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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
Timeline
Screening 3 weeks
Treatment Varies
Follow Up one year post transplant
Awards & highlights
BMT Trial 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.Check my eligibility
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.See study design
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.
BMT Trial 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.
BMT Trial Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 2 years post-transplant
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~2 years post-transplant
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Number of patients who die of treatment-related complications.
Secondary outcome measures
Number of patients with acute and delayed renal allograft rejection
Other outcome measures
Number of patients who are able to discontinue immunosuppressive therapy by one year post transplant
Number of patients who develop acute and chronic graft versus host disease (GVHD).
Number of patients who relapse from their underlying hematological disease
BMT 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
2,935 Previous Clinical Trials
13,198,631 Total Patients Enrolled
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.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Does the enrollment criteria extend to people aged 75 or older?
"To be eligible for the trial, patients must fall between 18 and 70 years of age. There are an abundance of studies that cater to those below 18 (917) or above 65 (3572)."
Answered by AI
What criteria must individuals meet to qualify for participation in this clinical research?
"This trial is enrolling 10 individuals with diamond-blackfan anemia that range from 18 to 70 years in age. All participants must have a haploidentical first degree relative who passes the standard evaluations for bone marrow and kidney donation, as well as boast a life expectancy of more than 6 months."
Answered by AI
What is the cohort size of this research experiment?
"Affirmative. According to information on clinicaltrials.gov, this experiment was initially posted on the 11th of November 2012 and is still open for enrolment. 10 volunteers are requested from 1 locale in order to fulfil the requirements of this research endeavour."
Answered by AI
Is this experiment presently recruiting participants?
"Affirmative. Clinicaltrials.gov displays that this experiment is recruiting participants at the present time, having first been posted on November 1st 2012 and recently edited on March 13th 2023. It aims to enrol 10 patients from a single site."
Answered by AI
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