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New treatment option for Hodgkin's Lymphoma
Official title A Phase II Study of the Combination of Azacitidine and Pembrolizumab for Patients Relapsed/Refractory Hodgkin's Lymphoma
ClinicalTrials.gov ID: NCT05355051
What this study is testing
What is Azacytidine?
Azacytidine is an investigational medicine, given as an infusion into a vein, being studied as a potential treatment for hodgkin's lymphoma.
Also referred to as 5-azacytidine, 5-aza.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- 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.
- Phase 2: a mid-size study of how well it works
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 1 and older. Healthy volunteers may be eligible.
You may be able to join if
- HL patients with relapse or progression. Prior checkpoint inhibitors will be allowed
- AML patients with relapse or progression. Patients may receive cytoreduction prior to enrollment for patients with rapidly proliferative disease...
- 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
You likely can't join if
- 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...
- 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...
- Pregnant or breastfeeding
- Has received a live vaccine within 30 days of planned start study therapy
See the full eligibility criteria
- HL patients with relapse or progression. Prior checkpoint inhibitors will be allowed
- AML patients with relapse or progression. Patients may receive cytoreduction prior to enrollment for patients with rapidly proliferative disease before the start of study therapy, as needed, for clinical benefit and...
- 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
- Eastern Cooperative Oncology Group (ECOG) performance status =\ = 50
- Adequate renal function per age unless related to the disease
- Adequate hepatic function including total bilirubin \< 2x upper limit of normal (ULN) unless increase is due to Gilbert's disease, and AST \< 3x ULN unless considered due to lymphoma involvement.
- Provision of written informed consent or assent as per MDACC policy for study people.
- 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...
- 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...
- 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...
- 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)
- As per Inclusion criteria #2
- Active or prior documented autoimmune disease (including inflammatory bowel disease, celiac disease, Wegener syndrome) within the past 2 years. people with childhood atopy or asthma, vitiligo, alopecia, Hashimoto...
- Has known active central nervous system metastases and/or carcinomatous meningitis
The study team makes the final eligibility decision.
Where it's taking place
- Houston, Texas, United States
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 1 year and older. Healthy volunteers may be eligible. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Houston, Texas, United States. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.