Study to Evaluate the Efficacy and Safety of Treatment With Bendamustine in Combination With Ofatumumab in Previously Untreated Patients With Indolent B-Cell Non-Hodgkin's Lymphoma (NHL) - Full Text View

Sponsor:	Cephalon
Information provided by (Responsible Party):	Cephalon
ClinicalTrials.gov Identifier:	NCT01108341

Purpose

The primary objective of the study is to determine the efficacy, as measured by overall response (complete response + partial response) of bendamustine in combination with ofatumumab in previously untreated patients with indolent B-Cell Non-Hodgkin's Lymphoma (NHL).

Condition	Intervention	Phase
Non-Hodgkin's Lymphoma (NHL)	Drug: Bendamustine and Ofatumumab	Phase II

Study Type:	Interventional
Study Design:	Intervention Model: Single Group Assignment Masking: Open Label Primary Purpose: Treatment
Official Title:	An Open-Label Study to Evaluate the Efficacy and Safety of Treatment With Bendamustine in Combination With Ofatumumab in Previously Untreated Patients With Indolent B-Cell Non-Hodgkin's Lymphoma (NHL)

Resource links provided by NLM:

MedlinePlus related topics: Lymphoma

Drug Information available for: Bendamustine Ofatumumab Bendamustine hydrochloride

U.S. FDA Resources

Further study details as provided by Cephalon:

Primary Outcome Measures:

Proportion of patients with an Overall Response outcome of Complete Response (CR) or Partial Response (PR), as determined by the IWG criteria (Cheson et al 2007) during treatment. [ Time Frame: at Cycle 3 (Week 12), Cycle 6 (Week 24), and Cycle 8 / End of Treatment (up to Week 32) ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

A best-response outcome of Complete Response (CR) as determined by the IWG criteria (see Appendix A) [ Time Frame: at Cycle 3 (Week 12), Cycle 6 (Week 24), and Cycle 8 / End of Treatment (up to Week 32) ] [ Designated as safety issue: No ]

Enrollment:	50
Study Start Date:	June 2010
Study Completion Date:	October 2011
Primary Completion Date:	July 2011 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
Experimental: Bendamustine and Ofatumumab Bendamustine administered at 90 mg/m2 iv days 1 and 2. Ofatumumab administered at 300 mg iv on day 1 and 1000 mg iv on day 8 of cycle 1. Ofatumumab administered at 1000 mg iv on day 1 of all additional cycles.	Drug: Bendamustine and Ofatumumab Bendamustine will be administered at 90 mg/m2 as a 30-minute iv infusion on days 1 and 2 of each cycle. Ofatumumab will be administered at 300 mg as an iv infusion on day 1 and 1000 mg on day 8 of cycle 1 and 1000 mg on day 1 of each subsequent cycle.

Eligibility

Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

Key Inclusion Criteria:

The patient has histopathologic confirmation of one of the protocol-specific CD20+ B-cell non-Hodgkin's lymphomas. Tissue diagnostic procedures must be performed within 6 months of study entry and with biopsy material available for review.
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
hyperviscosity syndrome due to monoclonal gammopathy
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 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
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).
The patient has adequate hematologic and hepatic function.
The patient has Eastern Cooperative Oncology Group (ECOG) performance status 0, 1, or 2.
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, or from a 24-hour urine collection.
The patient is willing to comply with contraception requirements.

Key Exclusion Criteria:

The patient:

Has small lymphocytic lymphoma or mantle cell lymphoma.
Has documented history of central nervous system (CNS) lymphomatous involvement.
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 .
Has New York Heart Association (NYHC) Class III or IV heart failure, uncontrolled arrythmias or unstable angina, electrocardiographic evidence of active ischemia or active conduction system abnormalities, or myocardial infarction within the last 6 months.
Has known human immunodeficiency virus (HIV) infection.
Has acute or chronic hepatitis B or hepatitis C infection.
Is a pregnant or lactating woman. (Any women becoming pregnant during the study will be withdrawn from the study.)
Has any serious uncontrolled, medical or psychological disorder that would impair the ability of the subject to receive study drugs.
Has received another investigational agent within 30 days of study entry.
Has known hypersensitivity to mannitol.
Has Ann Arbor stage I disease.

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT01108341

Show 39 Study Locations

Sponsors and Collaborators

Cephalon

Investigators

Study Director:

Sponsor's Medical Expert

Cephalon

More Information

No publications provided

Responsible Party:	Cephalon
ClinicalTrials.gov Identifier:	NCT01108341 History of Changes
Other Study ID Numbers:	C18083/2048
Study First Received:	April 14, 2010
Last Updated:	December 21, 2011
Health Authority:	United States: Food and Drug Administration; Belgium: Federal Agency for Medicinal Products and Health Products; France: Afssaps - French Health Products Safety Agency; Israel: Israeli Health Ministry Pharmaceutical Administration; Poland: Office for Registration of Medicinal Products, Medical Devices and Biocidal Products

Additional relevant MeSH terms:

Lymphoma
Lymphoma, Non-Hodgkin
Lymphoma, B-Cell
Neoplasms by Histologic Type
Neoplasms
Lymphoproliferative Disorders
Lymphatic Diseases
Immunoproliferative Disorders
Immune System Diseases

Bendamustine
Nitrogen Mustard Compounds
Antineoplastic Agents
Therapeutic Uses
Pharmacologic Actions
Antineoplastic Agents, Alkylating
Alkylating Agents
Molecular Mechanisms of Pharmacological Action

ClinicalTrials.gov processed this record on February 09, 2012