MT2022-60: Ph 2 Study of Pembro+ BEAM With ASCT for Relapsed Hodgkin Lymphoma
- Conditions
- Interventions
- Registration Number
- NCT06377540
- Lead Sponsor
- Masonic Cancer Center, University of Minnesota
- Brief 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- NOT_YET_RECRUITING
- Sex
- All
- Target Recruitment
- 28
- 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
- Patients with prior history of autoimmune reaction to PD-1 inhibitors greater than or equal to grade 3.
- 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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description Pembrolizumab+BEAM followed by ASCT followed by Pembrolizumab maintenance for 1 year. Autologous stem cell transplant 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. Pembrolizumab+BEAM followed by ASCT followed by Pembrolizumab maintenance for 1 year. Pembrolizumab 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. Pembrolizumab+BEAM followed by ASCT followed by Pembrolizumab maintenance for 1 year. Etoposide 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. Pembrolizumab+BEAM followed by ASCT followed by Pembrolizumab maintenance for 1 year. Carmustine 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. Pembrolizumab+BEAM followed by ASCT followed by Pembrolizumab maintenance for 1 year. Cytarabine 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. Pembrolizumab+BEAM followed by ASCT followed by Pembrolizumab maintenance for 1 year. Melphalan 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.
- Primary Outcome Measures
Name Time Method Progression free survival (PFS) 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.
- Secondary Outcome Measures
Name Time Method Overall Survival (OS) Baseline to 5 year post-ASCT 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.
Overall survival (OS) Baseline to 2 years post-ASCT 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.
Progression-free survival (PFS) Baseline to 2 years 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.Non-relapse mortality (NRM) Day 100 post-ASCT Number of participants experiencing death without relapse.
Rate of Complete Metabolic Response Day 28 Participants experiencing complete response at day 28 post-ASCT.