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Chemotherapy

Stem Cell Transplant for Blood Disorders

N/A

Recruiting

Led By Ashish Gupta, MBBS, MPH

Research Sponsored by Masonic Cancer Center, University of Minnesota

Eligibility Criteria Checklist

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

Must have

Absence of decompensated congestive heart failure, or uncontrolled arrhythmia and left ventricular ejection fraction > 40%

Acceptable stem cell source identified

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 6 months, 1 and 2 years

Awards & highlights

Study Summary

This trial is collecting data on the outcomes of stem cell transplants for patients with non-cancerous blood disorders.

Who is the study for?

This trial is for people with serious blood disorders like Sickle Cell Disease and Thalassemia, who have a suitable stem cell donor. They must be in stable heart health, have reasonable physical function, and normal liver/kidney function. It's not for those with active infections, pregnant or breastfeeding women, or HIV-positive individuals.Check my eligibility

What is being tested?

The study tests different ways to prepare patients for stem cell transplants using less intense chemotherapy (reduced intensity/toxicity regimens) or stronger chemo (myeloablative regimen), aiming to treat non-cancerous blood diseases.See study design

What are the potential side effects?

Potential side effects include reactions to the transplant like graft-versus-host disease, infection risks due to weakened immunity from chemo prep regimens, organ damage from high-dose treatments, and general transplant-related complications.

Eligibility Criteria

Inclusion Criteria

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

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My heart functions well, without severe failure or uncontrolled irregular heartbeat.

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I have a suitable stem cell donor or source.

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I have a blood disorder that may require a stem cell transplant.

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I am mostly active and can care for myself.

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My kidney function is within the required range.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 6 months, 1 and 2 years

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~6 months, 1 and 2 years

This trial's timeline: 3 weeks for screening, Varies for treatment, and 6 months, 1 and 2 years for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

incidence of graft failure

Secondary outcome measures

disease free survival

overall survival

Trial Design

3Treatment groups

Experimental Treatment

Group I: Reduced Toxicity Ablative RegimenExperimental Treatment1 Intervention

For use in patients with a matched sibling donor or unrelated UCB donor and DBA patients who are <12 years and/or have mild/moderate iron exposure.

Group II: Reduced Intensity Preparative RegimenExperimental Treatment1 Intervention

For use in patients with unrelated donor bone marrow and for DBA patients who are >12 years and/or have significant iron exposure.

Group III: Myeloablative Preparative RegimenExperimental Treatment1 Intervention

For use in patients with a matched sibling donor, unrelated umbilical cord blood and in those with severe thalassemia.

0 / 5Eligibility criteria met

Find a Location

Who is running the clinical trial?

Masonic Cancer Center, University of MinnesotaLead Sponsor

271 Previous Clinical Trials

14,600 Total Patients Enrolled

2 Trials studying Shwachman-Diamond Syndrome

32 Patients Enrolled for Shwachman-Diamond Syndrome

Ashish Gupta, MBBS, MPHPrincipal InvestigatorMasonic Cancer Center, University of Minnesota

3 Previous Clinical Trials

69 Total Patients Enrolled

Media Library

Myeloablative Preparative Regimen (Chemotherapy) Clinical Trial Eligibility Overview. Trial Name: NCT02179359 — N/A

Shwachman-Diamond Syndrome Research Study Groups: Myeloablative Preparative Regimen, Reduced Toxicity Ablative Regimen, Reduced Intensity Preparative Regimen

Shwachman-Diamond Syndrome Clinical Trial 2023: Myeloablative Preparative Regimen Highlights & Side Effects. Trial Name: NCT02179359 — N/A

Myeloablative Preparative Regimen (Chemotherapy) 2023 Treatment Timeline for Medical Study. Trial Name: NCT02179359 — N/A

Frequently Asked Questions

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

Is this investigation currently soliciting participants?

"Affirmative, the information hosted on clinicaltrials.gov displays that this research project is actively recruiting participants at present. The study was initially posted on September 2nd 2014 and most recently updated April 11th 2021 with 25 enrollees sought from 1 site in total."

Answered by AI

What is the scope of participation in this research endeavor?

"Affirmative. Clinicaltrials.gov data states that this research endeavour, which was initially advertised on September 2nd 2014, is currently recruiting participants. Twenty-five individuals are being accepted from one medical facility."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

Hematopoietic Stem Cell Transplant for High Risk Hemoglobinopathies

2014. "Hematopoietic Stem Cell Transplant for High Risk Hemoglobinopathies". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT02179359.

All > Stem Cell Transplant > Sickle Cell Anemia