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Reduced Intensity Conditioning Hematopoietic Cell Transplantation for Pediatric Patients With Hematologic Malignancies at High Risk for Transplant Related Mortality With Standard Transplantation


Phase 2
N/A
21 Years
Not Enrolling
Both
Graft vs Host Disease

Thank you

Trial Information

Reduced Intensity Conditioning Hematopoietic Cell Transplantation for Pediatric Patients With Hematologic Malignancies at High Risk for Transplant Related Mortality With Standard Transplantation


Inclusion Criteria:



- Allogeneic bone marrow transplantation (BMT) or stem cell transplantation (SCT)
recipients with refractory chronic GVHD

Exclusion Criteria:

- Study is defined as an adequate trial of an immunosuppressive or immunosuppressive
combination (patient was given drug or drugs for 3 months unless there was clear
progression during regimen).

- Calculated creatinine (Cr) clearance < 30 ml/min/1.73m2

- Active infection not responding to oral or IV antibiotics.

- Patients and families unwilling to firmly commit to return for follow-up doses and
appointments

- Use of any investigational agent in the past 30 days (this does not include the use
of licensed agents for indications not listed in the package insert).

- Pregnancy or nursing mother; females of child-bearing potential and sexually active
males should use effective contraception while on study.

- Active veno-occlusive disease of the liver.

Type of Study:

Interventional

Study Design:

Allocation: Non-Randomized, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Principal Investigator

Michael Pulsipher, M.D.

Investigator Role:

Study Chair

Investigator Affiliation:

Primary Children's Medical Center/University of Utah

Authority:

United States: Food and Drug Administration

Study ID:

045-2004

NCT ID:

NCT00228826

Start Date:

February 2004

Completion Date:

June 2009

Related Keywords:

  • Graft Vs Host Disease
  • Patients with refractory chronic GVHD
  • Graft vs Host Disease
  • Hematologic Neoplasms

Name

Location

Children's Healthcare of Atlanta/Emory University Atlanta, Georgia  30322