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Immunotherapy

Hematopoietic Cell Transplant for Sickle Cell Disease (STRIDE2 Trial)

Phase 2

Waitlist Available

Research Sponsored by Medical College of Wisconsin

Eligibility Criteria Checklist

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

Must have

Be younger than 65 years old

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 2 years

Awards & highlights

STRIDE2 Trial Summary

This trial will compare survival rates and sickle cell-related outcomes of adolescents and young adults with severe sickle cell disease who receive bone marrow transplants to those receiving standard care.

Eligible Conditions

Sickle Cell Disease

STRIDE2 Trial Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 2 years

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~2 years

This trial's timeline: 3 weeks for screening, Varies for treatment, 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

Overall Survival (OS)

Secondary outcome measures

Cardiac Function

Exercise Capacity

Health-Related Quality of Life (HRQoL)

+4 more

STRIDE2 Trial Design

2Treatment groups

Experimental Treatment

Active Control

Group I: Donor ArmExperimental Treatment11 Interventions

Donor Arm patients will undergo hematopoietic cell transplant. Patients with a matched unrelated donor will receive a bone marrow transplant (unless PBSC graft is pre-approved per section 2.5.1 using a preparative regimen with Busulfan, Fludarabine and rabbit ATG. Patients with an HLA-identical sibling donor can receive a transplant using one of three regimens: A. Busulfan, Fludarabine, and rabbit ATG using a bone marrow graft (preferred regimen) B. Alemtuzumab/TBI 300 cGy using a peripheral blood graft C. Alemtuzumab, fludarabine, melphalan using a bone marrow graft

Group II: No-Donor ArmActive Control1 Intervention

No-donor arm patients will continue with standard of care per their SCD physician.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Sirolimus

2013

Completed Phase 4

~2750

Methotrexate

2013

Completed Phase 4

~3800

Alemtuzumab

2004

Completed Phase 4

~1890

Melphalan

2008

Completed Phase 3

~1500

G-CSF

2014

Completed Phase 4

~1610

Busulfan

2008

Completed Phase 3

~1120

Fludarabine

2012

Completed Phase 3

~1100

r-ATG

2003

Completed Phase 2

~200

Tacrolimus

2011

Completed Phase 4

~4740

Hematopoietic Cell Transplant

2016

Completed Phase 2

~140

Total Body Irradiation (TBI)

2016

Completed Phase 3

~1220

Do I qualify?Apply below to find out

Find a Location

Who is running the clinical trial?

Medical College of WisconsinLead Sponsor

609 Previous Clinical Trials

1,162,445 Total Patients Enrolled

National Heart, Lung, and Blood Institute (NHLBI)NIH

3,835 Previous Clinical Trials

47,310,532 Total Patients Enrolled

National Marrow Donor ProgramOTHER

60 Previous Clinical Trials

202,422 Total Patients Enrolled

Frequently Asked Questions

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

Does this study involve only elderly patients?

"According to the age restriction guidelines set out by the investigators, the minimum age for potential participants is 15 while the maximum age is 40."

Answered by AI

Does this research on Hematopoietic Cell Transplant build on other scholarship in the field?

"There are nearly a thousand medical trials ongoing that involve Hematopoietic Cell Transplantation. The majority of these studies are in Phase 3. Most of these trials take place in Houston, Texas, but there are over 16,000 locations around the world where Hematopoietic Cell Transplant clinical trials are taking place."

Answered by AI

Has the FDA cleared Hematopoietic Cell Transplant for use?

"Hematopoietic Cell Transplantation falls into the category of being a Phase 2 trial, meaning that while there is evidence of safety, there is no existing data to support efficacy. Our team scored it as a 2."

Answered by AI

What conditions does Hematopoietic Cell Transplant commonly alleviate?

"Small cell lung cancer is most commonly treated using a Hematopoietic Cell Transplant. However, this method of treatment can also be effective for other conditions like organ transplantation, dermatitis, atopic, and multiple sclerosis."

Answered by AI

Recent research and studies

American Journal of HematologyJournal

Bone Marrow Transplantation for Adolescents and Young Adults with Sickle Cell Disease: Results of a Prospective Multicenter Pilot Study

Krishnamurti, Lakshmanan, Donna S. Neuberg, Keith M. Sullivan, Naynesh R. Kamani, Allistair Abraham, Federico Campigotto, Wandi Zhang, et al.. 2019. “Bone Marrow Transplantation for Adolescents and Young Adults with Sickle Cell Disease: Results of a Prospective Multicenter Pilot Study”. American Journal of Hematology. Wiley. doi:10.1002/ajh.25401.

clinicaltrials.govStudy

Bone Marrow Transplantation vs Standard of Care in Patients With Severe Sickle Cell Disease (BMT CTN 1503)

2016. "Bone Marrow Transplantation vs Standard of Care in Patients With Severe Sickle Cell Disease (BMT CTN 1503)". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT02766465.