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OPTmizing Advanced Stage HodgkIn LymphoMa patIentS Therapy

NCT03527628 · Status: UNKNOWN · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 220

Last updated 2019-11-18

No results posted yet for this study

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.

Conditions

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

Interventions

DRUG

Adriamycin

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

DRUG

Cyclophosphamide

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

DRUG

Vinblastine

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

DRUG

Dacarbazine

375mg/m2 Infusion in 500mls 0.9% NaCI over least 60mins. in days 1 and 15 of each 28 day cycle

DRUG

Brentuximab Vedotin

1.2mg/kg Intravenous infusion, in days 1 and 15 of each 28 day cycle

DRUG

ABVD

All enrolled patients receive 2 cycles of ABVD (Adriamycin 25mg/m2, Bleomycin10,000units/m2, Vinblastine 6mg/m2 and Dacarbazine 375mg/m2)

Sponsors & Collaborators

  • King Abdullah International Medical Research Center

    lead OTHER

Principal Investigators

  • Ayman Hejazi, MD · King Abdulaziz Medical City, Ministry of National Gaurd (KAMC)

Study Design

Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
14 Years
Max Age
60 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2018-01-01
Primary Completion
2021-01-15
Completion
2022-01-15

Countries

  • Saudi Arabia

Study Locations

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Entities

Drugs
Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03527628 on ClinicalTrials.gov