Is NCT06033196 recruiting in Boston, MA?

Yes, NCT06033196 is currently recruiting participants at its Boston, MA location. This lung transplant clinical trial is actively enrolling qualified participants.

How do I join the lung transplant clinical trial in Boston?

To join this clinical trial in Boston, 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 Boston 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.

Lung Transplant Clinical Trial in Boston, MA

About This Lung Transplant Study in Boston

This is a trial in which 350 primary lung transplant recipients will be randomized (1:1) to receive either Tocilizumab (six doses over 20 weeks) plus standard triple maintenance immunosuppression or placebo (sterile normal saline) plus standard triple maintenance immunosuppression (Tacrolimus, Mycophenolate Mofetil, corticosteroids). The primary objective is to test the hypothesis that treatment with triple maintenance immunosuppression plus Tocilizumab (TCZ) is superior to triple maintenance i

Sponsor: National Institute of Allergy and Infectious Diseases (NIAID)

Who Can Participate

Inclusion Criteria

Study Entry:

Subject and/or parent guardian must be able to understand the purpose of the study and willing to participate and sign informed consent/assent

Greater than or equal to 30 kg body weight

Listed or received for a primary lung transplant

No previous or planned desensitization therapy prior to transplant

Serum Immunoglobulin G (IgG) level greater than 400 mg/dL. Patients treated with intravenous immune globulin (IVIG) for hypogammaglobulinemia are eligible for enrollment if their serum IgG level is greater than 400 mg/dL 14 or more days after the most recent IVIG treatment

For women of child-bearing potential, willingness to use highly-effective contraception; according to the Food and Drug Administration (FDA) Office of Women's Health (http://www.fda.gov/birthcontrol). Female participants of child-bearing potential must consult with their physician and determine the most suitable method(s) from this list to be used for the duration of the study. Those who choose oral contraception must agree to use a second form of contraception after administration of study drug for a period of 1 year after the last dose of study drug

Tested negative for latent TB infection (LTBI) using a PPD or interferon-gamma release assay (i.e., QuantiFERON-TB, T-SPOT.TB) within 1 year prior to transplant or has completed appropriate LTBI therapy within the 1 year prior to transplant

Vaccinations must be up to date per the Division of Allergy, Immunology, and Transplantation (DAIT) Guidance for Patients in Transplant Trials Randomization:

Provide written informed consent for the study participation, and agree to continue in the study

Received a single or bilateral lung transplant

Agreement to use contraception; according to the FDA Office of Women's Health (http://www.fda.gov/birthcontrol), there are a number of birth control methods that are more than 80% effective. Female participants of child-bearing potential must consult with their physician and determine the most suitable method(s) from this list to be used for the duration of the study. Those who choose oral contraception must agree to use a second form of contraception after administration of study drug for a period of 1 year after the last dose of study drug

Negative physical crossmatch at the time of transplant or a crossmatch result that did not require specific treatment per the site's clinical protocol

Underwent bronchoscopy and found to have satisfactory bronchial anastomotic healing

No desensitization therapy prior to transplant

Negative pregnancy test (serum or urine) for women of child-bearing potential within 48 hours prior to randomization

Recipient of lungs that have been supported with ex vivo lung perfusion (EVLP) devices are permitted

Exclusion Criteria

Study Entry:

Listed for multi-organ transplant (e.g., heart-lung, liver-lung, kidney-lung)

Prior history of allogeneic organ or cellular transplantation

Received treatment to deplete Human Leukocyte Antigens (HLA) antibodies before transplantation

Currently breast-feeding a child or plans to become pregnant during the timeframe of the study follow up period

History of severe allergic and/or anaphylactic reactions to humanized or murine monoclonal antibodies

Known hypersensitivity or previous treatment with ACTEMRA(R) (tocilizumab) within the last 3 months

Infection with human immunodeficiency virus (HIV)

Hepatitis B virus surface antigen or core antibody positive

Hepatitis C virus PCR positive (HCV+) patients who have failed to demonstrate sustained viral remission (2 consecutive PCR or Nucleic Acid Tests (NAT) negative tests at least 24 weeks apart), with or without anti-viral treatment;

Chronic infection with Burkholderia cenocepacia or Burkholderia gladioli

Non-tuberculous mycobacterial (NTM) pulmonary disease; if there is a history of NTM pulmonary disease, culture conversion is necessary for eligibility

Presence of active malignancy or history of malignancy less than 5 years in remission, excluding adequately treated in-situ cervical carcinoma, low grade prostate carcinoma, or adequately treated basal or squamous cell carcinoma of the skin

History of hemolytic-uremic syndrome/ thrombotic thrombocytopenia purpura

History of demyelinating disorders (e.g., multiple sclerosis, chronic inflammation demyelinating polyneuropathy)

Current treatment with alkylating agents such as cyclophosphamide

History of gastrointestinal (GI) tract perforation

History of inflammatory bowel disease except fully excised ulcerative colitis

Any history of diverticulitis (event if not perforated) or confirmed diverticular bleeding. (Diverticulosis is not an exclusion).

Patients with a platelet count \< 100,000/mm\^3 (last measurement within 7 days prior to enrollment)

Patients with an absolute neutrophil count (ANC) \< 2,000/mm\^3 (last measurement within 7 days prior to enrollment)

Patients with Aspartate Aminotransferase (AST) or Alanine Aminotransferase (ALT) levels \>3 times upper limit of normal

Patients who use illegal drugs

Smoking or vaping within 6 months of listing for transplant

Use of investigational drugs within 4 weeks prior to enrollment

Any condition that in the opinion of the site Principal Investigator (PI) introduces undue risk by participating in this study Randomization:

Recipient of multi-organ or tissue transplants

Clinically stable, without clinical evidence of untreated infection

Received a live virus vaccine within 30 days prior to randomization

Received treatment to deplete HLA antibodies before transplantation to improve the possibility of transplantation

Patients with known donor-specific antibody that will require intervention based on local clinical protocols

History of GI tract perforation

History of inflammatory bowel disease except fully excised ulcerative colitis

History of diverticulitis (diverticulosis is not an exclusion) or diverticular bleeding

History of severe allergic anaphylactic reactions to humanized or murine monoclonal antibodies

Known hypersensitivity to ACTEMRA® (tocilizumab)

Previous treatment with ACTEMRA® (tocilizumab) within the last 3 months.

Recipient or donor with infection with human immunodeficiency virus (HIV)

Recipient with hepatitis B virus surface antigen or hepatitis B core antibody positive

Hepatitis B negative transplant recipient that received a transplant from a Hepatitis B core antibody positive donor unless the recipient has a Hepatitis B Surface Antigen (HBsAb) titer \>10U/L

Recipient of a hepatitis C virus nucleic acid test (NAT) positive donor organ

Latent TB infection (LTBI) and has not completed appropriate therapy

Chronic infection with Burkholderia cenocepacia or Burkholderia gladioli

Non-tuberculous mycobacterial (NTM) pulmonary disease; if there is a history of NTM pulmonary disease, culture conversion is necessary for eligibility

Presence of active malignancy (except for non-melanoma skin cancer)

History of hemolytic-uremic syndrome/ thrombotic thrombocytopenia purpura

History of demyelinating disorders (e.g., multiple sclerosis, chronic inflammation demyelinating polyneuropathy)

Current treatment with alkylating agents such as cyclophosphamide

Patients with AST or ALT levels \> 1.5 times upper limit of normal (last measurement within 1 day prior to randomization)

Patients with platelet count \<100,000/mm\^3 (last measurement within 1 day prior to randomization)

Patients with an absolute neutrophil count (ANC) \<2,000/mm\^3 (last measurement within 1 day prior to randomization)

Patients who are administered anti-thymocyte globulin as induction therapy in the immediate post- transplant period

Patients who have been treated in the past 3 months, or for whom it is anticipated that treatment with any immunomodulatory biological agents post-transplant are excluded

Use of an investigational drug after transplant

Smoking or vaping since enrollment

Any condition that in the opinion of the site PI introduces undue risk by participating in this study

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 Boston?

Yes, this clinical trial (NCT06033196) has an active research site in Boston, MA 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.

Lung Transplant Treatment Options in Boston, MA

If you're searching for lung transplant treatment options in Boston, MA, this clinical trial (NCT06033196) 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 Boston research site is actively enrolling participants for this phase 2 clinical trial. You'll receive care from experienced lung transplant 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 lung transplant clinical trials near you to find additional studies recruiting in your area.

Lung Transplant Clinical Trial in Boston, MA

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