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Stem Cell Transplant with Conditioning Regimen for Blood Diseases

Phase 2
Recruiting
Led By Lauri Burroughs
Research Sponsored by Fred Hutchinson Cancer Research Center
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
DONOR: Bone marrow is the preferred cell source (when feasible). However, peripheral blood stem cells (PBSC) is also allowed and the PI may determine if PBSC is preferred for certain patients
The recommended total nucleated cell count (TNC) for bone marrow grafts is >= 4.0 x 10^8 TNC/kg (actual recipient weight)
Timeline
Screening 3 weeks
Treatment Varies
Follow Up at 1 year post-transplant
Awards & highlights

Study Summary

This trial will study whether a new, less intensive conditioning regimen using the drugs treosulfan, thiotepa, and fludarabine phosphate is just as effective in treating patients with nonmalignant diseases as the current standard of care, which uses more powerful and potentially more toxic chemotherapy drugs.

Who is the study for?
This trial is for patients under 50 with non-cancerous blood diseases or conditions like immune disorders, who haven't found a genetic cause for their illness. They need a matching donor for stem cell transplant and must not have severe heart, lung, kidney issues, HIV, active hepatitis or be pregnant.Check my eligibility
What is being tested?
The study tests a less toxic conditioning regimen before stem cell transplantation using drugs treosulfan, thiotepa, fludarabine phosphate and rATG to treat non-malignant diseases by replacing faulty bone marrow with healthy donor cells.See study design
What are the potential side effects?
Potential side effects include allergic reactions to the medications used in the treatment regimen (treosulfan, fludarabine phosphate), damage to organs from powerful chemotherapy drugs and complications related to stem cell transplantation.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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My preferred cell source for donation is bone marrow, but peripheral blood stem cells may be used if needed.
Select...
My bone marrow graft meets the required cell count.
Select...
My donor matches me closely in immune system markers or has only one mismatch.
Select...
I am under 50 years old.
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My stem cell graft has the right number of CD34 cells.
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I have a non-cancerous condition that can be treated with a stem cell transplant from a donor.
Select...
I have a sibling donor whose bone marrow and umbilical cord blood match mine.
Select...
My disease is not cancerous and its genetic cause is unknown, but I have PI approval.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~at 1 year post-transplant
This trial's timeline: 3 weeks for screening, Varies for treatment, and at 1 year post-transplant for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Engraftment failure
Secondary outcome measures
Donor chimerism CD3 & CD33
Event-free survival
Incidence of chronic graft-versus-host disease
+3 more

Trial Design

1Treatment groups
Experimental Treatment
Group I: Treatment (chemotherapy, transplant)Experimental Treatment5 Interventions
Patients receive thiotepa IV BID over 2 hours on day -7, treosulfan IV over 120 minutes on days -6 to -4, fludarabine phosphate IV over 60 minutes on days -6 to -2, and rabbit anti-thymocyte globulin IV over 4-6 hours on days -4 to -2. Patients then undergo allogeneic hematopoietic cell transplant via infusion on day 0.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Fludarabine Phosphate
1997
Completed Phase 3
~2390
Allogeneic Hematopoietic Stem Cell Transplantation
2012
Completed Phase 2
~1200
Thiotepa
2008
Completed Phase 3
~2150
Treosulfan
2009
Completed Phase 3
~2320

Find a Location

Who is running the clinical trial?

Fred Hutchinson Cancer Research CenterLead Sponsor
443 Previous Clinical Trials
148,205 Total Patients Enrolled
Fred Hutchinson Cancer CenterLead Sponsor
556 Previous Clinical Trials
1,343,176 Total Patients Enrolled
Lauri BurroughsPrincipal InvestigatorFred Hutch/University of Washington Cancer Consortium
2 Previous Clinical Trials
35 Total Patients Enrolled

Media Library

Allogeneic Hematopoietic Stem Cell Transplantation Clinical Trial Eligibility Overview. Trial Name: NCT03980769 — Phase 2
Non-Hodgkin's Lymphoma Research Study Groups: Treatment (chemotherapy, transplant)
Non-Hodgkin's Lymphoma Clinical Trial 2023: Allogeneic Hematopoietic Stem Cell Transplantation Highlights & Side Effects. Trial Name: NCT03980769 — Phase 2
Allogeneic Hematopoietic Stem Cell Transplantation 2023 Treatment Timeline for Medical Study. Trial Name: NCT03980769 — Phase 2

Frequently Asked Questions

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

Has Allogeneic Hematopoietic Stem Cell Transplantation been cleared by the FDA?

"Allogeneic Hematopoietic Stem Cell Transplantation is currently in Phase 2 clinical trials. There is some evidence supporting its safety, but more research needs to be done to confirm efficacy."

Answered by AI

What medical conditions has Allogeneic Hematopoietic Stem Cell Transplantation been shown to improve?

"Allogeneic Hematopoietic Stem Cell Transplantation is a medical procedure used to treat conditions such as chronic lymphocytic leukemia and cancer. This therapy can also be useful in hsct conditioning and urinary bladder treatments."

Answered by AI

Can new patients still enroll in this research project?

"This clinical trial, which was originally posted on 5/5/2021 and most recently updated on 10/25/2022, is actively recruiting participants."

Answered by AI

Are there any other ongoing or completed medical studies involving Allogeneic Hematopoietic stem cell transplants?

"There are 31 Phase 3 trials and 413 active trials in total for Allogeneic Hematopoietic Stem Cell Transplantation. The majority of these clinical trials are based in Boston, however there are 4797 locations running similar studies."

Answered by AI

How many people fit the qualifications for this experiment?

"The most recent information available on clinicaltrials.gov suggests that this study is still enrolling patients. The trial was first posted on May 5th, 2021 and has been edited as recently as October 25th, 2022. This study needs 40 more patients from 2 different medical centres in order to complete its planned enrolment."

Answered by AI
~21 spots leftby Jul 2027