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NCT07428707
Immune Profiling of CLL/SLL Treated With First-Line Pirtobrutinib
EARLY_PHASE1 trial testing Pirtobrutinib in Chronic Lymphocytic Leukemia (CLL) in 30 participants. Currently enrolling.
1 February 2030
Quick facts
| Lead sponsor | National Heart, Lung, and Blood Institute (NHLBI) |
|---|---|
| Phase | EARLY_PHASE1 |
| Status | Recruiting now |
| Study type | INTERVENTIONAL |
| Allocation | na |
| Design | single group |
| Masking | none |
| Primary purpose | basic science |
| Enrollment | 30 |
| Start date | 11 March 2026 |
| Primary completion | 1 February 2030 |
| Estimated completion | 1 March 2030 |
| Sites | 1 location across United States |
Drugs / interventions tested
- Pirtobrutinib — full drug profile →
Conditions studied
- Chronic Lymphocytic Leukemia (CLL) — all drugs for Chronic Lymphocytic Leukemia (CLL) →
- Small Lymphocytic Lymphoma (SLL) — all drugs for Small Lymphocytic Lymphoma (SLL) →
Sponsor
National Heart, Lung, and Blood Institute (NHLBI)
Who can join
Adults 18 to 100, any sex, with Chronic Lymphocytic Leukemia (CLL) or Small Lymphocytic Lymphoma (SLL). Patients with the condition only — healthy volunteers not accepted.
Sponsor's own description
Background: Chronic lymphocytic leukemia (CLL) and small lymphocytic lymphoma (SLL) are blood cancers that affect certain white blood cells. Advanced forms of these diseases are difficult to treat. Pirtobrutinib is a drug approved to treat CLL and SLL after 2 previous treatments. Researchers want to know how this drug affects the immune system in those who have not yet started other treatments for CLL or SLL. Objective: To test pirtobrutinib as a first-line treatment for CLL or SLL. Eligibility: People aged 18 years and older with untreated CLL or SLL. Design: Participants will be screened. They will have a physical exam with blood tests. They will have imaging scans and tests of their heart function. They will have a lymph node biopsy: A large needle will be inserted into a lymph node to collect a small piece of tissue. Pirtobrutinib is a tablet taken by mouth. Participants will take 2 to 4 tablets daily in 4-week cycles. Participants will have clinic visits once every 4 weeks for the first 3 months. Then they will be seen once every 3 months. Imaging scans, lymph node biopsy, and other tests will be repeated at various study visits. A bone marrow biopsy (collection of soft tissue from inside a bone) may be done if there is no evidence of disease after 1 year of treatment with the study drug. Participants may opt to have cancer and immune cells collected from their blood. The cells will be used for research. Participants will have a clinic visit 1 month after their last dose of the study drug. Then they will have follow-up visits or phone calls every 6 to 12 months....
Publications & conference data
No peer-reviewed publications indexed yet for this trial.
Verify or expand the search:
- PubMed search for NCT07428707
- Europe PMC full search
- ASCO Meeting Library
- ESMO Meeting Library
- bioRxiv preprints
- medRxiv preprints
- Google Scholar
Related trials
Other trials of Pirtobrutinib
Trials testing the same drug.
- NCT07525817 — A Real-World Study of Pirtobrutinib in cBTKi-Resistant/Intolerant Mature B-Cell Lymphoma · not yet recruiting
- NCT07207785 — PirtobrUtinib as Frontline Therapy for Elderly Unfit/Frail Patient With MAntle Cell Lymphoma · Phase 2 · not yet recruiting
- NCT07342478 — ROCKET-CLL Global Phase 3 Study: Rocbrutinib vs Pirtobrutinib in cBTKi-Pretreated R/R CLL/SLL · Phase 3 · not yet recruiting
- NCT07255963 — Pirtobrutinib, Lisaftoclax, and Rituximab in the Treatment of R/R DLBCL · Phase 2 · recruiting
- NCT07052695 — Mosunetuzumab for CLL MRD Clearance · Phase 1, PHASE2 · recruiting
Other recruiting trials for Chronic Lymphocytic Leukemia (CLL)
Currently open trials in the same condition.
- NCT07205315 — A Clinical Study Evaluating the Safety and Efficacy of GT801 Injection in Adult Patients With Relapsed/Refractory CD19-p · EARLY_PHASE1 · recruiting
- NCT06788639 — A Study of Patients With Relapsed/Refractory Chronic Lymphocytic Leukemia/Small Lymphocytic Lymphoma Treated With Lisoca · recruiting
- NCT05908409 — A Phase 1/2 Study of IDP-121 in Patients With Relapsed/Refractory Hematologic Malignancies · Phase 1, PHASE2 · recruiting
- NCT05724121 — Observational Study of Cardiac Arrhythmias During Treatment With BTK Inhibitors or Venetoclax · recruiting
- NCT04758975 — Venetoclax, Rituximab and Ibrutinib in TN Patients With CLL Undetectable Minimal Residual Disease (uMRD) in Treatment-na · Phase 2 · recruiting
Other National Heart, Lung, and Blood Institute (NHLBI) trials
Trials by the same sponsor.
- NCT07566494 — Escalating Doses of VAS-101 in Subjects With Stable Sickle Cell Disease · Phase 1 · not yet recruiting
- NCT07516379 — GRAfT 2.0. A Multimodal Prospective Approach to Define the Mechanisms and Clinical Features of Acute and Chronic Rejecti · not yet recruiting
- NCT07137455 — EDEN Intracardiac Electrogram Recording and Classifying System · NA · enrolling by invitation
- NCT06948097 — Syk Inhibition in MItigating Lung Allograft Rejection (SIMILAR): A Trial to Evaluate the Safety and Tolerability of Fost · Phase 1 · not yet recruiting
- NCT05372627 — NHLBI-Emory Advanced Cardiac CT Reconstruction · not yet recruiting
Verify against primary sources
- ClinicalTrials.gov — authoritative US registry record
- WHO ICTRP — international registry index
- EU Clinical Trials Register
- Sponsor press releases (Google)
- Trial protocol + status: ClinicalTrials.gov NCT07428707 (US National Library of Medicine, public domain)
- Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
- Sponsor: as reported to ClinicalTrials.gov by National Heart, Lung, and Blood Institute (NHLBI)
- Last refreshed: 13 March 2026
Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT07428707.