * No prior cumulative lifetime dose of more than 480 mg/m2 of doxorubicin or an equivalent dose of any anthracycline * No other concurrent chemotherapy Endocrine therapy: * Not specified Radiotherapy: * No concurrent radiotherapy to an indicator lesion Surgery: * Not specified Other: * No other concurrent investigational drug

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

Sponsors & Collaborators

Study Sites (5)

Cancer and Blood Institute of the Desert

Rancho Mirage, California, 92270, United States

Location

Redding Medical Center

Redding, California, 96001, United States

Location

Oncology-Hematology Associates, P.A.

Clinton, Maryland, 20735, United States

Location

North Shore Hematology/Oncology Associates, P.C.

East Setauket, New York, 11733, United States

Location

Hematology Oncology Associates of Central New York, P.C.

Syracuse, New York, 13210, United States

Location

MeSH Terms

Conditions

LeukemiaLymphomaLeukemia, Lymphocytic, Chronic, B-CellLymphoma, FollicularLeukemia, ProlymphocyticLymphoma, B-Cell, Marginal Zone

Interventions

RituximabPentostatin

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 SymptomsLymphoma, Non-HodgkinLymphoma, B-Cell

Intervention Hierarchy (Ancestors)

Antibodies, Monoclonal, Murine-DerivedAntibodies, MonoclonalAntibodiesImmunoglobulinsImmunoproteinsBlood ProteinsProteinsAmino Acids, Peptides, and ProteinsSerum GlobulinsGlobulinsCoformycinFormycinsPyrimidine NucleosidesPyrimidinesHeterocyclic Compounds, 1-RingHeterocyclic CompoundsDeoxyribonucleosidesNucleosidesNucleic Acids, Nucleotides, and Nucleosides

Study Officials

  • Judy Poehlman

    Pharmatech Oncology

    STUDY CHAIR

Study Design

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

Study Record Dates

First Submitted

November 9, 2001

First Posted

June 25, 2003

Study Start

December 1, 2000

Study Completion

June 1, 2003

Last Updated

February 4, 2013

Record last verified: 2002-07

Locations

US(5)