Bendamustine Combined With Rituximab for Patients With Relapsed or Refractory Diffuse Large B-Cell Lymphoma (904)
The recruitment status of this study is unknown because the information has not been verified recently.
Verified May 2012 by Pharmatech.
Recruitment status was Active, not recruiting
Information provided by (Responsible Party):
First received: January 26, 2009
Last updated: May 9, 2012
Last verified: May 2012
A phase II trial to evaluate the efficacy and safety of combination bendamustine and rituximab in patients with relapsed or refractory diffuse large B-cell lymphoma. It is hypothesized that the BR combination will produce at least a 70% overall response rate.
Diffuse Large B-Cell Lymphoma
||Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
||Bendamustine Combined With Rituximab for Patients With Relapsed or Refractory Diffuse Large B-Cell Lymphoma
Primary Outcome Measures:
- Best Overall Response Rate (ORR) of bendamustine in combination with rituximab in patients with relapsed or refractory diffuse large B-cell lymphoma [ Time Frame: 1 year for 1st assessment and then 2.5 years for final assessment ] [ Designated as safety issue: No ]
Secondary Outcome Measures:
- Duration of Response (DOR) [ Time Frame: 1 year for 1st assessment and then 2.5 years for final assessment ] [ Designated as safety issue: No ]
- Time to Progression (TTP) [ Time Frame: 1 year for 1st assessment and then 2.5 years for final assessment ] [ Designated as safety issue: No ]
- Progression-Free Survival (PFS) [ Time Frame: 1 year for 1st assessment and then 2.5 years for final assessment ] [ Designated as safety issue: No ]
- Safety Profile of Study Treatment [ Time Frame: 1 year for 1st assessment and then 2.5 years for final assessment ] [ Designated as safety issue: Yes ]
- Overall Survival (OS) [ Time Frame: 1 year for 1st assessment and then 2.5 years for final assessment ] [ Designated as safety issue: No ]
| Study Start Date:
| Estimated Study Completion Date:
| Estimated Primary Completion Date:
||August 2013 (Final data collection date for primary outcome measure)
120 mg/m2 IV, Days 1, 2 of Cycles 1-6
Other Name: Treanda
375 mg/m2 IV, Day 1 of Cycles 1-6
Other Name: Rituxan
|Ages Eligible for Study:
||18 Years and older
|Genders Eligible for Study:
|Accepts Healthy Volunteers:
- Histologically confirmed CD20-positive, diffuse large B-cell lymphoma
- Measurable disease with at least one bidimensional lymph node or tumor mass > 1.5 cm in the longest diameter that can be followed for response as a target lesion as measured by PET or CT
- Relapsed or refractory after at least one prior therapeutic treatment for diffuse large B-cell lymphoma. Relapsed is defined as patients who initially responded and then progressed. Refractory is defined as patients, whom in the judgment of the Investigator, received adequate prior treatment and did not respond during treatment or progressed within 60 days of last treatment. Relapse following an autologous stem cell transplant allowed.
- Eastern Cooperative Oncology Group (ECOG) Performance Status (PS) 0-2
- Patient must understand and voluntarily sign IRB-approved informed consent
- Life expectancy ≥ three (3) months
- Age ≥ 18 years old
- Absolute neutrophil count ≥ 1,000 cells/mm(3)
- Platelet count ≥ 75,000 cells/mm(3)
- Hemoglobin ≥ 8 g/dL
- Creatinine ≤ 2.0 mg/dL or Creatinine Clearance ≥ 50 mL/min (calculated or 24-hr urine sample)
- AST/SGOT 2.0 x ULN (≤ 5.0 x ULN if secondary to liver metastases)
- ALT/SGPT 2.0 x ULN (≤ 5.0 x ULN if secondary to liver metastases)
- Total bilirubin ≤ 2.0 x ULN
- Patients with active/symptomatic central nervous system (CNS) involvement based on clinical evaluation. Previously treated CNS involvement that has remained asymptomatic for ≥ 90 days allowed if no CNS involvement shown by lumbar puncture, PET, CT or MRI.
- Prior treatment with bendamustine
- Known sensitivity to bendamustine or any component of bendamustine
- Known anaphylaxis or immunoglobulin E (IgE) mediated hypersensitivity to murine proteins or sensitivity to rituximab or any component of rituximab
- Eligible for stem cell transplant (patients who refuse procedure will not be excluded)
- Prior allogeneic stem cell transplant within 6 months of Cycle 1, Day 1
- Major surgery, not related to debulking procedures, within 21 days of Cycle 1, Day 1. Patients undergoing debulking procedures and minor surgery are allowed after a recovery period, in the judgment of the Investigator.
- Chemotherapy, immunotherapy, or irradiation within 28 days of Cycle 1, Day 1 (within 6 weeks for nitrosoureas or mitomycin). Patients on high dose corticosteroids must have tapered to a stable dose equivalent to Prednisone ≤ 15 mg per day within 28 days of Cycle 1, Day 1.
- Prior radioimmunotherapy (i.e. Zevalin®) within 10 weeks of Cycle 1, Day 1
- Prior use of investigational anti-cancer agents within 28 days of Cycle 1, Day 1
- Unresolved toxicities ≥ grade 2 from previous therapy
- Pregnant or lactating females. Females of childbearing potential (FCBP) and non-vasectomized men must agree to use effective methods of birth control during and 28 days following treatment period. FCBP must have a negative pregnancy test.
- HIV-related lymphoma
- Known active HIV or HCV infection, or known seropositivity for HIV, or current or chronic HBV or HCV infection. HBV test required at screening or within 6 months of screening and must indicate negative result. Patients with seropositivity presumed to be due to prior vaccination against Hepatitis B or resolved infection are not excluded (see HBV reactivation guidelines included in rituximab prescribing information).
- Concurrent active or history of other malignancies, except nonmelanoma skin cancer or carcinoma in situ of cervix or breast. Patients with previous malignancies are eligible provided they have been disease free for ≥ 1 year.
- Serious (grade 3-4), active, intercurrent infection requiring therapy, or deep seated or systemic mycotic infections
- Myocardial infarction within 6 months prior to registration or New York Hospital Association (NYHA) Class III or IV heart failure, uncontrolled angina, severe uncontrolled ventricular arrhythmias, or electrocardiographic evidence of acute ischemia or significant conduction system abnormalities, in the judgment of the Investigator
- Thyroid disease in which thyroid function cannot be maintained within normal range, in the judgment of the Investigator
- Concurrent uncontrolled serious medical or psychiatric conditions likely to interfere with participation in this clinical study, in the judgment of the Investigator
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Please refer to this study by its ClinicalTrials.gov identifier: NCT00831597
||Jeffrey L Vacirca, MD, FACP
||University Hospital, Stony Brook North Shore Hematology/Oncology Associates
No publications provided
History of Changes
|Other Study ID Numbers:
||PI-08904, IND Exemption Number 103985
|Study First Received:
||January 26, 2009
||May 9, 2012
||United States: Institutional Review Board
Keywords provided by Pharmatech:
Additional relevant MeSH terms:
ClinicalTrials.gov processed this record on October 19, 2014
Lymphoma, Large B-Cell, Diffuse
Neoplasms by Histologic Type
Immune System Diseases
Physiological Effects of Drugs
Antineoplastic Agents, Alkylating
Molecular Mechanisms of Pharmacological Action