Classical Hodgkin LymphomaPhase 2(Optimist)NCT03527628
OPTmizing Advanced Stage HodgkIn LymphoMa patIentS Therapy
A Phase 2 study testing Adriamycin, Cyclophosphamide and Vinblastine in people with Classical Hodgkin Lymphoma and Hodgkin Lymphoma (Category), run by King Abdullah International Medical Research Center at 1 site in Saudi Arabia.
Trial 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… Read more about this study
- Who is it for?
- Ages 14 to 60 years
- Conditions the study is for
- Classical Hodgkin Lymphoma, Hodgkin Lymphoma (Category), Hodgkin Disease
- What is being tested?
- Adriamycin, Cyclophosphamide and Vinblastine
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 220 participants
- Where
- 1 siteSaudi Arabia
- Study dates
- 1 Jan 2018to 15 Jan 2022
- Phase
- Phase 2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 14 to 60 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- 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
Who cannot join
- 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
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- 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).
Trial locations and contacts
1 site in 1 country.
Saudi Arabia1 site, 1 recruiting
- Recruiting
King Abdulaziz Medical City, Ministry of National Guard
Riyadh, 22390
Ayman Hejazi, MD, +966 8011111 ext. 53388, hejazia@ngha.med.sa
About this study
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
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.
Read the 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.
- Conditions
- Classical Hodgkin Lymphoma, Hodgkin Lymphoma (Category), Hodgkin Disease, Hodgkin Lymphoma
- Being tested
- Adriamycin, Cyclophosphamide, Vinblastine, Dacarbazine, Brentuximab Vedotin
- Keywords
- Stage II B Classical Hodgkin Lymphoma, Stage III Classical Hodgkin Lymphoma, Stage IV Classical Hodgkin Lymphoma
- Medical subject headings
- Hodgkin Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
AdriamycinDrug
Also called Doxorubicin
25mg/m2 Bolus injection via fast running drip of 0.9% NaCl in days 1 and 15 of each 28 day cycle.
CyclophosphamideDrug
Also called Cytoxan®, Neosar®, Cycloblastin, Revimmune
400mg/m2 Infusion in 500ml sodium chloride 0.9%over 30min. in days 1 and 15 of each 28 day cycle
VinblastineDrug
Also called Velbe ®
6mg/m2 Intravenous infusion in 50ml sodium chloride 0.9% over 10 minutes, in days 1 and 15 of each 28 day cycle
DacarbazineDrug
Also called DTIC
375mg/m2 Infusion in 500mls 0.9% NaCI over least 60mins. in days 1 and 15 of each 28 day cycle
Brentuximab VedotinDrug
Also called ADCETRIS®, SGN-35
1.2mg/kg Intravenous infusion, in days 1 and 15 of each 28 day cycle
ABVDDrug
Also called (Adriamycin, Bleomycin, Vinblastine and Dacarbazine )
All enrolled patients receive 2 cycles of ABVD (Adriamycin 25mg/m2, Bleomycin10,000units/m2, Vinblastine 6mg/m2 and Dacarbazine 375mg/m2)
| Study group | Role | What they receive |
|---|---|---|
| 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) Receives: 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 Receives: Drug: Adriamycin; Drug: Cyclophosphamide; Drug: Vinblastine; Drug: Dacarbazine; Drug: Brentuximab Vedotin; Drug: ABVD |
What is being measured
The primary outcome is the main question the study is designed to answer.
]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.
Measured: 3 years
Secondary outcomes (1)
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.
Measured: 5 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 May 2018
- Study start1 Jan 2018
- Primary completion15 Jan 2021 (estimated)
- Study completion15 Jan 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Classical Hodgkin LymphomaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 220 participants (estimated)
Sponsor and investigators
- Lead sponsor
- King Abdullah International Medical Research Center
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Ayman Hejazi, MD, Principal investigator, King Abdulaziz Medical City, Ministry of National Gaurd (KAMC)
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03527628
- Sponsor's protocol ID
- RC-16/150
- Acronym
- (Optimist)
- Status last verified
- Nov 2019
- First submitted
- 12 Dec 2017
- Last updated
- 18 Nov 2019
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 18 Nov 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT03527628
- Acronym / sponsor ID
- (Optimist) / RC-16/150
- 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
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 220 participants (estimated)
- Lead sponsor
- King Abdullah International Medical Research CenterUniversity, hospital or other
- Study start
- 1 Jan 2018 (actual)
- Primary completion
- 15 Jan 2021 (estimated)
- Study completion
- 15 Jan 2022 (estimated)
- First posted
- 17 May 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Patients with PET-2 Negative Result | Other | Drug: Adriamycin, Drug: Cyclophosphamide, Drug: Vinblastine, Drug: Dacarbazine, Drug: ABVDAfter 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) |
| Patients with PET-2 Positive Result | Other | Drug: Adriamycin, Drug: Cyclophosphamide, Drug: Vinblastine, Drug: Dacarbazine, Drug: Brentuximab Vedotin, Drug: ABVDAfter 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 |
Who may qualify
- Ages
- 14 to 60 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (8 listed)
- All the following parameters should be met
Key exclusion criteria (15 listed)
- Any of the following:
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| AdriamycinAlso: Doxorubicin25mg/m2 Bolus injection via fast running drip of 0.9% NaCl in days 1 and 15 of each 28 day cycle. | Drug | Patients with PET-2 Negative Result, Patients with PET-2 Positive Result |
| CyclophosphamideAlso: Cytoxan®, Neosar®, Cycloblastin, Revimmune400mg/m2 Infusion in 500ml sodium chloride 0.9%over 30min. in days 1 and 15 of each 28 day cycle | Drug | Patients with PET-2 Negative Result, Patients with PET-2 Positive Result |
| VinblastineAlso: Velbe ®6mg/m2 Intravenous infusion in 50ml sodium chloride 0.9% over 10 minutes, in days 1 and 15 of each 28 day cycle | Drug | Patients with PET-2 Negative Result, Patients with PET-2 Positive Result |
| DacarbazineAlso: DTIC375mg/m2 Infusion in 500mls 0.9% NaCI over least 60mins. in days 1 and 15 of each 28 day cycle | Drug | Patients with PET-2 Negative Result, Patients with PET-2 Positive Result |
| Brentuximab VedotinAlso: ADCETRIS®, SGN-351.2mg/kg Intravenous infusion, in days 1 and 15 of each 28 day cycle | Drug | Patients with PET-2 Positive Result |
| ABVDAlso: (Adriamycin, Bleomycin, Vinblastine and Dacarbazine )All enrolled patients receive 2 cycles of ABVD (Adriamycin 25mg/m2, Bleomycin10,000units/m2, Vinblastine 6mg/m2 and Dacarbazine 375mg/m2) | Drug | Patients with PET-2 Negative Result, Patients with PET-2 Positive Result |
Primary outcome
]Progression Free Survival (PFS)
Time frame: 3 years
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.
1 secondary outcome
Overall Survival (OS)
Time frame: 5 years
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Nov 2019.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Ayman Hejazi, MD principal investigator
King Abdulaziz Medical City, Ministry of National Gaurd (KAMC)
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Adriamycin, Cyclophosphamide and Vinblastine in people with Classical Hodgkin Lymphoma and Hodgkin Lymphoma (Category), run by King Abdullah International Medical Research Center at 1 site in Saudi Arabia.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 15 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 18 Nov 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Saudi Arabia. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Ayman Alhejazi, MD (801 1111 ext. 53388, hejazia@ngha.med.sa), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
]Progression Free Survival (PFS) (time frame: 3 years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 Nov 2019.