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A Phase 1b Study Evaluating the Safety and Pharmacokinetics of ABT-199 in Combination With Bendamustine/Rituximab (BR) in Subjects With Relapsed or Refractory Non-Hodgkin's Lymphoma

Phase 1
18 Years
Open (Enrolling)
Non-Hodgkin's Lymphoma

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Trial Information

A Phase 1b Study Evaluating the Safety and Pharmacokinetics of ABT-199 in Combination With Bendamustine/Rituximab (BR) in Subjects With Relapsed or Refractory Non-Hodgkin's Lymphoma

Inclusion Criteria:

- Subject must be greater than or equal to 18 years of age.

- Subject must have histologically documented diagnosis of non-Hodgkin's lymphoma as
defined by a B-cell neoplasm in the World Health Organization classification scheme
except as noted in exclusion criteria.

- Subject (non-diffuse large B-cell lymphoma) must have relapsed or refractory
non-Hodgkin's lymphoma, received no more than 5 prior myelosuppressive/chemotherapy
regimens, and require treatment in the opinion of the investigator. Subject must have
relapsed following or be refractory to standard treatments such as
Rituximab-Cyclophosphamide, Hydroxydaunomycin, Vincristine (Oncovin), Prednisone
(R-CHOP); Rituximab-Cyclophosphamide, Vincristine (Oncovin), and Prednisone (R-CVP);
or fludarabine-based regimens.

- Subject with diffuse large B-cell lymphoma must have relapsed diffuse large B-cell
lymphoma or must have progressed after salvage therapy (with or without standard
chemotherapy) for diffuse large B-cell lymphoma. The subject must have received first
line therapy with Rituximab-Cyclophosphamide, Hydroxydaunomycin, Vincristine
(Oncovin), Prednisone (R-CHOP) [or a similar standard rituximab-containing front-line
chemoimmunotherapy regimen including, but not limited to Etoposide, Prednisone,
Vincristine (Oncovin), Cyclophosphamide, Doxorubicin (Hydrochloride) + Rituximab
(EPOCH + R); Rituximab, Cyclophosphamide, Etoposide, Procarbazine, Prednisone
(RCEPP); Rituximab, Cyclophosphamide, Mitoxantrone (Novantrone), Vincristine
(Oncovin), Prednisone (RCNOP); Dose-adjusted-Etoposide, Prednisone,
Vincristine(Oncovin), Cyclophosphamide, Doxorubicin (Hydrocloride) (DA-EPOCH); and
Rituximab, Cyclophosphamide, Etoposide, Vincristine (Oncovin), Prednisone (RCEOP)].

- Subject must have adequate coagulation, renal, and hepatic function, per laboratory
reference range at Screening.

Exclusion Criteria:

- Subject has been diagnosed with Post-Transplant Lymphoproliferative Disease,
Burkitt's lymphoma, Burkitt-like lymphoma, lymphoblastic lymphoma/leukemia, chronic
lymphocytic leukemia or small lymphocytic lymphoma.

- Subject has refractory diffuse large B-cell lymphoma, defined as meeting any of the
following criteria:

- Subject progressed during or within 3 months of completion of a planned course
of first-line therapy with Rituximab-Cyclophosphamide, Hydroxydaunomycin,
Vincristine (Oncovin), Prednisone (R-CHOP) or an equivalent regimen;

- Subject had no response (i.e., stable disease only) to first-line therapy with
R-Cyclophosphamide, Hydroxydaunomycin, Vincristine (Oncovin), Prednisone
(R-CHOP) or an equivalent regimen;

- Subject progressed during or within 2 months of completion of their last planned
course of salvage therapy with chemotherapy (with or without rituximab, may
include autologous stem cell transplant).

- Subject has tested positive for human immunodeficiency virus (HIV).

- Subject has a cardiovascular disability status of New York Heart Association Class
greater or equal to 2. Class 2 is defined as cardiac disease in which patients are
comfortable at rest but ordinary physical activity, results in fatigue, palpitations,
dyspnea or anginal pain.

- Subject has a significant history of renal, neurologic, psychiatric, endocrinologic,
metabolic, immunologic, or hepatic disease that in the opinion of the Investigator
would adversely affect his/her participating in this study.

Type of Study:


Study Design:

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

Outcome Measure:

Determination of the maximum tolerated dose of ABT-199 when administered with Bendamustine and Rituximab in subjects with relapsed or refractory non-Hodgkin's lymphoma

Outcome Description:

Protocol-defined events, which can not be attributed by the investigator to a clearly identifiable cause such as tumor progression, concurrent illness, or concomitant medication, will be considered a dose limiting toxicity

Outcome Time Frame:

3 days of study drug administration within the 28-day cycle at the designated cohort dose

Safety Issue:


Principal Investigator

Justin Ricker, MD

Investigator Role:

Study Director

Investigator Affiliation:



United States: Food and Drug Administration

Study ID:




Start Date:

June 2012

Completion Date:

March 2015

Related Keywords:

  • Non-Hodgkin's Lymphoma
  • Safety
  • Maximum Tolerated Dose
  • ABT-199
  • Non-Hodgkin's Lymphoma
  • Cancer
  • Pharmacokinetics
  • Preliminary Efficacy
  • Bendamustine
  • Rituximab
  • Lymphoma
  • Lymphoma, Non-Hodgkin



Site Reference ID/Investigator# 67344 Harvey, Illinois  60426
Site Reference ID/Investigator# 67346 Detroit, Michigan  48202
Site Reference ID/Investigator# 67350 La Jolla, California  92093-0820
Site Reference ID/Investigator# 67343 Los Angeles, California  90095-1678
Site Reference ID/Investigator# 67342 Augusta, Georgia  30912
Site Reference ID/Investigator# 67345 Baltimore, Maryland  21231
Site Reference ID/Investigator# 69222 Houston, Texas  77030