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Alemtuzumab for Sickle Cell Disease

Phase 1

Waitlist Available

Research Sponsored by Monica Bhatia

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 180 days post transplant

Awards & highlights

Study Summary

This study is evaluating whether a drug called abatacept can be added to a standard GVHD prophylaxis regimen to reduce the risk of GVHD.

Eligible Conditions

Sickle Cell Disease
Graft-versus-Host Disease

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ up to 180 days post transplant

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~up to 180 days post transplant

This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 180 days 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

Number of patients who tolerate abatacept

Secondary outcome measures

Bearman Scale Score of Regimen-Related Toxicity (RRT)

Number of infections

Side effects data

From 2017 Phase 4 trial • 8 Patients • NCT01395316

13%

Hypothyroidism

100%

80%

60%

40%

20%

Study treatment Arm

Alemtuzumab

Trial Design

1Treatment groups

Experimental Treatment

Group I: Standard GVHD Prophylaxis + AbataceptExperimental Treatment16 Interventions

Subjects will receive premedication (Diphenhydramine, Acetaminophen, Methylprednisolone; and Meperidine as needed) immunosuppression (Alemtuzumab, or Thymoglobulin) conditioning regimen (Fludarabine, Thiotepa, and Melphalan) GVHD prophylaxis: calcineurin inhibitor (Cyclosporine,Tacrolimus, Sirolimus or Mycophenolate Mofetil with permission of the sponsor) and Methotrexate plus Abatacept on days -1, +5, +14 and +28, and a marrow infusion on day 0.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Methotrexate

FDA approved

Meperidine

FDA approved

Mycophenolate mofetil

FDA approved

Antithymocyte immunoglobulin (rabbit)

FDA approved

Alemtuzumab

FDA approved

Melphalan

FDA approved

Tacrolimus

FDA approved

Fludarabine

FDA approved

Sirolimus

FDA approved

Abatacept

FDA approved

Thiotepa

FDA approved

Cyclosporine

FDA approved

Diphenhydramine

FDA approved

Acetaminophen

FDA approved

Methylprednisolone

FDA approved

Do I qualify?Apply below to find out

Find a Location

Who is running the clinical trial?

Monica BhatiaLead Sponsor

Monica Bhatia, MDStudy ChairColumbia University

3 Previous Clinical Trials

102 Total Patients Enrolled

Frequently Asked Questions

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

Recent research and studies

clinicaltrials.govStudy

Abatacept for GVHD Prophylaxis After Hematopoietic Stem Cell Transplantation for Pediatric Sickle Cell Disease

Monica Bhatia 2016. "Abatacept for GVHD Prophylaxis After Hematopoietic Stem Cell Transplantation for Pediatric Sickle Cell Disease". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT02867800.

All > Gvhd > Restasis

~3 spots leftby Apr 2025

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