Ruxolitinib Phosphate in Treating Patients With Adult T-Cell Leukemia

Status: Active

Description

This phase II trial studies how well ruxolitinib phosphate works in treating patients with adult T-cell leukemia. Ruxolitinib phosphate may stop the growth of cancer cells by blocking some of the enzymes needed for cell growth.

Eligibility Criteria

Inclusion Criteria

  • Patients with pathologically confirmed smoldering or chronic adult T- cell leukemia as defined by Shimoyama
  • Patients must have serum antibodies directed to human T-cell lymphotropic virus (HTLV)-1
  • Patients must have measurable or evaluable disease; patients with > 10% of the peripheral blood mononuclear cells (PBMCs) having the characteristic abnormal (i.e., cluster of differentiation [CD]3dim, CD4+ CD25+ expressing) fluorescence-activated cell sorting (FACS) profile for circulating ATL cells will be considered to have evaluable disease
  • Absolute granulocyte count >= 1000 K/uL
  • Platelet count >= 75,000 K/uL
  • Hemoglobin >= 10 g/dL
  • Bilirubin =< 1.5 x institutional upper limit of normal (ULN)
  • Creatinine =< 1.5 x institutional ULN
  • Aspartate aminotransferase (AST), alanine aminotransferase (ALT) =< 3.0 x institutional ULN
  • Karnofsky performance score >= 70% or Eastern Cooperative Oncology Group (ECOG) =< 1
  • Patients must be able to understand and sign informed consent form

Exclusion Criteria

  • Patients previously treated with a Janus kinase (JAK) inhibitor
  • Patients with symptomatic leukemic meningitis, bony or gastrointestinal (GI) tract involvement, serum calcium or lactate dehydrogenase (LDH) > 1.5 X the upper limit of normal will be excluded; however, patients that have both ATL and another HTLV-1 associated disease such as tropical spastic paraparesis (HTLV-I-associated myelopathy [HAM]/tropical spastic paraparesis [TSP]) will be included
  • Patients who have received high doses of systemic corticosteroids for the treatment of their ATL within 4 weeks prior to the start of therapy
  • Patients who have received any cytotoxic therapy, immunotherapy, antitumor vaccines or monoclonal antibodies in the 4 weeks prior to the start of the study
  • Life expectancy of less than 3 months
  • Documented human immunodeficiency virus (HIV), active bacterial infections, active or chronic hepatitis B, hepatitis C or HTLV-II infection * A positive hepatitis B serology indicative of previous immunization (i.e., hepatitis B surface antibody [HBsAb] positive and hepatitis B core antibody [HBcAb] negative), or a fully resolved acute hepatitis B infection is not an exclusion criterion * A positive hepatitis C serology is an exclusion criterion
  • Pregnant and breast-feeding patients are not eligible for the study
  • Inability or refusal to practice effective contraception during therapy; men and women of childbearing potential must use an effective method of birth control or abstinence during treatment and for 4 months after completion of the treatment
  • Patient has significant and/or uncontrolled cardiac, renal, hepatic or other systemic disorders or significant psychological conditions at baseline visit that in the investigator’s judgment would jeopardize subject enrollment or compliance with the study procedures

Locations & Contacts

Maryland

Bethesda
National Institutes of Health Clinical Center
Status: Active
Contact: Kevin C. Conlon
Phone: 301-402-2913
Email: conlonkc@mail.nih.gov
NCI - Center for Cancer Research
Status: Active
Contact: Kevin C. Conlon

Trial Objectives and Outline

PRIMARY OBJECTIVES:

I. To determine the clinical response rate of patients with smoldering or chronic adult T-cell leukemia (ATL) to ruxolitinib (ruxolitinib phosphate) when administered at a dose of 20 mg orally twice a day for 28 days.

SECONDARY OBJECTIVES:

I. Define the safety profile, time to progression and survival time when ruxolitinib is administered at a dose of 20 mg orally twice a day to patients who have smoldering or chronic ATL.

II. Assess the duration of the response in patients off treatment after the initial 28 days of ruxolitinib and the ability of ruxolitinib to reinduce a response when treatment is restarted at the time of clinical progression.

OUTLINE:

Patients receive ruxolitinib phosphate orally (PO) twice daily (BID) on days 1-28. Courses repeat every 28 days (45 days for course 1) in the absence of disease progression or unacceptable toxicity.

After completion of study treatment, patients are followed up a 1, 2, 3, 6, 9, and 12 months.

Trial Phase & Type

Trial Phase

Phase II

Trial Type

Treatment

Lead Organization

Lead Organization
NCI - Center for Cancer Research

Principal Investigator
Kevin C. Conlon

Trial IDs

Primary ID 13-C-0006
Secondary IDs NCI-2013-01560, 335354, P12996, 130006
Clinicaltrials.gov ID NCT01712659