Study of Ibrutinib in Relapsed and Refractory T-cell Lymphoma

• Register: ClinicalTrials.gov
• Last refreshed on: 22 May 2023
• Main ID: NCT02309580
• Date of registration: 03/12/2014
• Prospective Registration: Yes
• Primary sponsor: Memorial Sloan Kettering Cancer Center
• Public title: Study of Ibrutinib in Relapsed and Refractory T-cell Lymphoma
• Scientific title: A Multicenter Phase I Study of Ibrutinib in Relapsed and Refractory T-cell Lymphoma
• Date of first enrolment: January 2015
• Target sample size: 14
• Recruitment status: Completed
• URL: https://clinicaltrials.gov/show/NCT02309580
• Study type: Interventional
• Study design: Allocation: N/A. Intervention model: Single Group Assignment. Primary purpose: Treatment. Masking: None (Open Label).
• Phase: Phase 1

Countries of recruitment

United States

Contacts

• Name: Anita Kumar, MD
• Affiliation: Memorial Sloan Kettering Cancer Center

Key inclusion & exclusion criteria

Inclusion Criteria:

- Pathology confirmed relapsed or refractory T-cell lymphoma (PTCL and stage >IBCTCL) at
treating institution

- Relapse or progression after at least 1 systemic therapy

- Age =18 years at the time of signing the informed consent form

- Able to adhere to the study visit schedule and other protocol requirements

- Previous systemic anti-cancer therapy must have been discontinued at least 3 weeks
prior to treatment in this study. If there is progression of disease on that therapy
and all adverse effects have resolved to Grade 1 or baseline, in which case 2 weeks is
acceptable

- Previous radiation, hormonal therapy, and surgery must have been discontinued at least
2 weeks prior to treatment in this study and adverse effects must have resolved. Lymph
node or other diagnostic biopsy within 2 weeks is not considered exclusionary

- Systemic corticosteroids are permissible in the following circumstances:

- Short course systemic corticosteroids for disease control, improvement of performance
status or non-cancer indication (= 7 days) must have been discontinued at least 7 days
prior to study treatment.

- Ongoing administration of a stable dose of corticosteroid therapy (previously received
for = 30 days) is permissible provided there is evidence of measurable disease and
there will be no increase in steroid dose during the clinical trial

- ECOG performance status of = 2 at study entry

- Patients who have undergone autologous stem cell transplant > 6 months prior are
eligible

- Patients who have undergone allogeneic stem cell transplant > 12 months, without
active graft-versus-host-disease, and not on immunosuppression for prevention of
graft-versus-host disease are eligible

- Laboratory test results within these range:

- Adequate hematologic function with screening laboratory assessment defined as:

- Absolute neutrophil count >1,000 cells/mm3 (1.0 x 10^9/L)

- Platelet count >75,000 cells/mm3 (75 x 10^9/L), if thrombocytopenia is due to bone
marrow involvement platelet count must be = 50,000 cells/mm3

- Hemoglobin >8.0 g/dL

- Adequate hepatic and renal function with screening laboratory assessment defined as:

- Serum aspartate transaminase (AST) or alanine transaminase (ALT)

=2.5 x upper limit of normal (ULN)

- Creatinine <2.0 x ULN or Estimated Glomerular Filtration Rate GFR [Cockcroft-Gault] >
30 mL/min.

- Bilirubin <1.5 x ULN [unless bilirubin rise is due to Gilbert's syndrome (as defined
by >80% unconjugated hyperbilirubinemia) or of nonhepatic origin]

- Females of childbearing potential (FCBP)† must have a negative serum pregnancy test
and agree to use appropriate methods of birth control

Exclusion Criteria:

- Patients who have a standard curative option for their lymphoid malignancy at current
state of disease are excluded. For eligibility on this trial, allogeneic stem cell
transplantation is not considered a standard curative option

- Concurrent systemic immunosuppressant therapy (eg, cyclosporine A, tacrolimus, etc.)
within 28 days of the first dose of study drug

- Recent infection requiring intravenous anti-infective treatment that was completed =14
days before the first dose of study drug

- Known bleeding diathesis (eg, von Willebrand's disease) or hemophilia

- Treatment with warfarin or other Vitamin K antagonists (eg, phenprocoumon)

- Any life-threatening illness, medical condition, or organ system dysfunction that, in
the opinion of the investigator, could compromise the subject's safety or put the
study outcomes at undue risk

- Unwilling or unable to participate in all required study evaluations and procedures.

- Unable to understand the purpose and risks of the study and to provide a signed and
dated informed consent form (ICF)

- Currently active, clinically significant cardiovascular disease, such as uncontrolled
arrhythmia or class 3 or 4 congestive heart failure as defined by the New York Heart
Association Functional Classification; or a history of myocardial infarction, unstable
angina, or acute coronary syndrome within 6 months prior to enrollment

- Unable to swallow capsules, malabsorption syndrome, disease significantly affecting
gastrointestinal function, resection of the stomach or small bowel, symptomatic
inflammatory bowel disease or ulcerative colitis, or partial or complete bowel
obstruction

- Pregnant females (Lactating females must agree not to breast feed while taking
ibrutinib

- Prior use of ibrutinib

- Known seropositive and requiring anti-viral therapy for human immunodeficiency virus
(HIV), hepatitis B virus (HBV) or hepatitis C virus (HCV) defined by PCR.

- Active concurrent malignancy requiring active therapy

- Known central nervous system or meningeal involvement (in the absence of symptoms
investigation into central nervous system involvement is not required)

- Patients who require treatment with a strong cytochrome P450 (CYP) 3A inhibitor



Age minimum: 18 Years
Age maximum: N/A
Gender: All

Health Condition(s) or Problem(s) studied

Relapsed and Refractory T-cell Lymphoma

T-cell Lymphoma

Intervention(s)

Drug: Ibrutinib

Primary Outcome(s)

Maximum tolerated does [Time Frame: 1 year]

Secondary Outcome(s)

overall response rate (ORR) [Time Frame: 1 year]

Secondary ID(s)

14-227

Source(s) of Monetary Support

Please refer to primary and secondary sponsors

Secondary Sponsor(s)

Janssen Biotech, Inc.

Pharmacyclics LLC.

Ohio State University