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Monoclonal Antibodies

Stem Cell Transplant for Sickle Cell Disease

Phase 2
Waitlist Available
Led By Monica Bhatia, MD
Research Sponsored by Columbia University
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 day +30, 60, 100, 180, 365, 730, and 1005
Awards & highlights

Study Summary

This trial is testing whether lower doses of chemo, followed by a stem cell transplant, will be successful in treating a patient's disease with fewer side effects.

Eligible Conditions
  • Sickle Cell Disease
  • Beta Thalassemia

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~day 30, day 60, day 100, day 180, 1 year, 2 years, 3 years, 5 years, 10 years
This trial's timeline: 3 weeks for screening, Varies for treatment, and day 30, day 60, day 100, day 180, 1 year, 2 years, 3 years, 5 years, 10 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
Prevalence of toxicity associated with moderately ablative therapy (busulfan/fludarabine/alemtuzumab) and allogeneic stem cell transplantation in selected patients with Sickle Cell Disease (SCD) and Beta Thalassemia (BT)
Secondary outcome measures
Incidence of acute and chronic graft versus host disease (GVHD) following moderately ablative therapy and allogeneic stem cell transplantation in selected patients with SCD and BT
Incidence of primary and secondary graft failure
Percent of mixed donor chimerism
+3 more

Trial Design

2Treatment groups
Experimental Treatment
Group I: SCD groupExperimental Treatment4 Interventions
Sickle Cell Disease patients receiving chemotherapy (Busulfan, Fludarabine and Alemtuzumab) will undergo allogeneic stem cell transplant.
Group II: BT groupExperimental Treatment4 Interventions
Beta Thalassemia patients receiving chemotherapy (Busulfan, Fludarabine and Alemtuzumab) will undergo allogeneic stem cell transplant.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Busulfan
FDA approved
Fludarabine
FDA approved
Alemtuzumab
FDA approved
Allogeneic stem cell transplant
2005
Completed Phase 2
~260

Find a Location

Who is running the clinical trial?

Columbia UniversityLead Sponsor
1,439 Previous Clinical Trials
2,448,766 Total Patients Enrolled
Monica Bhatia, MDPrincipal InvestigatorColumbia University
3 Previous Clinical Trials
73 Total Patients Enrolled

Media Library

Alemtuzumab (Monoclonal Antibodies) Clinical Trial Eligibility Overview. Trial Name: NCT00408447 — Phase 2
Sickle Cell Disease Research Study Groups: BT group, SCD group
Sickle Cell Disease Clinical Trial 2023: Alemtuzumab Highlights & Side Effects. Trial Name: NCT00408447 — Phase 2
Alemtuzumab (Monoclonal Antibodies) 2023 Treatment Timeline for Medical Study. Trial Name: NCT00408447 — Phase 2
~3 spots leftby Jun 2025
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