Combining Azacitidine and Pembrolizumab for Hodgkin's Lymphoma
A Phase II Study of the Combination of Azacitidine and Pembrolizumab for Patients Relapsed/Refractory Hodgkin's Lymphoma
This study is testing if combining two medications, azacitidine and pembrolizumab, can help children and adults with relapsed or hard-to-treat Hodgkin's lymphoma feel better and live longer.
Quick facts
| Phase | Phase 2 |
|---|---|
| Study type | Interventional |
| Enrollment | 24 (estimated) |
| Ages | 1 Year and up |
| Sex | All |
| Sponsor | M.D. Anderson Cancer Center Academic / other |
| Drugs / interventions | pembrolizumab, chemotherapy, prednisone |
| Locations | 1 site (Houston, Texas) |
| Trial ID | NCT05355051 on ClinicalTrials.gov |
What this trial studies
This Phase II clinical trial evaluates the effectiveness and safety of pembrolizumab combined with a 7-day regimen of azacitidine in patients with relapsed or refractory Hodgkin's lymphoma. The study aims to determine the overall response rate, duration of response, relapse-free survival, and overall survival among participants. Additionally, it will assess the safety of this combination treatment in children and the potential for patients to proceed to stem cell transplantation after achieving a response.
Who should consider this trial
Good fit: Ideal candidates include patients with relapsed or progressed classical Hodgkin lymphoma who are not suitable for high-dose chemotherapy.
Not a fit: Patients with Hodgkin's lymphoma who are candidates for high-dose conventional chemotherapy may not benefit from this study.
Why it matters
Potential benefit: If successful, this treatment could provide a new effective option for patients with relapsed or refractory Hodgkin's lymphoma.
How similar studies have performed: Other studies have shown promising results with similar combinations of immunotherapy and chemotherapy in treating Hodgkin's lymphoma.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * HL patients with relapse or progression. Prior checkpoint inhibitors will be allowed * Patients with relapsed HL involving extranodal sites * HL patients who are not regarded as a candidate for high-dose, conventional chemotherapy * Age of enrollment: Minimum age 1 year. No maximum age, study will include anyone in the pediatric/adolescent center at MD Anderson (MDA) * Eastern Cooperative Oncology Group (ECOG) performance status =\< 3 or Lansky performance status \>= 50 * Adequate renal function per age unless related to the disease * Total bilirubin \< 2 x upper limit of normal (ULN) unless increase is due to Gilbert's disease * Aspartate Aminotransferase (AST) \< 3 x ULN unless considered due to lymphoma involvement * Provision of written informed consent or assent as per MD Anderson Cancer Center (MDACC) policy for study subjects * 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 * 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 * 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 Exclusion criteria: * Allergy to azacitidine or pembrolizumab or the drugs' components * 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 * Patients with known infection with human immunodeficiency virus (HIV) or active Hepatitis B or C * 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 * Pregnant or breastfeeding * Has received a live vaccine within 30 days of planned start study therapy * Current or prior use of immunosuppressive medication within 14 days prior to the first dose of pembrolizumab. The following are exceptions to this criterion: * Intranasal, inhaled, topical steroids, or local steroid injections (eg, intra-articular injection) * Systemic corticosteroids at physiologic doses not to exceed 10 mg/day of prednisone or equivalent * Steroids as premedication for hypersensitivity reactions (eg, computed tomography \[CT\] scan premedication) * 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 * Has known active central nervous system metastases and/or carcinomatous meningitis
Where this trial is running
Houston, Texas
- MD Anderson Cancer Center — Houston, Texas, United States (Recruiting)
Study contacts
- Principal investigator: David McCall, MD — M.D. Anderson Cancer Center
- Study coordinator: David McCall, MD
- Email: dmccall1@mdanderson.org
- Phone: (713) 792-6604
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.