NCT03447808

Daratumumab and Ibrutinib in Treating Patients With Symptomatic Chronic Lymphocytic Leukemia

Active, enrolled Phase 1 Last updated 7 January 2026

What this trial tests

Phase 1 trial testing Daratumumab in Chronic Lymphocytic Leukemia in 15 participants. Participants enrolled and being followed up; not accepting new ones.

Timeline

16 August 2018

Primary endpoint
1 June 2026

1 June 2026

Quick facts

Lead sponsor	Jennifer Woyach
Phase	Phase 1
Status	Active, enrolled
Study type	INTERVENTIONAL
Allocation	na
Design	single group
Masking	none
Primary purpose	treatment
Enrollment	15
Start date	16 August 2018
Primary completion	1 June 2026
Estimated completion	1 June 2026
Sites	1 location across United States

Drugs / interventions tested

• Daratumumab (daratumumab) — full drug profile →
• Ibrutinib (ibrutinib) — full drug profile →
• Laboratory Biomarker Analysis — full drug profile →
• Pharmacological Study — full drug profile →

Conditions studied

• Chronic Lymphocytic Leukemia — all drugs for Chronic Lymphocytic Leukemia →

Sponsor

Jennifer Woyach

Who can join

18 and older, any sex, with Chronic Lymphocytic Leukemia. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

This phase Ib trials studies the side effects of daratumumab and ibrutinib and how well they work in treating patients with symptomatic chronic lymphocytic leukemia. Monoclonal antibodies, such as daratumumab, may interfere with the ability of cancer cells to grow and spread. Ibrutinib may stop the growth of cancer cells by blocking some of the enzymes needed for cell growth. Giving daratumumab and ibrutinib may work better in treating patients with chronic lymphocytic leukemia.

Publications & conference data

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

1. Evaluating Daratumumab in the Treatment of Multiple Myeloma: Safety, Efficacy and Place in Therapy.
   Dima D, Dower J, Comenzo RL, Varga C. · · 2020 · cited 36× · PMID 32904669 · DOI 10.2147/cmar.s212526
2. The Many Facets of CD38 in Lymphoma: From Tumor-Microenvironment Cell Interactions to Acquired Resistance to Immunotherapy.
   Calabretta E, Carlo-Stella C. · · 2020 · cited 28× · PMID 32225002 · DOI 10.3390/cells9040802
3. Trial Watch: combination of tyrosine kinase inhibitors (TKIs) and immunotherapy.
   Petrazzuolo A, Maiuri MC, Zitvogel L, Kroemer G, et al · · 2022 · cited 23× · PMID 35655707 · DOI 10.1080/2162402x.2022.2077898
4. Role of Non-Coding RNAs in the Development of Targeted Therapy and Immunotherapy Approaches for Chronic Lymphocytic Leukemia.
   Pepe F, Balatti V. · · 2020 · cited 17× · PMID 32098192 · DOI 10.3390/jcm9020593
5. Combinations or sequences of targeted agents in CLL: is the whole greater than the sum of its parts (Aristotle, 360 BC)?
   Sarraf Yazdy M, Mato AR, Cheson BD. · · 2019 · cited 14× · PMID 30429158 · DOI 10.1182/blood-2018-08-869503
6. Current Status of Novel Agents for the Treatment of B Cell Malignancies: What's Coming Next?
   Tannoury M, Garnier D, Susin SA, Bauvois B. · · 2022 · cited 10× · PMID 36551511 · DOI 10.3390/cancers14246026
7. Landscape of adenosine pathway and immune checkpoint dual blockade in NSCLC: progress in basic research and clinical application.
   Wang R, Liu Z, Wang T, Zhang J, et al · · 2024 · cited 7× · PMID 38348050 · DOI 10.3389/fimmu.2024.1320244
8. The Value of Neutrophil Gelatinase-Associated Lipocalin Receptor as a Novel Partner of CD38 in Chronic Lymphocytic Leukemia: From an Adverse Prognostic Factor to a Potential Pharmacological Target?
   Bauvois B, Chapiro E, Quiney C, Maloum K, et al · · 2023 · cited 4× · PMID 37760777 · DOI 10.3390/biomedicines11092335