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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 belowSelect...
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:Select...
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 weeks3 visits
Treatment ~ Varies
Follow Up ~ 100 days and 1 year post transplant
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~100 days and 1 year post transplant
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
3,026 Previous Clinical Trials
13,413,810 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
Eligibility Criteria:
This trial includes the following eligibility criteria:- You are expected to live for more than six months.Your lung function tests show that you can breathe out, breathe in, and transfer oxygen normally.Your heart's pumping function is good, as measured by a heart ultrasound or a special heart scan.My blood type matches the donor's for the transplant.I have a blood disorder that may be treated with a bone marrow transplant.I have tested positive for HIV, Hepatitis C, or Hepatitis B.I am currently fighting a serious infection.I have a close family member who can donate bone marrow or a kidney and has passed all necessary health checks.My kidney function is severely reduced or I am on dialysis.Your blood type is not compatible with the donated organ or tissue.I am allergic to some medications used in the trial.I am between 18 and 70 years old.I agree to use birth control during and for 1 year after treatment.I understand the study details and can give my consent.Your total bilirubin, AST, ALT, and alkaline phosphatase levels should be within certain limits, unless you have a specific condition called Gilbert's syndrome or hemolysis.
Research Study Groups:
This trial has the following groups:- Group 1: Haploidentical Bone Marrow/Kidney
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.