Know Cancer

forgot password

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

Phase 2
18 Years
Open (Enrolling)
Diffuse Large B-Cell Lymphoma

Thank you

Trial Information

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

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,

- 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

- 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

- 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

- 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

Type of Study:


Study Design:

Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

Best Overall Response Rate (ORR) of bendamustine in combination with rituximab in patients with relapsed or refractory diffuse large B-cell lymphoma

Outcome Time Frame:

1 year for 1st assessment and then 2.5 years for final assessment

Safety Issue:


Principal Investigator

Jeffrey L Vacirca, MD, FACP

Investigator Role:

Principal Investigator

Investigator Affiliation:

University Hospital, Stony Brook North Shore Hematology/Oncology Associates


United States: Institutional Review Board

Study ID:




Start Date:

November 2008

Completion Date:

September 2013

Related Keywords:

  • Diffuse Large B-Cell Lymphoma
  • Lymphoma
  • B-Cell
  • Lymphoma
  • Lymphoma, B-Cell
  • Lymphoma, Large B-Cell, Diffuse



Pharmatech Oncology Study Site Beverly Hills, California  90211
Pharmatech Oncology Study Site Washington, District of Columbia  20037
Pharmatech Oncology Study Site Boynton Beach, Florida  33435
Pharmatech Oncology Study Site Joliet, Illinois  60435
Pharmatech Oncology Study Site Lafayette, Indiana  47904
Pharmatech Oncology Study Site Dubuque, Iowa  52001
Pharmatech Oncology Study Site Paducah, Kentucky  42001
Pharmatech Oncology Study Site York, Maine  03909
Pharmatech Oncology Study Site Jackson, Mississippi  39202
Pharmatech Oncology Study Site Chesterfield, Missouri  63017
Pharmatech Oncology Study Site Cherry Hill, New Jersey  08003
Pharmatech Oncology Study Site Bay Shore, New York  11706
Pharmatech Oncology Study Site Akron, Ohio  44304
Pharmatech Oncology Study Site Bethlehem, Pennsylvania  18015
Pharmatech Oncology Study Site Hilton Head, South Carolina  29926
Pharmatech Oncology Study Site Germantown, Tennessee  38138
Pharmatech Oncology Study Site Austin, Texas  78759