Is NCT03618550 recruiting in Middletown, NJ?

Yes, NCT03618550 is currently recruiting participants at its Middletown, NJ location. This hodgkin lymphoma clinical trial is actively enrolling qualified participants.

How do I join the hodgkin lymphoma clinical trial in Middletown?

To join this clinical trial in Middletown, complete the eligibility form on this page. A study coordinator will contact you to discuss next steps and determine if you qualify.

Is participation in this Middletown clinical trial free?

Yes, all study-related care is provided at no cost to qualified participants. Many studies also offer compensation for time and travel expenses.

Hodgkin Lymphoma Clinical Trial in Middletown, NJ

Who Can Participate

Inclusion Criteria

Histologic diagnosis of classical Hodgkin's lymphoma. Primary refractory or relapsed disease proven by biopsy at enrolling institution.

Be willing and able to provide written informed consent/assent for the trial.

Be ≥ 18 years of age on day of signing informed consent.

PET scan before initiating pembro-GVD have measurable disease based on Lugano 2014 criteria

Have a performance status of 0 or 1 on the ECOG Performance Scale

Demonstrate adequate organ function as defined in table below

Demonstrate adequate organ function as defined in table below. Hematological\

Absolute neutrophil count (ANC) ≥1000 /mcL

Platelets ≥50,000 / mcL

Hemoglobin ≥8 g/dL Renal

Serum creatinine OR ≤1.5 X upper limit of normal (ULN) OR

Measured or calculated creatinine clearance (eGFR can also be used in place of creatinine) ≥60 mL/min for subject with creatinine levels \> 1.5 X institutional ULN Hepatic\

Serum total bilirubin ≤ 1.5 X ULN OR ≤ 3 X ULN for subjects with liver metastases

AST (SGOT) and ALT (SGPT) ≤ 2.5 X ULN OR ≤ 5 X ULN for subjects with liver metastases Pulmonary

Hemoglobin-adjusted diffusing capacity for carbon monoxide ≥50% (If unadjusted DLCO is \>/= 50% then there is no need to calculate adjusted) Cardiac

Ejection fraction ≥45% Coagulation

International normalized ratio (INR) OR prothrombin time (PT), Activated partial thromboplastin time (aPTT): ≤ 1.5 × ULN unless participant is receiving anticoagulant therapy as long as PT or aPTT is within therapeutic range of intended use of anticoagulants \*Lab values for eligibility should be based upon labs prior to Cycle 1 treatment of Pembro-GVD.

Female subject of childbearing potential should have a negative urine or serum pregnancy within 2 weeks prior to receiving the first dose of study medication. On the day of planned treatment, if a blood pregnancy test has not been performed within the two week window, a stat pregnancy test (urine or blood) should be performed and the results reviewed before treatment is begun.

Female subjects of childbearing potential must be willing to use an adequate method of contraception (see details in section 11.4.3).

Male subjects of childbearing potential must agree to use an adequate method of contraception.(see details in section 11.4.3).

HIV-infected participants must have well-controlled HIV on ART, defined as:

Participants on ART must have a CD4+ T-cell count ≥350 cells/mm3 at the time of screening

Participants on ART must have achieved and maintained virologic suppression defined as confirmed HIV RNA level below 50 copies/mL or the LLOQ (below the limit of detection) using the locally available assay at the time of screening and for at least 12 weeks before screening

It is advised that participants must not have had any AIDS-defining opportunistic infections within the past 12 months.

Participants on ART must have been on a stable regimen, without changes in drugs or dose modification, for at least 4 weeks before study entry (Day 1) and agree to continue ART throughout the study

Participants who have AEs due to previous anticancer therapies must have recovered to ≤Grade 1 or baseline. Participants with endocrine-related AEs who are adequately treated with hormone replacement or participants who have ≤Grade 2 neuropathy are eligible.

Exclusion Criteria

Known pregnancy or breast-feeding.

Breast-feeding should be discontinued prior to treatment initiation.

Medical illness unrelated to Hodgkin's Lymphoma, which, in the opinion of the attending physician and/or principal investigator, makes participation in this study inappropriate.

Has received prior radiotherapy within 2 weeks of start of study treatment. Participants must have recovered from all radiation-related toxicities, not require corticosteroids, and not have had radiation pneumonitis.

Has known active central nervous system (CNS) metastases and/or carcinomatous meningitis.

Has active autoimmune disease that has required systemic treatment in the 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 known active HIV, Hepatitis B (e.g., Hepatitis B PCR positive) or Hepatitis C (e.g., HCV RNA \[qualitative\] is detected).

Has received a live vaccine or live-attenuated vaccine within 30 days prior to the first dose of study drug. Administration of killed vaccines is allowed.

Has a history of pneumonitis related to PD-1 blockade that required steroids.

Has an active infection requiring systemic therapy.

Has not adequately recovered from major surgery or has ongoing surgical complications

Has undergone solid organ transplant at any time, or prior allogeneic hematopoietic stem cell transplantation within the last 5 years. (Subjects who have had an allogeneic hematopoietic transplant greater than 5 years ago are eligible as long as there are no symptoms of GVHD.)

Has a history or current evidence of any condition, therapy, or laboratory abnormality or other circumstance that might confound the results of the study, interfere with the participant's participation for the full duration of the study, such that it is not in the best interest of the participant to participate, in the opinion of the treating investigator

Has known psychiatric or substance abuse disorders that would interfere with cooperation with the requirements of the trial.

Not sure if you qualify? Submit your interest and a study coordinator will help determine your eligibility.

Frequently Asked Questions

Q:Is this study available in Middletown?

Yes, this clinical trial (NCT03618550) has an active research site in Middletown, NJ that is currently enrolling participants.

Q:Is it safe to participate?

Clinical trials follow strict safety guidelines and ethical standards. This study has been reviewed and approved, and participants are closely monitored by medical professionals. You can withdraw at any time.

Q:Will I be compensated?

Many clinical trials offer compensation for your time and travel expenses. Specific compensation details will be discussed during the screening process. All study-related medical care is provided at no cost.

Q:Can I leave the trial if I change my mind?

Absolutely. Participation is completely voluntary. You have the right to withdraw from the study at any time, for any reason, without penalty.

Still have questions? Our study coordinators are here to help.

Hodgkin Lymphoma Treatment Options in Middletown, NJ

If you're searching for hodgkin lymphoma treatment options in Middletown, NJ, this clinical trial (NCT03618550) may be an excellent opportunity. Clinical trials provide access to cutting-edge treatments that aren't yet available to the general public, often at no cost to participants.

Our Middletown research site is actively enrolling participants for this phase 2 clinical trial. You'll receive care from experienced hodgkin lymphoma specialists who are at the forefront of medical research. All study-related care, including examinations, treatments, and monitoring, is provided at no cost to qualified participants.

Looking for more options? Browse all hodgkin lymphoma clinical trials near you to find additional studies recruiting in your area.

Hodgkin Lymphoma Clinical Trial in Middletown, NJ

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About This Hodgkin Lymphoma Study in Middletown