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

This study is currently recruiting participants.
Verified May 2012 by UNC Lineberger Comprehensive Cancer Center

First Received on November 2, 2010.  
Last Updated on May 24, 2012  
History of Changes
This Clinical Trial Sponsored By: UNC Lineberger Comprehensive Cancer Center
Collaborator: Cephalon
Information provided by (Responsible Party): UNC Lineberger Comprehensive Cancer Center
ClinicalTrials.gov Identifier: NCT01234467
 

Purpose for Clinical Trial

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 Study Intervention Clinical Trial Phase
Diffuse Large B-Cell Lymphoma
Lymphoma, Diffuse Large-Cell
Diffuse Large-Cell Lymphoma
Lymphoma
Drug: Bendamustine
Drug: Rituximab
Phase 2

Study Type: Study Interventional
Study Design: Endpoint Classification: Safety/Efficacy Study
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

Resource links provided by NLM:

MedlinePlus related topics:
Cancer
Lymphoma
Drug Information available for:
Bendamustine hydrochloride
Bendamustine
Rituximab

U.S. FDA Resources

Further study details as provided by UNC Lineberger Comprehensive Cancer Center:

Primary Outcome Measures For Clinical Trial:

  • Complete response (CR) rate as defined by The International Harmonization Project for Response Criteria [ Time Frame: 2 years ] [ Designated as safety issue: No ]

Secondary Outcome Measures For Clinical Trial:

  • 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 Study 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:
  • TREANDA
  • BENDAMUSTINE HYDROCHLORIDE
  • (NDA) 022249

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:
  • Rituxan
  • (BLA) 103705

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
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 ot 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
  • Aspartate aminotransferase (AST) < 2.5 x upper l

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