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Spots Global Cancer Trial Database for OPTmizing Advanced Stage HodgkIn LymphoMa patIentS Therapy

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Trial Identification

Brief Title: OPTmizing Advanced Stage HodgkIn LymphoMa patIentS Therapy

Official Title: A Phase II, Multicenter, Open Label Study of Treatment Intensification With ACVD and Brentuximab-Vedotin in Advanced-stage Hodgkin Lymphoma Patients With a Positive Interim PET Scan After 2 ABVD Cycles

Study ID: NCT03527628

Study Description

Brief Summary: This is a prospective, multi-center, open-label, phase II clinical trial, aims to assess the effectiveness of the combination ACVD (Adriamycin, Cyclophosphamide, Vinblastine and Dacarbazine) and BV (Brentuximab Vedotin) in PET-2 positive advanced-stage HL patients, in order to improve the overall long-term disease control in the entire cohort of advanced-stage HL.

Detailed Description: With the aim of reducing Blemoycin pulmonary injury (BPI) , Bleomycin was withdrawn and substituted with Cyclophosphamide (ACVD cycle) in patients with a PET-2 negative. All advanced stage HL patients will receive 2 cycles of the standard treatment ABVD and assessed with PET-2 scan. Knowing that Cyclophosphamide toxicities include cytopenias, amenorrhea and male infertility. These toxicities are mainly dependent on the total cumulative dose. Doses less than 4 g/m2 are not associated with sterility or major toxicity, doses higher than this can lead to azoospermia which was reversible in many cases therefore the cumulative dose will be used in this study is 3200 mg. Additionally, Brentuximab Vedotin has shown significant activity in relapsed refractory HL with minor toxicities. PET scan after 2 cycles of ABVD has proven to be an excellent tool to identify patients that will have long term PFS of 95% when it is negative and only progression-free survival (PFS) of less than 15% when it is positive. The primary endpoint of the study will be to assess the overall 3-Y PFS of the entire cohort of patients.

Eligibility

Minimum Age: 14 Years

Eligible Ages: CHILD, ADULT

Sex: ALL

Healthy Volunteers: No

Locations

King Abdulaziz Medical City, Ministry of National Guard, Riyadh, , Saudi Arabia

Contact Details

Name: Ayman Hejazi, MD

Affiliation: King Abdulaziz Medical City, Ministry of National Gaurd (KAMC)

Role: PRINCIPAL_INVESTIGATOR

Useful links and downloads for this trial

Clinicaltrials.gov

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