Phase
Condition
Lymphoma
Marginal Zone Lymphoma
Follicular Lymphoma
Treatment
L-Bcl-2 antisense oligonucleotide
Clinical Study ID
Ages > 18 All Genders
Study Summary
Eligibility Criteria
Inclusion
Inclusion Criteria:
Adults ≥18 years of age
Patient has a life expectancy ≥ 3 month
Patient has relapsed or refractory disease Relapsed lymphoma: Relapsed lymphoma isdisease that has responded to treatment but then returns. Refractory lymphoma: Failure to achieve complete response at the end of therapy orprogression within 6 months from completion of therapy
Included Diseases
DLBCL, including transformed lymphoma
Mantle Cell Lymphoma
PTCL
CTCL
CLL/SLL
Follicular lymphoma
Marginal zone lymphoma
Hodgkin lymphoma (both classical and lymphocyte predominant)
Waldenströms Macroglobulinemia
Must has failed or is not a candidate for available therapies with reasonablelikelihood of clinical benefit, which includes FDA approved products and standard ofcare regimens
Therapy means at least three front lines of therapy including Hematopoeitic StemCell Transplant (HSCT and/or Chimeric Antigen Receptor (CAR) T cells, whenapplicable
Females must be of non-childbearing potential, surgically sterile, postmenopausal,or practice adequate methods of contraception during the study
Males must agree to use an adequate method of contraception during the study
Eastern Cooperative Oncology Group (ECOG) Performance score of 0, 1, or 2
Adequate hepatic and renal functions as defined by:
Aspartate transaminase (AST) and alanine transaminase (ALT) ≤2.5 times theupper limit of normal (ULN); and
Total bilirubin ≤1.5 times ULN; and
Estimated glomerular filtration rate (eGFR) of at least 50ml/min. Theseestimations can be calculated using the following methods:
Chronic Kidney Disease Epidemiology Collaboration (CKD-Epi) equation
Cockcroft Gault equation
Modification of Diet in Renal Disease (MDRD study equation)
Creatinine clearance estimated by 24-hr urine collection for creatinineclearance
Recovered from the effects of any prior surgery, radiotherapy, or antineoplastictreatment (with the exception of alopecia), based on Investigator assessment
Willing and able to provide written informed consent
Exclusion
Exclusion Criteria:
Active non-hematologic malignancy other than lymphoid malignancies treated withimmuno- or chemotherapy within the previous 12 months except active non-melanoma,non-invasive skin cancer will be allowed
Known, active Central Nervous System (CNS) involvement of disease requiringintrathecal therapy. Note: Patients with a history of CNS disease may be allowed toparticipate based on at least 1 documented, negative spinal fluid assessment within 28 days prior to Screening
Patient eligible for high dose chemotherapy and autologous stem cell transplant
Indolent non-Hodgkin lymphoma (iNHL)
Patients at high risk of Tumor Lysis Syndrome (TLS) a. Bulky disease i. A unidimensional lesion greater than 10 cm and/or b. Lymphocytecount greater than 25,000 per µL
Receipt of any anti-cancer therapy within 14 days prior to Cycle 1 Day 1 (C1D1)
Uncontrolled active, untreated, or progressive infection
Receipt of any investigational agent or on study treatment within 30 days prior toC1D1
Females who are pregnant, test positive for pregnancy, or are breast-feeding duringthe Screening period, or intend to become pregnant or breast-feed during the courseof the study or within 30 days after last dose of study drug
Serious intercurrent medical or psychiatric illness which, in the opinion of theInvestigator, would interfere with the ability of the participant to complete thestudy
Active hepatitis B infection (based on positive surface antigen [HBsAg]), hepatitisC infection (based on Hepatitis C Virus (HCV) positive antibody [HCV Ab]), or humanimmunodeficiency virus (HIV-1 or HIV-2, based on positive antibody)
Presence of concurrent conditions that, in the opinion of the Investigator and/orMedical Monitor, may compromise or interfere with any aspect of study conduct orinterpretation of results. This includes, but is not limited to, unstable oruncontrolled angina, New York Heart Association (NYHA) class III or IV congestiveheart failure, uncontrolled and sustained hypertension, clinically significantcardiac dysrhythmia or clinically significant baseline EKG abnormality (e.g., QTcF >470 msec)
Within the past 6 months, has had any of the following: myocardial infarction,unstable angina pectoris, coronary/peripheral artery bypass graft, cerebrovascularaccident or transient ischemic attack
Uncontrolled seizure disorder
Unable or unwilling to communicate or cooperate with the Investigator or follow theprotocol for any reason.
Study Design
Connect with a study center
Georgia Cancer Center
Augusta, Georgia 30912
United StatesSite Not Available
New York Medical College / Westchester Medical Center
Valhalla, New York 10595
United StatesSite Not Available
Westchester Medical Center
Valhalla, New York 10595
United StatesActive - Recruiting
Sarah Cannon Research Institute/Tennesee Oncology
Nashville, Tennessee 37203
United StatesSite Not Available
University of Texas Southwestern Medical Center
Dallas, Texas 75390
United StatesSite Not Available
MD Anderson Cancer Research Center
Houston, Texas 77030
United StatesSite Not Available
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