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NCT06377540 | RECRUITING | Autologous Stem Cell Transplant

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

Condition or disease

Autologous Stem Cell Transplant

Classic Hodgkin Lymphoma

Intervention/treatment

Pembrolizumab

Autologous stem cell transplant

Carmustine

Etoposide

Cytarabine

Melphalan

Phase

PHASE2

Study Type : INTERVENTIONAL
Estimated Enrollment : 28 participants
Masking : NONE
Primary Purpose : TREATMENT
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
Actual Study Start Date : 2024-12-04
Estimated Primary Completion Date : 2026-09-01
Estimated Study Completion Date : 2027-09-01

Information not available for Arms and Intervention/treatment

Ages Eligible for Study: 18 Years
Sexes Eligible for Study: ALL
Accepts Healthy Volunteers:
Criteria
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
MT2022-60: Ph 2 Study of Pembro+ BEAM With ASCT for Relapsed Hodgkin Lymphoma

Location Details

NCT06377540

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How to Participate

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Locations

RECRUITING

United States, Minnesota

Masonic Cancer Center

Minneapolis, Minnesota, United States, 55455