RECRUITING

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

Conditions

Autologous Stem Cell Transplant Classic Hodgkin Lymphoma BEAM cHL ASCT

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Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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.

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

Quick Facts

Study Start:2024-12-04

Study Completion:2027-09-01

Study Type:Not specified

Phase:Not Applicable

Enrollment:Not specified

Status:RECRUITING

Study ID

NCT06377540

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:18 Years

Sexes Eligible for Study:ALL

Accepts Healthy Volunteers:No

Standard Ages:ADULT, OLDER_ADULT

Inclusion Criteria	Exclusion 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	* 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

Inclusion Criteria

Exclusion 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

* 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

Contacts and Locations

Study Contact

Sanjal Desai

CONTACT

612-625-5469

desai171@umn.edu

Roberta Nicklow

CONTACT

nickl004@umn.edu

Study Locations (Sites)

Masonic Cancer Center

Minneapolis, Minnesota, 55455

United States

Collaborators and Investigators

Sponsor: Masonic Cancer Center, University of Minnesota

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2024-12-04

Study Completion Date2027-09-01

Study Record Updates

Study Start Date2024-12-04

Study Completion Date2027-09-01

Terms related to this study

Keywords Provided by Researchers

BEAM
cHL
ASCT

Additional Relevant MeSH Terms

Autologous Stem Cell Transplant
Classic Hodgkin Lymphoma