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High Dose Donor Hematopoietic Stem Cell Infusion for Relapsed/Refractory AML

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.
 
ClinicalTrials.gov Identifier: NCT03080922
Recruitment Status : Unknown
Verified March 2017 by The Affiliated Hospital of the Chinese Academy of Military Medical Sciences.
Recruitment status was:  Recruiting
First Posted : March 15, 2017
Last Update Posted : April 4, 2017
Sponsor:
Information provided by (Responsible Party):
The Affiliated Hospital of the Chinese Academy of Military Medical Sciences

Brief Summary:
The purpose of this study is to evaluate the safety and efficiency of high dose allogeneic mismatched hematopoietic stem cells infusions after normal chemotherapy in patients with relapsed/refractory acute myeloid leukemia(AML).

Condition or disease Intervention/treatment Phase
Leukemia, Myeloid Biological: hematopoietic stem cell Phase 1 Phase 2

Detailed Description:

The relapsed/refractory AML patients will receive IA/DA/MA(I,Idamycin,D,Daunorubicin,M,Mitoxantrone,A,cytosine arabinoside) chemotherapy followed by infusion of high dose allogeneic mismatched hematopoietic stem cells.

no graft-versus-host disease (GVHD) prevention will be conducted before transplantation. Cytokine storm,GVHD snd donor graft will be detected post-transplantation.


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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 10 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Treatment of Relapsed/Refractory Acute Myeloblastic Leukemia(AML) by Infusion of Donor High Dose Allogeneic Mismatched Hematopoietic Stem Cells After Chemotherapy
Actual Study Start Date : March 2016
Estimated Primary Completion Date : March 2018
Estimated Study Completion Date : March 2019


Arm Intervention/treatment
Experimental: hematopoietic stem cell
high dose of donor granulocyte colony-stimulating factor(G-CSF)mobilized peripheral blood hematopoietic stem cell are infused to patient received normal chemotherapy
Biological: hematopoietic stem cell
high dose of donor G-CSF mobilized peripheral blood hematopoietic stem cell are infused to patient received normal chemotherapy




Primary Outcome Measures :
  1. complete remission rate [ Time Frame: 2 months ]

Secondary Outcome Measures :
  1. Disease-free survival [ Time Frame: 2 years ]
  2. Overall survival [ Time Frame: 2 years ]
  3. donor graft rate [ Time Frame: 6 months ]
  4. Occurrence of study related adverse events [ Time Frame: 6 months ]
    defined as >= Grade 3 signs/symptoms, laboratory toxicities, and clinical events) that are possibly, likely, or definitely related to study treatment



Information from the National Library of Medicine

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Ages Eligible for Study:   15 Years to 85 Years   (Child, Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Patient with relapsed and/or refractory AML
  • Estimated life expectancy ≥ 12 weeks (according to investigator's judgment)
  • Eastern Cooperative Oncology Group (ECOG) performance status ≤ 2

Exclusion Criteria:

  • Previous treatment with investigational gene or cell therapy medicine products
  • Any uncontrolled active medical disorder that would preclude participation as outlined

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): NCT03080922


Contacts
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Contact: HUISHENG AI HUISHNGAI@163.COM

Locations
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China, Beijing
Affiliated Hospital of Academy of Military Medical Sciences , Recruiting
Beijing, Beijing, China, 100071
Contact: Huisheng Ai, MD    86-1066947126    huishengai@163.com   
Principal Investigator: Huisheng Ai, MD         
Sponsors and Collaborators
The Affiliated Hospital of the Chinese Academy of Military Medical Sciences
Investigators
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Study Chair: HUISHENG AI Affiliated Hospital of Academy of Military Medical Sciences

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Responsible Party: The Affiliated Hospital of the Chinese Academy of Military Medical Sciences
ClinicalTrials.gov Identifier: NCT03080922     History of Changes
Other Study ID Numbers: HD-DSI-AML
First Posted: March 15, 2017    Key Record Dates
Last Update Posted: April 4, 2017
Last Verified: March 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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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:
Acute Myeloid Leukemia
Relapsed
Refractory
hematopoietic stem cell
Additional relevant MeSH terms:
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Leukemia
Leukemia, Myeloid
Neoplasms by Histologic Type
Neoplasms