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New treatment option for Relapsed Hodgkin Lymphoma
Official title A Phase II Study of the Combination of Pembrolizumab and ATRA Combination Treatment of Relapsed HL and B-NHL
ClinicalTrials.gov ID: NCT06484920
What this study is testing
What is ATRA?
ATRA is an investigational medicine, given as a pill taken by mouth, being studied as a potential treatment for relapsed hodgkin lymphoma.
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 is a Phase II single-center open label trial of the combination of ATRA and pembrolizumab treatment in patients with histologically proven, relapsed or refractory Hodgkin Lymphoma or B-Non-Hodgkin-lymphoma.
- 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 18 and older
You may be able to join if
- ≥ 18 years old at the time of informed consent
- Ability to provide written informed consent and HIPAA authorization
- Willingness to comply with all study procedures and be available for the duration of the trial
- Have a performance status of 0 to 2 on the ECOG Performance Scale.
- Life expectancy ≥12 weeks as per investigator discretion
You likely can't join if
- Patients currently participating and receiving study therapy or has participated in a study of an investigational agent and received study therapy or...
- Known brain metastases and/or leptomeningeal disease. people with previously treated brain metastases may participate provided they are...
- Significant reduction in ECOG performance status between the screening/ baseline visit and within 72 hours prior to commencement of treatment as per...
- Patients with a diagnosis of immunodeficiency or receiving systemic steroid therapy or any other form of immunosuppressive therapy (i.e., with use of...
- Hypersensitivity to pembrolizumab or any of its excipients.
- Contraindication to the use of ATRA including but not limited to: patients with a history of hypersensitivity reaction to tretinoin, vesanoid or...
See the full eligibility criteria
Who can join
- ≥ 18 years old at the time of informed consent
- Ability to provide written informed consent and HIPAA authorization
- Willingness to comply with all study procedures and be available for the duration of the trial
- Have a performance status of 0 to 2 on the ECOG Performance Scale.
- Life expectancy ≥12 weeks as per investigator discretion
- Patients with histologically proven, relapsed or refractory HL or B-NHL as follows:
- HL after failure of at least 1 prior line of systemic therapy
- Primary mediastinal large B-cell lymphoma (PMBCL) that is refractory to first-line therapy
- Other B-cell NHLs after failure of at least 2 prior lines of systemic therapy. The eligible types of B-cell NHLs are: i. Diffuse large B cell lymphoma ii. Follicular lymphoma iii. Marginal Zone lymphoma iv. Mantle Cell...
- Adequate hematologic and end organ function, defined by the following laboratory results obtained within 10 days prior to the first study treatment: Hematological Absolute neutrophil count (ANC) ≥1,500 /mcL Platelets...
- 1.5 X ULN OR Direct bilirubin ≤ ULN for people with total bilirubin levels \> 1.5 ULN (patients with known Gilbert disease who have bilirubin levels ≤ 3 x ULN may be enrolled). Patients must be able to undergo biliary...
- 5 X ULN for people with liver metastases Albumin \>2.5 mg/dL
- Female subject of childbearing potential should have a negative urine or serum pregnancy within 72 hours prior to receiving the first dose of study medication. If the urine test is positive or cannot be confirmed as...
- Has not undergone a hysterectomy or bilateral oophorectomy; or
- Has not been naturally postmenopausal for at least 24 consecutive months (i.e., has had menses at any time in the preceding 12 consecutive months).
- Female people of childbearing potential must be willing to use an adequate method of contraception for the course of the study through 120 days after the last dose of study medication. Abstinence is acceptable if this...
- Male people of childbearing potential must agree to use an adequate method of contraception of the protocol, starting with the first dose of study therapy through 120 days after the last dose of study therapy...
- Acceptable methods of contraception include IUD, oral contraceptive, subdermal implant, and double barrier (condom with a contraceptive sponge or contraceptive pessary). Micro-dosed progesterone preparations...
- Patients with a history of CAR-T cell therapy are eligible if ≥ 3 months post treatment.
What rules you out
- Patients currently participating and receiving study therapy or has participated in a study of an investigational agent and received study therapy or used an investigational device within 4 weeks of the first dose of...
- Known brain metastases and/or leptomeningeal disease. people with previously treated brain metastases may participate provided they are radiologically stable, i.e., without evidence of progression for at least 4 weeks...
- Significant reduction in ECOG performance status between the screening/ baseline visit and within 72 hours prior to commencement of treatment as per trial protocol, as per the Investigator's assessment, defined as a...
- Patients with a diagnosis of immunodeficiency or receiving systemic steroid therapy or any other form of immunosuppressive therapy (i.e., with use of disease modifying agents, corticosteroids, or immunosuppressive...
- Hypersensitivity to pembrolizumab or any of its excipients.
- Contraindication to the use of ATRA including but not limited to: patients with a history of hypersensitivity reaction to tretinoin, vesanoid or related compounds ( i.e. acitretin, isotretinoin, vitamin A)...
- Prior anti-cancer monoclonal antibody (mAb) within 4 weeks prior to study Day -1 or who have not recovered (i.e., ≤ Grade 1 or at baseline) from adverse events due to agents administered more than 4 weeks earlier.
- Prior chemotherapy targeted small molecule therapy, or radiation therapy within 2 weeks prior to study Day -1 or who have not recovered (i.e., ≤ Grade 1 or at baseline) from adverse events due to a previously...
- History of malignancy in the last 5 years with the exception of prior history of in situ cancer or basal cell carcinoma of the skin or squamous cell carcinoma of the skin that has undergone potentially curative therapy...
- Patient has undergone major surgery, other than diagnostic surgery (i.e., surgery done to obtain a biopsy for diagnosis without removal of an organ), within 4 weeks prior to Day -1 of treatment in this study. Note: If...
- Known history of, or any evidence of active, non-infectious pneumonitis.
- Active, uncontrolled bacterial, viral, or fungal infection(s) requiring systemic therapy.
- History or current evidence of any condition, therapy, or laboratory abnormality that might confound the results of the trial, interfere with the subject's participation for the full duration of the trial, or is not in...
- Known psychiatric or substance abuse disorders that would interfere with cooperation with the requirements of the trial.
- Pregnant or breastfeeding or expecting to conceive or father children within the projected duration of the trial, starting with the screening visit through 120 days after the last dose of trial treatment.
- Patients on micro-dosed progesterone preparations ("mini-pill") who are unwilling to receive an alternative form of contraception.
- Prior therapy with an anti-PD-1, anti-PD-L1, or anti-PD-L2 agent.
- Known history of Human Immunodeficiency Virus (HIV) (HIV 1/2 antibodies)
- Known active Hepatitis B (e.g., HBsAg reactive) or Hepatitis C (e.g., HCV RNA [qualitative] is detected).
- known history of active TB (Bacillus Tuberculosis).
- Receipt of live vaccine within 30 days of planned start of study therapy. Note: Seasonal influenza vaccines for injection are generally inactivated flu vaccines and are allowed; however, intranasal influenza vaccines...
- Patients who receive a COVID shot and/or booster within 4 weeks of Cycle 1 Day -1.
- Known sensitivity to retinoic acid derivatives.
- Patient is taking any prohibited concurrent medication, including Vitamin A supplements, and CYP3A modulators (inducers and inhibitors) and is unwilling to stop use (washout period of 3 days for this protocol) prior to...
- History of allogenic stem cell transplant or received a solid organ transplant. Note: If history of transplant is ≥ 5 years, people may be deemed eligible at the discretion of the treating physician. Note: Patients with...
The study team makes the final eligibility decision.
Where it's taking place
- Indianapolis, Indiana, 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, 18 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Indianapolis, Indiana, 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.