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Combined Haploidentical-Cord Blood Transplantation for Adults and Children

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ClinicalTrials.gov Identifier: NCT00943800
Recruitment Status : Completed
First Posted : July 22, 2009
Results First Posted : October 27, 2020
Last Update Posted : January 27, 2021
Sponsor:
Information provided by (Responsible Party):
University of Chicago

Tracking Information
First Submitted Date  ICMJE July 20, 2009
First Posted Date  ICMJE July 22, 2009
Results First Submitted Date  ICMJE October 5, 2020
Results First Posted Date  ICMJE October 27, 2020
Last Update Posted Date January 27, 2021
Actual Study Start Date  ICMJE October 9, 2006
Actual Primary Completion Date September 2018   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: January 8, 2021)
Percentage of Participants With Neutrophil Engraftment [ Time Frame: Transplant (Day 0) through Day +28 ]
Cumulative incidence of graft failure (neutrophil) by day 28 was reported. Patients who did not have neutrophil engraftment before death was considered as a competing risk. Failure to engraft was defined as lack of evidence of hematopoietic recovery (ANC <500/mm3 and platelet count < 20,000/mm3) by day +35, confirmed by a biopsy revealing a marrow cellularity < 5%. Graft failure was also defined as initial myeloid engraftment by day +35, documented to be of donor origin, followed by a drop in the ANC to < 500/mm3 for more than three days, independent of any myelosuppressive drugs, severe GVHD, CMV, or other infection.
Original Primary Outcome Measures  ICMJE
 (submitted: July 21, 2009)
To assess the rate of engraftment with combined haploidentical-cord blood [ Time Frame: 5 years ]
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: January 8, 2021)
  • Percentage of Participants With Incidence of Acute (Grade II-IV) and Chronic Graft-vs-host Disease(GVHD) [ Time Frame: Up to 2 years ]
    Acute GVHD is defined by the Przepiorka criteria, which stages the degree of organ involvement in the skin, liver, and gastrointestinal (GI) tract, based on severity, with Stage 1+ being least severe and stage 4+ being the most severe. Grading of acute GVHD is as follows: Grade II (skin involvement stages 1+ to 3+, liver 1+, GI tract 1+), Grade III (skin involvement stages 2+ to 3+, liver 1+, GI tract 2+ to 4+), Grade IV (skin involvement stages 4+, Liver 4+). Chronic GVHD is assessed by NIH consensus development project on criteria for clinical trials in chronic graft-versus-host disease: I. Diagnosis and staging working group report. Biol Blood Marrow Transplant. 2005; 11:945-56., for grading criteria. (See Citation: Filipovich AH et al) The incidence of patients with acute GVHD (Grade II-IV) was determined at 180 days. The incidence of Chronic GVHD by 2 years was reported
  • Overall Survival- Percentage of Participants Who Survived at 2 Years and 5 Years [ Time Frame: up to 5 years ]
    We reported overall survival at 2 years and 5 years after transplant
Original Secondary Outcome Measures  ICMJE
 (submitted: July 21, 2009)
To assess the rates of GVHD with combined haploidentical-cord blood (acute & chronic) [ Time Frame: 5 years ]
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Combined Haploidentical-Cord Blood Transplantation for Adults and Children
Official Title  ICMJE Combined Haploidentical-Cord Blood Transplantation for Adults and Children
Brief Summary The primary objective is to assess the rate of engraftment with combined haploidentical-cord blood transplantation. The secondary objective is to evaluate the incidence and severity of acute and chronic graft-versus-host disease (GVHD).
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE
  • Leukemia
  • Myelodysplastic Syndrome
  • Multiple Myeloma
  • Lymphoma
Intervention  ICMJE
  • Drug: Fludarabine-Melphalan & Rabbit antithymocyte globulin (r-ATG)
    Fludarabine is given through the vein daily for 5 days. Melphalan is given through the vein daily for 2 days. ATG is given every day in the vein for four days.
  • Procedure: Stem Cell Transplant
    Infusion of haploidentical donor, umbilical cord blood
  • Procedure: Stem Cells Collections
    Haploidentical cells will be T-cell depleted using the Miltenyi Clinimax device.
  • Drug: Fludarabine, Thiotepa, Antithymocyte globulin (ATG), and Total Body Irradiation (TBI)
    Fludarabine is given through the vein daily for 5 days. Thiotepa is given through the vein daily for 2 days. ATG is given through the vein every other day for 4 days. TBI is given twice a day for 3 days.
  • Drug: Fludarabine, Busulfan, and ATG
    Fludarabine is given through the vein daily for 5 days. Busulfan is given through the vein daily for 4 days. ATG is given through the vein every other day for 4 days.
Study Arms  ICMJE
  • Experimental: Good Risks patients
    For patients transplanted in remission.
    Interventions:
    • Drug: Fludarabine-Melphalan & Rabbit antithymocyte globulin (r-ATG)
    • Procedure: Stem Cell Transplant
    • Procedure: Stem Cells Collections
  • Experimental: High Risk Patients eligible for radiation
    Interventions:
    • Procedure: Stem Cell Transplant
    • Procedure: Stem Cells Collections
    • Drug: Fludarabine, Thiotepa, Antithymocyte globulin (ATG), and Total Body Irradiation (TBI)
  • Experimental: High Risk Patients not eligible for radiation
    Interventions:
    • Procedure: Stem Cell Transplant
    • Procedure: Stem Cells Collections
    • Drug: Fludarabine, Busulfan, and ATG
Publications *

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: October 5, 2020)
87
Original Estimated Enrollment  ICMJE
 (submitted: July 21, 2009)
53
Actual Study Completion Date  ICMJE September 2018
Actual Primary Completion Date September 2018   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

Patients will be eligible for this study if they have any one of the diseases that are known to be cured after allogeneic stem cell transplantation.

  1. Relapsed or refractory acute leukemia (myeloid or lymphoid)
  2. Acute leukemia in first remission at high-risk for recurrence
  3. Chronic myelogenous leukemia in accelerated phase or blast-crisis
  4. Chronic myelogenous leukemia in chronic phase
  5. Recurrent or refractory malignant lymphoma or Hodgkin lymphoma
  6. Chronic lymphocytic leukemia, relapsed or with poor prognostic features
  7. Multiple myeloma
  8. Myelodysplastic syndrome
  9. Chronic myeloproliferative disease
  10. Hemoglobinopathies
  11. Aplastic anemia

Exclusion Criteria:

  1. Zubrod performance status > 2
  2. Life expectancy is severely limited by concomitant illness
  3. Patients with severely decreased LVEF or impaired pulmonary function tests(PFT's)
  4. Estimated Creatinine Clearance <50 ml/min
  5. Serum bilirubin> 2.0 mg/dl or SGPT >3 x upper limit of normal
  6. Evidence of chronic active hepatitis or cirrhosis
  7. HIV-positive
  8. Patient is pregnant
  9. Patient or guardian not able to sign informed consent
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 1 Year and older   (Child, Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT00943800
Other Study ID Numbers  ICMJE 14736B
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party University of Chicago
Study Sponsor  ICMJE University of Chicago
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Hongtao Liu, M.D. University of Chicago
PRS Account University of Chicago
Verification Date January 2021

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