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Investigator(s):
Wyndham H. Wilson, M.D., Ph.D. Principal Investigator Phone: 301-435-2415 wilsonw@mail.nih.gov
Referral Contact(s):
Peggy Shovlin, R.N., B.S.N. Research Nurse Phone: 301-594-6597 mshovlin@mail.nih.gov

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Primary Eligibility:

Phase I

• Histologically confirmed B- and T-cell lymphoid malignancies
• Refractory or progressive disease
• At least one prior chemotherapy regimen
• No prior allogeneic or autologous stem cell transplant
• No prior or concurrent diagnosis of the following:
• Post-transplant lymphoproliferative disease
• Burkitt’s-like lymphoma
• Lymphoblastic lymphoma/leukemia
• Multiple myeloma
• HIV-associated lymphoma

Phase II

• One of the following histologically confirmed lymphoid malignancies:
• Arm A
• Follicular lymphoma
• Arm B
• Mantle cell lymphoma
• Peripheral T-cell lymphoma
• Cutaneous T-cell lymphoma including mycosis fungoides and Sezary syndrome
• Other indolent B-cell lymphoma such as marginal zone lymphoma
• Arm C
• Diffuse large B-cell lymphoma

• Measurable disease
• Archived diagnostic tissue available for assessment of Bcl-2 family protein expression

Phase I and Phase II

• ≥ 18 years of age
• No HIV
• Subjects receiving SSRI must be on a stable dose for 21 days before starting study drug
• Males and females of reproductive potential must agree to use an effective contraceptive method
• ECOG Performance Status 0–1
• Adequate bone marrow, renal, and hepatic function
• No history of cancer-related CNS disease, lymphoid or non-lymphoid
• No underlying, predisposing condition of bleeding or current signs of bleeding
• No anticoagulation therapy or any drugs that affect platelet function with the exception of low-dose anticoagulation medications that are used to maintain the patency of a central venous catheter

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Treatment Plan:

This is a multicenter, phase I, dose escalation study followed by an open-label, phase II study (phase II pending approval).

Phase I

• Patients receive oral ABT-263 once daily starting with a 7-day lead-in period at a lower dose, then begin continuous daily dosing
• Courses repeat every 21 days for up to 1 year in the absence of disease progression or unacceptable toxicity
• Blood samples are acquired periodically during study treatment; samples are examined for pharmacokinetics and proteomics
• After completion of study treatment, patients are followed at 21 and 30 days

Phase II

• Patients receive oral ABT-263 at the maximum tolerated dose determined in phase I

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Additional Information:

• This trial will be conducted at the NIH Clinical Center in Bethesda, MD. It is open to patients who meet the eligibility requirements, regardless of where they live in the United States.
• There is no charge for medical care received at NIH Clinical Center.
• FAQs about this study - provides information for patients about the trial such as frequency and duration of visits, costs, how to enroll, treatment plan.
• PDQ (Physicians Data Query) - provides additional details about this study for health care providers.

Reviewed: 7/8/08
Updated: 7/2/08