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Comparison Study of Cord Blood and GPBSC on Microtransplantation for Treatment of Acute Myeloid Leukemia

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ClinicalTrials.gov Identifier: NCT04174586
Recruitment Status : Not yet recruiting
First Posted : November 22, 2019
Last Update Posted : November 22, 2019
Sponsor:
Information provided by (Responsible Party):
The Affiliated Hospital of the Chinese Academy of Military Medical Sciences

Brief Summary:
Compare the effectiveness and safety of cord blood with HLA-mismatched donor cells infusion on microtransplantation for treatment of acute myeloid leukemia

Condition or disease Intervention/treatment Phase
Safety Issues Efficiency Biological: microtransplantation Phase 1

Detailed Description:
The investigators conducted a prospective, multicenter clinical trial of HLA-mismatched MST to to compare the outcomes and toxicities of cord blood with HLA-mismatched donor cells infusion after chemotherapy (microtransplantation) in older patients with acute myeloid leukemia (AML)

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 20 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Comparison Study of Cord Blood and GPBSC on Microtransplantation for Treatment of Acute Myeloid Leukemia
Estimated Study Start Date : December 1, 2019
Estimated Primary Completion Date : August 31, 2024
Estimated Study Completion Date : August 31, 2024


Arm Intervention/treatment
Experimental: cord blood group
standard induction and consolidation chemotherapy with cord blood microtransplantation
Biological: microtransplantation
HLA mismatched donor cord blood infusion

No Intervention: G-CSF mobilized peripheral blood
standard induction and consolidation chemotherapy with G-CSF mobilized HLA -mismatched peripheral blood stem cells microtransplantation



Primary Outcome Measures :
  1. complete remission rate [ Time Frame: 1 month ]
    Bone marrow <5% blasts; Absolute neutrophil count >1000/mcL; Platelets ≥100,000/mcL;No residual evidence of extramedullary disease.

  2. time of hematopoietic recovery [ Time Frame: 1 month ]
    Absolute neutrophil count >500/mcL; Platelets ≥20,000/mcL


Secondary Outcome Measures :
  1. time to progression [ Time Frame: 2 year ]
    Measured from complete remission to the relapse


Other Outcome Measures:
  1. diease free survival [ Time Frame: 2 year ]
    Measured from complete remission to the date of death or the date of last follow-up examination.

  2. overall survival [ Time Frame: 2 year ]
    Measured from the date of beginning therapy to the date of death or the date of last follow-up examination.

  3. rate of early mortality [ Time Frame: 1 month ]
    Death within 4 weeks after initiation of induction therapy



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Ages Eligible for Study:   60 Years to 80 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. de novo acute myeloid leukemia
  2. age 60-80
  3. have HLA mismatched donor

Exclusion Criteria:

  1. have no suitable donor or donor refused
  2. patient refused to accept donor cells

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Responsible Party: The Affiliated Hospital of the Chinese Academy of Military Medical Sciences
ClinicalTrials.gov Identifier: NCT04174586     History of Changes
Other Study ID Numbers: CB-GPBSC 001
First Posted: November 22, 2019    Key Record Dates
Last Update Posted: November 22, 2019
Last Verified: November 2019

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by The Affiliated Hospital of the Chinese Academy of Military Medical Sciences:
Cord blood microtransplatation
mobilized prepheral stem cell microtransplatation
Additional relevant MeSH terms:
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Leukemia, Myeloid, Acute
Leukemia
Neoplasms by Histologic Type
Neoplasms
Leukemia, Myeloid