RECRUITING

A Phase II Study of the Combination of Azacitidine and Pembrolizumab for Patients Relapsed/Refractory Hodgkin's Lymphoma

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Conditions

Hodgkin's Lymphoma

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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 study is a Phase II single-center clinical trial designed to assess the efficacy, safety, and tolerability of pembrolizumab in combination with the 7-day regimen of azacitidine for the treatment of relapsed/refractory HL.

Official Title

A Phase II Study of the Combination of Azacitidine and Pembrolizumab for Patients Relapsed/Refractory Hodgkin's Lymphoma

Quick Facts

Study Start:2022-10-05
Study Completion:2026-12-31
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:RECRUITING

Study ID

NCT05355051

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:1 Year
Sexes Eligible for Study:ALL
Accepts Healthy Volunteers:Yes
Standard Ages:CHILD, ADULT, OLDER_ADULT
Inclusion CriteriaExclusion Criteria
  1. * HL patients with relapse or progression. Prior checkpoint inhibitors will be allowed
  2. * Patients with relapsed HL involving extranodal sites
  3. * HL patients who are not regarded as a candidate for high-dose, conventional chemotherapy
  4. * Age of enrollment: Minimum age 1 year. No maximum age, study will include anyone in the pediatric/adolescent center at MD Anderson (MDA)
  5. * Eastern Cooperative Oncology Group (ECOG) performance status =\< 3 or Lansky performance status \>= 50
  6. * Adequate renal function per age unless related to the disease
  7. * Total bilirubin \< 2 x upper limit of normal (ULN) unless increase is due to Gilbert's disease
  8. * Aspartate Aminotransferase (AST) \< 3 x ULN unless considered due to lymphoma involvement
  9. * Provision of written informed consent or assent as per MD Anderson Cancer Center (MDACC) policy for study subjects
  10. * Females must be surgically or biologically sterile or if of childbearing potential, must have a negative serum or urine pregnancy test within 72 hours before the start of the treatment and each subsequent dose
  11. * Women of childbearing potential must agree to use an adequate method of contraception during the study and until 4 months after the last treatment. Males must be surgically or biologically sterile or agree to use an adequate method of contraception during the study until 1 month after the last treatment
  12. * Males need to inform the doctor right away if the partner becomes pregnant or suspects pregnancy. While in this study and for 30 days after the last treatment the patient should not donate sperm for the purposes of reproduction. He will need to use a condom while in this study and for 30 days after the last treatment
  1. * Allergy to azacitidine or pembrolizumab or the drugs' components
  2. * Active and uncontrolled comorbidities including active uncontrolled infection, uncontrolled hypertension despite adequate medical therapy, active and uncontrolled congestive heart failure New York Heart Association (NYHA) class III/IV, clinically significant and uncontrolled arrhythmia as judged by the treating physician
  3. * Patients with known infection with human immunodeficiency virus (HIV) or active Hepatitis B or C
  4. * Any other medical, psychological, or social condition that may interfere with study participation or compliance, or compromise patient safety in the opinion of the investigator
  5. * Pregnant or breastfeeding
  6. * Has received a live vaccine within 30 days of planned start study therapy
  7. * Current or prior use of immunosuppressive medication within 14 days prior to the first dose of pembrolizumab. The following are exceptions to this criterion:
  8. * Intranasal, inhaled, topical steroids, or local steroid injections (eg, intra-articular injection)
  9. * Systemic corticosteroids at physiologic doses not to exceed 10 mg/day of prednisone or equivalent
  10. * Steroids as premedication for hypersensitivity reactions (eg, computed tomography \[CT\] scan premedication)
  11. * Active or prior documented autoimmune disease (including inflammatory bowel disease, celiac disease, Wegener syndrome) within the past 2 years. Subjects with childhood atopy or asthma, vitiligo, alopecia, Hashimoto syndrome, Grave's disease, or psoriasis not requiring systemic treatment (within the past 2 years) are not excluded
  12. * Has known active central nervous system metastases and/or carcinomatous meningitis

Contacts and Locations

Study Contact

David McCall, MD
CONTACT
(713) 792-6604
dmccall1@mdanderson.org

Principal Investigator

David McCall, MD
PRINCIPAL_INVESTIGATOR
M.D. Anderson Cancer Center

Study Locations (Sites)

MD Anderson Cancer Center
Houston, Texas, 77030
United States

Collaborators and Investigators

Sponsor: M.D. Anderson Cancer Center

  • David McCall, MD, PRINCIPAL_INVESTIGATOR, M.D. Anderson Cancer Center

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 Date2022-10-05
Study Completion Date2026-12-31

Study Record Updates

Study Start Date2022-10-05
Study Completion Date2026-12-31

Terms related to this study

Additional Relevant MeSH Terms

  • Hodgkin's Lymphoma