NCT03980002 (BDHCLL001) is a Phase 2 clinical trial of FCR and Ibrutinib in Chronic Lymphocytic Leukemia, sponsored by Institute of Hematology & Blood Diseases Hospital, China.

Who is sponsoring NCT03980002?

NCT03980002 is sponsored by Institute of Hematology & Blood Diseases Hospital, China.

What drugs are being tested in NCT03980002?

Interventions in NCT03980002: FCR and Ibrutinib, BR and Ibrutinib, Ibrutinib and Thalidomide.

What condition does NCT03980002 study?

NCT03980002 studies Chronic Lymphocytic Leukemia.

Is NCT03980002 still recruiting?

NCT03980002 is currently recruiting now. Last updated 10 June 2019.

Last reviewed 2019-06-10 · How we verify

NCT03980002: BDHCLL001

Name: Drug Landscape Pharmaceutical Database
Creator: Drug Landscape
Published: 2026-01-01
License: https://creativecommons.org/licenses/by/4.0/

A Prospective Multicenter Phase 2 Study of FCR/BR Alternating With Ibrutinib in Treatment-naive Patients With CLL

Recruiting now Phase 2 Last updated 10 June 2019

What this trial tests

Phase 2 trial testing FCR and Ibrutinib in Chronic Lymphocytic Leukemia in 50 participants. Currently enrolling.

Timeline

15 May 2019

Primary endpoint
15 December 2022

30 December 2027

Quick facts

Lead sponsor	Institute of Hematology & Blood Diseases Hospital, China
Phase	Phase 2
Status	Recruiting now
Study type	INTERVENTIONAL
Allocation	na
Design	single group
Masking	none
Primary purpose	treatment
Enrollment	50
Start date	15 May 2019
Primary completion	15 December 2022
Estimated completion	30 December 2027
Sites	1 location across China

Drugs / interventions tested

FCR and Ibrutinib — full drug profile →
BR and Ibrutinib — full drug profile →
Ibrutinib and Thalidomide — full drug profile →

Conditions studied

Chronic Lymphocytic Leukemia — all drugs for Chronic Lymphocytic Leukemia →

Sponsor

Institute of Hematology & Blood Diseases Hospital, China

Who can join

Adults 18 to 75, any sex, with Chronic Lymphocytic Leukemia. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

This is a prospective multicenter phase 2 study designed with the purpose to evaluate the response rate and safety of treatment with FCR/BR alternating with ibrutinib in treatment-naive patients with chronic lymphocytic leukemia.

Publications & conference data

3 peer-reviewed publications reference this trial (live from Europe PMC):

Chronic lymphocytic leukemia in China.
Gale RP. · · 2022 · cited 17× · PMID 34636775 · DOI 10.1097/cm9.0000000000001811
Ikaros Proteins in Tumor: Current Perspectives and New Developments.
Xia R, Cheng Y, Han X, Wei Y, et al · · 2021 · cited 12× · PMID 34950704 · DOI 10.3389/fmolb.2021.788440
Ibrutinib alternating with three cycles of interval fludarabine, cyclophosphamide, and rituximab (FCR) in adults with untreated chronic lymphocytic leukaemia as time-limited regimen: a single-arm, multicentre phase 2 trial in China.
Wang T, Yan Y, Wang H, Sun Y, et al · · 2025 · PMID 41497516 · DOI 10.1016/j.eclinm.2025.103688

Verify or expand the search:

Other recruiting trials for Chronic Lymphocytic Leukemia

Currently open trials in the same condition.

NCT07020533 — A Vaccine (CMV-MVA Triplex Vaccine) for the Enhancement of CMV-Specific Immunity and the Prevention of CMV Viremia in Pa · Phase 1 · recruiting
NCT06863402 — Nemtabrutinib and Pembrolizumab for the Treatment of Richter Transformation, Diffuse Large B-cell Lymphoma Subtype · Phase 2 · recruiting
NCT07218510 — Venetoclax and Obinutuzumab Followed by Epcoritamab for the Treatment of Untreated Chronic Lymphocytic Leukemia and Smal · Phase 2 · recruiting
NCT07288515 — Observ Prosp Study of Acalabrutinib in CLL Therapy in Real Clinical Practice in Belarus · recruiting
NCT07014917 — Intermittent Versus Continuous Venetoclax With Acalabrutinib for CLL/SLL · Phase 2 · recruiting

Other Institute of Hematology & Blood Diseases Hospital, China trials

Trials by the same sponsor.

NCT06991920 — Immune-targeted Combination With Chemotherapy for Acute Leukemia of Ambiguous Lineage · NA · not yet recruiting
NCT07407010 — BCMA/CD3 Bispecific Antibody as Bridging Therapy Before CAR-T Cell Infusion in RRMM · Phase 1 · not yet recruiting
NCT07407140 — VAG Versus Standard Chemotherapy With FLT3 Inhibitor in Adult Patients With FLT3-Mutated AML · Phase 3 · not yet recruiting
NCT07454226 — ABL/JAK Inhibitors With Chemotherapy and Venetoclax for Ph-like ALL · NA · not yet recruiting
NCT07490288 — Venetoclax, Azacitidine and Liposomal Mitoxantrone for Newly Diagnosed AML · NA · 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)

Data sources for this page

Trial protocol + status: ClinicalTrials.gov NCT03980002 (US National Library of Medicine, public domain)
Publications: Europe PMC API search by NCT ID, retrieved 10 June 2026
Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
Sponsor: as reported to ClinicalTrials.gov by Institute of Hematology & Blood Diseases Hospital, China
Last refreshed: 10 June 2019

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/NCT03980002.

Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing