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

ConditionLymphoma
Trial statusRecruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexAll
Age18+
SponsorMemorial Sloan Kettering Cancer Center

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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

Disqualifiers

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

Trial design

Design model

Parallel

Treatments tested in this trial

  • Ruxolitinib

    Drug

Treatment groups

83 Participants
are divided into 4 treatment groups
Group A: rel/ref PTCLtumors are known to contain mutations associExperimental treatment 1 intervention
Group B: with rel/ref PTCL with functional evidence of JAK/STATExperimental treatment 1 intervention
Group C: with rel/ref PTCL who do not meet criteria for cohort 1 or 2.Experimental treatment 1 intervention
Group D: Rare sub-type expansion cohort: T-PLL and T-LGL & any T-Cell/NK Lymphoma with JAK fusion mutations.Experimental treatment 1 intervention

Trial outcomes

Primary outcomes

1

disease control rate

defined as the combination of complete response (CR), partial response (PR) and stable disease (SD). The reason we use this definition instead of the more conventional partial/complete response rate is twofold.

Time frame
2 years

Secondary outcomes

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Memorial Sloan Kettering Cancer Center

Lead sponsor

Cornell University

Collaborator

Dana-Farber Cancer Institute

Collaborator

Thomas Jefferson University

Collaborator

Source ClinicalTrials.gov
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