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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

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).

Condition or disease Intervention/treatment Phase
Leukemia Myelodysplastic Syndrome Multiple Myeloma Lymphoma Drug: Fludarabine-Melphalan & Rabbit antithymocyte globulin (r-ATG) Procedure: Stem Cell Transplant Procedure: Stem Cells Collections Drug: Fludarabine, Thiotepa, Antithymocyte globulin (ATG), and Total Body Irradiation (TBI) Drug: Fludarabine, Busulfan, and ATG Not Applicable

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 87 participants
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Combined Haploidentical-Cord Blood Transplantation for Adults and Children
Actual Study Start Date : October 9, 2006
Actual Primary Completion Date : September 2018
Actual Study Completion Date : September 2018


Arm Intervention/treatment
Experimental: Good Risks patients
For patients transplanted in remission.
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.

Experimental: High Risk Patients eligible for radiation 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.

Experimental: High Risk Patients not eligible for radiation 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, 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.




Primary Outcome Measures :
  1. 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.


Secondary Outcome Measures :
  1. 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


  2. 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



Information from the National Library of Medicine

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Ages Eligible for Study:   1 Year and older   (Child, Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00943800


Locations
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United States, Illinois
The University of Chicago
Chicago, Illinois, United States, 60637
Sponsors and Collaborators
University of Chicago
Investigators
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Principal Investigator: Hongtao Liu, M.D. University of Chicago
  Study Documents (Full-Text)

Documents provided by University of Chicago:
Publications of Results:
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: University of Chicago
ClinicalTrials.gov Identifier: NCT00943800    
Other Study ID Numbers: 14736B
First Posted: July 22, 2009    Key Record Dates
Results First Posted: October 27, 2020
Last Update Posted: January 27, 2021
Last Verified: January 2021
Keywords provided by University of Chicago:
Appropriate candidate for transplantation
An HLA-identical related or unrelated donor cannot be identified within an appropriate time frame.
Additional relevant MeSH terms:
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Multiple Myeloma
Myelodysplastic Syndromes
Neoplasms, Plasma Cell
Neoplasms by Histologic Type
Neoplasms
Hemostatic Disorders
Vascular Diseases
Cardiovascular Diseases
Paraproteinemias
Blood Protein Disorders
Hematologic Diseases
Hemorrhagic Disorders
Lymphoproliferative Disorders
Immunoproliferative Disorders
Immune System Diseases
Bone Marrow Diseases
Vidarabine
Fludarabine
Fludarabine phosphate
Melphalan
Busulfan
Thiotepa
Antilymphocyte Serum
Thymoglobulin
Antineoplastic Agents
Antimetabolites, Antineoplastic
Antimetabolites
Molecular Mechanisms of Pharmacological Action
Immunosuppressive Agents
Immunologic Factors