Bendamustine + Rituximab in Older Patients With Previously Untreated Diffuse Large B-cell Lymphoma
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Purpose
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.
| Condition | Intervention | Phase |
|---|---|---|
|
Diffuse Large B-Cell Lymphoma Lymphoma, Diffuse Large-Cell Diffuse Large-Cell Lymphoma Lymphoma |
Drug: Bendamustine Drug: Rituximab |
Phase 2 |
| Study Type: | Interventional |
| Study Design: | Endpoint Classification: Safety/Efficacy Study Intervention Model: Single Group Assignment Masking: Open Label Primary Purpose: Treatment |
| Official Title: | A Phase II Trial of Bendamustine in Combination With Rituximab in Older Patients With Previously Untreated Diffuse Large B-cell Lymphoma |
- Complete response (CR) rate as defined by The International Harmonization Project for Response Criteria [ Time Frame: 2 years ] [ Designated as safety issue: No ]
- Overall response rate (ORR, CR + PR) [ Time Frame: 2 years ] [ Designated as safety issue: No ]The CR and ORR rates will be estimated and 95% confidence interval computed
- Estimate the disease-free survival (DFS), progression-free and overall survival [ Time Frame: 3 years ] [ Designated as safety issue: No ]Progression-free survival will be summarized using the Kaplan-Meier method.
- Evaluate the toxicity and tolerability of bendamustine in combination with rituximab [ Time Frame: 3 years ] [ Designated as safety issue: Yes ]
| Estimated Enrollment: | 37 |
| Study Start Date: | November 2010 |
| Estimated Study Completion Date: | November 2016 |
| Estimated Primary Completion Date: | November 2015 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
| Experimental: Bendamustine, Rituximab |
Drug: Bendamustine
Dosage Form: Intravenous (60 minute infusion) Dosage: 120mg/m2 (ECOG = 0-2) or 90mg/m2 (ECOG = 3) Frequency: Day 1 and Day 2; Every 3 weeks of a 21 day cycle. Duration: 3-6 Cycles
Other Names:
Drug: Rituximab
Dosage form: Intravenous Dosage: 375 mg/m2 Frequency: Day 1 of every 3 weeks of a 21 day Cycle Duration: 3-6 Cycles
Other Names:
|
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| Ages Eligible for Study: | 65 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
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.
Contacts and Locations| Contact: Maureen Tynan, RN | (919) 843-7039 | maureen_tynan@med.unc.edu |
| Contact: Diane Winans | (919) 843-2742 | diane_winans@med.unc.edu |
| United States, North Carolina | |
| Seby B. Jones Cancer Center | Recruiting |
| Boone, North Carolina, United States, 28607 | |
| Principal Investigator: Anna Sobel, MD | |
| University of North Carolina at Chapel Hill | Recruiting |
| Chapel Hill, North Carolina, United States, 27599 | |
| Contact: Ranju Singh, RN, BSN 919-843-7146 ranju_singh@med.unc.edu | |
| Principal Investigator: Steven Park, MD | |
| Northeast Medical Center | Recruiting |
| Concord, North Carolina, United States, 28025 | |
| Principal Investigator: James Wall, MD | |
| Moses Cone Regional Cancer Center | Recruiting |
| Greensboro, North Carolina, United States, 27403 | |
| Principal Investigator: James Granfortuna, MD | |
| Leo Jenkins Cancer Center, East Carolina University Medical Center | Recruiting |
| Greenville, North Carolina, United States, 27834 | |
| Principal Investigator: Adam Asch, MD | |
| Rex Healthcare | Recruiting |
| Raleigh, North Carolina, United States, 27607 | |
| Principal Investigator: Oludamilola Olajide, MD | |
| Marion L. Shepard Cancer Center | Recruiting |
| Washington, North Carolina, United States, 27889 | |
| Principal Investigator: John Inzerillo, MD | |
| Principal Investigator: | Steven Park, MD | University of North Carolina, Chapel Hill |
More Information
Additional Information:
No publications provided
| Responsible Party: | UNC Lineberger Comprehensive Cancer Center |
| ClinicalTrials.gov Identifier: | NCT01234467 History of Changes |
| Other Study ID Numbers: | LCCC 1011, 10-1405 |
| Study First Received: | November 2, 2010 |
| Last Updated: | February 15, 2013 |
| Health Authority: | United States: Institutional Review Board |
Keywords provided by UNC Lineberger Comprehensive Cancer Center:
|
Diffuse Large B-Cell Lymphoma Elderly Newly Diagnosed Lineberger Comprehensive Cancer Center University of North Carolina Bendamustine |
Rituximab Rituxan Treanda Phase 2 Geriatric Lymphoma |
Additional relevant MeSH terms:
|
Lymphoma Lymphoma, Non-Hodgkin Lymphoma, B-Cell Lymphoma, Large B-Cell, Diffuse Neoplasms by Histologic Type Neoplasms Lymphoproliferative Disorders Lymphatic Diseases Immunoproliferative Disorders Immune System Diseases Bendamustine |
Rituximab Nitrogen Mustard Compounds Antineoplastic Agents Therapeutic Uses Pharmacologic Actions Antineoplastic Agents, Alkylating Alkylating Agents Molecular Mechanisms of Pharmacological Action Immunologic Factors Physiological Effects of Drugs Antirheumatic Agents |
ClinicalTrials.gov processed this record on May 16, 2013