82 Participants Needed

Ruxolitinib for Lymphoma

Recruiting at 9 trial locations
Alison Moskowitz, MD profile photo
Steven M. Horwitz, MD profile photo
Overseen BySteven M. Horwitz, MD
Age: 18+
Sex: Any
Trial Phase: Phase 2
Sponsor: Memorial Sloan Kettering Cancer Center
Must be taking: Antivirals
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)
Prior Safety DataThis treatment has passed at least one previous human trial
Approved in 2 JurisdictionsThis treatment is already approved in other countries

Trial Summary

Will I have to stop taking my current medications?

The trial requires that any previous systemic anti-cancer therapy for T-cell lymphoma must be stopped at least 2 weeks before starting the study drug. However, glucocorticoids (a type of steroid) can be used to control symptoms if reduced to 20mg or less, and topical steroids for skin conditions are allowed.

What data supports the effectiveness of the drug Ruxolitinib for treating lymphoma?

Ruxolitinib, a drug that blocks certain proteins involved in cell growth, has shown some activity in treating relapsed or hard-to-treat Hodgkin lymphoma, with a small percentage of patients experiencing partial responses. While its effects were short-lived, it was generally well-tolerated, suggesting it might be useful when combined with other treatments.12345

Is Ruxolitinib generally safe for humans?

Ruxolitinib has been studied for safety in various conditions, showing some side effects like skin reactions and anemia (low red blood cell count), but it is generally considered safe for use in humans. In animal studies, it did not increase cancer risk, and in a study with Japanese patients, most completed treatment without serious issues.678910

How is the drug Ruxolitinib unique for treating lymphoma?

Ruxolitinib is unique because it is an oral drug that inhibits Janus kinases (JAK) 1 and 2, which are involved in the signaling pathways that can contribute to cancer growth. This mechanism of action is different from many traditional chemotherapy treatments, which often target rapidly dividing cells more broadly.27111213

What is the purpose of 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.

Research Team

Alison J. Moskowitz, MD - MSK Lymphoma ...

Alison Moskowitz, MD

Principal Investigator

Memorial Sloan Kettering Cancer Center

Eligibility Criteria

Adults with relapsed or refractory T or NK cell lymphoma who've had at least one prior systemic therapy can join this trial. They must have measurable disease, adequate blood counts, and organ function. Those with HIV may participate if treated and without active infections. Pregnant women, individuals in poor health, or those on certain other treatments are excluded.

Inclusion Criteria

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
I have HIV but am on treatment and have no active infections.
Measurable disease defined by:
See 15 more

Exclusion Criteria

Any serious medical condition, laboratory abnormality, or psychiatric illness that would prevent the subject from signing the informed consent form.
I have been treated with ruxolitinib before.
I need help with my daily activities due to my health condition.
See 6 more

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive ruxolitinib 20mg BID orally on 28-day cycles. Treatment may continue until disease progression, unacceptable toxicity, recommended termination by the treating physician, or termination of the study.

Variable (until disease progression or study termination)

Follow-up

Participants are monitored for safety and effectiveness after treatment

2 years

Treatment Details

Interventions

  • Ruxolitinib
Trial Overview The trial is testing Ruxolitinib's effectiveness for shrinking T or NK-cell lymphomas by blocking a protein called JAK that helps these cancer cells survive. Participants will receive Ruxolitinib to see how well it works against their lymphoma.
Participant Groups
4Treatment groups
Experimental Treatment
Group I: with rel/ref PTCL with functional evidence of JAK/STATExperimental Treatment1 Intervention
Patients will receive ruxolitinib 20mg BID orally on 28 day cycles. Ruxolitinib should be taken by mouth every 12 hours approximately the same time each day (+/- 2 hours). Treatment may continue until disease progression, unacceptable toxicity, recommended termination by the treating physician, or termination of the study.
Group II: with rel/ref PTCL who do not meet criteria for cohort 1 or 2.Experimental Treatment1 Intervention
Patients will receive ruxolitinib 20mg BID orally on 28 day cycles. Ruxolitinib should be taken by mouth every 12 hours approximately the same time each day (+/- 2 hours).Treatment may continue until disease progression, unacceptable toxicity, recommended termination by the treating physician, or termination of the study.
Group III: rel/ref PTCLtumors are known to contain mutations associExperimental Treatment1 Intervention
Patients will receive ruxolitinib 20mg BID orally on 28 day cycles. Ruxolitinib should be taken by mouth every 12 hours approximately the same time each day (+/- 2 hours). Treatment may continue until disease progression, unacceptable toxicity, recommended termination by the treating physician, or termination of the study.
Group IV: Rare sub-type expansion cohort: T-PLL and T-LGL & any T-Cell/NK Lymphoma with JAK fusion mutations.Experimental Treatment1 Intervention
Patients will receive ruxolitinib 20mg BID orally on 28 day cycles. Treatment may continue until disease progression, unacceptable toxicity, recommended termination by the treating physician, or termination of the study.

Ruxolitinib is already approved in United States, European Union for the following indications:

🇺🇸
Approved in United States as Jakafi for:
  • Intermediate or high-risk myelofibrosis
  • Polycythemia vera
  • Steroid-refractory acute graft-versus-host disease
  • Chronic graft-versus-host disease
  • Vitiligo
🇪🇺
Approved in European Union as Jakavi for:
  • Intermediate or high-risk myelofibrosis
  • Polycythemia vera
  • Steroid-refractory acute graft-versus-host disease
  • Chronic graft-versus-host disease
  • Non-segmental vitiligo

Find a Clinic Near You

Who Is Running the Clinical Trial?

Memorial Sloan Kettering Cancer Center

Lead Sponsor

Trials
1,998
Recruited
602,000+

Cornell University

Collaborator

Trials
179
Recruited
14,090,000+

Dana-Farber Cancer Institute

Collaborator

Trials
1,128
Recruited
382,000+

Thomas Jefferson University

Collaborator

Trials
475
Recruited
189,000+

Findings from Research

Ruxolitinib, the first JAK2 inhibitor, has significantly improved symptoms, spleen size, and overall survival in patients with myelofibrosis compared to traditional chemotherapy, but about 50% of patients discontinue it after 3 years due to resistance or intolerance.
While second-generation tyrosine kinase inhibitors have been tested for patients who discontinue ruxolitinib, they have not shown significant effects on disease progression, highlighting the need for new treatments that target different pathways.
Novel therapeutic agents for myelofibrosis after failure or suboptimal response to JAK2 inhbitors.Breccia, M., Assanto, GM., Laganà, A., et al.[2023]
Patients treated with ruxolitinib, a JAK inhibitor for myelofibrosis and polycythemia vera, have a significantly increased risk of developing Mycobacterium tuberculosis (MTB) and atypical mycobacterial infections (AMI), with reporting odds ratios of 9.2 and 8.3, respectively.
Out of the reported cases, 13.2% of patients with MTB and 34.8% with AMI died, highlighting the importance of screening for latent MTB before starting ruxolitinib treatment.
Mycobacterial Infections With Ruxolitinib: A Retrospective Pharmacovigilance Review.Anand, K., Burns, EA., Ensor, J., et al.[2021]
In a 3-year follow-up of the COMFORT-II Trial involving 219 patients with myelofibrosis, ruxolitinib demonstrated sustained reductions in spleen size and improved quality of life, with 45% of patients remaining on treatment after 3 years.
Ruxolitinib was well tolerated, with manageable side effects like anemia and thrombocytopenia, and it was associated with longer overall survival compared to the best available therapy, indicating its efficacy and safety as a treatment option.
Three-year efficacy, safety, and survival findings from COMFORT-II, a phase 3 study comparing ruxolitinib with best available therapy for myelofibrosis.Cervantes, F., Vannucchi, AM., Kiladjian, JJ., et al.[2022]

References

Novel therapeutic agents for myelofibrosis after failure or suboptimal response to JAK2 inhbitors. [2023]
Mycobacterial Infections With Ruxolitinib: A Retrospective Pharmacovigilance Review. [2021]
Three-year efficacy, safety, and survival findings from COMFORT-II, a phase 3 study comparing ruxolitinib with best available therapy for myelofibrosis. [2022]
A phase II study of the oral JAK1/JAK2 inhibitor ruxolitinib in advanced relapsed/refractory Hodgkin lymphoma. [2021]
Janus activated kinase inhibition in myelofibrosis. [2021]
Erythematous skin lesions with necrotic centers on lower extremities due to the use of ruxolitinib for primary myelofibrosis. [2021]
Case-report: EBV driven lymphoproliferative disorder associated with Ruxolitinib. [2022]
Off-label Studies on the Use of Ruxolitinib in Dermatology. [2021]
Results from oral gavage carcinogenicity studies of ruxolitinib in Tg.rasH2 mice and Sprague-Dawley (Crl:CD) rats. [2021]
Assessing the safety and efficacy of ruxolitinib in a multicenter, open-label study in Japanese patients with myelofibrosis. [2021]
11.United Statespubmed.ncbi.nlm.nih.gov
Peritransplantation Use of Ruxolitinib in Myelofibrosis. [2021]
Ruxolitinib: a review of its use in patients with myelofibrosis. [2021]
Ruxolitinib protects lipopolysaccharide (LPS)-induced sepsis through inhibition of nitric oxide production in mice. [2022]
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