Medical Information Only. Always consult your healthcare provider before enrolling in any clinical trial.
NCT05010005 · ClinicalTrials.gov registry record · Phase 1
A Study of Ruxolitinib and Duvelisib in People With Lymphoma
A Phase 1 study of T-cell-prolymphocytic Leukemia and T-cell Large Granular Lymphocyte Leukemia, sponsored by Memorial Sloan Kettering Cancer Center.
- Recruiting
- Registry status
- Phase 1
- Development phase
- 70
- Enrollment target
- 9
- Study locations
NCT05010005: Recruiting Phase 1 study of T-cell-prolymphocytic Leukemia and T-cell Large Granular Lymphocyte Leukemia, sponsored by Memorial Sloan Kettering Cancer Center.
NCT05010005 is a Phase 1 study of T-cell-prolymphocytic Leukemia and T-cell Large Granular Lymphocyte Leukemia that is actively recruiting participants, run by Memorial Sloan Kettering Cancer Center. The registered enrollment target is 70 participants, below the 171-participant average among 7 other T-cell-prolymphocytic Leukemia trials with a reported enrollment target (59% lower). The trial reports 9 study locations across 4 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT05010005, a Phase 1 study of T-cell-prolymphocytic Leukemia and T-cell Large Granular Lymphocyte Leukemia, is actively recruiting participants, sponsored by Memorial Sloan Kettering Cancer Center.
- RECRUITING
- Registry status
- Phase 1
- Development phase
- 70 participants
- Enrollment target
- 9
- Study locations
Study Summary
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).
Primary Outcome
3 subjects will be enrolled and followed for eight weeks of safety assessments. If no DLT is observed after all three subjects have been observed for eight weeks, a second cohort of 3 subjects will be enrolled at the next highest dose level. Cohorts will continue to be enrolled and observed until one subject experiences a DLT or the maximum dose level is reached with 0 or 1/6 DLTs.
Conditions Studied
Interventions
- DRUG Ruxolitinib
- DRUG Duvelisib
Study Locations (9)
New York
- Memorial Sloan Kettering Commack (Limited Protocol Activities) - Commack
- Memorial Sloan Kettering Westchester (Limited Protocol Activities) - Harrison
- Memorial Sloan Kettering Cancer Center - New York
- Memorial Sloan Kettering Nassau (Limited Protocol Activities) - Uniondale
New Jersey
- Memorial Sloan Kettering Basking Ridge (Limited Protocol Activities) - Basking Ridge
- Memorial Sloan Kettering Monmouth (Limited Protocol Activities) - Middletown
- Memorial Sloan Kettering Bergen (Limited Protocol Activities) - Montvale
Florida
- University of Miami (Data Collection Only) - Miami
Massachusetts
- Dana Farber Cancer Institute - Boston
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 70 participants |
| Start Date | 2021-08-12 |
| Est. Completion | 2027-08 |
| Phase | Phase 1 |
What NCT05010005 shows while recruiting
NCT05010005 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 70 participants, a relatively small participant target, below the 171-participant average among 7 other T-cell-prolymphocytic Leukemia trials with a reported enrollment target (59% lower).
The record links to 4 conditions, with T-cell-prolymphocytic Leukemia appearing as the primary indexed condition, and to 2 interventions - of which Ruxolitinib is the first listed.
NCT05010005 lists 9 locations in 4 states (New York, New Jersey, Florida).
Frequently Asked Questions
What is clinical trial NCT05010005 about?
NCT05010005 is a clinical study titled "A Study of Ruxolitinib and Duvelisib in People With Lymphoma". 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 (P...
What is the current status of trial NCT05010005?
This trial is currently recruiting. It is a Phase 1 study. The enrollment target is 70 participants. The study started on 2021-08-12. Estimated completion is 2027-08.
What conditions does trial NCT05010005 study?
This clinical trial studies the following conditions: T-cell-prolymphocytic Leukemia, T-cell Large Granular Lymphocyte Leukemia, T-cell Lymphomas, NK-Cell Lymphomas.
What interventions are being tested in trial NCT05010005?
The interventions under investigation include: Ruxolitinib (DRUG), Duvelisib (DRUG).
Who is sponsoring clinical trial NCT05010005?
This trial is sponsored by Memorial Sloan Kettering Cancer Center, which has 1,884 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT05010005 being conducted?
This trial has 9 study locations across Florida, Massachusetts, New Jersey, New York. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
Similar trials for T-cell-prolymphocytic Leukemia
Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.
-
Duvelisib and Venetoclax in Patients With Relapsed or Refractory Peripheral T-cell Lymphoma (PTCL)
RECRUITING · Phase 1
-
Study of Oral Administration of LP-118 in Patients With Relapsed or Refractory CLL, SLL, MDS, MDS/MPN, AML, CMML-2, MPN-BP, ALL, MF, NHL, RT, MM or T-PLL.
RECRUITING · Phase 1
-
Itacitinib With High-dose Posttransplantation Cyclophosphamide in Older Patients
ACTIVE NOT RECRUITING · Phase 1
-
Dose-Escalation and Dose-Expansion Study to Evaluate the Safety and Tolerability of Anti-CD7 Allogeneic CAR T-Cells (WU-CART-007) in Patients With CD7+ Hematologic Malignancies
ACTIVE NOT RECRUITING · Phase 1
-
A Registry for People With T-cell Lymphoma
RECRUITING
-
Ruxolitinib Maintenance Post-Hematopoietic Stem Cell Transplant T-Cell Lymphoma
RECRUITING · Phase 2
Nationwide trials with similar profiles
Cross-condition peers matched on enrollment target and registry start date, not the same-condition list above.
Similar enrollment target
- NCT00969111 · 70 participants · NA
Postoperative or Salvage Radiotherapy (RT) for Node Negative Prostate Cancer Following Radical Prostatectomy
- NCT01712620 · 70 participants · Phase 2
Spironolactone for Pulmonary Arterial Hypertension
- NCT02143830 · 70 participants · Phase 2
HSCT for Patients With Fanconi Anemia Using Risk-Adjusted Chemotherapy
- NCT02601339 · 70 participants
NIRS Monitoring in Premature Infants
Similar registry start date
- NCT05962346 · started 2026-12 · NA
Fetal Endoscopic Tracheal Occlusion for Congenital Diaphragmatic Hernia
- NCT07125183 · started 2026-12 · Phase 2
Study on Efficacy and Tolerability of Weekly Doxorubicin in Elderly Patients With Advanced or Metastatic Leiomyosarcoma
- NCT07292298 · started 2026-11 · Phase 2
Phase 2 Single-Arm Rectal Cancer Brachytherapy for Patients With Low-Lying Residual Adenocarcinoma After Total Neoadjuvant Therapy to Improve Organ Preservation Rates
- NCT04263285 · started 2026-10 · NA
Treatment of Depression Post-SCI