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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT00553098
Other study ID # 2007.00
Secondary ID NCI-2009-0155020
Status Completed
Phase Phase 2
First received
Last updated
Start date June 2006

Study information

Verified date February 2020
Source Fred Hutchinson Cancer Research Center
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

This phase II trial studies fludarabine phosphate and total-body irradiation with or without alemtuzumab followed by donor stem cell transplant to see how well it works in treating patients with immunodeficiency or other nonmalignant inherited disorders. Giving chemotherapy, such as fludarabine phosphate, a monoclonal antibody such as alemtuzumab, and radiation therapy before a donor stem cell transplant helps stop the growth of abnormal cells. It may also stop the patient's immune system from rejecting the donor's stem cells. The donated stem cells may replace the patient's immune cells and help destroy any remaining abnormal cells.


Description:

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Study Design


Intervention

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Locations

Country Name City State
United States Cleveland Clinic Foundation Cleveland Ohio
United States Children's Hospital of Wisconsin Milwaukee Wisconsin
United States Vanderbilt University/Ingram Cancer Center Nashville Tennessee
United States Children's Hospital and Research Center at Oakland Oakland California
United States Oregon Health and Science University Portland Oregon
United States Fred Hutch/University of Washington Cancer Consortium Seattle Washington

Sponsors (3)

Lead Sponsor Collaborator
Fred Hutchinson Cancer Research Center National Cancer Institute (NCI), National Heart, Lung, and Blood Institute (NHLBI)

Country where clinical trial is conducted

United States, 

Outcome

Type Measure Description Time frame Safety issue
Primary Number of Patients Who Achieve Greater Than 50% Donor T-cell Chimerism The study will be considered a success and the protocol worthy of further study if there is sufficient evidence that this rate is greater than the 50% rate observed in the most recently transplanted patients with nonmalignant disorders. Analyses will be carried out separately for the alemtuzumab recipients and the TBI recipients. We will be 80% confidence of success if a one-sided 80% confidence interval for the proportion of patients with successful chimerism exceeds 50%. Cumulative incidence will be used to evaluate the probability of chimerism. At 1 year post transplant
Secondary Overall Survival Number of patients alive at 1 year 1 year
Secondary Immune Reconstitution by 1 Year Post Transplant Number of patients with normal range CD3 at 1 year post transplant 1 year
Secondary Disease Response by 1 Year Post Transplant Number of patients at 1 year with disease response (defined as no clinical evidence of active disease and/or sufficient level of donor chimerisms to prevent disease recurrence) 1 year
Secondary Greater Than 50% CD33+ Donor Chimerisms at 1 Year Post Transplant Number of patients who achieve greater than 50% CD33+ donor chimerisms at 1 year post transplant. 1 year
Secondary Greater Than 50% CD19+ Donor Chimerisms at 1 Year Post Transplant Number of Patients Who Achieve Greater Than 50% CD19+ Donor Chimerisms at 1 Year Post Transplant 1 year
Secondary Clinical Significant Infection, Requiring Treatment, Within 100 Days Post Transplant Number of patients who experienced a clinical significant infection, requiring treatment, within 100 days post transplant. 100 days
Secondary Number of Patients Diagnosed With Acute GVHD Number of patients diagnosed with acute GVHD by Day 100 post transplant Day 100
Secondary Number of Patients Diagnosed With Overall Grade 1 or Grade 2 Acute GVHD Number of patients diagnosed with overall grade I or grade II acute GVHD by Day 100 post transplant Day 100
Secondary Number of Patients Diagnosed With Overall Grade III or Grade IV Acute GVHD Number of patients diagnosed with overall Grade III or Grade IV Acute GVHD by Day 100 post transplant Day 100
Secondary Number of Patients Diagnosed With Chronic GVHD Number of patients diagnosed with chronic GVHD within 1 year post transplant 1 year
See also
  Status Clinical Trial Phase
Terminated NCT00358657 - Fludarabine Phosphate, Cyclophosphamide, and Total-Body Irradiation Followed by Donor Bone Marrow Transplant and Cyclophosphamide, Mycophenolate Mofetil, Tacrolimus, and Sirolimus in Treating Patients With Primary Immunodeficiency Disorders or Noncancerous Inherited Disorders Phase 2
Active, not recruiting NCT03333486 - Fludarabine Phosphate, Cyclophosphamide, Total Body Irradiation, and Donor Stem Cell Transplant in Treating Patients With Blood Cancer Phase 2