MT2022-60: Ph 2 Study of Pembro+ BEAM With ASCT for Relapsed Hodgkin Lymphoma

Classic Hodgkin Lymphoma Clinical Trial

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT06377540
• Other study ID #: 2022LS174
• Status: Not yet recruiting
• Phase: Phase 2
• Start date: August 1, 2024
• Est. completion date: September 1, 2027

Study information

• Verified date: April 2024
• Source: Masonic Cancer Center, University of Minnesota
• Contact: Sanjal Desai
• Phone: 612-625-5469
• Email: desai171[@]umn.edu
• Is FDA regulated: No
• Study type: Interventional

Clinical 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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 28
• Est. completion date: September 1, 2027
• Est. primary completion date: September 1, 2026
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• 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

Exclusion Criteria:

• 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

Related Conditions & MeSH terms

• Autologous Stem Cell Transplant
• Classic Hodgkin Lymphoma
• Hodgkin Disease
• Lymphoma

Intervention

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.
• Etoposide
Etoposide will be given at dose 100 mg/m2 BID intravenously on days -5, - 4, -3, and -2.
• Cytarabine
Cytarabine will be given at dose 100 mg/m2 BID intravenously on days -5, -4, - 3, and -2.
• 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.

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Masonic Cancer Center, University of Minnesota

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	Baseline to 1 year post-ASCT
Secondary	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.	Baseline to 2 years post-ASCT
Secondary	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.	Baseline to 2 years post-ASCT
Secondary	Non-relapse mortality (NRM)	Number of participants experiencing death without relapse.	Day 100 post-ASCT
Secondary	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.	Baseline to 5 year post-ASCT
Secondary	Rate of Complete Metabolic Response	Participants experiencing complete response at day 28 post-ASCT.	Day 28