Know Cancer

or
forgot password

A Phase II, Multicenter, Randomized, Controlled, Open-Label Study of Bendamustine + Rituximab With or Without Navitoclax in Patients With Relapsed Diffuse Large B-Cell Lymphoma


Phase 2
18 Years
N/A
Not Enrolling
Both
Lymphoma, B-Cell

Thank you

Trial Information

A Phase II, Multicenter, Randomized, Controlled, Open-Label Study of Bendamustine + Rituximab With or Without Navitoclax in Patients With Relapsed Diffuse Large B-Cell Lymphoma


Inclusion Criteria:



- Histologically documented diagnosis of diffuse large B-cell lymphoma

- Patients must have relapsed or developed progressive disease following salvage
therapy, or must have relapsed or progressed following initial therapy and in the
opinion of the investigator are medically unfit to receive high dose chemotherapy
with autologous stem cell transplant (SCT) or other salvage therapy of higher
priority

- Eastern cooperative Oncology Group (ECOG) performance status 0, 1 or 2

- Patients who have undergone STC must be more than 100 days from autologous stem cell
infusion prior to first dose of study drug, must have recovered from any transplant
related toxicity and must have adequate bone marrow function as defined by protocol
independent of any growth factor support

- Patients who have not undergone SCT must have adequate bone marrow function as
defined by protocol independent of any growth factor support

- Adequate coagulation, renal and hepatic function

Exclusion Criteria:

- Refractory DLBCL

- History of other malignancies within 2 years prior to initiation of study treatment
except for adequately treated carcinoma in situ of the cervix, basal or squamous cell
skin carcinoma, low-grade localized prostate cancer treated surgically with curative
intent or one that carries a good prognosis, in situ ductal carcinoma of the breast
treated with lumpectomy (with and without radiation) with curative intent

- Active infection requiring parenteral antibiotics or antiviral or antifungal agents

- Inherited or acquired bleeding diathesis, anticoagulant drugs or drugs that inhibit
platelet function, underlying conditions that predisposes to abnormal bleeding, or
refractoriness to platelet transfusions

- Clinically significant cardiovascular disease, New York Heart Association Grade II or
greater congestive heart failure, or ventricular tachyarrhythmias requiring
medication within 1 year prior to the initiation of study treatment

- Positive for hepatitis B, hepatitis C or HIV infection

Type of Study:

Interventional

Study Design:

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

Progression-free survival (time from randomization to progression, relapse or death of any cause)

Outcome Time Frame:

up to approximately 33 months

Safety Issue:

No

Principal Investigator

Clinical Trials

Investigator Role:

Study Director

Investigator Affiliation:

Genentech

Authority:

United States: Food and Drug Administration

Study ID:

GP27814

NCT ID:

NCT01423539

Start Date:

October 2011

Completion Date:

February 2014

Related Keywords:

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

Name

Location

Hinsdale, Illinois  60521
Albany, Georgia  31701
Great Falls, Montana  59405
Fountain Valley, California  92708
Miami, Florida  33176
Columbia, Missouri  65203
Cleveland, Ohio  44195
Nashville, Tennessee  37203-1632
Louisville, Kentucky  40207
Baltimore, Maryland  21287
Indianapolis, Indiana