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Interferon-α Prevents Leukemia Relapse of AML Patients After Transplantation

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ClinicalTrials.gov Identifier: NCT03121079
Recruitment Status : Withdrawn (there was almost no patient would enroll in this study.)
First Posted : April 19, 2017
Last Update Posted : September 23, 2020
Sponsor:
Information provided by (Responsible Party):
Xiaojun Huang,MD, Peking University People's Hospital

Brief Summary:
Allogeneic stem cell transplantation (SCT) remains a powerful therapeutic modality for patients with acute myeloid leukemia (AML).The superior clinical outcomes of allogeneic human SCT versus chemotherapy alone as post-remission treatment could be related to the graft-versus-leukemia (GVL) effects of recovered donor T cells. Our previous study investigated both the association of MRD status with transplant outcomes in haplo-SCT and matched sibling donor transplantation(MSDT), and also possible differences in the transplant outcomes of patients with positive pre-MRD (as determined by MFC) who underwent haplo-SCT versus MSDT. It provided new evidence that unmanipulated haplo-SCT is superior to matched sibling donor transplantation in eradicating pre-transplantation MRD, indicating that unmanipulated haploidentical allografts have stronger GVL effects.As to the AML patients in standard-risk, who have a positive MRD before MSDT, whether these patients should be given any relapse prevention is the question to be answered in this study. Interferon α-2b exerts a relatively strong immunomodulatory effect. It can kill AL cells by regulating T-cell and/or natural killer cell functions.Consequently, interferon α-2b may have potential value for high-risk AL patients after transplantation. The study hypothesis: Using interferon α-2b following hematopoietic stem cell transplantation in patients with standard-risk AML can further reduce relapse rate and improve leukemia-free survival.

Condition or disease Intervention/treatment Phase
Interferon-A-2B Relapse Prevention Hematopietic Stem Cell Transplantation Drug: Interferon-alpha Not Applicable

Detailed Description:
The standard-risk AML patients (18-60 years) receiving HLA-identical allogeneic stem cell transplantation in Peking University Institute of Hematology will be enrolled in this study if their MRD were positive before SCT, in CR1/CR2, remain in CR and MRD negative in the first two months after transplantation. The patients in this study will be treated with interferon-alpha injection twice a week (3 million units / time, iH) since the third month posttransplant. If the patients were well tolerated, the interferon-alpha treatment will continue 6 months. All the enrolled patients will undergo MRD monitoring after SCT as the same as the routine procedure. Bone marrow examination will be performed at the regular time points (+1, 2,3, 4, 5, 6, 9, 12 month) and 8-colour flow cytometry and RQ-PCR-based WT1 examination will be empolyed to evaluate MRD and disease status. Based on the statistical calculation, in order to reduce the incidence of relapse from 40% (previous data) to 15% (the cumulative incidence of relapse in pre-MRD- AML patients), total 29 patients will be enrolled. The main side effects might related to interferon-alpha include induction of severe GVHD, hematological toxicity and Flu - like symptoms. If the patients met the following criteria, they will withdraw from the trial: 1)met the combined criteria for positive MRD (MRDco+) which was defined as 2 consecutive FCM+ or WT1+ results or both FCM+ and WT1+ in a single sample within 1 year after transplantation; 2)hematological relapse; 3) grade III or IV acute GVHD, or moderate/ severe chronic GVHD; 4) severe infection; 5) grade IV hematological toxicity; 6) organ failure; 7) death; 8) patients refuse to continue the interferon-alpha treatment. The main end point of the study is one-year cumulative incidence of relapse. the second end points include OS, NRM, DFS, MRD, GVHD, infection and hematological toxicity.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 0 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Intervention Model Description: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Prevention
Official Title: Interferon-α Prevents Leukemia Relapse of AML Patients Undergoing HLA-identical Allogeneic Hematopoietic Stem Cell Transplantation With Pretransplant MRD
Actual Study Start Date : May 1, 2017
Actual Primary Completion Date : December 31, 2019
Actual Study Completion Date : December 31, 2019


Arm Intervention/treatment
Experimental: Interferon alpha group
The patients in arm will be receive interferon alpha injection (3 million U/time)twice a week, as the intervention since the third month after HLA-identical transplantation.
Drug: Interferon-alpha
patients in Interferon-alpha group will receive Interferon-alpha injection since the third month after transplantation for six months.




Primary Outcome Measures :
  1. cumulative incidence of relapse [ Time Frame: within the first year after transplantation ]
    the cumulative incidence of relapse


Secondary Outcome Measures :
  1. OS [ Time Frame: within the first year after transplantation ]
    overall survival

  2. NRM [ Time Frame: within the first year after transplantation ]
    non-relapse motality

  3. DFS [ Time Frame: within the first year after transplantation ]
    disease-free survival

  4. MRD [ Time Frame: within the first year after transplantation ]
    cumulative incidence of MRD+

  5. acute GVHD [ Time Frame: within 100 days after transplantation ]
    acute graft-versus-host disease

  6. chronic GVHD [ Time Frame: within the first year after transplantation ]
    chronic graft-versus-host disease

  7. infection [ Time Frame: within the first year after transplantation ]
    bacteria, fungal, virus, etc.


Other Outcome Measures:
  1. Hematologic toxicity [ Time Frame: within the first year after transplantation ]
    any decrease of blood cells including white, red blood cells and platelet



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 60 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • standard-risk AML in CR1/CR2
  • without t(9;22) and t(15;17)
  • receive HLA-identical transplantation
  • with positive MRD before transplantation (measured by flow cytometry)
  • CR within the first two months posttransplantation and MRD is negative
  • between 18-60 years

Exclusion Criteria:

  • uncontrolled GVHD
  • be in myelosuppression (WBC<1.5x10^9/L, ANC<0.5×10^9/L,PLT<25×10^9/L,HB<65g/L)
  • severe infection
  • organ failure
  • the patients do not agree to participate in the study

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): NCT03121079


Locations
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China
Peking University People's Hospital
Beijing, China, 100044
Sponsors and Collaborators
Peking University People's Hospital
Investigators
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Principal Investigator: Xiaojun Huang, Dr. Peking University Institute of Hematology
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Responsible Party: Xiaojun Huang,MD, Director of Peking University Institute of Hematology, Peking University People's Hospital
ClinicalTrials.gov Identifier: NCT03121079    
Other Study ID Numbers: 2017PHB013-01
First Posted: April 19, 2017    Key Record Dates
Last Update Posted: September 23, 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
Product Manufactured in and Exported from the U.S.: No
Keywords provided by Xiaojun Huang,MD, Peking University People's Hospital:
Interferon-alpha
Relapse
prevention
hematopietic stem cell transplantation
acute myeloid leukemia
Additional relevant MeSH terms:
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Leukemia
Recurrence
Neoplasms by Histologic Type
Neoplasms
Disease Attributes
Pathologic Processes
Interferons
Interferon-alpha
Antineoplastic Agents
Antiviral Agents
Anti-Infective Agents
Immunologic Factors
Physiological Effects of Drugs