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HSCT For Patients With High Risk Hemoglobinopathies Using Reduced Intensity

NCT02435901 · Status: COMPLETED · Phase: PHASE1/PHASE2 · Type: INTERVENTIONAL · Enrollment: 29

Last updated 2021-08-24

Study results available
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Summary

This study will evaluate the use of reduced intensity conditioning regimen in patients with high risk hemoglobinopathy Sickle Cell and B-Thalassemia Major in combination with standard immunosuppressive medications, followed by a routine stem cell transplant in order to assess whether or not it is as effective as myeloablative high dose chemotherapy and transplant.

Conditions

Interventions

DRUG

alemtuzumab (Campath IH)

Alemtuzumab (Campath IH) is given daily over first 4 days, Day -20 to Day -17

DRUG

Fludarabine

Fludarabine 35/m2 is given daily over 4 days on Day -7 to Day -4.

DRUG

Melphalan

Melphalan 70mg/m2 is given daily over 2 days on Day -3 to Day -2.

DRUG

Cyclosporine

Immunosuppressant to prevent graft vs host disease is given on Day -1 prior to stem cell infusion

DRUG

Mycophenolate mofetil

Immunosuppressant to prevent graft vs host disease is given on Day -1.

DRUG

Tacrolimus

Immunosuppressant to prevent graft vs host disease is given Day -1 prior to stem cell infusion

BIOLOGICAL

Hematopoietic Stem Cell Transplantation

Human Leukocyte Antigen (HLA) matched or mismatched; related or unrelated hematopoietic stem cells to be transplanted on Day 0.

Sponsors & Collaborators

  • Northwell Health

    lead OTHER

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
1 Year
Max Age
21 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2008-12-31
Primary Completion
2019-03-31
Completion
2019-12-31
FDA Drug
Yes

Countries

  • United States

Study Locations

More Related Trials

Entities

Drugs
Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02435901 on ClinicalTrials.gov