RECRUITING

A Study of Ruxolitinib and Duvelisib in People With Lymphoma

Conditions

T-cell Lymphomas NK-Cell Lymphomas T-cell Prolymphocytic Leukemia T-cell Large Granular Lymphocyte Leukemia mature T-cell lymphomas Ruxolitinib Duvelisib Relapsed or Refractory 21-176

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Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

This study will test the safety of ruxolitinib, given at one dose that does not change, and duvelisib, given at different doses, to find out what effects, if any, the study treatment has on people with relapsed or refractory NK-cell or T-cell lymphoma. This study has three parts: dose escalation (Part 1), dose expansion (Part 2), and TFH/T-PLL cohort expansion (Part 3).

Official Title

Phase I Multicenter Study of Ruxolitinib and Duvelisib in Relapsed or Refractory T- or NK-Cell Lymphomas

Quick Facts

Study Start:2021-08-12

Study Completion:2027-08

Study Type:Not specified

Phase:Not Applicable

Enrollment:Not specified

Status:RECRUITING

Study ID

NCT05010005

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:18 Years

Sexes Eligible for Study:ALL

Accepts Healthy Volunteers:No

Standard Ages:ADULT, OLDER_ADULT

Inclusion Criteria	Exclusion Criteria
1. Absolute neutrophil count ≥1.0 K/mcL (Note: growth factor is allowed) 2. Platelet count ≥80 K/μl or ≥50 K/μl if due to lymphoma 3. Creatinine ≤1.5 × ULN OR Measured calculated creatinine clearance ≥30 mL/min for participant with creatinine levels \>1.5 × institutional ULN 1. Absolute neutrophil count ≥1.0 K/mcL or ≥0.5 K/mcL if due to lymphoma or ≥0.0 K/mcL if due to T-PLL or large granular lymphocytic leukemia (LGL) (Note: growth factor is allowed). 2. Platelet count ≥80 K/μl or ≥50 K/μl if due to lymphoma 3. c. Creatinine ≤1.5 × ULN OR Measured calculated creatinine clearance ≥30 mL/min for participant with creatinine levels \>1.5 × institutional ULN * Revised International Working Group Classification for systemic lymphoma19 * Atypical T lymphocytes quantifiable by flow cytometry or morphology in the peripheral blood or bone marrow * mSWAT (Modified Severity Weighted Assessment Tool) \>0 * A woman of reproductive potential is a sexually-mature woman 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). * The effects of duvelisib on conception, pregnancy, and lactation are unknown. Since duvelisib has not been evaluated in pregnant or nursing women, the treatment of pregnant women or women of childbearing potential who are not using a highly effective contraception is contraindicated.	1. Any serious medical condition, laboratory abnormality, or psychiatric illness that would prevent the subject from signing the informed consent form. 2. Pregnant women. (Lactating women must agree not to breast feed while taking study medications). 3. Prior allogeneic stem cell transplant within 6 months of starting treatment or patients with active GVHD requiring immunosuppression. * Subjects with a negative HBsAg and a positive HBcAb require an undetectable/negative hepatitis B DNA test (e.g., polymerase chain reaction \[PCR\] test) to be enrolled, and must receive hepatitis B prophylaxis until at least 6 months after completion of study drug(s). * Such agents must be discontinued at least 2 weeks prior to study intervention * Patients who (after enrollment) require use of a strong CYP3A4 inhibitor to treat a fungal/mold infection will require dose reductions n) Receipt of treatment for tuberculosis within 2 years prior to enrollment * Patients with more than one type of lymphoma may be enrolled after discussion with the MSK Principal Investigator. * Early-stage cutaneous basal cell and squamous cell carcinomas are permissible * Adjuvant or maintenance therapy to reduce the risk of recurrence of other malignancy is potentially permissible after discussion with the MSK Principal Investigator.

Inclusion Criteria

Exclusion Criteria

1. Absolute neutrophil count ≥1.0 K/mcL (Note: growth factor is allowed)
2. Platelet count ≥80 K/μl or ≥50 K/μl if due to lymphoma
3. Creatinine ≤1.5 × ULN OR Measured calculated creatinine clearance ≥30 mL/min for participant with creatinine levels \>1.5 × institutional ULN
1. Absolute neutrophil count ≥1.0 K/mcL or ≥0.5 K/mcL if due to lymphoma or ≥0.0 K/mcL if due to T-PLL or large granular lymphocytic leukemia (LGL) (Note: growth factor is allowed).
2. Platelet count ≥80 K/μl or ≥50 K/μl if due to lymphoma
3. c. Creatinine ≤1.5 × ULN OR Measured calculated creatinine clearance ≥30 mL/min for participant with creatinine levels \>1.5 × institutional ULN
* Revised International Working Group Classification for systemic lymphoma19
* Atypical T lymphocytes quantifiable by flow cytometry or morphology in the peripheral blood or bone marrow
* mSWAT (Modified Severity Weighted Assessment Tool) \>0
* A woman of reproductive potential is a sexually-mature woman 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).
* The effects of duvelisib on conception, pregnancy, and lactation are unknown. Since duvelisib has not been evaluated in pregnant or nursing women, the treatment of pregnant women or women of childbearing potential who are not using a highly effective contraception is contraindicated.

1. Any serious medical condition, laboratory abnormality, or psychiatric illness that would prevent the subject from signing the informed consent form.
2. Pregnant women. (Lactating women must agree not to breast feed while taking study medications).
3. Prior allogeneic stem cell transplant within 6 months of starting treatment or patients with active GVHD requiring immunosuppression.
* Subjects with a negative HBsAg and a positive HBcAb require an undetectable/negative hepatitis B DNA test (e.g., polymerase chain reaction \[PCR\] test) to be enrolled, and must receive hepatitis B prophylaxis until at least 6 months after completion of study drug(s).
* Such agents must be discontinued at least 2 weeks prior to study intervention
* Patients who (after enrollment) require use of a strong CYP3A4 inhibitor to treat a fungal/mold infection will require dose reductions n) Receipt of treatment for tuberculosis within 2 years prior to enrollment
* Patients with more than one type of lymphoma may be enrolled after discussion with the MSK Principal Investigator.
* Early-stage cutaneous basal cell and squamous cell carcinomas are permissible
* Adjuvant or maintenance therapy to reduce the risk of recurrence of other malignancy is potentially permissible after discussion with the MSK Principal Investigator.

Contacts and Locations

Study Contact

Alison Moskowitz, MD

CONTACT

646-608-3726

moskowia@mskcc.org

Steven Horwitz, MD

CONTACT

646-608-3725

Principal Investigator

Alison Moskowitz, MD

PRINCIPAL_INVESTIGATOR

Memorial Sloan Kettering Cancer Center

Study Locations (Sites)

University of Miami (Data Collection Only)

Miami, Florida, 33125

United States

Dana Farber Cancer Institute

Boston, Massachusetts, 02115

United States

Memorial Sloan Kettering Basking Ridge (Limited Protocol Activities)

Basking Ridge, New Jersey, 07920

United States

Memorial Sloan Kettering Monmouth (Limited Protocol Activities)

Middletown, New Jersey, 07748

United States

Memorial Sloan Kettering Bergen (Limited Protocol Activities)

Montvale, New Jersey, 07645

United States

Memorial Sloan Kettering Commack (Limited Protocol Activities)

Commack, New York, 11725

United States

Memorial Sloan Kettering Westchester (Limited Protocol Activities)

Harrison, New York, 10604

United States

Memorial Sloan Kettering Cancer Center

New York, New York, 10065

United States

Memorial Sloan Kettering Nassau (Limited Protocol Activities)

Uniondale, New York, 11553

United States

Collaborators and Investigators

Sponsor: Memorial Sloan Kettering Cancer Center

Alison Moskowitz, MD, PRINCIPAL_INVESTIGATOR, Memorial Sloan Kettering Cancer Center

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2021-08-12

Study Completion Date2027-08

Study Record Updates

Study Start Date2021-08-12

Study Completion Date2027-08

Terms related to this study

Keywords Provided by Researchers

mature T-cell lymphomas
Ruxolitinib
Duvelisib
Relapsed or Refractory
21-176
T-cell Large Granular Lymphocyte Leukemia
T-cell Prolymphocytic Leukemia

Additional Relevant MeSH Terms

T-cell Lymphomas
NK-Cell Lymphomas
T-cell Prolymphocytic Leukemia
T-cell Large Granular Lymphocyte Leukemia