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
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