Hodgkin LymphomaPhase 2NCT02398240
Brentuximab for Newly Diagnosed Hodgkin Disease
A Phase 2 study testing Brentuximab Vedotin, Doxorubicin and Vincristine in people with Hodgkin Lymphoma, run by Mitchell Cairo at 1 site in United States.
Trial summary
The addition of Brentuximab vedotin (Bv) to combination chemotherapy will be safe, well tolerated and effective in children, adolescents and young adults with all stages of newly diagnosed Hodgkin lymphoma (HL). Read more about this study
- Who is it for?
- Ages 1 year to 29 years
- Conditions the study is for
- Hodgkin Lymphoma
- What is being tested?
- Brentuximab Vedotin, Doxorubicin and Vincristine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 1 siteUnited States
- Study dates
- May 2015to Dec 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 1 year to 29 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- Normal Serum creatinine based on age or creatinine clearance >60 ml/min/1.73 m2 or an equivalent radioisotope glomerular filtration rate (GFR) as determined by the institutional normal range.
- Direct bilirubin < 1.5 upper limit of normal (ULN) for age, and SGOT (AST) or SGPT (ALT) <3 x ULN
- Shortening fraction >27% by echocardiogram, or
- Ejection fraction of >50% by radionuclide angiogram or echocardiogram.
- For patients age 1-16 years, Lansky score of ≥60.
- For patients > 16 years, Karnofsky score of ≥60.
- No prior Hodgkin lymphoma directed therapy is allowed except for emergent mediastinal irradiation (<1000cGy) for superior vena cava (SVC) syndrome.
Who cannot join
- Females who are pregnant (positive HCG) or lactating.
- Karnofsky <60% or Lansky <60% if less than 16 years of age.
- Age ≤1 year or >29.99 years of age.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Pilot Study of Risk Adapted Therapy Utilizing Upfront Brentuximab With Combination Chemotherapy in the Treatment of Children, Adolescents and Young Adults With Newly Diagnosed Hodgkin Lymphoma
The addition of Brentuximab vedotin (Bv) to combination chemotherapy will be safe, well tolerated and effective in children, adolescents and young adults with all stages of newly diagnosed Hodgkin lymphoma (HL).
- Conditions
- Hodgkin Lymphoma
- Being tested
- Brentuximab Vedotin, Doxorubicin, Vincristine, Rituximab
- Medical subject headings
- Hodgkin Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Brentuximab VedotinDrug
Also called Adcetris
Day 1 and 15 Dose: 1.2 mg/kg/dose. (Maximum dose is 120 mg)
DoxorubicinDrug
Also called Doxil, Adriamycin
Days: 1 and 15 Dose: 25 mg/m2/dose.
VincristineDrug
Also called Oncovin
Days: 1 and 15 Dose: 1.5 mg/m2/dose (max: 2 mg/dose).
RituximabDrug
Also called Rituxan
Days: 2 and 16 Dose: 375 mg/m2/dose.
| Study group | Role | What they receive |
|---|---|---|
| Low Risk | Experimental | Low Risk Patients (Stage IA, IIA; no bulky disease or extension): 3 cycles of chemotherapy Receives: Drug: Brentuximab Vedotin; Drug: Doxorubicin; Drug: Vincristine |
| Intermediate Risk | Experimental | Intermediate Risk Patients (Stage IA bulk/E, IB, IIA bulk/E, IIB, IIIA): 4 cycles of chemotherapy Receives: Drug: Brentuximab Vedotin; Drug: Doxorubicin; Drug: Vincristine; Drug: Rituximab |
| High Risk | Experimental | High Risk Patients (Stage IIIA bulk/ E, IIIB, IVA/B): 6 cycles of chemotherapy Receives: Drug: Brentuximab Vedotin; Drug: Doxorubicin; Drug: Vincristine; Drug: Rituximab |
What is being measured
The primary outcome is the main question the study is designed to answer.
To determine if this combination of chemoimmunotherapy is safe to administer. (Adverse events)
Adverse events will be monitored each cycle to determine if there are any events related possibly, probably or definitely related to study therapy
Measured: 1 year
To determine the response rate
disease evaluations will be performed after the 2nd, 4th and 6th cycles.
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Mar 2015 (estimated)
- Study startMay 2015
- Primary completionJun 2022
- Study completionDec 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for 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
- Single group
- Masking
- None (open label)
- Enrolment
- 40 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Mitchell Cairo
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Mitchell Cairo, New York Medical College
- Investigators
- Jessica Hochberg, MD, Principal investigator, New York Medical College
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02398240
- Sponsor's protocol ID
- NYMC-568
- Status last verified
- Oct 2023
- First submitted
- 15 Mar 2015
- Last updated
- 26 Oct 2023
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Publications
Hochberg J, Basso J, Shi Q, Klejmont L, Flower A, Bortfeld K, Harrison L, van de Ven C, Moorthy C, Islam H, Gerard P, Voss S, Cairo MS. Risk-adapted chemoimmunotherapy using brentuximab vedotin and rituximab in children, adolescents, and young adults with newly diagnosed Hodgkin's lymphoma: a phase II, non-randomized controlled trial. J Immunother Cancer. 2022 May;10(5):e004445. doi: 10.1136/jitc-2021-004445.
PubMed 35584865
Study at a glance
From the registry record, last updated by the sponsor on 26 Oct 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Pilot Study of Risk Adapted Therapy Utilizing Upfront Brentuximab With Combination Chemotherapy in the Treatment of Children, Adolescents and Young Adults With Newly Diagnosed Hodgkin Lymphoma
- ClinicalTrials.gov ID
- NCT02398240
- Acronym / sponsor ID
- NYMC-568
- Conditions
- Hodgkin Lymphoma
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- Mitchell CairoUniversity, hospital or other
- Study start
- May 2015 (actual)
- Primary completion
- Jun 2022 (actual)
- Study completion
- Dec 2022 (actual)
- First posted
- 25 Mar 2015 (estimated)
- 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.
The addition of Brentuximab vedotin (Bv) to combination chemotherapy will be safe, well tolerated and effective in children, adolescents and young adults with all stages of newly diagnosed Hodgkin lymphoma (HL).
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Low Risk | Experimental | Drug: Brentuximab Vedotin, Drug: Doxorubicin, Drug: VincristineLow Risk Patients (Stage IA, IIA; no bulky disease or extension): 3 cycles of chemotherapy |
| Intermediate Risk | Experimental | Drug: Brentuximab Vedotin, Drug: Doxorubicin, Drug: Vincristine, Drug: RituximabIntermediate Risk Patients (Stage IA bulk/E, IB, IIA bulk/E, IIB, IIIA): 4 cycles of chemotherapy |
| High Risk | Experimental | Drug: Brentuximab Vedotin, Drug: Doxorubicin, Drug: Vincristine, Drug: RituximabHigh Risk Patients (Stage IIIA bulk/ E, IIIB, IVA/B): 6 cycles of chemotherapy |
Who may qualify
- Ages
- 1 year to 29 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (7 listed)
- Normal Serum creatinine based on age or creatinine clearance >60 ml/min/1.73 m2 or an equivalent radioisotope glomerular filtration rate (GFR) as determined by the institutional normal range.
- Direct bilirubin < 1.5 upper limit of normal (ULN) for age, and SGOT (AST) or SGPT (ALT) <3 x ULN
- Shortening fraction >27% by echocardiogram, or
- Ejection fraction of >50% by radionuclide angiogram or echocardiogram.
- For patients age 1-16 years, Lansky score of ≥60.
Key exclusion criteria (3 listed)
- Females who are pregnant (positive HCG) or lactating.
- Karnofsky <60% or Lansky <60% if less than 16 years of age.
- Age ≤1 year or >29.99 years of age.
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 |
|---|---|---|
| Brentuximab VedotinAlso: AdcetrisDay 1 and 15 Dose: 1.2 mg/kg/dose. (Maximum dose is 120 mg) | Drug | High Risk, Intermediate Risk, Low Risk |
| DoxorubicinAlso: Doxil, AdriamycinDays: 1 and 15 Dose: 25 mg/m2/dose. | Drug | High Risk, Intermediate Risk, Low Risk |
| VincristineAlso: OncovinDays: 1 and 15 Dose: 1.5 mg/m2/dose (max: 2 mg/dose). | Drug | High Risk, Intermediate Risk, Low Risk |
| RituximabAlso: RituxanDays: 2 and 16 Dose: 375 mg/m2/dose. | Drug | High Risk, Intermediate Risk |
Primary outcome
To determine if this combination of chemoimmunotherapy is safe to administer. (Adverse events)
Time frame: 1 year
Adverse events will be monitored each cycle to determine if there are any events related possibly, probably or definitely related to study therapy
To determine the response rate
Time frame: 1 year
disease evaluations will be performed after the 2nd, 4th and 6th cycles.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Oct 2023.
- Background: PubMed 35584865Hochberg J, Basso J, Shi Q, Klejmont L, Flower A, Bortfeld K, Harrison L, van de Ven C, Moorthy C, Islam H, Gerard P, Voss S, Cairo MS. Risk-adapted chemoimmunotherapy using brentuximab vedotin and rituximab in children, adolescents, and young adults with newly diagnosed Hodgkin's lymphoma: a phase II, non-randomized controlled trial. J Immunother Cancer. 2022 May;10(5):e004445. doi: 10.1136/jitc-2021-004445.
- Individual participant dataSharing planned: No
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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.
Jessica Hochberg, MD principal investigator
New York Medical College
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 Brentuximab Vedotin, Doxorubicin and Vincristine in people with Hodgkin Lymphoma, run by Mitchell Cairo at 1 site in United States.
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 7 inclusion and 3 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: finished, as of the sponsor's last update on 26 Oct 2023. 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 United States. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
To determine if this combination of chemoimmunotherapy is safe to administer. (Adverse events) (time frame: 1 year). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02398240, which also lists 1 linked publication.
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 26 Oct 2023.