Study of Ruxolitinib in Relapsed or Refractory T or NK Cell Lymphoma

Официальное название

Phase II Multicenter Study of Ruxolitinib in Relapsed or Refractory T or NK Cell Lymphoma

Обзор

The purpose of this study is to test any good and bad effects of the study drug called ruxolitinib. Ruxolitinib works by blocking a protein called JAK. JAK works along with another protein called STAT and is important for survival of many T or NK-cell lymphomas. By blocking JAK, ruxolitinib may cause T or NK-cell lymphomas to shrink.

Вмешательства

• Препарат Ruxolitinib

Первичные конечные точки

• disease control rate [Срок оценки: 2 years]

Критерии участия

Критерии включения

• Pathologically confirmed T or NK cell lymphoma at the enrolling institution. For CTCL, patients with stage IB disease or greater are eligible.
• Relapse or refractory disease after at least 1 systemic therapy except for T-PLL, LGL, or T-cell Lymphoproliferative diseases with JAK2 fusion.
• Untreated patients may be allowed after discussion with P.I.
• Age ≥ 18
• ECOG ≤ 2
• Measurable disease defined by:

• Lugano Classification for systemic lymphoma or
• Atypical and or malignant lymphocytes quantifiable by flow cytometry or morphology in blood or bone marrow or
• mSWAT > 0 or Sezary count ≥ 1000 cells/μL for CTCL
• Previous systemic anti-cancer therapy for T-cell lymphoma must have been discontinued at least 2 weeks prior to treatment.

• Glucocorticoids aimed at controlling lymphoma-related symptoms are allowed as long as they are tapered down to 20mg or less by the time of ruxolitiib initiation
• Topical steroids for CTCL are permitted
• See section 6.2 Subject Exclusion Criteria for guideline regarding adjuvant and maintenance therapy for prior malignancy
• Patients must meet the following lab criteria:

• ANC ≥ 1.0/mm\^3 or ANC >/= 0.5/mm\^3 (if patient has baseline neutropenia due to lymphoma), platelets ≥ 100 x 10\^9/L or ≥ 50 x 10\^9/L (if related to lymphoma), Hgb ≥ 8g/dL
• Patients with LGL or T-PLL are not required to meet a minimum ANC or hemoglobin value for eligibility
• Total bilirubin ≤ 1.5 x upper limit of normal (ULN) or; ≤ 3 x ULN if documented hepatic involvement with lymphoma, or ≤ 5 x ULN if history of Gilbert's ; AST and ALT ≤ 3 x ULN; ≤ 5 x ULN if due to lymphoma involvement
• Creatinine clearance ≥ 30 mL/min; creatinine clearance of 15-29 mL/min will be allowed as long as baseline platelets are ≥ 150 x 10\^9/L
• For patients with positive hepatitis B core antibody or surface antigen, hepatitis B PCR must be negative and prophylaxis with entecavir or equivalent is required.
• Patients with HIV are allowed provided that they are on anti-retroviral treatment with no active infections.

Критерии исключения

• Any serious medical condition, laboratory abnormality, or psychiatric illness that would prevent the subject from signing the informed consent form.
• Uncontrolled concurrent illness including, but not limited to, ongoing or active infection, uncontrolled diabetes, clinically significant pneumonitis, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, or psychiatric illness/social situations that would limit compliance with study requirements.
• ECOG performance status >2
• Prior therapy with ruxolitinib
• Receiving systemic therapy for another primary malignancy (other than T-cell lymphoma)

• Patients with more than one type of lymphoma may be enrolled after discussion with the MSK Principal Investigator
• Adjuvant or maintenance therapy to reduce the risk of recurrence of other malignancy (other than T-cell lymphoma) is permissible after discussion with the MSK principal Investigator
• Women of reproductive potential† must have a negative Serum ß human chorionic gonadotropin (ß-HCG) pregnancy test.

• A female of reproductive potential is a sexually mature female who: has not undergone a hysterectomy or bilateral oophorectomy; or has not been naturally postmenopausal for at least 24 consecutive months (i.e. has had menses at any time in the preceding 24 consecutive months).

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Нерандомизированное

Модель

Параллельные группы

Маскирование

Открытое

Основная цель

Лечение

Центры проведения

США · 10 центров

• University of Miami — Miami
• Northwestern Medicine (Data collection and specimen analysis) — Chicago
• Dana Farber Cancer Institute — Boston
• Memorial Sloan Kettering Basking Ridge — Basking Ridge
• Memorial Sloan Kettering Monmouth (All Protocol Activities) — Middletown
• Memorial Sloan Kettering Commack — Commack
• Memorial Sloan Kettering Westchester — Harrison
• Memorial Sloan Kettering Cancer Center — New York
• … и ещё 2 центра

Публикации

• Moskowitz AJ, Ghione P, Jacobsen E, Ruan J, Schatz JH, Noor S, Myskowski P, Vardhana S, Ganesan N, Hancock H, Davey T, Perez L, Ryu S, Santarosa A, Dowd J, Obadi O, Pomerantz L, Yi N, Sohail S, Galasso N, Neuman R, Liotta B, Blouin W, Baik J, Geyer MB, Noy A, Straus D, Kumar P, Dogan A, Hollmann T, Drill E, Rademaker J, Schoder H, Inghirami G, Weinstock DM, Horwitz SM. A phase 2 biomarker-driven s PMID 34653242

Идентификаторы

NCT: NCT02974647 · 16-1542

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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