CompletedPhase 1

Safety Study of ABT-263 in Combination With Rituximab in Lymphoid Cancers

United States, Australia29 participantsStarted 2009-07-21

Plain-language summary

This is a Phase 1 study evaluating the safety of ABT-263 administered in combination with rituximab in participants with CD20-positive lymphoproliferative disorders. The extension portion of the study will allow active participants to continue to receive ABT-263 for up to 14 years after the last participant transitions with quarterly study evaluations.

Who can participate

Age range

18 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion Criteria: * Diagnosed with a CD20-positive lymphoproliferative disorder (Revised European American Lymphoma \[REAL\]/World Health Organization \[WHO\]) and bi-dimensionally measurable disease with at least 1 lesion \>= 1.0 cm * Eastern Cooperative Oncology Group (ECOG) performance score of \<= 1 * Adequate bone marrow function, independent of growth factor support (with the exception of participants with bone marrow that is heavily infiltrated with underlying disease \[80% or more\] who may use growth factor to achieve Absolute Neutrophil count (ANC) eligibility criteria) per local laboratory reference range as follows: Absolute Neutrophil count (ANC) \>= 1000/μL; Platelets \>= 100,000/mm3 (untransfused); Hemoglobin \>= 9.0 g/dL. * Participants who have a history of autologous stem cell transplant (e.g., bone marrow) must be \> 6 months post transplant and have adequate bone marrow function, independent of any growth stimulating factors (with the exception of participants with bone marrow that is heavily infiltrated with underlying disease \[80% or more\] who may use growth factor to achieve ANC eligibility criteria) per local laboratory reference range as follows: Absolute Neutrophil count (ANC) \>= 1500/μL; Platelets \>= 125,000/mm3 (untransfused); Hemoglobin \>= 10.0 g/dL. * Participant must have adequate renal, hepatic and coagulation function per local laboratory reference range as follows: Serum creatinine \<= 2.0 mg/dL or calculated creatinine clearance \>= …

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

Extension Study: Continued assessment of the safety profile of ABT-263 when administered in combination with rituximab

Timeframe: Safety will be assessed until the participant discontinues the extension portion of the study.

Assess the safety profile and characterize the pharmacokinetics of ABT-263 when administered in combination with rituximab

Timeframe: Safety and pharmacokinetics will be assessed until the participant discontinues the study or transitions to the extension portion of the study (whichever comes first).

Determination of dose limiting toxicity (DLT) and maximum tolerated dose (MTD) when ABT-263 is administered in combination with rituximab

Timeframe: DLTs and MTD will be assessed after all participants in a dose level have completed the lead-in period plus 28 days if dosing with ABT-263 and rituximab

Trial details

NCT IDNCT00788684

SponsorAbbVie

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2025-02-07

View on ClinicalTrials.gov More CD20-Positive Lymphoid Malignancies trials