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Phase 2 Haplotype Mismatched HSCT in Patients With Hematological Malignancies

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ClinicalTrials.gov Identifier: NCT00593554
Recruitment Status : Terminated (Slow accrual)
First Posted : January 15, 2008
Results First Posted : April 10, 2018
Last Update Posted : April 10, 2018
Sponsor:
Information provided by (Responsible Party):
Sherif S. Farag, Indiana University

January 4, 2008
January 15, 2008
March 12, 2018
April 10, 2018
April 10, 2018
August 7, 2007
August 27, 2016   (Final data collection date for primary outcome measure)
Treatment-related Mortality (TRM) Rate at 6 Months After Transplantation [ Time Frame: thru 6 months after transplant ]
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. The percent of patients with the exact 95% confidence interval who had treatment-related mortality within 6 months of their transplant is presented.
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 ]
Complete list of historical versions of study NCT00593554 on ClinicalTrials.gov Archive Site
  • Regimen-related Toxicity [ Time Frame: Up to 1 year ]
    The number of unique patients who had adverse events that were possibly/probably/definitely related to treatment/regimen.
  • Time to Neutrophil Engraftment [ Time Frame: Transplant (Day 0) up to 1 year ]
    Time to neutrophil engraftment will be analyzed by the Kaplan-Meier method. The time to engraftment of neutrophil is defined as the time from transplant until absolute neutrophil count (ANC) > 500 uL for 3 consecutive days. The median and 95% confidence intervals will be provided.
  • Time to Platelet Engraftment [ Time Frame: Transplant (Day 0) up to 1 year ]
    Time to platelet engraftment will be analyzed by the Kaplan-Meier method. The time to engraftment of platelets is defined as the time from day 0 to the first of seven consecutive days after transplantation during which the platelet count is at least 20 x109/l without transfusion support. Only patients who achieved engraftment of platelets will be included in the analysis. The median and 95% confidence intervals will be provided.
  • Acute Graft vs. Host Disease (GvHD) [ Time Frame: Up to 1 year ]
    Number of unique patients who had acute Graft vs. Host Disease (GvHD) diagnosed while on the study.
  • Chronic Graft vs. Host Disease (GvHD) [ Time Frame: Up to 1 year ]
    Number of unique patients who had chronic Graft vs. Host Disease (GvHD) diagnosed while on the study.
  • Frequency of Infection [ Time Frame: Day 0 through 1 year post transplantation ]
    Number of unique patients with bacterial and/or viral infections reported.
  • 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
46
July 28, 2017
August 27, 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, Older Adult)
No
Contact information is only displayed when the study is recruiting subjects
United States
 
 
NCT00593554
0704-19 IUCRO-0184
Yes
Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
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
March 2018

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