Autologous Stem Cell TransplantPhase 2NCT06377540
MT2022-60: Ph 2 Study of Pembro+ BEAM With ASCT for Relapsed Hodgkin Lymphoma
A Phase 2 study testing Pembrolizumab, Autologous stem cell transplant and Carmustine in people with Autologous Stem Cell Transplant and Classic Hodgkin Lymphoma, run by Masonic Cancer Center, University of Minnesota at 1 site in United States.
Trial summary
This is a Phase 2 single arm study to evaluate efficacy and safety of Pembrolizumab before with BEAM ASCT followed by Pembrolizumab maintenance for 1 year. Patients will receive 200 mg Pembrolizumab Q3week starting at day - 28 before stem cell transplant until 1 year after autologous stem cell transplant. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Autologous Stem Cell Transplant, Classic Hodgkin Lymphoma
- What is being tested?
- Pembrolizumab, Autologous stem cell transplant and Carmustine
- Type of treatment
- Injection or infusion, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 28 participants
- Where
- 1 siteUnited States
- Study dates
- 4 Dec 2024to 1 Sep 2028
- Phase
- Phase 2
- Are there results?
- Not yet: the study is under way
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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Eligible for autologous stem cell transplant (ASCT) with BEAM conditioning regimen
- KPS greater than 70 or ECOG ≤ 1
- Adequate organ function and blood counts within 14 days of study registration
- Participants who are HBsAg positive are eligible if they have received HBV anti-viral therapy for at least 4 weeks, and have undetectable HBV viral load prior to randomization.
- Participants with a history of HCV infection are eligible if HCV viral load is undetectable at screening.
- HIV-infected participants must have well-controlled HIV on ART
Who cannot join
- Patients with prior history of any grade 2 or higher autoimmune reaction to PD-1 inhibitors, necessitating permanent discontinuation of the PD-1 inhibitor or necessitating systemic immunosuppressants.
- Has received prior radiotherapy within 2 weeks of start of study intervention or radiation-related toxicities requiring corticosteroids.
- Has received a live vaccine or live-attenuated vaccine within 30 days before the first dose of study intervention. Administration of killed vaccines is allowed.
- Has received any chemotherapy within 3 weeks prior to the first dose of study intervention
- Has known active CNS disease.
- History of or active autoimmune disease, or other syndrome that requires systemic steroids or autoimmune agents. Exceptions: Participants with vitiligo, resolved childhood asthma or atopy, hypothyroidism, or Sjogren's syndrome, as well as participants requiring only intranasal steroids, intermittent use of bronchodilators, local steroid injections, or physiologic replacement doses of prednisone (≤ 10 mg/d) may enroll.
- Has had an allogenic tissue/solid organ transplant.
- Pregnant or breastfeeding as agents used in this study are Pregnancy Category D (positive evidence of risk). Females of childbearing potential must have a negative pregnancy test (serum or urine) within 14 days of study registration
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Roberta Nicklow contact
United States1 site, 1 recruiting
- Recruiting
Masonic Cancer Center
Minneapolis, Minnesota, 55455
Sanjal Desai, MD
About this study
Official title: MT2022-60: A Phase II Study of Pembrolizumab+ BEAM Conditioning Regimen Before Autologous Stem Cell Transplant (ASCT) Followed by Pembrolizumab Maintenance in Patients of Relapsed or Refractory Classic Hodgkin Lymphoma
This is a Phase 2 single arm study to evaluate efficacy and safety of Pembrolizumab before with BEAM ASCT followed by Pembrolizumab maintenance for 1 year. Patients will receive 200 mg Pembrolizumab Q3week starting at day - 28 before stem cell transplant until 1 year after autologous stem cell transplant.
- Being tested
- Pembrolizumab, Autologous stem cell transplant, Carmustine, Etoposide, Cytarabine
- Keywords
- BEAM, cHL, ASCT
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PembrolizumabDrug
Also called Keytruda; MK-3475
Patients will receive 200 mg Pembrolizumab on Day -28 and Day -6 by IV infusion.
Pembrolizumab 200 mg IV will resume at day 30+ after ASCT every 3 weeks for 1 year.
Autologous stem cell transplantProcedure or surgery
Also called ASCT
On day 0 the stem cells will be infused immediately after thawing over 15-60 minutes per institutional guidelines.
CarmustineDrug
Also called BCNU, BICNU
Patient will receive a single dose of BCNU on day -6, dose of 300 mg/m2 by IV infusion.
EtoposideDrug
Etoposide will be given at dose 100 mg/m2 BID intravenously on days -5, - 4, -3, and -2.
CytarabineDrug
Also called Ara-C
Cytarabine will be given at dose 100 mg/m2 BID intravenously on days -5, -4, - 3, and -2.
MelphalanDrug
Melphalan will be given at dose of 140 mg/m2 intravenously on day -1 in a single 20 minute infusion; dose will be based on actual body weight but capped at 3.6 mg/kg as part of BEAM conditioning.
| Study group | Role | What they receive |
|---|---|---|
| Pembrolizumab+BEAM followed by ASCT followed by Pembrolizumab maintenance for 1 year. | Experimental | Patients will receive Pembrolizumab before BEAM ASCT followed by Pembrolizumab maintenance for 1 year. Patients will receive 200 mg Pembrolizumab starting at day - 28 before stem cell transplant until 1 year after autologous stem cell transplant. Receives: Drug: Pembrolizumab; Procedure: Autologous stem cell transplant; Drug: Carmustine; Drug: Etoposide; Drug: Cytarabine; Drug: Melphalan |
What is being measured
The primary outcome is the main question the study is designed to answer.
Progression free survival (PFS)
Number of participants with progression free survival at 1 year post transplant.
Time from date of study enrollment to date of first documented progression, or death. Patients who do not progress or die at the time of analysis will be censored at their last known date alive.
Measured: Baseline to 1 year post-ASCT
Secondary outcomes (5)
Overall survival (OS)
Time from date of study enrollment to date of death. Patients who do not die at the time of analysis will be censored at their last known date alive.
Measured: Baseline to 2 years post-ASCT
Progression-free survival (PFS)
Number of participants with progression free survival at 1 year post transplant.
Time from date of study enrollment to date of first documented progression, or death. Patients who do not progress or die at the time of analysis will be censored at their last known date alive.
Measured: Baseline to 2 years post-ASCT
Non-relapse mortality (NRM)
Number of participants experiencing death without relapse.
Measured: Day 100 post-ASCT
Overall Survival (OS)
Time from date of study enrollment to date of death. Patients who do not die at the time of analysis will be censored at their last known date alive.
Measured: Baseline to 5 year post-ASCT
Complete Radiologic Response Rate
Participants experiencing complete radiologic response rate at day 28 post-ASCT.
Measured: Day 28
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Apr 2024
- Study start4 Dec 2024
- Primary completion1 Sep 2027 (estimated)
- Study completion1 Sep 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Autologous Stem Cell TransplantStudies of the same condition, open and under way.
- More trials run by Masonic Cancer Center, University of MinnesotaThe sponsor's other registered studies.
- 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
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 28 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Masonic Cancer Center, University of Minnesota
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06377540
- Sponsor's protocol ID
- 2022LS174
- Status last verified
- Sep 2026
- First submitted
- 17 Apr 2024
- Last updated
- 29 Sep 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 29 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- MT2022-60: A Phase II Study of Pembrolizumab+ BEAM Conditioning Regimen Before Autologous Stem Cell Transplant (ASCT) Followed by Pembrolizumab Maintenance in Patients of Relapsed or Refractory Classic Hodgkin Lymphoma
- ClinicalTrials.gov ID
- NCT06377540
- Acronym / sponsor ID
- 2022LS174
- Keywords
- BEAM, cHL, ASCT
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 28 participants (estimated)
- Lead sponsor
- Masonic Cancer Center, University of MinnesotaUniversity, hospital or other
- Study start
- 4 Dec 2024 (actual)
- Primary completion
- 1 Sep 2027 (estimated)
- Study completion
- 1 Sep 2028 (estimated)
- First posted
- 22 Apr 2024 (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 Phase 2 single arm study to evaluate efficacy and safety of Pembrolizumab before with BEAM ASCT followed by Pembrolizumab maintenance for 1 year. Patients will receive 200 mg Pembrolizumab Q3week starting at day - 28 before stem cell transplant until 1 year after autologous stem cell transplant.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Pembrolizumab+BEAM followed by ASCT followed by Pembrolizumab maintenance for 1 year. | Experimental | Drug: Pembrolizumab, Procedure: Autologous stem cell transplant, Drug: Carmustine, Drug: Etoposide, Drug: Cytarabine, Drug: MelphalanPatients will receive Pembrolizumab before BEAM ASCT followed by Pembrolizumab maintenance for 1 year. Patients will receive 200 mg Pembrolizumab starting at day - 28 before stem cell transplant until 1 year after autologous stem cell transplant. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Eligible for autologous stem cell transplant (ASCT) with BEAM conditioning regimen
- KPS greater than 70 or ECOG ≤ 1
- Adequate organ function and blood counts within 14 days of study registration
- Participants who are HBsAg positive are eligible if they have received HBV anti-viral therapy for at least 4 weeks, and have undetectable HBV viral load prior to randomization.
- Participants with a history of HCV infection are eligible if HCV viral load is undetectable at screening.
Key exclusion criteria (8 listed)
- Patients with prior history of any grade 2 or higher autoimmune reaction to PD-1 inhibitors, necessitating permanent discontinuation of the PD-1 inhibitor or necessitating systemic immunosuppressants.
- Has received prior radiotherapy within 2 weeks of start of study intervention or radiation-related toxicities requiring corticosteroids.
- Has received a live vaccine or live-attenuated vaccine within 30 days before the first dose of study intervention. Administration of killed vaccines is allowed.
- Has received any chemotherapy within 3 weeks prior to the first dose of study intervention
- Has known active CNS disease.
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 |
|---|---|---|
| PembrolizumabAlso: Keytruda; MK-3475Patients will receive 200 mg Pembrolizumab on Day -28 and Day -6 by IV infusion. Pembrolizumab 200 mg IV will resume at day 30+ after ASCT every 3 weeks for 1 year. | Drug | Pembrolizumab+BEAM followed by ASCT followed by Pembrolizumab maintenance for 1 year. |
| Autologous stem cell transplantAlso: ASCTOn day 0 the stem cells will be infused immediately after thawing over 15-60 minutes per institutional guidelines. | Procedure or surgery | Pembrolizumab+BEAM followed by ASCT followed by Pembrolizumab maintenance for 1 year. |
| CarmustineAlso: BCNU, BICNUPatient will receive a single dose of BCNU on day -6, dose of 300 mg/m2 by IV infusion. | Drug | Pembrolizumab+BEAM followed by ASCT followed by Pembrolizumab maintenance for 1 year. |
| EtoposideEtoposide will be given at dose 100 mg/m2 BID intravenously on days -5, - 4, -3, and -2. | Drug | Pembrolizumab+BEAM followed by ASCT followed by Pembrolizumab maintenance for 1 year. |
| CytarabineAlso: Ara-CCytarabine will be given at dose 100 mg/m2 BID intravenously on days -5, -4, - 3, and -2. | Drug | Pembrolizumab+BEAM followed by ASCT followed by Pembrolizumab maintenance for 1 year. |
| MelphalanMelphalan will be given at dose of 140 mg/m2 intravenously on day -1 in a single 20 minute infusion; dose will be based on actual body weight but capped at 3.6 mg/kg as part of BEAM conditioning. | Drug | Pembrolizumab+BEAM followed by ASCT followed by Pembrolizumab maintenance for 1 year. |
Primary outcome
Progression free survival (PFS)
Time frame: Baseline to 1 year post-ASCT
Number of participants with progression free survival at 1 year post transplant. Time from date of study enrollment to date of first documented progression, or death. Patients who do not progress or die at the time of analysis will be censored at their last known date alive.
5 secondary outcomes
Overall survival (OS)
Time frame: Baseline to 2 years post-ASCT
Progression-free survival (PFS)
Time frame: Baseline to 2 years post-ASCT
Non-relapse mortality (NRM)
Time frame: Day 100 post-ASCT
Overall Survival (OS)
Time frame: Baseline to 5 year post-ASCT
Complete Radiologic Response Rate
Time frame: Day 28
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Sep 2026.
- 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.
Roberta Nicklow contact
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 Pembrolizumab, Autologous stem cell transplant and Carmustine in people with Autologous Stem Cell Transplant and Classic Hodgkin Lymphoma, run by Masonic Cancer Center, University of Minnesota 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 6 inclusion and 8 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: looking for participants now, as of the sponsor's last update on 29 Sep 2026. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Sanjal Desai (612-625-5469, desai171@umn.edu), 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: Baseline to 1 year post-ASCT). 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 29 Sep 2026.