OPTmizing Advanced Stage HodgkIn LymphoMa patIentS Therapy

NCT03527628 | Unknown Phase 2 DMC

• 1 other identifier: RC-16/150
• Study Type: interventional
• Target: 220
• Locations: 1 country
• Sites: 1

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.

Conditions

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

Keywords

Stage II B Classical Hodgkin Lymphoma; Stage III Classical Hodgkin Lymphoma; Stage IV Classical Hodgkin Lymphoma

Outcome Measures

Primary Outcomes (1)

• ]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.

  3 years

Secondary Outcomes (1)

• Overall Survival (OS)

  5 years

Other Outcomes (2)

• Reduction of lung toxicity

  6 months

• Overall toxicity

  6 months

Study Arms (2)

Patients with PET-2 Negative Result

OTHER

After 2 ABVD cycles an interim PET-2 will be performed, and treatment will be adapted according to to PET results PET-2 negative patients will be treated with 4 cycles of ACVD (Adriamycin, Cyclophosphamide, Vinblastine And Dacarbazine)

Drug: Adriamycin; Drug: Cyclophosphamide; Drug: Vinblastine; Drug: Dacarbazine; Drug: ABVD

Patients with PET-2 Positive Result

OTHER

After 2 ABVD cycles an interim PET-2 will be performed, and treatment will be adapted according to to PET results PET-2 positive patients will be treated with 4 cycles of ACVD with addition of Brentuximab Vedotin

Drug: Adriamycin; Drug: Cyclophosphamide; Drug: Vinblastine; Drug: Dacarbazine; Drug: Brentuximab Vedotin; Drug: ABVD

Interventions

Adriamycin DRUG

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

Also known as: Doxorubicin

Patients with PET-2 Negative Result; Patients with PET-2 Positive Result

Cyclophosphamide DRUG

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

Also known as: Cytoxan®, Neosar®, Cycloblastin, Revimmune

Patients with PET-2 Negative Result; Patients with PET-2 Positive Result

Vinblastine DRUG

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

Also known as: Velbe ®

Patients with PET-2 Negative Result; Patients with PET-2 Positive Result

Dacarbazine DRUG

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

Also known as: DTIC

Patients with PET-2 Negative Result; Patients with PET-2 Positive Result

Brentuximab Vedotin DRUG

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

Also known as: ADCETRIS®, SGN-35

Patients with PET-2 Positive Result

ABVD DRUG

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

Also known as: (Adriamycin, Bleomycin, Vinblastine and Dacarbazine )

Patients with PET-2 Negative Result; Patients with PET-2 Positive Result

Eligibility Criteria

• Age: 14 Years - 60 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• Any of the following:
• Pregnant or lactating women.
• Presence of the following:
• Heart failure with LVEF \<50%
• Liver enzymes, \>2 ULN not attributed to Hodgkin Lymphoma.
• 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).

Sponsors & Collaborators

• King Abdullah International Medical Research Center: lead

Study Sites (1)

King Abdulaziz Medical City, Ministry of National Guard

Riyadh, 22390, Saudi Arabia

RECRUITING

MeSH Terms

Conditions

Hodgkin Disease

Interventions

Doxorubicin; Cyclophosphamide; Vinblastine; Dacarbazine; Brentuximab Vedotin; Bleomycin

Condition Hierarchy (Ancestors)

Lymphoma; Neoplasms by Histologic Type; Neoplasms; Lymphoproliferative Disorders; Lymphatic Diseases; Hemic and Lymphatic Diseases; Immunoproliferative Disorders; Immune System Diseases

Intervention Hierarchy (Ancestors)

Daunorubicin; Anthracyclines; Naphthacenes; Polycyclic Aromatic Hydrocarbons; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons; Organic Chemicals; Polycyclic Compounds; Aminoglycosides; Glycosides; Carbohydrates; Phosphoramide Mustards; Nitrogen Mustard Compounds; Mustard Compounds; Hydrocarbons, Halogenated; Phosphoramides; Organophosphorus Compounds; Vinca Alkaloids; Secologanin Tryptamine Alkaloids; Indole Alkaloids; Alkaloids; Heterocyclic Compounds; Indoles; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Indolizidines; Indolizines; Triazenes; Imidazoles; Azoles; Heterocyclic Compounds, 1-Ring; Oligopeptides; Peptides; Amino Acids, Peptides, and Proteins; Antibodies, Monoclonal, Humanized; Antibodies, Monoclonal; Antibodies; Immunoglobulins; Immunoproteins; Blood Proteins; Proteins; Serum Globulins; Globulins; Glycopeptides; Glycoconjugates

Study Officials

• Ayman Hejazi, MD

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

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Ayman Alhejazi, MD

CONTACT

801 1111; hejazia@ngha.med.sa

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 12, 2017
• First Posted: May 17, 2018
• Study Start: January 1, 2018
• Primary Completion: January 15, 2021
• Study Completion: January 15, 2022
• Last Updated: November 18, 2019

Record last verified: 2019-11

Locations

SA (1)