TMLI and Alemtuzumab for Treatment of Sickle Cell Disease

Part of paid clinical trials in Duarte, California.

Sponsor
City of Hope Medical Center
Study ID
NCT05384756
Phase
PHASE1
Status
Recruiting
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Conditions

Eligibility Criteria

Sex
ALL
Age
12 Years - 40 Years
Healthy Volunteers
Accepted

Interventions

  • Alemtuzumab — DRUG
    Given IV
  • Hematopoietic Cell Transplantation — PROCEDURE
    Undergo HCT
  • Intensity-Modulated Radiation Therapy — RADIATION
    Undergo TMLI
  • Sirolimus — DRUG
    Medication to prevent the development of graft-versus-host disease (GVHD)

Study Details

This phase I trial tests the safety and effectiveness of total marrow and lymphoid irradiation (TMLI) and alemtuzumab as a conditioning regimen in patients with sickle cell disease. Conditioning regimens are treatments used to prepare a patient for stem cell transplantation. A stem cell transplant is a procedure in which a person receives blood stem cells, which make any type of blood cell. A conditioning regimen may include chemotherapy, monoclonal antibody therapy, and radiation to the entire body. It helps make room in the patient's bone marrow for new blood stem cells to grow, and helps prevent the patient's body from rejecting the transplanted cells. Alemtuzumab is a monoclonal antibody that may interfere with the ability of cancer cells to grow and spread. Graft-versus-host disease (GVHD) is a complication that may occur after hematopoietic cell transplantation (HCT) in which donated cells view the recipient's cells as foreign and attack them. Giving TMLI and alemtuzumab may help reduce organ damage that can be caused by radiation and decrease the risk of GVHD.

Key Dates

First listed
May 20, 2022
Start date
Jul 13, 2022
Status verified
Jul 2026
Primary completion
Dec 1, 2026
Completion
Dec 1, 2026

Study Design

Enrollment
20 participants (estimated)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • Experimental: Treatment (TMLI, alemtuzumab)
    Patients receive alemtuzumab IV over 4 hours QD on days -7 to -3. Patients undergo TMLI BID on day -2. Patients also undergo HCT on day 0 and receive sirolimus on day -1 and day 0.

Primary Outcome Measure

Incidence of adverse events [ Time Frame: Up to day 100 post-transplant ]

Locations (1)

FacilityCityStateZIPSite coordinators
City of Hope Medical CenterDuarteCalifornia91010
Anna Pawlowska
[email protected]
626-218-8442
Anna Pawlowska (PRINCIPAL_INVESTIGATOR)

Find similar trials in Duarte, CA

By condition
Sickle cell disease
By research site
City of Hope Medical Center· Duarte, CA

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