Non-Hodgkin’s Lymphoma MedDRA version: 13.1 Level: PT Classification code 10029547 Term: Non-Hodgkin's lymphoma System Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Conditions
Interventions
Product Name: Bendamustine hydrochloride
Product Code: CEP-18083
Pharmaceutical Form: Powder for infusion
INN or Proposed INN: Bendamustine hydrochloride
CAS Number: 3543-75-7
Current Sponsor code: CE
Sponsors
Cephalon, Inc.
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: Patients are included in the study if all of the following criteria are met: (a) The patient has histopathologic confirmation of 1 of the following CD20+ B-cell non-Hodgkin’s lymphomas (WHO/Revised European American Classification of Lymphoid Neoplasms [REAL] classifications described below [see Appendix F]). Tissue diagnostic procedures must be performed within 6 months of study entry and with biopsy material available for review: ? follicular lymphoma (grade 1 to 3a) (see Appendix G) ? immunoplasmacytoma/immunocytoma/lymphoplasmacytic lymphoma (Waldenstrom’s macroglobulinemia) ? splenic marginal zone B-cell lymphoma ? extra-nodal marginal zone lymphoma of mucosa associated lymphoid tumor (MALT) type ? nodal marginal zone B-cell lymphoma (b) The patient meets 1 of the following need-for–treatment criteria: ? presence of at least 1 of the following B-symptoms: • fever (>38ºC) of unclear etiology • night sweats • weight loss of greater than 10% within the prior 6 months ? large tumor mass (bulky disease) characterized by lymphomas with a diameter of more than 3 cm in 3 or more regions or by a lymphoma with a diameter of more than 7 cm in 1 region ? presence of lymphoma-related complications, including narrowing of ureters or bile ducts, tumor-related compression of a vital organ, lymphoma induced pain, cytopenias related to lymphoma/leukemia, splenomegaly, pleural effusions, or ascites ? hyperviscosity syndrome due to monoclonal gammopathy (c) The patient’s tumor is verified to be CD20+ positive from current or previous excisional or incisional tissue diagnostic procedures performed within 6 months of study entry. The excisional or incisional tissue diagnostic procedure has to be redone if there is clinical suspicion that the indolent lymphoma has transformed to aggressive lymphoma or a higher malignancy grade. (d) The screening phase CT scan (based on local evaluation) shows: ? 2 or more clearly demarcated lesions with a largest diameter =1.5 cm, or ? 1 clearly demarcated lesion with a largest diameter =2.0 cm (e) Inclusion criterion (e) is replaced by (e1). (e1) The patient was not previously treated for indolent lymphoma (with the exception of a single course of local radiation therapy not exceeding 2 adjacent lymph node regions). (f) The patient has adequate hematologic function (unless abnormalities are related to lymphoma infiltration of the bone marrow or hypersplenism due to lymphoma) as evidenced by the following: ? hemoglobin of 9.0 g/dl or greater without a growth factor ? absolute neutrophil count (ANC) of 1.5 x 109/L or greater without a growth factor ? platelet count of 75 x 109/L or greater independent of a platelet transfusion (g) The patient has the ability to provide written and dated informed consent. (h) The patient is 18 years of age or older at the time of informed consent. (i) The patient has ECOG performance status 0, 1, or 2. (j) The patient has serum creatinine of 2.0 mg/dL or less or creatinine clearance of 30 mL/min or more based on the Cockcroft-Gault method (see Appendix H) or from a 24-hour urine collection. (k) The patient has adequate hepatic function as evidenced by total bilirubin 1.5 times the ULN or less, unless secondary to Gilbert’s disease, and ALT and AST 2.5 times the ULN or less. (l) Women of childbearing potential (not surgically sterile or at least 12 months naturally postmenopausal) must use a medically accepted method of contraception and must agree to continue use of this method for the du
Exclusion criteria
Exclusion criteria: Patients are excluded from participating in this study if 1 or more of the following criteria are met: (a) Exclusion criterion (a) is replaced by (a1). (a1) The patient has small lymphocytic lymphoma or mantle cell lymphoma. (b) Exclusion criterion (b) is deleted. (c) The patient has documented history of central nervous system (CNS) lymphomatous involvement. (d) The patient has or has had an active malignancy, other than NHL, within the past 3 years except for localized prostate cancer without evidence of bone metastases,bladder, cervical, or breast carcinoma in-situ, or non-melanoma skin cancer (e) The patient has New York Heart Association (NYHC) Class III or IV heart failure, uncontrolled arrhythmias or unstable angina, electrocardiographic evidence of active ischemia or active conduction system abnormalities, or myocardial infarction within the last 6 months. (f) The patient has known human immunodeficiency virus (HIV) infection (g) Exclusion criterion (g) is replaced by (g1). (g1) The patient has acute or chronic hepatitis B or hepatitis C infection. (h) The patient is a pregnant or lactating woman. (Any women becoming pregnant during the study will be withdrawn from the study.) (i) The patient has any serious uncontrolled, medical or psychological disorder that would impair the ability of the subject to receive study drugs. (j) The patient has any condition which places the patient at unacceptable risk or confounds the ability of the investigators to interpret study data. (k) The patient has received other investigational agent within 30 days of study entry. (l) The patient has known hypersensitivity to mannitol. (m) The patient has Ann Arbor stage I disease.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Secondary Objective: The secondary objectives of the study are as follows: • to determine the CR rate of bendamustine in combination with ofatumumab in previously untreated patients with indolent B-Cell NHL • to assess the safety and tolerability of bendamustine in combination with ofatumumab in previously untreated patients with indolent B-Cell NHL by assessing the following: occurrence of adverse events throughout the study ? serum chemistry test results at the beginning of each cycle ? hematology test results on days 1 and 15 of each cycle (and on days 8 and 22 of cycle 1) ? vital signs measurements at each visit ? physical examination findings at the beginning of each cycle ? body weight measurements at day 1 of each cycle ? Eastern Cooperative Oncology Group (ECOG) performance status at the beginning of each cycle ? concomitant medication usage throughout the study;Primary end point(s): The primary efficacy measure is the proportion of patients with the outcome of complete response or partial response (overall response) determined by the IWG criteria during treatment.;Timepoint(s) of evaluation of this end point: Each 3th cycle;Main Objective: The primary objective of the study is to determine the efficacy, as measured by overall response (complete response [CR] + partial response [PR]), of bendamustine in combination with ofatumumab in previously untreated patients with indolent B-Cell Non-Hodgkin’s Lymphoma (NHL). | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): not applicable;Timepoint(s) of evaluation of this end point: not applicable | — |
Countries
Belgium, United States
Contacts
Public ContactNathalie Thomas-Pujol
Cephalon France
Outcome results
None listed