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COMPLETED Phase 1

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

NCT01328626 · View on ClinicalTrials.gov ↗

Study Summary

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.

Interventions

  • DRUG ABT-199

Study Locations (10)

Washington

  • Swedish Medical Center /ID# 135853 — Seattle
  • Fred Hutchinson Cancer Research /ID# 52882 — Seattle

Victoria

  • Peter MacCallum Cancer Ctr /ID# 48323 — Melbourne
  • Royal Melbourne Hospital /ID# 48322 — Parkville

Arizona

  • University of Arizona Cancer Center - North Campus /ID# 52902 — Tucson

California

  • Ucsd /Id# 48325 — La Jolla

Massachusetts

  • Dana-Farber Cancer Institute /ID# 48324 — Boston

New York

  • Memorial Sloan Kettering Cancer Center /ID# 56810 — New York

Texas

  • University of Texas MD Anderson Cancer Center /ID# 48326 — Houston

Wisconsin

  • Univ of Wisconsin Hosp/Clinics /ID# 56811 — Madison

Trial Details

FieldValue
Enrollment Target 222 participants
Start Date 2011-05-23
Est. Completion 2020-05-08
Phase Phase 1

Sponsor

AbbVie

603 total trials

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Full Details on ClinicalTrials.gov ↗

What the Registry Record Tells You About NCT01328626

The ClinicalTrials.gov registry entry for NCT01328626 describes a study currently listed as completed. It is categorized as Phase 1, which is the standard way researchers label where a study sits along the investigational pathway from early safety work through later efficacy and post-marketing evaluation. The registered enrollment target is 222 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is AbbVie, which has 603 total studies on file at ClinicalTrials.gov, and sponsors are the parties responsible for study design, oversight, and regulatory filings.

The record links to 2 conditions, with Chronic Lymphocytic Leukemia appearing as the primary indexed condition, and to 1 intervention — of which ABT-199 is the first listed. Interventions can include drugs, devices, procedures, behavioral programs, or observational arms, and each is tracked as a separate registry field so that downstream queries can filter accurately. When a trial lists multiple interventions, it usually reflects a multi-arm design or a comparison protocol rather than a single treatment being tested in isolation. The brief summary published in the registry is the clearest source of protocol intent and should be read before drawing conclusions from any sidebar tags.

Geographic footprint matters for practical reasons: NCT01328626 reports 10 study locations spanning 8 distinct geographic areas — top geographies include Washington, Victoria, Arizona. A larger site network tends to correlate with broader recruitment capacity, but it does not imply anything about study quality, and site-level enrollment status can diverge from the overall registry status shown above. Every data point on this page comes from the public ClinicalTrials.gov dataset and is reproduced here for reference only; it is not a medical recommendation, an endorsement of the sponsor, or an invitation to enroll. Verify current status, eligibility criteria, and contact details directly at ClinicalTrials.gov, and discuss any participation decision with your own healthcare provider.

Frequently Asked Questions

What is clinical trial NCT01328626 about?

NCT01328626 is a clinical study titled "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". 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...

What is the current status of trial NCT01328626?

This trial is currently completed. It is a Phase 1 study. The enrollment target is 222 participants. The study started on 2011-05-23. Estimated completion is 2020-05-08.

What conditions does trial NCT01328626 study?

This clinical trial studies the following conditions: Chronic Lymphocytic Leukemia, Non-Hodgkin Lymphoma. These conditions were identified from the trial registry and reflect the primary focus areas of the research.

What interventions are being tested in trial NCT01328626?

The interventions under investigation include: ABT-199 (DRUG). Each intervention is being evaluated for safety and efficacy as part of this clinical study.

Who is sponsoring clinical trial NCT01328626?

This trial is sponsored by AbbVie, which has 603 total clinical trials registered on ClinicalTrials.gov. The sponsor is responsible for the study's design, funding, and regulatory compliance.

Where is trial NCT01328626 being conducted?

This trial has 10 study locations across Arizona, California, Massachusetts, New York, Texas. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.

Related

Data sourced from official U.S. government datasets. See our methodology for details. Retrieved and formatted by PlainTrial Editorial