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Monoclonal Antibodies

Tocilizumab for Lung Transplant (ALL IN LUNG Trial)

Phase 2
Recruiting
Research Sponsored by National Institute of Allergy and Infectious Diseases (NIAID)
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Listed for a primary lung transplant
No previous or planned desensitization therapy prior to transplant
Timeline
Screening 3 weeks
Treatment Varies
Follow Up at 3 years after transplantation
Awards & highlights

ALL IN LUNG Trial Summary

This trial tests whether adding a drug to standard lung transplant care improves outcomes in 350 patients.

Who is the study for?
This trial is for individuals over 30 kg awaiting their first lung transplant, who understand the study and consent to participate. They must not be pregnant, use effective contraception if applicable, have up-to-date vaccinations, no prior desensitization therapy or organ transplants, a negative TB test within a year or completed LTBI treatment, and an adequate level of IgG.Check my eligibility
What is being tested?
The trial tests whether Tocilizumab (six doses over 20 weeks) combined with standard immunosuppression is more effective than placebo plus standard care in preventing complications like CLAD, re-transplantation listing or death in primary lung transplant recipients.See study design
What are the potential side effects?
Tocilizumab may cause allergic reactions similar to other humanized monoclonal antibodies. It can also increase the risk of infections due to its immune-modulating effects. Other potential side effects include liver enzyme elevations and blood count changes.

ALL IN LUNG Trial Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
Select...
I am on the waiting list for my first lung transplant.
Select...
I have not had, nor am I planning to have, desensitization therapy before a transplant.
Select...
I weigh at least 30 kg.

ALL IN LUNG Trial Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~at 3 years after transplantation
This trial's timeline: 3 weeks for screening, Varies for treatment, and at 3 years after transplantation for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Proportion of subjects who meet any one of the pre-specified events detailed in the outcome description: from Baseline up to 36 months
Secondary outcome measures
Cumulative incidence listed for re-transplantation
Cumulative incidence of Chronic Lung Allograft Dysfunction (CLAD)
Cumulative incidence of death
+22 more

Side effects data

From 2017 Phase 4 trial • 59 Patients • NCT02034474
11%
Low ANC
5%
nausea
5%
Inpatient admission
5%
fatigue
5%
agranulocytosis
100%
80%
60%
40%
20%
0%
Study treatment Arm
Tocilizumab
Placebo

ALL IN LUNG Trial Design

2Treatment groups
Experimental Treatment
Placebo Group
Group I: Tocilizumab GroupExperimental Treatment1 Intervention
Subject in this group will receive ACTEMRA(R) (Tocilizumab) ,(six injections over 20 weeks) plus standard triple maintenance immunosuppression of Tacrolimus, Mycophenolate Mofetil, corticosteroids
Group II: Placebo GroupPlacebo Group1 Intervention
Subject in this group will receive placebo for Tocilizumab (sterile normal saline) plus standard triple maintenance immunosuppression of Tacrolimus, Mycophenolate Mofetil, corticosteroids
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Tocilizumab
2012
Completed Phase 4
~1840

Find a Location

Who is running the clinical trial?

National Institute of Allergy and Infectious Diseases (NIAID)Lead Sponsor
3,270 Previous Clinical Trials
5,484,887 Total Patients Enrolled
4 Trials studying Lung Transplant
1,074 Patients Enrolled for Lung Transplant
Joren Madsen, MD, D.Phil.Study ChairMassachusetts General Hospital: Transplantation
Ramsey Hachem, MDStudy ChairWashington University School of Medicine Division of Pulmonary Medicine
2 Previous Clinical Trials
116 Total Patients Enrolled

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Has the Tocilizumab Group been granted regulatory approval by the FDA?

"Our team at Power rated tocilizumab's safety a 2, as this is only Phase 2. This indicates that while there are some data indicating its security, there are no studies validating its efficacy."

Answered by AI

Are there available openings to join the current trial?

"As of the latest update on September 8th 2023, this clinical trial is not actively recruiting. Although it was initially posted on October 1st 2023, there are 16 other medical trials that are presently searching for suitable candidates."

Answered by AI

What proportion of this medical experiment is being conducted in city?

"For this research trial, patients are being recruited from Cedars Sinai Medical Center: Transplantation in Los Angeles, California; University of Maryland Medical Center: Transplantation in Baltimore, Maryland; Ronald Reagan UCLA Medical Center: Transplantation in Boston, Massachusetts. Additionally, there are 17 other sites where enrolment is available."

Answered by AI

Is it feasible for those under 35 years old to participate in this research endeavor?

"Prospective participants must be between the ages of 12 and 75 in order to meet this clinical study's enrollment requirements."

Answered by AI

Who is eligible to join this research program?

"This research project requires participants to have a history of lung transplant and be aged between 12-75. The team aims to recruit roughly 350 individuals in total."

Answered by AI
Recent research and studies
clinicaltrials.govStudy
Tocilizumab in Lung Transplantation
2024. "Tocilizumab in Lung Transplantation". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT06033196.
~233 spots leftby Jan 2029
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