NCT02343536

A Phase 1, Open-label Trial of Oral Azacitidine (CC-486) Plus RCHOP in Subjects With Large B-Cell Lymphoma or Follicular Lymphoma or Transformed Lymphoma

Completed Phase 1 Last updated 28 August 2020

What this trial tests

Phase 1 trial testing Oral Azacitidine in Lymphoma, Large B-Cell, Diffuse in 59 participants. Completed in 29 January 2020.

Timeline

29 April 2015

Primary endpoint
29 January 2020

29 January 2020

Quick facts

Lead sponsor	Celgene
Phase	Phase 1
Status	Completed
Study type	INTERVENTIONAL
Allocation	non randomized
Design	single group
Masking	none
Primary purpose	treatment
Enrollment	59
Start date	29 April 2015
Primary completion	29 January 2020
Estimated completion	29 January 2020
Sites	7 locations across United States

Drugs / interventions tested

• Oral Azacitidine
• Rituximab — full drug profile →
• cyclophosphamide (cyclophosphamide) — full drug profile →
• Vincristine (vincristine) — full drug profile →
• Prednisone (prednisone) — full drug profile →

Conditions studied

• Lymphoma, Large B-Cell, Diffuse — all drugs for Lymphoma, Large B-Cell, Diffuse →
• Lymphoma, Follicular — all drugs for Lymphoma, Follicular →

Sponsor

Celgene — full company profile →

Who can join

18 and older, any sex, with Lymphoma, Large B-Cell, Diffuse or Lymphoma, Follicular. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

The goal of the study is to identify a dose and schedule of CC-486 that can be safely administered with R-CHOP. To evaluate the safety and maximum tolerated dose (MTD) or the maximal administered dose (MAD) of CC-486 in combination with rituximab, cyclophosphamide, doxorubicin, vincristine, and prednisone (R-CHOP) in subjects with high risk (IPI 2 or more) previously untreated DLBCL or Grade 3B FL.

Also, to determine pharmacokinetics (PK) of CC-486 when administered alone and in combination with R-CHOP and to explore preliminary efficacy of CC-486 plus R-CHOP by 2007 International Working Group (IWG) criteria.

Publications & conference data

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

1. A clinical-molecular update on azanucleoside-based therapy for the treatment of hematologic cancers.
   Diesch J, Zwick A, Garz AK, Palau A, et al · · 2016 · cited 139× · PMID 27330573 · DOI 10.1186/s13148-016-0237-y
2. Altered pathways and targeted therapy in double hit lymphoma.
   Zhuang Y, Che J, Wu M, Guo Y, et al · · 2022 · cited 26× · PMID 35303910 · DOI 10.1186/s13045-022-01249-9
3. Phase 1 study of oral azacitidine (CC-486) plus R-CHOP in previously untreated intermediate- to high-risk DLBCL.
   Martin P, Bartlett NL, Chavez JC, Reagan JL, et al · · 2022 · cited 25× · PMID 34428285 · DOI 10.1182/blood.2021011679
4. Recent Advances in the Targeting of Epigenetic Regulators in B-Cell Non-Hodgkin Lymphoma.
   Ribeiro ML, Reyes-Garau D, Armengol M, Fernández-Serrano M, et al · · 2019 · cited 20× · PMID 31681423 · DOI 10.3389/fgene.2019.00986
5. Epigenetics: Mechanisms, potential roles, and therapeutic strategies in cancer progression.
   Wang D, Zhang Y, Li Q, Li Y, et al · · 2024 · cited 14× · PMID 38988323 · DOI 10.1016/j.gendis.2023.04.040
6. Epigenetic Symphony in Diffuse Large B-Cell Lymphoma: Orchestrating the Tumor Microenvironment.
   Caloian AD, Cristian M, Calin E, Pricop AR, et al · · 2025 · cited 7× · PMID 40299416 · DOI 10.3390/biomedicines13040853
7. Can we use epigenetics to prime chemoresistant lymphomas?
   Amengual JE. · · 2020 · cited 6× · PMID 33275728 · DOI 10.1182/hematology.2020000092
8. Epigenetic targets in B- and T-cell lymphomas: latest developments.
   Ribeiro ML, Sánchez Vinces S, Mondragon L, Roué G. · · 2023 · cited 3× · PMID 37273421 · DOI 10.1177/20406207231173485