Bendamustine Combined With Rituximab for Patients With Relapsed or Refractory Diffuse Large B-Cell Lymphoma

• Register: ClinicalTrials.gov
• Last refreshed on: 2 May 2016
• Main ID: NCT00831597
• Date of registration: 26/01/2009
• Prospective Registration: No
• Primary sponsor: Pharmatech
• Public title: Bendamustine Combined With Rituximab for Patients With Relapsed or Refractory Diffuse Large B-Cell Lymphoma 904
• Scientific title: Bendamustine Combined With Rituximab for Patients With Relapsed or Refractory Diffuse Large B-Cell Lymphoma
• Date of first enrolment: November 2008
• Target sample size: 61
• Recruitment status: Completed
• URL: https://clinicaltrials.gov/show/NCT00831597
• Study type: Interventional
• Study design: Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
• Phase: Phase 2

Countries of recruitment

United States

Contacts

• Name: Jeffrey L Vacirca, MD, FACP
• Affiliation: University Hospital, Stony Brook North Shore Hematology/Oncology Associates

Key inclusion & exclusion criteria

Inclusion Criteria:

- 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

- Laboratory parameters:

- 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

Exclusion Criteria:

- 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



Age minimum: 18 Years
Age maximum: N/A
Gender: Both

Health Condition(s) or Problem(s) studied

Diffuse Large B-Cell Lymphoma

Intervention(s)

Drug: rituximab

Drug: bendamustine

Primary Outcome(s)

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]

Secondary Outcome(s)

Progression-Free Survival (PFS) [Time Frame: 1 year for 1st assessment and then 2.5 years for final assessment]

Safety Profile of Study Treatment [Time Frame: 1 year for 1st assessment and then 2.5 years for final assessment]

Duration of Response (DOR) [Time Frame: 1 year for 1st assessment and then 2.5 years for final assessment]

Time to Progression (TTP) [Time Frame: 1 year for 1st assessment and then 2.5 years for final assessment]

Overall Survival (OS) [Time Frame: 1 year for 1st assessment and then 2.5 years for final assessment]

Secondary ID(s)

PI-08904

IND Exemption Number 103985

Source(s) of Monetary Support

Please refer to primary and secondary sponsors

Secondary Sponsor(s)

Cephalon