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

Официальное название

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

Обзор

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.

Вмешательства

• Препарат 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.
• Процедура Autologous stem cell transplant
  On day 0 the stem cells will be infused immediately after thawing over 15-60 minutes per institutional guidelines.
• Препарат Carmustine
  Patient will receive a single dose of BCNU on day -6, dose of 300 mg/m2 by IV infusion.
• Препарат Etoposide
  Etoposide will be given at dose 100 mg/m2 BID intravenously on days -5, - 4, -3, and -2.
• Препарат Cytarabine
  Cytarabine will be given at dose 100 mg/m2 BID intravenously on days -5, -4, - 3, and -2.
• Препарат 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.

Первичные конечные точки

• Progression free survival (PFS) [Срок оценки: Baseline to 1 year post-ASCT]

Вторичные конечные точки (5)

• Overall survival (OS) [Срок оценки: Baseline to 2 years post-ASCT]
• Progression-free survival (PFS) [Срок оценки: Baseline to 2 years post-ASCT]
• Non-relapse mortality (NRM) [Срок оценки: Day 100 post-ASCT]
• Overall Survival (OS) [Срок оценки: Baseline to 5 year post-ASCT]
• Complete Radiologic Response Rate [Срок оценки: Day 28]

Критерии участия

Критерии включения

• 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

Критерии исключения

• 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

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Не применимо

Модель

Одна группа

Маскирование

Открытое

Основная цель

Лечение

Центры проведения

США · 1 центр

• Masonic Cancer Center — Minneapolis

Идентификаторы

NCT: NCT06377540 · 2022LS174

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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