NCT00062296

Brief Summary

RATIONALE: Drugs used in chemotherapy such as epirubicin 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 epirubicin with rituximab may kill more cancer cells. PURPOSE: Phase II trial to study the effectiveness of combining epirubicin with rituximab in treating patients who have relapsed or refractory B-cell 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

Enrollment
5

participants targeted

Target at below P25 for phase_2 leukemia

Timeline
Completed

Started Mar 2003

Shorter than P25 for phase_2 leukemia

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

March 1, 2003

Completed
3 months until next milestone

First Submitted

Initial submission to the registry

June 5, 2003

Completed
1 day until next milestone

First Posted

Study publicly available on registry

June 6, 2003

Completed
2.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2005

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2005

Completed
Last Updated

July 11, 2013

Status Verified

July 1, 2013

Enrollment Period

2.4 years

First QC Date

June 5, 2003

Last Update Submit

July 10, 2013

Conditions

LeukemiaLymphoma

Keywords

B-cell chronic lymphocytic leukemiarefractory chronic lymphocytic leukemiarecurrent adult diffuse large cell lymphomarecurrent adult diffuse mixed cell lymphomarecurrent adult diffuse small cleaved cell lymphomarecurrent adult Burkitt lymphomarecurrent adult immunoblastic large cell lymphomarecurrent grade 1 follicular lymphomarecurrent grade 2 follicular lymphomarecurrent grade 3 follicular lymphomarecurrent mantle cell lymphomarecurrent adult lymphoblastic lymphomarecurrent marginal zone lymphomarecurrent small lymphocytic lymphomaextranodal marginal zone B-cell lymphoma of mucosa-associated lymphoid tissuenodal marginal zone B-cell lymphomasplenic marginal zone lymphoma

Interventions

rituximabBIOLOGICAL
epirubicin hydrochlorideDRUG

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
DISEASE CHARACTERISTICS: * Histologically confirmed B-cell non-Hodgkin's lymphoma (any grade) or chronic lymphocytic leukemia meeting 1 of the following criteria: * Primary refractory disease * Disease progression after at least 1 but no more than 4 prior cytotoxic chemotherapy regimens * Rituximab administered alone is not considered 1 prior regimen * High-dose chemotherapy with stem cell support is considered 1 prior regimen * Bidimensionally measurable or evaluable disease outside prior irradiation port * No clinical evidence of CNS involvement PATIENT CHARACTERISTICS: Age * 18 and over Performance status * ECOG 0-2 Life expectancy * Not specified Hematopoietic * Neutrophil count at least 2,000/mm\^3\* * Platelet count at least 100,000/mm\^3\* NOTE: \*Unless due to bone marrow involvement Hepatic * Bilirubin no greater than 1.5 mg/dL * SGOT and SGPT no greater than 2 times upper limit of normal (ULN) Renal * Creatinine no greater than 2 times ULN Cardiovascular * No unstable angina * No uncontrolled congestive heart failure * LVEF at least 45% Other * Not pregnant or nursing * Negative pregnancy test * Fertile patients must use effective contraception during and for 6 months after study treatment * HIV negative * No other concurrent primary malignancy except basal cell or squamous cell skin cancer, carcinoma in situ, or localized solid tumors cured more than 5 years ago * No acute infection requiring systemic therapy * No confusion, disorientation, or major psychiatric illness that would preclude understanding of informed consent PRIOR CONCURRENT THERAPY: Biologic therapy * See Disease Characteristics * At least 4 weeks since prior biologic therapy Chemotherapy * See Disease Characteristics * At least 4 weeks since prior chemotherapy (6 weeks for nitrosoureas) * Prior cumulative doxorubicin dose no greater than 6 courses at 50 mg/m\^2 Endocrine therapy * Not specified Radiotherapy * See Disease Characteristics * No prior radiotherapy to the entire pelvis * At least 4 weeks since prior radiotherapy Surgery * Not specified Other * More than 7 days since prior cimetidine * No concurrent cimetidine

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

Sponsors & Collaborators

Study Sites (1)

Fox Chase Cancer Center

Philadelphia, Pennsylvania, 19111, United States

Location

MeSH Terms

Conditions

LeukemiaLymphomaLeukemia, Lymphocytic, Chronic, B-CellLymphoma, Large B-Cell, DiffuseLymphoma, Non-HodgkinBurkitt LymphomaLymphoma, Large-Cell, ImmunoblasticLymphoma, FollicularLymphoma, Mantle-CellPrecursor Cell Lymphoblastic Leukemia-LymphomaLymphoma, B-Cell, Marginal Zone

Interventions

RituximabEpirubicin

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, B-CellEpstein-Barr Virus InfectionsHerpesviridae InfectionsDNA Virus InfectionsVirus DiseasesInfectionsTumor Virus Infections

Intervention Hierarchy (Ancestors)

Antibodies, Monoclonal, Murine-DerivedAntibodies, MonoclonalAntibodiesImmunoglobulinsImmunoproteinsBlood ProteinsProteinsAmino Acids, Peptides, and ProteinsSerum GlobulinsGlobulinsDoxorubicinDaunorubicinAnthracyclinesNaphthacenesPolycyclic Aromatic HydrocarbonsHydrocarbons, AromaticHydrocarbons, CyclicHydrocarbonsOrganic ChemicalsPolycyclic CompoundsAminoglycosidesGlycosidesCarbohydrates

Study Officials

  • Mitchell R. Smith, MD, PhD

    Fox Chase Cancer Center

    STUDY CHAIR

Study Design

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

Study Record Dates

First Submitted

June 5, 2003

First Posted

June 6, 2003

Study Start

March 1, 2003

Primary Completion

August 1, 2005

Study Completion

August 1, 2005

Last Updated

July 11, 2013

Record last verified: 2013-07

Locations

US(1)