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An Open-Label Expanded Access Trial for Bendamustine HCl in Patients With Indolent Non-Hodgkin's Lymphoma That Has Progressed During or Following Treatment With a Rituximab Regimen or Previously Untreated Chronic Lymphocytic Leukemia


Phase 3
18 Years
N/A
Not Enrolling
Both
Indolent Non-Hodgkin's Lymphoma, Chronic Lymphocytic Leukemia

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Trial Information

An Open-Label Expanded Access Trial for Bendamustine HCl in Patients With Indolent Non-Hodgkin's Lymphoma That Has Progressed During or Following Treatment With a Rituximab Regimen or Previously Untreated Chronic Lymphocytic Leukemia

Inclusion Criteria


Inclusion Criteria for iNHL:

- The patient has biopsy-confirmed diagnosis of indolent B-cell NHL documented as
relapsed or refractory iNHL (following rituximab-based therapy).

- The patient has one of the following types of indolent B-cell lymphoma:

- follicular lymphoma grade 1, 2, or 3A

- marginal zone lymphoma

- lymphoplasmacytic lymphoma

- small lymphocytic lymphoma

- The patient has adequate haematologic function (unless abnormalities are related to
lymphoma involvement of the bone marrow or hypersplenism caused by lymphoma).

Inclusion Criteria for CLL:

- The patient has previously confirmed (according to WHO criteria) untreated
symptomatic chronic B-cell lymphocytic leukemia Binet Stage B or Binet Stage C or Rai
stage II to IV in need of medical treatment.

- The patient has an Eastern Cooperative Oncology Group (ECOG) performance status of
0-2.

Exclusion Criteria:

- The patient has participated in a clinical study <30 days prior to the Screening
Visit.

- The patient has one or more of the following conditions:

- active transformed lymphoma

- any history of central nervous system or leptomeningeal lymphoma

- an active malignancy other than the target cancer within the past 5 years

- human immunodeficiency virus

- The patient is, in the investigator's opinion, unlikely to comply with the protocol
or is unsuitable for any reason.

Other inclusion and exclusion criteria may apply.

Type of Study:

Interventional

Study Design:

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

Outcome Measure:

Number of adverse events in patients in Canada with iNHL that has progressed during or following treatment with a rituximab regimen

Outcome Time Frame:

Up to 266 days

Safety Issue:

Yes

Principal Investigator

Email contact via H. Lundbeck A/S

Investigator Role:

Study Director

Investigator Affiliation:

LundbeckClinicalTrials@lundbeck.com

Authority:

Canada: Health Canada

Study ID:

14293A

NCT ID:

NCT01500083

Start Date:

March 2012

Completion Date:

Related Keywords:

  • Indolent Non-Hodgkin's Lymphoma
  • Chronic Lymphocytic Leukemia
  • iNHL
  • CLL
  • Leukemia
  • Leukemia, Lymphocytic, Chronic, B-Cell
  • Leukemia, Lymphoid
  • Lymphoma
  • Lymphoma, Non-Hodgkin

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