NCT05490953

Enhancing Effect on Tumour Apoptosis With the Use of Pentoxifylline in Patients With Hodgkin Lymphoma

Status unknown Phase 4 Last updated 18 April 2023

What this trial tests

Phase 4 trial testing Pentoxifylline in Hodgkin Lymphoma in 30 participants. Status unknown.

Timeline

11 July 2022

Primary endpoint
31 December 2023

1 July 2024

Quick facts

Lead sponsor	University of Guadalajara
Phase	Phase 4
Status	Status unknown
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	triple
Primary purpose	treatment
Enrollment	30
Start date	11 July 2022
Primary completion	31 December 2023
Estimated completion	1 July 2024
Sites	1 location across Mexico

Drugs / interventions tested

• Pentoxifylline — full drug profile →
• Placebo

Conditions studied

• Hodgkin Lymphoma — all drugs for Hodgkin Lymphoma →

Sponsor

University of Guadalajara

Who can join

Adults 6 to 35, any sex, with Hodgkin Lymphoma. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

Hodgkin's Lymphoma (HL) is a neoplasm that affects the lymph nodes and the lymphatic system. In Mexico, HL is the seventh most incident cancer and the ninth with the highest mortality. It is characterized by the presence of Reed-Sternberg (HRS) cells derived from B cells of the germinal center. They harbor mutations that activate the NF-κB pathway, favoring cell survival and their reprogramming. Currently, the available therapeutic options are chemotherapy and radiotherapy, achieving cure rates of 75% in patients in advanced stages, in which 70% of these are found at the time of diagnosis. The investigators proposed the use of pentoxifylline (PTX) as a therapeutic option to enhance the antitumor effect generated by the treatment since it can increase the efficacy of apoptosis, in vitro and in vivo, induced by doxorubicin, cisplatin, and adriamycin in human leukemic and cervical cancer cells, through inhibition of NF-κB by preventing phosphorylation of serine 32 of the inhibitor κB; it also decreases the expression of Bcl-2 and Bcl-XL, induces the releasement of cytochrome c and caspases 3, 9, and cleavage of caspase 8. The investigators evaluated the effects of PTX during the steroid window phase at induction to remission in pediatric patients with LLA of a recent diagnosis, where it was shown that the combined treatment of prednisone (PRD) with PTX achieves greater percentages of apoptosis compared to individual treatment. In addition, the effect of PTX on the expression of genes associated with apoptosis was evaluated; where it was shown that it activates the intrinsic and extrinsic pathways of apoptosis. Fortilin is a protein whose serum levels increase 2.4 times more after treatment with chemotherapy or radiotherapy in patients with malignancies, so it is considered a specific and sensitive biomarker of early apoptosis in vivo. The present protocol will evaluate the enhancing effect of PTX on tumor apoptosis in combination with chemotherapeutical agents in pediatric and AYA patients with HL. Apoptosis will be measured in vivo by quantifying serum levels of fortilin and cytochrome c in participants before and after treatment by ELISA; as well as an evaluation of the clinical response based on the results of the PET-Scan, overall and event-free survival according to the Kaplan-Meier curves, and the adverse effects associated with the use of PTX according to the common terminology criteria for adverse events and causality algorithms.

Publications & conference data

1 peer-reviewed publication reference this trial (live from Europe PMC):

1. Potential Associations between Vascular Biology and Hodgkin's Lymphoma: An Overview.
   Rodrigues WF, Miguel CB, Abreu MCM, Neto JM, et al · · 2023 · cited 1× · PMID 37958472 · DOI 10.3390/cancers15215299