OPTmizing Advanced Stage HodgkIn LymphoMa patIentS Therapy

King Abdullah International Medical Research Center220 enrolled

Overview

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.

With the aim of reducing Blemoycin pulmonary injury (BPI) , Bleomycin was withdrawn and substituted with Cyclophosphamide (ACVD cycle) in patients with a PET-2 negative.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.

Study Type

INTERVENTIONAL

Allocation

NON_RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Enrollment

220

Conditions

Classical Hodgkin Lymphoma Hodgkin Lymphoma (Category)Hodgkin Disease Hodgkin Lymphoma

Interventions

AdriamycinDRUG

25mg/m2 Bolus injection via fast running drip of 0.9% NaCl in days 1 and 15 of each 28 day cycle.

CyclophosphamideDRUG

400mg/m2 Infusion in 500ml sodium chloride 0.9%over 30min. in days 1 and 15 of each 28 day cycle

VinblastineDRUG

6mg/m2 Intravenous infusion in 50ml sodium chloride 0.9% over 10 minutes, in days 1 and 15 of each 28 day cycle

Eligibility

Sex: ALLMin age: 14 YearsMax age: 60 Years

Medical Language ↔ Plain English

Inclusion Criteria: * All the following parameters should be met * Newly diagnosed untreated ,histologically proven CD30 positive classical Hodgkin Lymphoma (cHL) * Advanced stage (Stage IIB to IVB) as defined by Ann Arbor Staging System (Appendix 1) * Age ≥ 14, \< 60 years * ECOG performance status 0-2 * Written informed consent for the trial * Adequate contraceptive precautions for all patients of childbearing potential * All prognostic group Exclusion Criteria: * Any of the following: * Pregnant or lactating women. * Presence of the following: 1. Heart failure with LVEF \<50% 2. Liver enzymes, \>2 ULN not attributed to Hodgkin Lymphoma. 3. Another malignancy that is currently clinically significant or requires active intervention * Early-stage disease (Stage I- IIA). * Patients who are already participating to another clinical trial. * Known history of HIV seropositive status * ECOG performance status 3-4 * Creatinin clearance \<50 ml/min * Prior treatment for Hodgkin Lymphoma excluding steroids * Medical or psychiatric conditions compromising the patient's ability to give informed consent * Patients with serious active infection * Pre-existing peripheral neuropathy (grade 2 or more).

Locations (1)

King Abdulaziz Medical City, Ministry of National Guard

Riyadh, Saudi Arabia

RECRUITING

Outcomes

Primary Outcomes

]Progression Free Survival (PFS)

PFS is estimated from the date of diagnosis until the date of first disease progression or relapse, death for any cause. Superior overall 3 year progression-free survival of patients with PET 2 positive after 2 cycles of ABVD with ACVD and BV compared to historical control of ABVD treated patients and PET 2 negative patients with ACVD only after 2 cycles of ABVD.

Time frame: 3 years

Secondary Outcomes

Overall Survival (OS)

Superior overall survival of PET 2 positive patients treated with ACVD + BV after 2 cycles of ABVD and PET 2 negative treated with ACVD after 2 cycles of ABVD. It is estimated from the date of diagnosis up to study completion or death, whichever came first, assessed up to 5 years.

Time frame: 5 years

Central Contacts

Ayman Alhejazi, MD

CONTACT

801 1111 hejazia@ngha.med.sa

Data from ClinicalTrials.gov

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