Trials / Recruiting
RecruitingNCT06377540
MT2022-60: Ph 2 Study of Pembro+ BEAM With ASCT for Relapsed Hodgkin Lymphoma
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
- Status
- Recruiting
- Phase
- Phase 2
- Study type
- Interventional
- Enrollment
- 28 (estimated)
- Sponsor
- Masonic Cancer Center, University of Minnesota · Academic / Other
- Sex
- All
- Age
- 18 Years
- Healthy volunteers
- Not accepted
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.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | Pembrolizumab | 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. |
| PROCEDURE | Autologous stem cell transplant | On day 0 the stem cells will be infused immediately after thawing over 15-60 minutes per institutional guidelines. |
| DRUG | Carmustine | Patient will receive a single dose of BCNU on day -6, dose of 300 mg/m2 by IV infusion. |
| DRUG | Etoposide | Etoposide will be given at dose 100 mg/m2 BID intravenously on days -5, - 4, -3, and -2. |
| DRUG | Cytarabine | Cytarabine will be given at dose 100 mg/m2 BID intravenously on days -5, -4, - 3, and -2. |
| DRUG | Melphalan | 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. |
Timeline
- Start date
- 2024-12-04
- Primary completion
- 2026-09-01
- Completion
- 2027-09-01
- First posted
- 2024-04-22
- Last updated
- 2025-07-01
Locations
1 site across 1 country: United States
Regulatory
- FDA-regulated drug study
Source: ClinicalTrials.gov record NCT06377540. Inclusion in this directory is not an endorsement.