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Stem Cell Transplant

Bone Marrow/Kidney Transplant for Blood Disorders & Chronic Kidney Disease (BMT Trial)

N/A
Recruiting
Led By Yi-Bin A Chen, M.D.
Research Sponsored by Massachusetts General Hospital
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
ABO compatibility in the host vs. graft direction
Existence of haploidentical first degree relative who passes standard donor evaluations for bone marrow and kidney donation
Must not have
Serologic positivity for HIV, HCV, or HbsAg positivity
Contraindication to therapy with any one of the proposed agents (e.g., history of allergy to rabbit serum in ATG)
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 100 days and 1 year post transplant
Awards & highlights
No Placebo-Only Group

Summary

This trial is for a combined bone marrow and kidney transplant from a partially matched related donor to treat a blood disorder and kidney disease. The expectation is to have 10 people participate.

Who is the study for?
This trial is for adults aged 18-70 with certain blood disorders (like leukemia, lymphoma, myeloma) and chronic kidney disease who have a related donor that partially matches their bone marrow and can donate a kidney. Participants must have reasonable lung and heart function, agree to birth control measures, not be HIV or hepatitis positive, and cannot be part of another drug study.
What is being tested?
The study tests a combined bone marrow and kidney transplant from the same family donor to treat both blood disorders and kidney disease. It uses less intense chemotherapy before the transplant in hopes of reducing complications like organ damage or graft versus host disease.
What are the potential side effects?
Potential side effects include toxicity to liver, lungs, mucous membranes, intestines due to chemotherapy; risk of graft versus host disease where new cells attack the body; infection risks; possible allergic reactions to treatment drugs.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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My blood type matches the donor's for the transplant.
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I have a close family member who can donate bone marrow or a kidney and has passed all necessary health checks.
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My kidney function is severely reduced or I am on dialysis.
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I am between 18 and 70 years old.
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I understand the study details 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 tested positive for HIV, Hepatitis C, or Hepatitis B.
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I am allergic to some medications used in the trial.
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I am currently fighting a serious infection.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~100 days and 1 year post transplant
This trial's timeline: 3 weeks for screening, Varies for treatment, and 100 days and 1 year post 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
Number of patients who die of treatment-related complications.

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: Haploidentical Bone Marrow/KidneyExperimental Treatment1 Intervention
Single Arm Study

Find a Location

Who is running the clinical trial?

Massachusetts General HospitalLead Sponsor
3,010 Previous Clinical Trials
13,309,010 Total Patients Enrolled
1 Trials studying Thalassemia
2 Patients Enrolled for Thalassemia
Yi-Bin A Chen, M.D.Principal InvestigatorDirector of Clinical Research, Massachusetts General Hospital Bone Marrow Transplant Program

Media Library

Haploidentical Bone Marrow/Kidney (Stem Cell Transplant) Clinical Trial Eligibility Overview. Trial Name: NCT01758042 — N/A
Thalassemia Research Study Groups: Haploidentical Bone Marrow/Kidney
Thalassemia Clinical Trial 2023: Haploidentical Bone Marrow/Kidney Highlights & Side Effects. Trial Name: NCT01758042 — N/A
Haploidentical Bone Marrow/Kidney (Stem Cell Transplant) 2023 Treatment Timeline for Medical Study. Trial Name: NCT01758042 — N/A
~0 spots leftby Jul 2025
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