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

Purpose

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

  • Autologous Stem Cell Transplant
  • Classic Hodgkin Lymphoma

Eligibility

Eligible Ages
Over 18 Years
Eligible Sex
All
Accepts Healthy Volunteers
No

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 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

Study Design

Phase
Phase 2
Study Type
Interventional
Allocation
N/A
Intervention Model
Single Group Assignment
Primary Purpose
Treatment
Masking
None (Open Label)

Arm Groups

ArmDescriptionAssigned Intervention
Experimental
Pembrolizumab+BEAM followed by ASCT followed by Pembrolizumab maintenance for 1 year. 		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.
  • 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.
    Other names:
    • Keytruda; MK-3475
  • Procedure: Autologous stem cell transplant
    On day 0 the stem cells will be infused immediately after thawing over 15-60 minutes per institutional guidelines.
    Other names:
    • ASCT
  • Drug: Carmustine
    Patient will receive a single dose of BCNU on day -6, dose of 300 mg/m2 by IV infusion.
    Other names:
    • BCNU
    • BICNU
  • 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.
    Other names:
    • Ara-C
  • 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.

Recruiting Locations

Masonic Cancer Center
Minneapolis, Minnesota 55455
Contact:
Sanjal Desai, MD

More Details

Status
Recruiting
Sponsor
Masonic Cancer Center, University of Minnesota

Study Contact

Sanjal Desai
612-625-5469
desai171@umn.edu