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A Phase 1 Study Evaluating the Safety and Pharmacokinetics of ABT-199 in Subjects With Relapsed or Refractory Chronic Lymphocytic Leukemia and Non-Hodgkin Lymphoma


Phase 1
18 Years
N/A
Open (Enrolling)
Both
Chronic Lymphocytic Leukemia, Non-Hodgkin Lymphoma

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Trial Information

A Phase 1 Study Evaluating the Safety and Pharmacokinetics of ABT-199 in Subjects With Relapsed or Refractory Chronic Lymphocytic Leukemia and Non-Hodgkin Lymphoma


Interventional Study Design - Primary Purpose: Determination of safety and tolerability


Inclusion Criteria:



- Subject must be at least 18 years of age.

- Subject must have either:

- (Arm A) relapsed or refractory CLL/SLL and require treatment in the opinion of
the Investigator. Subject must have relapsed following or be refractory to
standard treatments such as fludarabine based regimens (F, FC, FR, FCR) or
alkylator (chlorambucil, bendamustine) based regimens. In addition, there are
no other curative options, and the subject has exhausted options that would be
considered standard of care, or

- (Arm B) relapsed or refractory NHL and require treatment in the opinion of the
Investigator. Subject must have histologically documented diagnosis of NHL as
defined in the World Health Organization classification scheme, except as noted
in the exclusion criteria. Subject must have relapsed following or be
refractory to standard treatments such as R-CHOP, R-CVP, or fludarabine based
regimens. In addition, there are no other curative options, and the subject has
exhausted options that would be considered standard of care. Subjects with
other lymphoproliferative diseases can be considered in consultation with the
Abbott medical monitor.

- Subject has an Eastern Cooperative Oncology Group (ECOG) performance score less than
or equal to 1.

- Subject must have adequate bone marrow independent of growth factor support per local
laboratory reference range at Screening.

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

Exclusion Criteria:

- CLL subject has undergone an allogeneic or autologous stem cell transplant or NHL
subject has undergone an allogeneic stem cell transplant or has been diagnosed with
Post-Transplant Lymphoproliferative Disease, Burkitt's lymphoma, Burkitt-like
lymphoma, or lymphoblastic lymphoma/leukemia.

- Subject has tested positive for 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, cardiovascular, or hepatic disease that in the opinion of the
Investigator would adversely affect his/her participating in this study.

- Subject has received a monoclonal antibody for anti-neoplastic intent within 8 weeks
prior to the first dose of study drug.

Type of Study:

Interventional

Study Design:

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

Outcome Measure:

Determination of dose limiting toxicity (DLT), maximum tolerated dose (MTD), recommended phase two dose (RPTD), and lead-in period regimen

Outcome Description:

Protocol-defined events, which can not be attributed by the investigator to a clearly identifiable cause such as tumor progression, underlying illness, concurrent illness, or concomitant medication, will be considered a DLT. Dose limiting toxicities of tumor lysis syndrome observed during the lead-in period will be attributed to the lead-in period.

Outcome Time Frame:

Lead-in period (2-5 weeks) plus 3 weeks of study drug administration at the designated cohort dose (continuous dosing)

Safety Issue:

Yes

Principal Investigator

Sari Enschede, MD

Investigator Role:

Study Director

Investigator Affiliation:

AbbVie

Authority:

Australia: Department of Health and Ageing Therapeutic Goods Administration

Study ID:

M12-175

NCT ID:

NCT01328626

Start Date:

June 2011

Completion Date:

July 2014

Related Keywords:

  • Chronic Lymphocytic Leukemia
  • Non-Hodgkin Lymphoma
  • Safety,Chronic Lymphocytic Leukemia,Non-Hodgkin Lymphoma,Cancer,Preliminary Efficacy,ABT-199,Pharmacokinetics,Maximum Tolerated Dose
  • Leukemia
  • Leukemia, Lymphocytic, Chronic, B-Cell
  • Leukemia, Lymphoid
  • Lymphoma
  • Lymphoma, Non-Hodgkin

Name

Location

Site Reference ID/Investigator# 52902Tucson, Arizona  85724-5024
Site Reference ID/Investigator# 48325La Jolla, California  92093
Site Reference ID/Investigator# 48324Boston, Massachusetts  02115
Site Reference ID/Investigator# 56810New York, New York  10065
Site Reference ID/Investigator# 48326Houston, Texas  77030-4009
Site Reference ID/Investigator# 52882Seattle, Washington  98109
Site Reference ID/Investigator# 56811Madison, Wisconsin  53705-2275