Hodgkin LymphomaPhase 1/2NCT02098512
Immunotherapy Following Reduced Intensity Conditioning and Allogeneic Stem Cell Transplant for Poor Risk CD30+ Hodgkin Lymphoma Patients
A Phase 1/2 study testing Brentuximab Vedotin, Allogeneic Stem Cell Transplantation and Reduced Intensity Conditioning in people with Hodgkin Lymphoma, run by New York Medical College at 1 site in United States.
Trial summary
Patients with relapsed or refractory Hodgkin Lymphoma who are CD30+ will receive a standard of care reduced intensity regimen and an allogeneic stem cell transplant (from another person, related or unrelated). Read more about this study
- Who is it for?
- Ages Up to 45 yearsHealthy volunteers can take part
- Conditions the study is for
- Hodgkin Lymphoma
- What is being tested?
- Brentuximab Vedotin, Allogeneic Stem Cell Transplantation and Reduced Intensity Conditioning
- Type of treatment
- Injection or infusion, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Mar 2014to 31 Dec 2022
- Phase
- Phase 1/2
- 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 Up to 45 years
- All sexes
- Healthy volunteers accepted
- Child, Adult
Who may be able to join
- 45 years of age or less.
- Patients with Hodgkin Lymphoma with either of the following:
- Primary induction failure (failure to achieve initial CR) and/or primary refractory disease OR First, Second or Third relapse AND History of prior ablative auto HSCT or ineligible for an ablative auto HSCT or ≥25% residual disease after at least two reinduction chemotherapy cycles AND HLA matched family donor (6/6 or 5/6) or matched unrelated adult donor (MUD) (8/8) or matched umbilical cord blood unit (≥5/6) with prethaw cell dose of at least 3 x 107/kg TNC.
- off other investigational therapy for one month prior to entry in this study.
- adequate organ function
Who cannot join
- Patients with HD with 4th or greater CR, PR, and/or SD are ineligible.
- Patients with rapidly progressive disease (PD) unresponsive to reinduction chemo, radio, or immunotherapy are ineligible.
- Patients who don't have an eligible donor are ineligible.
- Women who are pregnant are ineligible.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Multicenter Pilot Study of Reduced Intensity Conditioning and Allogeneic Stem Cell Transplantation Followed by Targeted Immunotherapy in Children, Adolescents and Young Adults With Poor Risk CD30+ Hodgkin Lymphoma (HL)
Patients with relapsed or refractory Hodgkin Lymphoma who are CD30+ will receive a standard of care reduced intensity regimen and an allogeneic stem cell transplant (from another person, related or unrelated). Following recovery, patients will receive a medication called Brentuximab Vendotin which is targeted against CD30+ cells. The study hypothesis is that this treatment will be safe and well tolerated in children and young adults.
- Conditions
- Hodgkin Lymphoma
- Being tested
- Brentuximab Vedotin, Allogeneic Stem Cell Transplantation, Reduced Intensity Conditioning
- Keywords
- Brentuximab Vedotin, Immunotherapy, Relapsed Hodgkin Lymphoma, Refractory Hodgkin Lymphoma, Reduced Intensity Conditioning, Allogeneic Stem Cell Transplantation
- 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
Brentuximab Vedotin will be administered every 21 days starting on or around Day +42 post allogeneic stem cell transplant for a TOTAL of 4 doses as outlined below:
- 42 (+/-7 days) Brentuximab Vedotin 1.8 mg/kg (max=180 mg) IV x 1
- 63 (+/- 7 days) Brentuximab Vedotin 1.8 mg/kg (max=180 mg) IV x 1
- 84 (+/- 7 days) Brentuximab Vedotin 1.8 mg/kg (max = 180 mg) IV x 1
- 105 (+/- 7 days) Brentuximab Vedotin 1.8 mg/kg (max=180 mg) IV x 1
Allogeneic Stem Cell TransplantationProcedure or surgery
Following conditioning with chemotherapy, patients will receive stem cells from a matched related or unrelated donor.
Reduced Intensity ConditioningDrug
Patients will receive reduced intensity chemotherapy with one of three regimens: Busulfan/Fludarabine; Gemcitabine/Fludarabine/Melphalan; Fludarabine/Cyclophosphamide
| Study group | Role | What they receive |
|---|---|---|
| Allogeneic Transplant and Immunotherapy | Experimental | We intend to utilize reduced intensity conditioning and allogeneic stem cell transplant from HLA matched sibling or unrelated adult donor followed by post-AlloSCT Brentuximab Vedotin in patients with poor risk Hodgkin Lymphoma. Receives: Drug: Brentuximab Vedotin; Procedure: Allogeneic Stem Cell Transplantation; Drug: Reduced Intensity Conditioning |
What is being measured
The primary outcome is the main question the study is designed to answer.
Safety
Patients will be followed for one year for adverse events related to the administration of study drug.
Measured: 1 year
Overall Survival
patients will be assessed for one year to determine survival status
Measured: 1 year
Secondary outcomes (1)
To assess feasibility of developing a bank of LMP-specific CTLs from healthy donors
A bank of from identified EBV positive donors will be established for potential use in current and future clinical trials in LMP-positive lymphomas. Annual review will occur to assess the feasibility of recruiting healthy donors to help build this cell line bank. If there are no cell lines developed within the first year, an alternative design may be considered.
Measured: 3 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Mar 2014 (estimated)
- Study start1 Mar 2014
- Primary completion1 Dec 2021
- Study completion31 Dec 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- 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 1/2
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 20 participants (estimated)
Sponsor and investigators
- Lead sponsor
- New York Medical College
- Sponsor type
- University, hospital or other
- Collaborators
- St. Baldrick's Foundation
- Responsible party
- Sponsor
- Investigators
- Mitchell Cairo, MD, Principal investigator, New York Medical College
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02098512
- Sponsor's protocol ID
- NYMC 564
- Status last verified
- Oct 2022
- First submitted
- 17 Mar 2014
- Last updated
- 27 Oct 2022
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 27 Oct 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Multicenter Pilot Study of Reduced Intensity Conditioning and Allogeneic Stem Cell Transplantation Followed by Targeted Immunotherapy in Children, Adolescents and Young Adults With Poor Risk CD30+ Hodgkin Lymphoma (HL)
- ClinicalTrials.gov ID
- NCT02098512
- Acronym / sponsor ID
- NYMC 564
- Conditions
- Hodgkin Lymphoma
- Keywords
- Brentuximab Vedotin, Immunotherapy, Relapsed Hodgkin Lymphoma, Refractory Hodgkin Lymphoma, Reduced Intensity Conditioning, Allogeneic Stem Cell Transplantation
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 20 participants (estimated)
- Lead sponsor
- New York Medical CollegeUniversity, hospital or other
- Collaborators
- St. Baldrick's Foundation
- Study start
- 1 Mar 2014 (actual)
- Primary completion
- 1 Dec 2021 (actual)
- Study completion
- 31 Dec 2022 (estimated)
- First posted
- 28 Mar 2014 (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.
Patients with relapsed or refractory Hodgkin Lymphoma who are CD30+ will receive a standard of care reduced intensity regimen and an allogeneic stem cell transplant (from another person, related or unrelated). Following recovery, patients will receive a medication called Brentuximab Vendotin which is targeted against CD30+ cells. The study hypothesis is that this treatment will be safe and well tolerated in children and young adults.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Allogeneic Transplant and Immunotherapy | Experimental | Drug: Brentuximab Vedotin, Procedure: Allogeneic Stem Cell Transplantation, Drug: Reduced Intensity ConditioningWe intend to utilize reduced intensity conditioning and allogeneic stem cell transplant from HLA matched sibling or unrelated adult donor followed by post-AlloSCT Brentuximab Vedotin in patients with poor risk Hodgkin Lymphoma. |
Who may qualify
- Ages
- Up to 45 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult
Key inclusion criteria (5 listed)
- 45 years of age or less.
- Patients with Hodgkin Lymphoma with either of the following:
- off other investigational therapy for one month prior to entry in this study.
- adequate organ function
Key exclusion criteria (4 listed)
- Patients with HD with 4th or greater CR, PR, and/or SD are ineligible.
- Patients with rapidly progressive disease (PD) unresponsive to reinduction chemo, radio, or immunotherapy are ineligible.
- Patients who don't have an eligible donor are ineligible.
- Women who are pregnant are ineligible.
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: AdcetrisBrentuximab Vedotin will be administered every 21 days starting on or around Day +42 post allogeneic stem cell transplant for a TOTAL of 4 doses as outlined below: * 42 (+/-7 days) Brentuximab Vedotin 1.8 mg/kg (max=180 mg) IV x 1 * 63 (+/- 7 days) Brentuximab Vedotin 1.8 mg/kg (max=180 mg) IV x 1 * 84 (+/- 7 days) Brentuximab Vedotin 1.8 mg/kg (max = 180 mg) IV x 1 * 105 (+/- 7 days) Brentuximab Vedotin 1.8 mg/kg (max=180 mg) IV x 1 | Drug | Allogeneic Transplant and Immunotherapy |
| Allogeneic Stem Cell TransplantationFollowing conditioning with chemotherapy, patients will receive stem cells from a matched related or unrelated donor. | Procedure or surgery | Allogeneic Transplant and Immunotherapy |
| Reduced Intensity ConditioningPatients will receive reduced intensity chemotherapy with one of three regimens: Busulfan/Fludarabine; Gemcitabine/Fludarabine/Melphalan; Fludarabine/Cyclophosphamide | Drug | Allogeneic Transplant and Immunotherapy |
Primary outcome
Safety
Time frame: 1 year
Patients will be followed for one year for adverse events related to the administration of study drug.
Overall Survival
Time frame: 1 year
patients will be assessed for one year to determine survival status
1 secondary outcome
To assess feasibility of developing a bank of LMP-specific CTLs from healthy donors
Time frame: 3 years
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Oct 2022.
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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.
Mitchell Cairo, 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 1/2 study testing Brentuximab Vedotin, Allogeneic Stem Cell Transplantation and Reduced Intensity Conditioning in people with Hodgkin Lymphoma, run by New York Medical College 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 5 inclusion and 4 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 27 Oct 2022. 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 combined phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
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?
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?
Safety (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?
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 27 Oct 2022.