Ruxolitinib for Lymphoma, T-Cell

Phase-Based Progress Estimates
1
Effectiveness
1
Safety
Dana Farber Cancer Institute, Boston, MA
Lymphoma, T-Cell+4 More
Ruxolitinib - Drug
Eligibility
18+
All Sexes
Eligible conditions
Select

Study Summary

This study is evaluating whether a drug called ruxolitinib or a drug called duvelisib can be given safely to people with relapsed or refractory NK-cell or T-cell lymphoma.

See full description

Eligible Conditions

  • Lymphoma, T-Cell
  • T-cell Lymphomas
  • NK-Cell Lymphomas

Treatment Effectiveness

Effectiveness Progress

1 of 3

Study Objectives

This trial is evaluating whether Ruxolitinib will improve 1 primary outcome in patients with Lymphoma, T-Cell. Measurement will happen over the course of 1 year.

1 year
Assessment for MTD/optimal dose

Trial Safety

Safety Progress

1 of 3

Trial Design

1 Treatment Group

Ruxolitinib and Duvelisib
1 of 1
Experimental Treatment

This trial requires 52 total participants across 1 different treatment group

This trial involves a single treatment. Ruxolitinib is the primary treatment being studied. Participants will all receive the same treatment. There is no placebo group. The treatments being tested are in Phase 1 and are in the first stage of evaluation with people.

Ruxolitinib and DuvelisibRuxolitinib 20mg BID plus Duvelisib 25mg, 50mg, or 75mg BID. Patients will be instructed to take duvelisib and ruxolitinib by mouth every 12 hours, the same time each day, +/- 2 hours. Duvelisib and ruxolitinib will be provided via the institutional investigational pharmacy. The researchers will utilize a dose-escalation standard 3+3 design in which we evaluate 3 doses of duvelisib (25mg BID, 50mg BID, and 75mg BID) in combination with ruxolitinib 20mg BID. A minus-1 dose level of duvelisib (15mg BID) can be used if de-escalation is needed. The cohort expansion phase will have two treatment groups JAK/STAT activation or mutation present or JAK/STAT activation or mutation absent or unknown.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Duvelisib
FDA approved
Ruxolitinib
FDA approved

Trial Logistics

Trial Timeline

Approximate Timeline
Screening: ~3 weeks
Treatment: Varies
Reporting: 1 year
This trial has the following approximate timeline: 3 weeks for initial screening, variable treatment timelines, and roughly 1 year for reporting.

Closest Location

Dana Farber Cancer Institute - Boston, MA

Eligibility Criteria

This trial is for patients born any sex aged 18 and older. You must have received 1 prior treatment for Lymphoma, T-Cell or one of the other 4 conditions listed above. There are 10 eligibility criteria to participate in this trial as listed below.

Mark “yes” if the following statements are true for you:
i) Stage ≥Ib CTCL, which has relapsed or progressed after at least two systemic therapies. In order to ensure balanced enrollment for patients with systemic T-cell lymphoma and CTCL, a maximum of 15 CTCL patients will be enrolled in expansion cohort.
ii) Systemic anaplastic large cell lymphoma that has relapsed after therapy containing brentuximab vedotin.
iii) T-cell prolymphocytic leukemia (treatment naïve permitted)
Pathologically-confirmed mature T-cell lymphomas at the enrolling institution.
iv) T-cell large granular lymphocytic leukemia
v) Aggressive NK-cell leukemia
vi) Adult T-cell leukemia/lymphoma
vii) Extranodal NK/T- cell lymphoma, nasal type
viii) Enteropathy-associated T-cell lymphoma
ix) Monomorphic epitheliotropic intestinal t-cell lymphoma

Patient Q&A Section

How quickly does lymphoma, t-cell spread?

"The rapid spread of lymphoma (or 'lymphomatosis') describes a subset of patients who have an increased risk of relapse and death after autologous stem cell transplantation (ASCT). Results from a recent clinical trial suggests that the presence of B-symptoms at ASCT should prompt a more intensive post-transplant follow-up." - Anonymous Online Contributor

Unverified Answer

What are the signs of lymphoma, t-cell?

"Lymphomas may present with symptoms similar to other illnesses. For example, B-cell lymphomas may resemble arthritis or fever. Other symptoms include swollen lymph nodes, unintentional weight loss, coughing up blood, feeling tired, hair loss, and skin changes. Symptoms usually improved after treatment." - Anonymous Online Contributor

Unverified Answer

Has ruxolitinib proven to be more effective than a placebo?

"In summary, our meta-analysis suggests that RAI therapy is significantly superior to the standard care. We found no evidence for any superiority regarding OS compared to the current standard care. However, we could not observe any significant difference between the two groups regarding RR." - Anonymous Online Contributor

Unverified Answer

Who should consider clinical trials for lymphoma, t-cell?

"Clinical trials can help patients get better care for their cancer. Physicians and nurses should counsel patients about possible risks and benefits of clinical trials. Families should great participate in the decision-making process by sharing their views." - Anonymous Online Contributor

Unverified Answer

What are the common side effects of ruxolitinib?

"Ruxolitinib is well tolerated in patients with ALK+ large B-cell lymphomas. Common adverse reactions included muscle aches and weakness, headache, nausea, vomiting, and decreased appetite. Serious adverse events were uncommon, but included myelosuppression, elevated transaminases and diarrhea. Arrhythmia was infrequent, but may require close monitoring." - Anonymous Online Contributor

Unverified Answer

Can lymphoma, t-cell be cured?

"Lymphoma, t-cell has been treated with chemotherapy and radiotherapy, but there is no effective cure for it. In the future, we need to develop new treatments for lymphomas, especially T-cells." - Anonymous Online Contributor

Unverified Answer

What is lymphoma, t-cell?

""Lymphoma, T-cell" is a breach of medical ethics because patients would not be able to know what type of cancer they have until they undergo diagnostic evaluation and treatment. show how medical professionals and ethicists work together to help patients make good decisions in the care of their own health." - Anonymous Online Contributor

Unverified Answer

What are the chances of developing lymphoma, t-cell?

"Of all people with an autoimmune disorder and no history of lymphoma, 7.7% will develop it at some point in their lifetimes. In contrast, only 1.3% will develop it within the first year of diagnosis.\n" - Anonymous Online Contributor

Unverified Answer

Is ruxolitinib safe for people?

"Ruxolitinib has been well tolerated in this patient population. Although the safety of ruxolitinib in children has not yet been established, it appears to be efficacious in adults with relapsed or refractory indolent lymphomas." - Anonymous Online Contributor

Unverified Answer

What is the latest research for lymphoma, t-cell?

"Researchers have made advances in the diagnosis of lymphoma. Type of lymphoma being diagnosed will vary depending upon the location of the lymphoma in the body. Some lymphomas are treated using chemotherapy alone, whereas others require combination therapy that includes radiation. Lymphoma tends to affect older men, although its exact cause remains unknown. Please see the table below for more information about the types of lymphoma and treatments available for each type of lymphoma." - Anonymous Online Contributor

Unverified Answer

What does ruxolitinib usually treat?

"This data shows that ruxolitinib is effective against relapsed/refractory aggressive lymphomas including T-cell lymphomas such as primary mediastinal large B cell lymphoma (PMLBCL) and hairy cell leukemia. It should be used in combination with other agents or chemotherapy regimens when warranted." - Anonymous Online Contributor

Unverified Answer
Please Note: These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
See if you qualify for this trial
Get access to this novel treatment for Lymphoma, T-Cell by sharing your contact details with the study coordinator.