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Phase 2 Haplotype Mismatched HSCT in Patients With Hematological Malignancies

This study has been terminated.
(Slow accrual)
Sponsor:
ClinicalTrials.gov Identifier:
NCT00593554
First Posted: January 15, 2008
Last Update Posted: February 1, 2017
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
Sherif S. Farag, Indiana University
January 4, 2008
January 15, 2008
February 1, 2017
August 7, 2007
May 5, 2016   (Final data collection date for primary outcome measure)
To determine if haplotype-mismatched HSCT is associated with a ≤40% treatment-related mortality (TRM) rate at 6 months after transplantation; a TRM ≥60% being considered unacceptable. [ Time Frame: thru 6 months after transplant ]
Same as current
Complete list of historical versions of study NCT00593554 on ClinicalTrials.gov Archive Site
  • Describe regimen-related toxicity [ Time Frame: baseline through end of treatment ]
  • Describe the time to engraftment of neutrophils and platelets following haplotype-mismatched CD34 selected cells [ Time Frame: baseline through end of study ]
  • Assess the risks of acute and chronic GvHD following infusion of highly purified CD34 cells [ Time Frame: baseline through end of study ]
  • Describe the frequency and type of infections occurring within the first year following transplantation. [ Time Frame: Day 0 through 1 year post transplantation ]
  • Describe and gather preliminary data on thymic immune reconstitution following transplantation in patients receiving and not receiving KGF. [ Time Frame: Day -11, -10 and -9 pre transplant ]
  • Explore the correlation between KIR-ligand mismatching and KIR gene mismatching between donor and recipient and outcome, including relapse rate, event-free survival, and overall survival. [ Time Frame: Baseline until death ]
  • Describe the rate of progression-free survival and overall survival [ Time Frame: Baseline until death ]
  • Describe regimen-related toxicity [ Time Frame: baseline through end of treatment ]
  • Describe the time to engraftment of neutrophils and platelets following haplotype-mismatched CD34 selected cells [ Time Frame: baseline through end of study ]
  • Assess the risks of acute and chronic GvHD following infusion of highly purified CD34 cells [ Time Frame: baseline through end of study ]
Not Provided
Not Provided
 
Phase 2 Haplotype Mismatched HSCT in Patients With Hematological Malignancies
A Phase II Trial of Haplotype Mismatched Hematopoietic Stem Cell Transplantation Using Highly Purified CD34 Cells in Patients With Hematological Malignancies
The purpose of this study is to determine if haplotype-mismatched HSCT is associated with an improvement in treatment-related mortality (TRM) rate at 6 months.
Not Provided
Interventional
Phase 2
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
  • Acute Myeloid Leukemia
  • Acute Lymphoblastic Leukemia
  • Myelodysplasia
  • Chronic Myeloid Leukemia
  • Radiation: Total Body Irradiation
    8 Gy on Day -9
  • Drug: Thiotepa
    5 mg/kg/d on Day -8 to -7
  • Drug: Fludarabine
    40 mg/m2/d on Day -6 to -3
  • Biological: Rabbit ATG
    2.5 mg/kg/d on Day -5 to -2
    Other Names:
    • Antithymocyte globulin
    • Thymoglobulin
  • Drug: Palifermin
    60 ug/kg (actual body weight) on Day -9 to -7 and Day 0 to +2
    Other Names:
    • Recombinant human keratinocyte growth factor
    • Kepivance
  • Active Comparator: 1
    Total body Irradiation; Thiotepa; Fludarabine; Rabbit ATG;
    Interventions:
    • Radiation: Total Body Irradiation
    • Drug: Thiotepa
    • Drug: Fludarabine
    • Biological: Rabbit ATG
  • Experimental: 2
    Palifermin; Total Body Irradiation; Thiotepa; Fludarabine; Rabbit ATG
    Interventions:
    • Radiation: Total Body Irradiation
    • Drug: Thiotepa
    • Drug: Fludarabine
    • Biological: Rabbit ATG
    • Drug: Palifermin
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Terminated
9
May 5, 2016
May 5, 2016   (Final data collection date for primary outcome measure)

Inclusion Criteria:

  • Patients must have histologically documented AML, ALL, MDS, CML, Acute myeloid leukemia (AML) with one or more of the following criteria

    • CR 1 with poor risk features
    • CR 2, or higher order CR
  • Acute lymphoblastic leukemia (ALL) with one of the following criteria

    • CR 1 with poor risk features
    • CR 2, or higher order CR
  • Myelodysplasia, RAEB I
  • Donor has been identified
  • Age ≤ 65 years.
  • Performance Status 0-1.

Exclusion Criteria:

  • Patients relapsing <6 months after autologous SCT are not eligible.
  • Patients with active infections requiring oral or intravenous antibiotics are not eligible for enrollment until resolution of infection.
  • Non-pregnant and non-nursing
Sexes Eligible for Study: All
18 Years to 65 Years   (Adult)
No
Contact information is only displayed when the study is recruiting subjects
United States
 
 
NCT00593554
0704-19 IUCRO-0184
Yes
Not Provided
Not Provided
Sherif S. Farag, Indiana University
Sherif S. Farag
Not Provided
Principal Investigator: Sherif Farag, MD/PhD Indiana University School of Medicine
Indiana University
January 2017

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP