Summary

for people ages 18-99 (full criteria)
at La Jolla, California and other locations
study started
estimated completion:

Description

Summary

This is a Phase 1, open-label, multicenter study evaluating the safety, pharmacokinetic profile, and preliminary efficacy of ABT-199 in combination with Bendamustine/Rituximab in approximately 60 subjects with relapsed or refractory non-Hodgkin's lymphoma. This study will evaluate the safety and pharmacokinetic profile of ABT-199 in approximately 60 subjects when administered in combination with Bendamustine/Rituximab following a dose escalation scheme, with the objective of defining the dose limiting toxicity and the maximum tolerated dose.

Official Title

A Phase 1 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

Keywords

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

Eligibility

You can join if…

Open to people ages 18-99

  • 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

You CAN'T join if...

.

  • Subject (non-diffuse large B-cell lymphoma) must have relapsed or refractory non-Hodgkin's lymphoma, and require treatment in the opinion of the investigator.
  • 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, small lymphocytic lymphoma or mantle cell lymphoma (MCL).
  • 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.

Locations

  • Ucsd /Id# 67350
    La Jolla California 92037 United States
  • University of California, Los Angeles /ID# 67343
    Santa Monica California 90404 United States

Details

Status
in progress, not accepting new patients
Start Date
Completion Date
(estimated)
Sponsor
AbbVie
ID
NCT01594229
Phase
Phase 1
Study Type
Interventional
Last Updated
July 25, 2018