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Bendamustine + Rituximab in Older Patients With Previously Untreated Diffuse Large B-cell Lymphoma

Information source: UNC Lineberger Comprehensive Cancer Center
ClinicalTrials.gov processed this data on August 23, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Diffuse Large B-Cell Lymphoma; Lymphoma, Diffuse Large-Cell; Diffuse Large-Cell Lymphoma; Lymphoma

Intervention: Bendamustine (Drug); Rituximab (Drug)

Phase: Phase 2

Status: Active, not recruiting

Sponsored by: UNC Lineberger Comprehensive Cancer Center

Official(s) and/or principal investigator(s):
Steven Park, MD, Principal Investigator, Affiliation: University of North Carolina, Chapel Hill

Summary

The purpose of this research study is to learn about the safety of the treatment with a combination of bendamustine and rituximab and to find out what effects, both good and bad this treatment has on DLBCL. In addition to learning about the combination of bendamustine and rituximab, the researchers are interested in learning about how this cancer treatment affects daily activities. Subjects will be asked to complete a Geriatric Assessment (GA). GAs are designed to gather information on memory, nutritional status, mental health, and level of social support. GAs are also designed to help the health care team understand how well subjects can carry out their day to day activities and to briefly describe what other medical conditions subjects may have. This assessment will help the health care team understand a subject's "functional age" (the age a subject functions at) as compared to a subject's actual age. The researchers also want to learn how chemotherapy affects the aging process in our bodies. This is done by measuring the amount of p16 in blood. Researchers want to understand if chemotherapy changes the levels of p16 in blood.

Clinical Details

Official title: A Phase II Trial of Bendamustine in Combination With Rituximab in Older Patients With Previously Untreated Diffuse Large B-cell Lymphoma

Study design: Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Primary outcome: Complete response (CR) rate as defined by The International Harmonization Project for Response Criteria

Secondary outcome:

Overall response rate (ORR, CR + PR)

Estimate the disease-free survival (DFS), progression-free and overall survival

Evaluate the toxicity and tolerability of bendamustine in combination with rituximab

Detailed description: This multicenter Phase II clinical study will investigate the complete response (CR) rate after therapy with bendamustine combined with rituximab in older (≥65 years old) patients with previously untreated stage II-IV DLBCL deemed poor candidates for cyclophosphamide, doxorubicin hydrochloride, vincristine (Oncovin®), prednisone, rituximab (CHOP-R); n=37. The hypothesis being tested is that this regimen will be safe and effective as frontline therapy in older DLBCL patients deemed poor candidates for CHOP-R. After 3 cycles of therapy, patients with less than a partial response (PR) will come off study, and be managed at the discretion of their treating physician. Patients who achieve a PR after 3 cycles will continue for a total of 8 cycles of therapy, while patients who achieve a CR will continue for a total of 6 cycles of therapy. Secondary objectives include overall response rates (ORR), disease-free, progression-free and overall survival, and an evaluation of the toxicity and tolerability of the regimen. This trial also includes an exploratory analysis designed to evaluate a potential correlation between expression of the senescence marker p16INK4a and the toxicity associated with this regimen. In addition, patients will be asked to participate in a Geriatric Assessment (GA) tool during the trial.

Eligibility

Minimum age: 65 Years. Maximum age: N/A. Gender(s): Both.

Criteria:

Inclusion Criteria:

- Patients with previously untreated , histologically confirmed, diffuse large

B-cell lymphoma (DLBCL), immunophenotyped for CD20

- Age greater than or equal to 65 years

- Stage II-IV

- Measurable disease including lesions that can be accurately measured in 2 dimensions

by CT and have a greatest transverse diameter of 1cm or greater, and/or by bone marrow histopathology.

- ECOG performance status of 0-3

- Deemed poor candidate for CHOP-R due to ejection fraction less than or equal to 45%,

ECOG performance status of 2, or in the opinion of the treating physician, patient would not tolerate administration of CHOP-R chemotherapy for other reasons,

- Life expectancy of at least 3 months;

- Documented negative serologic testing for HIV, Hepatitis B (unless positive due to

prior vaccination), and hepatitis C within the year prior to enrollment

- Adequate bone marrow function (without transfusion support within one week of

screening) function:

- Hemoglobin > 8 g/dL

- Absolute neutrophil count (ANC) >1000 cells/mm3

- Platelet count > 75,000/mm3

- Adequate hepatic and renal function as demonstrated by:

- Aspartate aminotransferase (AST) < 2. 5 x upper limit of normal (ULN)

- Total serum bilirubin < 2. 5 x ULN

- Serum creatinine < 1. 5 x ULN

- If sexually active male of reproductive capability, has agreed to use a medically

accepted form of contraception from time of enrollment to completion of all follow-up study visits

- Signed an institutional review board (IRB) approved informed consent document

Exclusion Criteria:

- Central nervous system involvement by lymphoma

- History of previous allergic reactions to compounds of similar biological or chemical

composition as rituximab or bendamustine

- Medical or other condition that would represent an inappropriate risk to the patient

or would likely compromise achievement of the primary study objective.

- Other active malignancies (except: non-melanoma skin cancer, cervical carcinoma in

situ without evidence of disease, prostatic intraepithelial neoplasia without evidence of prostate cancer)

- Patients on strong inhibitors of CYP1A2.

Locations and Contacts

Seby B. Jones Cancer Center, Boone, North Carolina 28607, United States

University of North Carolina at Chapel Hill, Chapel Hill, North Carolina 27599, United States

Northeast Medical Center, Concord, North Carolina 28025, United States

Moses Cone Regional Cancer Center, Greensboro, North Carolina 27403, United States

Leo Jenkins Cancer Center, East Carolina University Medical Center, Greenville, North Carolina 27834, United States

Rex Healthcare, Raleigh, North Carolina 27607, United States

Marion L. Shepard Cancer Center, Washington, North Carolina 27889, United States

Additional Information

Lineberger Comprehensive Cancer Center website

Starting date: November 2010
Last updated: December 2, 2013

Page last updated: August 23, 2015

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