Ignite Creation Date:
2025-12-24 @ 12:05 PM
Ignite Modification Date:
2025-12-27 @ 9:09 PM
Study NCT ID:
NCT02185261
Status:
UNKNOWN
Last Update Posted:
2018-06-07
First Post:
2014-02-10
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Interferon α for the Therapy of Minimal Residual Disease
Sponsor:
Peking University People's Hospital
Organization:
Study Overview
Official Title:
Interferon α for the Therapy of Minimal Residual Disease Following Hematopoietic Stem Cell Transplantation
Status:
UNKNOWN
Status Verified Date:
2018-06
Last Known Status:
RECRUITING
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
This study aimed to evaluate the efficacy of interferon α among patients undergone unmanipulated blood and marrow transplantation following day 60 post-transplantation who were minimal residual disease positive after transplantation.
Hematopoietic stem cell transplantation (HSCT) is an effective treatment option for acute leukemia and many other hematological malignancies. However, post-transplant relapse can occur in some patients, and the prognosis of these patients is usually very poor.The persistence or recurrence of minimal residual disease (MRD) in the post-transplant period is an independent risk factor of relapse. Therefore, MRD monitoring can be used to screen patients with a high risk of relapse to provide timely intervention and prevent post-transplant relapse.Interferon α-2b exerts a relatively strong immunomodulatory effect. It can kill acute leukemia (AL) cells by regulating T-cell and/or natural killer cell functions.Consequently, interferon α-2b may have potential therapeutic value for AL patients with MRD-positive after transplantation.
The study hypothesis:
Prevention of relapse using interferon α-2b following hematopoietic stem cell transplantation in patients with standard risk acute leukemia can reduce relapse rate.
Hematopoietic stem cell transplantation (HSCT) is an effective treatment option for acute leukemia and many other hematological malignancies. However, post-transplant relapse can occur in some patients, and the prognosis of these patients is usually very poor.The persistence or recurrence of minimal residual disease (MRD) in the post-transplant period is an independent risk factor of relapse. Therefore, MRD monitoring can be used to screen patients with a high risk of relapse to provide timely intervention and prevent post-transplant relapse.Interferon α-2b exerts a relatively strong immunomodulatory effect. It can kill acute leukemia (AL) cells by regulating T-cell and/or natural killer cell functions.Consequently, interferon α-2b may have potential therapeutic value for AL patients with MRD-positive after transplantation.
The study hypothesis:
Prevention of relapse using interferon α-2b following hematopoietic stem cell transplantation in patients with standard risk acute leukemia can reduce relapse rate.
Detailed Description:
Standard risk acute leukemia patients (except t(9;22)(q34; q11), t(15;17), inv(16)(p13q22), t(16;16)(p13; q22), or t(8;21)(q22; q22) cytogenetic abnormalities.) undergone unmanipulated blood and marrow transplantation following day 60 post-transplantation who were minimal residual disease positive after hematopoietic stem cell transplantation received interferon α-2b. The end points were safety and immunologic response. Following time is 12 months.
Primary Outcome Measures:
\*The feasibility and efficacy of administering of subcutaneous interferon α-2b in this patient population. \[ Time Frame: 1 years \]
Secondary Outcome Measures:
\*The immunologic impact and clinical outcomes of subcutaneous interferon α-2b in patients after unmanipulated blood and marrow transplantation \[ Time Frame: 1 years \] Estimated Enrollment:81 Study Start Date: Jun 2014 Estimated Study Completion Date: Jun 2016
Intervention Details Description:
\*Drug:Interferon α-2b (subcutaneously at dosages of 3 million units 2-3 times per week) for 6 months in the absence of disease progression or unacceptable toxicity.
Acute leukemia patients who were MRD positive after day 60 post-transplantation receive interferon α-2b(subcutaneously at dosages of 3 million units 2-3 times per week). Interferon α-2b continues for 6 months in the absence of disease progression or unacceptable toxicity.
Participants will be seen periodically while they are receiving interferon α-2b. Physical exams and blood tests will be performed weekly for the first two weeks and then every other week until the completion of 6 months therapy.
Eligibility Ages Eligible for Study: 1-60 Years Genders Eligible for Study: Both Accepts Healthy Volunteers: No Criteria
The trial will be terminated in following situation
1. Severe toxicity occurrence
2. Cumulative incidence of relapse increased) (≥ 30%)
3. Cumulative incidence of mortality increased (≥ 30%)
4. Cumulative incidence of severe graft-versus-host disease increased (≥ 30%)
5. Although large enough sample had been enrolled, it did not reach statistical significance
Primary Outcome Measures:
\*The feasibility and efficacy of administering of subcutaneous interferon α-2b in this patient population. \[ Time Frame: 1 years \]
Secondary Outcome Measures:
\*The immunologic impact and clinical outcomes of subcutaneous interferon α-2b in patients after unmanipulated blood and marrow transplantation \[ Time Frame: 1 years \] Estimated Enrollment:81 Study Start Date: Jun 2014 Estimated Study Completion Date: Jun 2016
Intervention Details Description:
\*Drug:Interferon α-2b (subcutaneously at dosages of 3 million units 2-3 times per week) for 6 months in the absence of disease progression or unacceptable toxicity.
Acute leukemia patients who were MRD positive after day 60 post-transplantation receive interferon α-2b(subcutaneously at dosages of 3 million units 2-3 times per week). Interferon α-2b continues for 6 months in the absence of disease progression or unacceptable toxicity.
Participants will be seen periodically while they are receiving interferon α-2b. Physical exams and blood tests will be performed weekly for the first two weeks and then every other week until the completion of 6 months therapy.
Eligibility Ages Eligible for Study: 1-60 Years Genders Eligible for Study: Both Accepts Healthy Volunteers: No Criteria
The trial will be terminated in following situation
1. Severe toxicity occurrence
2. Cumulative incidence of relapse increased) (≥ 30%)
3. Cumulative incidence of mortality increased (≥ 30%)
4. Cumulative incidence of severe graft-versus-host disease increased (≥ 30%)
5. Although large enough sample had been enrolled, it did not reach statistical significance
Study Oversight
Has Oversight DMC:
True
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: