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Chemotherapy

hydroxyurea, azathioprine, alemtuzumab, thioptepa, low dose total body irradiation and sirolimus for Sickle Cell Disease

Phase 2
Waitlist Available
Led By Akshay Sharma, MBBS
Research Sponsored by St. Jude Children's Research Hospital
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 up to 6 months after hct
Awards & highlights

Study Summary

This trial is testing a transplant method that may have fewer side effects than conventional high dose chemotherapy conditioning-based transplants for children and young adults with Sickle Cell Disease.

Eligible Conditions
  • Sickle Cell Disease

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to 6 months after hct
This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 6 months after hct for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Donor T-cell chimerism at 1-year post transplant in each respective arm (MSD, HAPLO) of the trial.
Secondary outcome measures
Graft rejection rate.
Incidence and severity of acute and chronic (GVHD).
Incidence of SCD recurrence after transplant.
+2 more

Trial Design

2Treatment groups
Experimental Treatment
Group I: Matched Sibling Donor (MSD)Experimental Treatment1 Intervention
Patients with a suitable HLA matched sibling donor (MSD) will be enrolled on the MSD arm.
Group II: Haploidentical (HAPLO)Experimental Treatment1 Intervention
Patients without an eligible MSD who have a suitable haploidentical (HAPLO) donor available will be enrolled on the HAPLO arm of the study.

Find a Location

Who is running the clinical trial?

St. Jude Children's Research HospitalLead Sponsor
428 Previous Clinical Trials
5,306,573 Total Patients Enrolled
Akshay Sharma, MBBSPrincipal InvestigatorSt. Jude Children's Research Hospital
2 Previous Clinical Trials
21 Total Patients Enrolled

Frequently Asked Questions

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

In what medical scenarios are hydroxyurea, azathioprine, alemtuzumab, thioptepa, low dose total body irradiation and sirolimus usually recommended?

"Hydroxyurea, azathioprine, alemtuzumab, thioptepa, low dose total body irradiation and sirolimus are employed to treat several medical conditions including organ transplants. Furthermore this treatment has proven effective for multiple sclerosis, lupus nephritis, leukemia and myelocytic acute diseases."

Answered by AI

Are any other research initiatives currently exploring the effects of hydroxyurea, azathioprine, alemtuzumab, thioptepa, low dose total body irradiation and sirolimus?

"At the present, there are 995 clinical trials exploring hydroxyurea, azathioprine, alemtuzumab, thioptepa, low dose total body irradiation and sirolimus with 180 being in Phase 3. Of which Philadelphia Pennsylvania is conducting a portion of these studies yet 29496 sites nationwide are running research on said medications."

Answered by AI

Is the combination of hydroxyurea, azathioprine, alemtuzumab, thioptepa, low dose total body irradiation and sirolimus sanctioned by the FDA?

"Our team at Power assessed the safety of hydroxyurea, azathioprine, alemtuzumab, thioptepa, low dose total body irradiation and sirolimus to be a 2 since this is merely Phase 2 trial without confirmed efficacy."

Answered by AI

Does this trial involve elderly participants?

"Within the age range of 2 to 25, this research project is looking for participants."

Answered by AI

Is recruitment for this experiment still ongoing?

"Affirmative. Clinicaltrials.gov verifies that this trial, which was initially published on April 30th 2020, is actively enrolling patients. 40 individuals are needed from a single site in order to fulfill the study's requirements."

Answered by AI

Is it feasible for me to partake in this trial?

"This study calls for 40 participants aged between 2 and 25 years old with anemia, sickle cell. The following criteria must also be satisfied: inclusion criterion related to the transplant recipient's age, HLA-matched sibling donor (MSD) availability, abnormal transcranial Doppler measurement history, cerebral infarction record on brain MRI scan, two or more episodes of acute chest syndrome in preceding 24 months; opiate/IV pain medication administered due to SCD pain event twice within 12 months; hospitalisation during hydroxyurea treatment period over last year; erection lasting 4+ hours requiring medical attention documented twice in recent times"

Answered by AI

What is the cap for participants in this clinical investigation?

"Affirmative. Clinicaltrials.gov has the newest information indicating that this medical trial is still recruiting subjects, with 40 participants needed from one site. The study was initially posted on April 30th 2020 and recently updated on May 5th 2022."

Answered by AI
Recent research and studies
clinicaltrials.govStudy
Reduced Intensity Transplantation for Severe Sickle Cell Disease
2020. "Reduced Intensity Transplantation for Severe Sickle Cell Disease". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT04362293.
~2 spots leftby Jul 2024
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