Overview

OPTmizing Advanced Stage HodgkIn LymphoMa patIentS Therapy

Status:
Recruiting
Trial end date:
2022-01-15
Target enrollment:
0
Participant gender:
All
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.
Phase:
Phase 2
Accepts Healthy Volunteers?
No
Details
Lead Sponsor:
King Abdullah International Medical Research Center
Treatments:
Antibodies, Monoclonal
Bleomycin
Brentuximab Vedotin
Cyclophosphamide
Dacarbazine
Doxorubicin
Liposomal doxorubicin
Vinblastine
Criteria
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).