Pembrolizumab and Involved Site Radiation Therapy for Early Stage Relapsed or Primary Refractory Hodgkin Lymphoma

  • STATUS
    Recruiting
  • End date
    Jun 8, 2022
  • participants needed
    22
  • sponsor
    Memorial Sloan Kettering Cancer Center
Updated on 8 July 2021
lymphoma
granulocyte colony stimulating factor
chemotherapy regimen
classical hodgkin lymphoma
refractory hodgkin lymphoma

Summary

This study is being done to test the safety and effectiveness of pembrolizumab followed by radiation therapy in Hodgkin lymphoma.

The purpose of this study is to determine how effective combining the research drug, pembrolizumab, with a targeted form of radiation therapy known as involved site radiotherapy can be in patients with relapsed or refractory early stage classical Hodgkin lymphoma. The goal is to see whether this treatment strategy can cure a significant number of patients with relapsed or refractory early stage classical Hodgkin lymphoma while avoiding the toxicity of either a large radiation field or further chemotherapy and stem cell transplant.

Details
Condition Hodgkin's Disease, Lymphoma, hodgkin, hodgkin's lymphomas, hodgkin lymphomas, hodgkins lymphoma, hodgkin's lymphoma
Treatment Pembrolizumab, Involved Site Radiation Therapy
Clinical Study IdentifierNCT03179917
SponsorMemorial Sloan Kettering Cancer Center
Last Modified on8 July 2021

Eligibility

Yes No Not Sure

Inclusion Criteria

Three populations of patients are eligible for enrollment
(1) Patients with early stage disease at diagnosis (stage I-II) who were
treated with chemotherapy alone and relapsed with early stage disease (stage
RI-II)
(2) Patients with early stage disease at diagnosis (stage I-II) who were
treated with chemotherapy alone and have early stage (stage RI-II) primary
refractory disease (residual disease on a scan 1 month after the completion of
initial therapy) without B-symptoms and with each area of disease less than 10
cm in size
(3) Patients with early stage disease at diagnosis (stage I-II) who were
treated with combined modality therapy (chemotherapy and radiation) who
relapse with early stage disease (stage RI-II) outside the prior radiation
therapy field
Histologic confirmation of classical Hodgkin Lymphoma after imaging documenting primary refractory or relapsed disease
Age 18 or older
ECOG Performance Status of 0-1
Adequate organ function. Screening labs should be performed within 14 days of treatment initiation
Hematologic
Absolute neutrophil count (ANC) 1,000 /mcL
Platelets 75,000 / mcL
Hemoglobin 8 g/dL Renal
Creatinine OR Measured or calculated creatinine clearance CrCl (GFR can also be used in place of creatinine or 1.5 X upper limit of normal (ULN) OR 60 mL/min for subject with creatinine levels > 1.5 X institutional ULN Hepatic
Total bilirubin 1.5 X ULN OR Direct bilirubin ULN for subjects with total bilirubin levels >1.5 ULN
AST (SGOT) and ALT (SGPT) 2.5 X ULN OR 5 X ULN for subjects with liver involvement Coagulation International Normalized Ratio (INR) or Prothrombin Time (PT) Activated Partial Thromboplastin Time (aPTT) 1.5 X ULN unless subject is receiving anticoagulant therapy, then as long as PT or PTT is within therapeutic range of intended use of anticoagulants
5 X ULN unless subject is receiving anticoagulant therapy, then as long as PT or PTT is within therapeutic range of intended use of anticoagulants Hemoglobin and platelet requirements cannot be met by use of recent transfusion or growth factor support (GCSF or erythropoietin) within 2 weeks prior to treatment initiation
Creatinine clearance should be calculated per institutional standard
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 negative, a serum pregnancy test will be required
Female subjects of childbearing potential should be willing to use 2 methods
of birth control or be surgically sterile, or abstain from sexual activity for
the course of the study through 120 days after the last dose of study
medication (Reference Section 5.7.2). Subjects of child bearing potential are
those who have not been surgically sterilized or have not been free from
menses for > 1 year
Note: Abstinence is acceptable if this is the established and preferred
contraception for the subject
Male subjects should agree to use an adequate method of contraception starting with the first dose of study therapy through 120 days after the last dose of study therapy
Note: Abstinence is acceptable if this is the established and preferred
contraception for the subject

Exclusion Criteria

Ann Arbor Stage III or IV disease at diagnosis or at relapse/refractory disease confirmation
Bulky disease (>10cm) at diagnosis or at relapse/refractory disease confirmation
Active B symptoms
Received >1 line of therapy for Hodgkin lymphoma
Relapsed/refractory disease within a prior radiation field
Has had prior chemotherapy, targeted small molecule therapy, or radiation therapy within 2 weeks prior to study Day 1 or who has not recovered (i.e. Grade 1 or at baseline) from adverse events due to a previously administered agent
Diagnosis of immunosuppression or is receiving systemic steroid therapy or any other form of immunosuppressive therapy within 7 days prior to the first dose of trial treatment. The use of physiologic doses of corticosteroids may be approved after consultation with the Sponsor
Has a known additional malignancy that is progressing or requires active treatment. Exceptions include basal cell carcinoma of the skin, squamous cell carcinoma of the skin, or in situ cervical cancer that has undergone potentially curative therapy
Has active autoimmune disease that has required systemic treatment in past 2 years (i.e. with use of disease modifying agents, corticosteroids or immunosuppressive drugs). Replacement therapy (e.g., thyroxine, insulin, or physiologic corticosteroid replacement therapy for adrenal or pituitary insufficiency, etc.) is not considered a form of systemic treatment
Has history of (non-infectious) pneumonitis that required steroids, evidence of interstitial lung disease or active, non infectious pneumonitis
Has an active infection requiring intravenous systemic therapy
Has a known Human Immunodeficiency Virus (HIV), Hepatitis B (HBV), or Hepatitis C (HCV) infection
Has received a live vaccine or live attenuated vaccine within 30 days prior to first dose of study drug. Administration of killed vaccines is allowed
Any other medical condition or laboratory evaluation that, in the treating physician's or principal investigator's opinion, makes the patient unsuitable to participate in this clinical trial
Has had a prior monoclonal antibody within 4 weeks prior to study Day 1 or who has not recovered (i.e. Grade 1 or at baseline) from adverse events due to agents administered more than 4 weeks earlier
Has had treatment a prior monoclonal antibody targeting PD-1, PD-L1, PD-L2, or CTLA-4
Has a pre-treatment TTE showing a calculated left ventricular ejection fraction of less than 50%
Has a pre-treatment PFT showing an DLCO adjusted for hemoglobin of less than 60%
Is pregnant or breastfeeding, or expecting to conceive or father children within the projected duration of the trial, starting with the pre-screening or screening visit through 120 days after the last dose of trial treatment
Clear my responses

How to participate?

Step 1 Connect with a site
What happens next?
  • You can expect the study team to contact you via email or phone in the next few days.
  • Sign up as volunteer to help accelerate the development of new treatments and to get notified about similar trials.

You are contacting

Investigator Avatar
Name

Primary Contact

site
Name

0/250
Preferred Language
Other Language
Please verify that you are not a bot.

Additional screening procedures may be conducted by the study team before you can be confirmed eligible to participate.

Learn more

If you are confirmed eligible after full screening, you will be required to understand and sign the informed consent if you decide to enroll in the study. Once enrolled you may be asked to make scheduled visits over a period of time.

Learn more

Complete your scheduled study participation activities and then you are done. You may receive summary of study results if provided by the sponsor.

Learn more

Similar trials to consider

Loading...

Browse trials for

Not finding what you're looking for?

Every year hundreds of thousands of volunteers step forward to participate in research. Sign up as a volunteer and receive email notifications when clinical trials are posted in the medical category of interest to you.

Sign up as volunteer

user name

Added by • 

 • 

Private

Reply by • Private
Loading...

Lorem ipsum dolor sit amet consectetur, adipisicing elit. Ipsa vel nobis alias. Quae eveniet velit voluptate quo doloribus maxime et dicta in sequi, corporis quod. Ea, dolor eius? Dolore, vel!

  The passcode will expire in None.
Loading...

No annotations made yet

Add a private note
  • abc Select a piece of text from the left.
  • Add notes visible only to you.
  • Send it to people through a passcode protected link.
Add a private note