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Low-dose Decitabine for the Treatment of Decreased Donor Chimerism After Allogeneic Stem Cell Transplantation

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: NCT03663751
Recruitment Status : Active, not recruiting
First Posted : September 10, 2018
Last Update Posted : September 10, 2020
Sponsor:
Information provided by (Responsible Party):
Jiong HU, Shanghai Jiao Tong University School of Medicine

Brief Summary:
Decreasing donor chimerism is considered as an early sign of graft failure or relapse in patients undergoing allogeneic stem cell transplantation. The treatment option included tapering or stop of immunosuppression and or donor lymphocyte infusion (DLI) which may restore a full donor chimerism but subsequent graft versus host disease (GVHD) is the major complications. In this single arm prospective study, the investigator evaluate the effect and safety of low-dose decitabine alone or with DLI in patients with decreased donor chimerism after allo-HSCT.

Condition or disease Intervention/treatment Phase
Response Rate Drug: Decitabine Phase 2

Detailed Description:
Decreasing donor chimerism is considered as an early sign of graft failure or relapse in patients undergoing allogeneic stem cell transplantation. The treatment option included tapering or stop of immunosuppression and or donor lymphocyte infusion (DLI) which may restore a full donor chimerism but subsequent GVHD is the major complications. In this single arm prospective study, the investigator plan to evaluate the effect and safety of low-dose decitabine treatment alone in patients with decreased donor chimerism after allo-HSCT. The investigators expect an overall response rate of 80% without serious toxicity such as grade III-IV aGVHD, ext cGVHD and lethal infection event associated with low-dose decitabine (LD-DAC) treatment. In case of donor chimerism decreasing, 5-day low-dose decitabine (5mg/m2) will given every 6 to 8 weeks until full donor chimerism is achieved (>98%). Fast withdraw of immuno-suppression or stop of immunosupression is not carried out in the study.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 14 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Pre-emptive Therapy With Low-dose Decitabine for Patients With Decreased Donor Chimerism After Allogeneic Stem Cell Transplantation
Actual Study Start Date : July 1, 2018
Estimated Primary Completion Date : December 2020
Estimated Study Completion Date : March 2021

Resource links provided by the National Library of Medicine

Drug Information available for: Decitabine

Arm Intervention/treatment
Experimental: Treatment
The peripheral and bone marrow T cell and mono nucleated cell chimerism will be closely followed-up. In case of decreasing donor chimerism, patients will receive low-dose decitabine with 5mg/m2 daily for 5 days every 6-8 weeks until the chimerism recovered to full donor type (>98%).
Drug: Decitabine
low-dose decitabine: 5mg/m2 daily for 5 days
Other Name: LD-DAC




Primary Outcome Measures :
  1. Complete response rate [ Time Frame: 6 months after initiation of treatment ]
    Documentation >98% donor chimerism of T cells or mononuclear cell in either peripheral blood or bone marrow


Secondary Outcome Measures :
  1. relapse rate [ Time Frame: 12 months after initiation of treatment ]
    Documentation of blast in bone marrow >5%

  2. engraftment failure [ Time Frame: 12 months after initiation of treatment ]
    Documentation of pancytopenia with donor chimerism <5%

  3. survival rate [ Time Frame: 12 months after initiation of treatment ]
    event counted as death due to any cause

  4. incidence of grade III-IV aGVHD [ Time Frame: 12 months after initiation of treatment ]
    event counted as documentation of new onset or aggravation of pre-existing aGVHD into grade III-IV

  5. incidence of moderate to severe chronic GVHD [ Time Frame: 12 months after initiation of treatment ]
    event counted as documentation of moderate to severe chronic GVHD

  6. Overall response [ Time Frame: 6 months after initiation of treatment ]
    Documentation of complete or partial response



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Ages Eligible for Study:   16 Years to 60 Years   (Child, Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • all patients after allogeneic stem cell transplantation
  • decreasing of donor chimerism to less than 97%
  • providing inform consent

Exclusion Criteria:

  • patients with documented relapse disease
  • patients with documented positive MRD+ (>0.1% via flowcytometry or PCR)
  • patients with active infection or grade III-IV GVHD

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): NCT03663751


Locations
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China, Shanghai
Blood & Marrow Transplantation Center, RuiJin Hospital
Shanghai, Shanghai, China, 200025
Sponsors and Collaborators
Shanghai Jiao Tong University School of Medicine
Investigators
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Principal Investigator: Jiong HU Department of Hematology, Rui jin Hospital
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Responsible Party: Jiong HU, Head, BMT program, Deputy director, Department of Hematology, Rui Jin Hospital, Shanghai Jiao Tong University School of Medicine
ClinicalTrials.gov Identifier: NCT03663751    
Other Study ID Numbers: RJ-BMT-2018-1
First Posted: September 10, 2018    Key Record Dates
Last Update Posted: September 10, 2020
Last Verified: September 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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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 Jiong HU, Shanghai Jiao Tong University School of Medicine:
donor chimerism,
decitabine,
allo-HSCT
Additional relevant MeSH terms:
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Decitabine
Antimetabolites, Antineoplastic
Antimetabolites
Molecular Mechanisms of Pharmacological Action
Antineoplastic Agents
Enzyme Inhibitors