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Hematopoietic Stem Cell Transplantation

Lung and Bone Marrow Transplant for Pulmonary Fibrosis

Phase 1 & 2

Recruiting

Research Sponsored by Paul Szabolcs

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Patients must have evidence of end stage lung disease such as Pulmonary Fibrosis or COPD/Emphysema

Male or female, 18 through 60 years old, inclusive, at the time of informed consent

Must not have

Patients who have underlying malignant conditions

Females who are pregnant or who are lactating

Timeline

Screening 3 weeks

Treatment Varies

Follow Up up to 2 years post stem cell transplant

Awards & highlights

No Placebo-Only Group

Summary

This trial is testing whether having a lung transplant before a bone marrow transplant helps improve lung function before the marrow transplant.

Who is the study for?

This trial is for adults aged 18-60 with severe lung diseases like Pulmonary Fibrosis or COPD and bone marrow failure, who are eligible for a lung transplant. They must understand the study, not be pregnant, agree to birth control post-transplant, and have no allergies to stem cell product ingredients or recent live vaccines.

What is being tested?

The study tests if performing a lung transplant before a bone marrow transplant can restore lung function enough to proceed with bone marrow transplantation using various drugs (Rituximab, Alemtuzumab) and stem cells to improve blood cell counts.

What are the potential side effects?

Potential side effects include reactions to medications such as Rituximab and Alemtuzumab (infusion reactions), low blood counts from chemotherapy agents like Fludarabine and Thiotepa, increased risk of infections due to immune suppression, and organ toxicity.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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I have advanced lung disease like Pulmonary Fibrosis or COPD.

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I am between 18 and 60 years old.

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I am eligible for a lung transplant according to UNOS standards.

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I understand the study and can give my consent.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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I have a cancer diagnosis.

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I am currently pregnant or breastfeeding.

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I haven't had any live vaccines in the last 4 weeks before my transplant.

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I have a condition that does not require a bone marrow transplant.

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I do not have any infections that are not responding to treatment.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ up to 2 years post stem cell transplant

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~up to 2 years post stem cell transplant

This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 2 years post stem cell transplant for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

BOS Score

Death

Engraftment failure

+5 more

Secondary study objectives

Ability to withdrawal immunosuppression

Acute cellular rejection

Acute graft-versus-host-disease (GVHD)

+9 more

Other study objectives

In vitro immune tolerance

Mixed chimerism

Pace of immune reconstitution

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Trial Design

1Treatment groups

Experimental Treatment

Group I: Lung and Bone Marrow TransplantationExperimental Treatment7 Interventions

All patients will undergo a cadaveric, partially HLA-matched lung transplantation followed by a CD3+/CD19+ depleted BMT from the same donor. In this study, the investigators will use a ≥1/6 HLA-matched T cell depleted bone marrow transplantation from a cadaveric organ donor with an identical ABO blood type as the recipient. Prior to transplantation, the marrow will be negatively selected for CD3/CD19 using a CliniMACS® depletion device. Subjects will undergo lung transplantation utilizing standard induction regimens selected by the CO-PIs based on the subject's underlying comorbidities and allosensitization. Rituximab may be initiated prior to the lung transplantation with tacrolimus as the ongoing maintenance immunosuppression. Subjects will undergo BMT utilizing CD3+/CD19+-depleted bone marrow with bone marrow conditioning beginning no less than 8 weeks after lung transplantation. Bone marrow will be recovered alongside solid organs and will be processed and cryopreserved.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Alemtuzumab

2004

Completed Phase 4

~1880

Fludarabine

2012

Completed Phase 4

~1860