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
Public ClinicalTrials.gov record NCT01328626. Field values are reproduced from the official study page; the official ClinicalTrials.gov record remains the source of truth for eligibility, enrollment, and contact information.
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Brief summary
Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.
This is a Phase 1, open-label, multicenter study evaluating the safety and PK profile of ABT-199 under a once daily dosing schedule. Two arms will be implemented for dose escalation: Arm A, CLL/SLL subjects and Arm B, NHL subjects. Arm A is designed to enroll approximately 116 subjects with relapsed or refractory CLL or SLL and Arm B is designed to enroll approximately 95 subjects with relapsed or refractory NHL. Fifty-six subjects were enrolled in Arm A and approximately 55 subjects will be enrolled in Arm B during the dose escalation portion of the study, with the objective of defining dose limiting toxicities (DLTs) and the MTD. Once the MTD is declared for the arm, approximately 60 additional CLL/SLL subjects in Arm A and approximately 20 additional DLBCL subjects and 20 additional follicular lymphoma subjects in Arm B will be enrolled in an expanded safety portion of the study at the recommended phase 2 dose (RPTD) and schedule.
Study identification
- NCT ID
- NCT01328626
- Recruitment status
- Completed
- Study type
- Interventional
- Phase
- Phase 1
- Enrollment
- 222 participants
Conditions and interventions
Conditions
Eligibility (public fields only)
- Age range
- 18 Years to 99 Years
- Sex
- All
- Healthy volunteers
- Healthy volunteers not accepted
This page does not interpret eligibility. Detailed inclusion and exclusion criteria are on the official ClinicalTrials.gov record.
Study timeline
- Start date
- May 23, 2011 (Actual)
- Primary completion
- May 8, 2020 (Actual)
- Completion
- May 8, 2020 (Actual)
- Last update posted
- Feb 23, 2022
2011 – 2020
United States locations
- U.S. sites
- 8
- U.S. states
- 7
- U.S. cities
- 7
| Facility | City | State | ZIP | Site status |
|---|---|---|---|---|
| University of Arizona Cancer Center - North Campus /ID# 52902 | Tucson | Arizona | 85719-1478 | — |
| Ucsd /Id# 48325 | La Jolla | California | 92093 | — |
| Dana-Farber Cancer Institute /ID# 48324 | Boston | Massachusetts | 02215 | — |
| Memorial Sloan Kettering Cancer Center /ID# 56810 | New York | New York | 10065-6007 | — |
| University of Texas MD Anderson Cancer Center /ID# 48326 | Houston | Texas | 77030 | — |
| Swedish Medical Center /ID# 135853 | Seattle | Washington | 98104 | — |
| Fred Hutchinson Cancer Research /ID# 52882 | Seattle | Washington | 98109 | — |
| Univ of Wisconsin Hosp/Clinics /ID# 56811 | Madison | Wisconsin | 53792-0001 | — |
Site contact phone numbers, emails, and investigator names are intentionally not displayed here. Open the official ClinicalTrials.gov record for site contact information.
Non-U.S. locations
This page focuses on the U.S. directory. The official record also lists 2 non-U.S. sites.
About this trial record page
- What this page shows
- Public field values for ClinicalTrials.gov record NCT01328626, including study identification, conditions, interventions, eligibility (age, sex, healthy volunteer), timeline, and U.S. site list.
- What this page does not do
- No medical advice, eligibility judgments, treatment recommendations, study quality scoring, or AI-generated medical summaries. No site contact phone numbers, emails, or investigator names.
- Where the data comes from
- Sourced from the official ClinicalTrials.gov public API. The official record is the source of truth.
- Last refresh
- Last update posted Feb 23, 2022 · Synced Nov 9, 2026
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Open the official record
The complete public registry record, listed eligibility criteria, and available contact information for NCT01328626 live on ClinicalTrials.gov.