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New treatment option for Lymphoma
Official title Study of Ruxolitinib in Relapsed or Refractory T or NK Cell Lymphoma
ClinicalTrials.gov ID: NCT02974647
What this study is testing
What is Ruxolitinib?
Ruxolitinib is an investigational medicine, being studied as a potential treatment for lymphoma.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- 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.
- Phase 2: a mid-size study of how well it works
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 and older
You may be able to join if
- 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
You likely can't join if
- 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...
- 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...
- 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
See the full eligibility criteria
- 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
- 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. Exclusion Criteria:
- 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...
- 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...
The study team makes the final eligibility decision.
Where it's taking place
- Miami, Florida, United States
- Chicago, Illinois, United States
- Boston, Massachusetts, United States
- Basking Ridge, New Jersey, United States
- Middletown, New Jersey, United States
- Commack, New York, United States
- Harrison, New York, United States
- New York, New York, United States
- Uniondale, New York, United States
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Miami, Florida, United States; Chicago, Illinois, United States; Boston, Massachusetts, United States; Basking Ridge, New Jersey, United States; Middletown, New Jersey, United States; Commack, New York, United States and 3 more location(s). Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.