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A Dose Study of Doxil in a Dose Dense, 14 Day CDOP/Rituximab Regimen for Patients With Diffuse Large B-Cell Non-Hodgkin Lymphoma (NHL)> 60 Years or With Compromised Cardiac Status.

NCT ID: NCT00333008

Last Updated: 2006-09-26

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

PHASE2

Total Enrollment

27 participants

Study Classification

INTERVENTIONAL

Study Start Date

2006-05-31

Brief Summary

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The purpose of this study is to evaluate the feasibility and tolerability of delivering a full dose, on time schedule of dose-dense CDOP-R (cyclophosphamide, doxil, vincristine, prednisone, and rituximab) in NHL.

Detailed Description

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Diffuse large B-cell lymphoma (DLBCL) is the most frequent type of non-Hodgkin's lymphoma with more than half of the patients being over the age of 60 years. Elderly patients with cancer are defined by the American Society of Clinical Oncology as a "special population" due to their disease characteristics, additional health problems, and need for aggressive supportive care strategies to reduce morbidity and mortality. The combination of cyclophosphamide, doxorubicin, vincristine, and prednisone (CHOP) remains as standard therapy for the treatment of DLBCL, but elderly patients tend to tolerate the CHOP therapy less when compared to younger patients. Cardiac toxicity, as well as decrease in blood counts, are the most common side effects in the elderly population. For these reasons, many doctors are reluctant to use standard combinations and doses of chemotherapy in the elderly for fear of increased morbidity. DLBCL in the elderly is also somewhat unique in that the elderly patients appear to have more aggressive disease and poor overall outcome. In order to maximize the tolerability of treatment and thus potentially enhance overall treatment success in this population, it is necessary to look at alternative treatments. This clinical trial is based on currently accepted standard NHL therapy (CHOP-Rituximab) in which Doxil is substituted for Adriamycin. Growth factor will be used for support of acceptable blood counts. Chemotherapy regimens that include rituximab are now the gold standard for treatment of DLBCL. If indeed, delivering full dose chemotherapy without treatment delays leads to higher remission and cure rates, then this offers a significant proportion of NHL patients who are elderly a chance for cure rather than providing treatment for comfort measures while preserving quality of life.

Conditions

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Diffuse Large B Cell Lymphoma Lymphoma, Non-Hodgkin

Keywords

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Diffuse Large B Cell Lymphoma CDOP Dose Dense Anne Arbor Stage I-IV Any IPI score

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Interventions

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Doxil

Intervention Type DRUG

Cyclophosphamide

Intervention Type DRUG

Vincristine

Intervention Type DRUG

Prednisone

Intervention Type DRUG

Rituximab

Intervention Type DRUG

Pegfilgrastim

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

* 60 years old and older or 18 years old and older with significant/potential cardiac morbidity
* Diagnosis of diffuse large B cell lymphoma, Ann Arbor stage I-IV, any International Prognostic Index (IPI) score.
* Previously untreated
* New York Heart Association (NYHA) classification of Class III or better
* Baseline ejection fraction (EF) \> 25%
* Eastern Cooperative Oncology Group (ECOG) performance status (PS) 0-3
* Unless attributable to NHL: absolute neutrophil count (ANC) \> 1500/uL, platelets \> 100,000/uL; hemoglobin \> 9.0 g/dl
* Bilirubin \< 1.5 mg/dL (unless related to lymphoma)
* Hepatic: transaminases \< 2.5 x upper limit of normal (ULN) (unless related to lymphoma)
* Creatinine \< 2.5 mg/dl (unless related to lymphoma)

Exclusion Criteria

* No HIV+ individuals
* No primary central nervous system (CNS) lymphoma
* No pregnant or lactating women
* No serious active infection
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Ortho Biotech Products, L.P.

INDUSTRY

Sponsor Role collaborator

The Alvin and Lois Lapidus Cancer Institute

OTHER

Sponsor Role lead

Principal Investigators

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Stephen Noga, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

Sinai Hospital of Baltimore, The Alvin and Lois Lapidus Cancer Institute

Locations

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Sinai Hospital of Baltimore

Baltimore, Maryland, United States

Site Status RECRUITING

Northwest Hospital Center

Randallstown, Maryland, United States

Site Status RECRUITING

Countries

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United States

Central Contacts

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Pam Nickoles, RN, BSN

Role: CONTACT

Phone: 410-601-0729

Email: [email protected]

Judy Bosley, RN, BSN

Role: CONTACT

Phone: 410-601-4392

Email: [email protected]

Facility Contacts

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Pam Nickoles, RN, BSN

Role: primary

Judy Bosley, RN, BSN

Role: backup

Pam Nickoles, RN, BSN

Role: primary

Judy Bosley, RN, BSN

Role: backup

Other Identifiers

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LY-012006

Identifier Type: -

Identifier Source: org_study_id