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

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

NCT ID: NCT06377540

Condition: Autologous Stem Cell Transplant
Classic Hodgkin Lymphoma

Conditions: Official terms:
Lymphoma
Hodgkin Disease
Cytarabine
Pembrolizumab
Etoposide
Melphalan
Carmustine

Conditions: Keywords:
BEAM
cHL
ASCT

Study type: Interventional

Study phase: Phase 2

Overall status: Not yet recruiting

Study design:

Allocation: N/A

Intervention model: Single Group Assignment

Primary purpose: Treatment

Masking: None (Open Label)

Intervention:

Intervention type: Drug
Intervention name: Pembrolizumab
Description: 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.
Arm group label: Pembrolizumab+BEAM followed by ASCT followed by Pembrolizumab maintenance for 1 year.

Other name: Keytruda; MK-3475

Intervention type: Procedure
Intervention name: Autologous stem cell transplant
Description: On day 0 the stem cells will be infused immediately after thawing over 15-60 minutes per institutional guidelines.
Arm group label: Pembrolizumab+BEAM followed by ASCT followed by Pembrolizumab maintenance for 1 year.

Other name: ASCT

Intervention type: Drug
Intervention name: Carmustine
Description: Patient will receive a single dose of BCNU on day -6, dose of 300 mg/m2 by IV infusion.
Arm group label: Pembrolizumab+BEAM followed by ASCT followed by Pembrolizumab maintenance for 1 year.

Other name: BCNU

Other name: BICNU

Intervention type: Drug
Intervention name: Etoposide
Description: Etoposide will be given at dose 100 mg/m2 BID intravenously on days -5, - 4, -3, and -2.
Arm group label: Pembrolizumab+BEAM followed by ASCT followed by Pembrolizumab maintenance for 1 year.

Intervention type: Drug
Intervention name: Cytarabine
Description: Cytarabine will be given at dose 100 mg/m2 BID intravenously on days -5, -4, - 3, and -2.
Arm group label: Pembrolizumab+BEAM followed by ASCT followed by Pembrolizumab maintenance for 1 year.

Other name: Ara-C

Intervention type: Drug
Intervention name: Melphalan
Description: 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.
Arm group label: Pembrolizumab+BEAM followed by ASCT followed by Pembrolizumab maintenance for 1 year.

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.

Criteria for eligibility:
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

Gender: All

Minimum age: 18 Years

Maximum age: N/A

Healthy volunteers: No

Start date: December 1, 2024

Completion date: September 1, 2027

Lead sponsor:
Agency: Masonic Cancer Center, University of Minnesota
Agency class: Other

Source: Masonic Cancer Center, University of Minnesota

Record processing date: ClinicalTrials.gov processed this data on November 12, 2024

Source: ClinicalTrials.gov page: https://clinicaltrials.gov/ct2/show/NCT06377540