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Details for trial 13NHL-06-3

Description:	A Phase I/IIa Study Evaluating the Safety, Pharmacokinetics, and Efficacy of ABT-263 in Subjects with Relapsed or Refractory Lymphoid Malignancies.
Status:	Open
Randomized?	No

Researchers

Principal Investigator	Title
Anil Tulpule	M.D.

Data Management

Name	Title
Nancy Berman	R.N.
Gerry Gorospe	R.N.

You may participate in this study if:

	Requirement
1	INCLUSION for PHASE I only (must also meet all Other Inclusion Criteria listed below): • Histologically documented diagnosis of a lymphoid malignancy by WHO classification except as noted in Exclusion Criteria. • At least 1 prior chemotherapy regimen for a lymphoid malignancy & disease is refractory or patient has disease progression following treatment.
2	INCLUSION for PHASE IIa only (must also meet all Other Inclusion Criteria listed below): • Histologically documented follicular lymphoma. • Measurable disease by International Working Group (IWG) Criteria for Tumor Response. • Not > 4 prior conventional chemotherapy regimens. • Must have archived diagnostic tissue available for assessment of Bcl-2 family protein expression. • Has 1 of the following available for pharmacodynamic analyses: Core needle biopsy of malignant Lymph Node at Screening, Bone Marrow aspirate or core obtained at Screening, (+) for lymphoma, Archived tumor tissue with no intervening treatment since the biopsy (e.g. from debulking, tissue obtained at relapse or bone marrow sample).
3	OTHER INCLUSION CRITERIA: PHASE I & PHASE IIa
4	18 y/o and above.
5	If clinically indicated (e.g. > 70 y/o), must have documented Brain CT or MRI (-) for subdural or epidural hematoma w/i 28 days prior to study treatment.
6	ECOG Performance Status 0-2.
7	ANC 1000 or greater; Platelets 100,000 or greater; Hgb 9.0 or greater.
8	Serum creatinine 1.5 or less or calculated Creatinine Clearance 50 or greater.
9	AST & ALT less than or equal to 1.5 x ULN (less than or equal to 2.5 x ULN if with liver mets).
10	Bilirubin less than or equal to 1.5 x ULN (> 1.5 x ULN if with Gilbert’s Syndrome).
11	aPTT, PT, INR within normal limits.
12	Women must be either surgically sterile or postmenopausal for at least 1 yr or if women of child-bearing potential, must have (-) serum pregnancy test w/i 14 days prior to initial treatment & (-) urine pregnancy test prior to dosing on C1D-3 for Ph I & on C1D1 for Ph II.
13	Women who are not surgically sterile or post- menopausal for at least 1 yr, & non-vasectomized male pts must practice at least 1 method of birth control: total abstinence ( minimum of 1 complete menstrual cycle), vasectomized male partner, hormonal contraceptives (oral, parenteral or transdermal) for at least 3 mos prior to treatment, double-barrier method (condoms, contraceptive sponge, diaphragm, or vaginal ring with spermicidal jellies or cream).
14	Signed informed consent (including HIPAA authorization).

You may not participate in this study if:

1	EXCLUSION for PHASE I only (see also Other Exclusion Criteria listed below): Diagnosed with Post-Transplant Lymphoproliferative Disease (PTLD), Burkitt's lymphoma, Burkitt-like lymphoma, lymphoblastic lymphoma/leukemia, multiple myeloma, or HIV-associated lymphoma.
2	EXCLUSION for PHASE IIa only (see also Other Exclusion Criteria listed below): Rituxamib w/i 3 mos prior to treatment, except patients with objective Progressive Disease following Rituxamib.
3	OTHER EXCLUSION CRITERIA: PHASE I & PHASE IIa
4	History of, or is clinically suspicious for, cancer-related CNS disease, lymphoid or non-lymphoid.
5	Has undergone an allogeneic or autologous stem cell transplant.
6	Has underlying, predisposing condition of bleeding or currently exhibits signs of bleeding; history of non-chemotherapy-induced thrombocytopenic-associated bleeding w/i 1 yr prior to treatment.
7	Active peptic ulcer disease or other hemorrhagic esophagitis/gastritis.
8	History of of platelet autoantibodies or autoimmune phenomena including Immune Thrombocytopenic Purpura (ITP) or autoimmune hemolytic anemia (AIHA).
9	Significant history of cardiac, renal, neurologic, psychiatric, endocrinologic, metabolic, immunologic, or hepatic disease that would adversely affect study participation.
10	Pregnant or breast-feeding women.
11	HIV posiitve.
12	Previous or current malignancies at other sites except adequately treated cervical carcinoma-in-situ, basal or squamous cell cancer of the skin or non-pulmonary malignancy (e.g. localized prostate cancer) confined & surgically resected with no evidence of disease w/i 3 yrs.
13	Other clinically significant uncontrolled conditions including, but not limited to active systemic fungal infection & fever & neutropenia w/i 1 wk prior to treatment.
14	Steroid therapy w/i 7 days prior to treatment.
15	Anti-cancer treatment including chemotherapy, immunoherapy,radiotherapy, hormonal, biologic, or any investigational treatment w/i 28 days prior to study treatment (steroids w/i 7 days).
16	Currently receiving or requires anticoagulation or drugs that effect platelet function.
17	SSRI antidepressant (e.g. Prozac) w/i 28 days prior to treatment.
18	Consumed grapefruit or grapefruit products w/i 3 days prior to treatment.

For further information on, or to sign up for this study, please contact the Clinical Investigation Support Office at (323) 865-0451 or the Principal Investigator noted above.