NCT04305444

Study of a Triple Combination Therapy, DTRM-555, in Patients With R/R CLL or R/R Non-Hodgkin's Lymphomas

Terminated Phase 2 Last updated 8 January 2025

What this trial tests

Phase 2 trial testing DTRM-555 in Relapsed Chronic Lymphocytic Leukemia in 55 participants. Terminated before completion.

Timeline

24 April 2020

Primary endpoint
31 December 2024

31 December 2024

Quick facts

Lead sponsor	Zhejiang DTRM Biopharma
Phase	Phase 2
Status	Terminated
Study type	INTERVENTIONAL
Allocation	na
Design	single group
Masking	none
Primary purpose	treatment
Enrollment	55
Start date	24 April 2020
Primary completion	31 December 2024
Estimated completion	31 December 2024
Sites	8 locations across United States

Drugs / interventions tested

• DTRM-555 — full drug profile →

Conditions studied

• Relapsed Chronic Lymphocytic Leukemia — all drugs for Relapsed Chronic Lymphocytic Leukemia →
• Refractory Chronic Lymphocytic Leukemia — all drugs for Refractory Chronic Lymphocytic Leukemia →
• Diffuse Large B Cell Lymphoma — all drugs for Diffuse Large B Cell Lymphoma →
• Follicular Lymphoma — all drugs for Follicular Lymphoma →

Sponsor

Zhejiang DTRM Biopharma — full company profile →

Who can join

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

Sponsor's own description

Targeted drug therapies have greatly improved outcomes for patients with relapsed or refractory (R/R) chronic lymphocytic leukemia (CLL) and non-Hodgkin's lymphoma. However, single drug therapies have limitations, therefore, the current study is evaluating a novel oral combination of targeted drugs as a way of overcoming these limitations. This study will determine the efficacy of the triple combination therapy, DTRM-555, in patients with R/R CLL or R/R non-Hodgkin's lymphoma.

Publications & conference data

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

1. 2021 Update on Diffuse large B cell lymphoma: A review of current data and potential applications on risk stratification and management.
   Susanibar-Adaniya S, Barta SK. · · 2021 · cited 250× · PMID 33661537 · DOI 10.1002/ajh.26151
2. Small Molecule NF-κB Pathway Inhibitors in Clinic.
   Ramadass V, Vaiyapuri T, Tergaonkar V. · · 2020 · cited 154× · PMID 32708302 · DOI 10.3390/ijms21145164
3. New agents and regimens for diffuse large B cell lymphoma.
   Wang L, Li LR, Young KH. · · 2020 · cited 109× · PMID 33317571 · DOI 10.1186/s13045-020-01011-z
4. BTK inhibitors in the treatment of hematological malignancies and inflammatory diseases: mechanisms and clinical studies.
   Alu A, Lei H, Han X, Wei Y, et al · · 2022 · cited 88× · PMID 36183125 · DOI 10.1186/s13045-022-01353-w
5. The Role of Bruton's Kinase Inhibitors in Chronic Lymphocytic Leukemia: Current Status and Future Directions.
   Robak T, Witkowska M, Smolewski P. · · 2022 · cited 42× · PMID 35159041 · DOI 10.3390/cancers14030771
6. Managing Ibrutinib-Intolerant Patients With B-Cell Malignancies.
   Muñoz J, Sarosiek S, Castillo JJ. · · 2023 · cited 8× · PMID 36723874 · DOI 10.1093/oncolo/oyac260
7. Richter Syndrome: From Molecular Pathogenesis to Druggable Targets.
   Mouhssine S, Gaidano G. · · 2022 · cited 8× · PMID 36230566 · DOI 10.3390/cancers14194644
8. mTORC1-selective activation of translation elongation promotes disease progression in chronic lymphocytic leukemia.
   Malik N, Hay J, Almuhanna HNB, Dunn KM, et al · · 2023 · cited 7× · PMID 37775560 · DOI 10.1038/s41375-023-02043-3