LeukemiaNCT02185261
Interferon α for the Therapy of Minimal Residual Disease
A study testing Interferon Alfa-2b in people with Leukemia, run by Peking University People's Hospital at 1 site in China.
Trial 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. Read more about this study
- Who is it for?
- Ages 1 year to 60 years
- Conditions the study is for
- Leukemia
- What is being tested?
- Interferon Alfa-2b
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 81 participants
- Where
- 1 siteChina
- Study dates
- Jun 2014to Jun 2021
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 1 year to 60 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- Patients who had standard-risk acute myeloid leukemia(CR1 or CR2) had minimal residual disease positive after hematopoietic stem cell transplantation
Who cannot join
- Patients with t(9;22)(q34; q11), t(15;17), inv(16)(p13q22), t(16;16)(p13; q22), or t(8;21)(q22; q22) cytogenetic abnormalities;active graft-versus-host disease; active infection; organ failure; exposure to donor lymphocyte infusion prior to enrollment
Trial locations and contacts
1 site in 1 country.
Xiao-Dong Mo, MD contact
China1 site, 1 recruiting
- Recruiting
Peking University Institute of Hematology,Beijing
Beijing, Beijing Municipality, 100044
Xiao-Dong Mo, mxd453@163.com
Xiao-Jun Huang, MD
About this study
Official title: Interferon α for the Therapy of Minimal Residual Disease Following Hematopoietic Stem Cell Transplantation
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.
Read more
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.
Read the 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
- Severe toxicity occurrence
- Cumulative incidence of relapse increased) (≥ 30%)
- Cumulative incidence of mortality increased (≥ 30%)
- Cumulative incidence of severe graft-versus-host disease increased (≥ 30%)
- Although large enough sample had been enrolled, it did not reach statistical significance
- Conditions
- Leukemia
- Being tested
- Interferon Alfa-2b
- Keywords
- Relapse, Minimal residual disease, Graft-versus-host disease, Acute leukemia, Interferon Alfa-2b
- Medical subject headings
- Leukemia, Recurrence, Neoplasm, Residual, Graft vs Host Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Interferon Alfa-2bDrug
Also called INF α-2b
Patients who were deemed MRD-positive after day 60 post-transplantation receive interferon α-2b (subcutaneously at dosages of 3 million units 2-3 times per week) . Interferon treatment continues for 6 months in the absence of disease progression or unacceptable toxicity.
| Study group | Role | What they receive |
|---|---|---|
| interferon Alfa-2b group | Experimental | Acute leukemia patients who are minimal residual disease positive after hematopoietic stem cell transplantation receive interferon Alfa-2b Receives: Drug: Interferon Alfa-2b |
What is being measured
The primary outcome is the main question the study is designed to answer.
relapse rate
number of participants with morphologic relapse at one year
Measured: participants will be followed for an expected average of 1 year
Secondary outcomes (1)
The immunologic impact of subcutaneous interferon α-2b
examine the immune reconstitution of subgroups of T cells and nature killer cells after interferon α-2b application
Measured: participants will be followed for an expected average of 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Jul 2014 (estimated)
- Study startJun 2014
- Primary completionJun 2021 (estimated)
- Study completionJun 2021 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (5)Papers the sponsor has linked to this study.
- Other trials for LeukemiaStudies of the same condition, open and under way.
- More trials run by Peking University People's HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 81 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Peking University People's Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Xiaojun Huang, Peking University People's Hospital
- Investigators
- Xiao-Jun Huang, MD, Principal investigator, Peking University Institute of Hematology
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02185261
- Sponsor's protocol ID
- 2014-02
- Status last verified
- Jun 2018
- First submitted
- 10 Feb 2014
- Last updated
- 7 Jun 2018
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Shen MZ, Zhang XH, Xu LP, Wang Y, Yan CH, Chen H, Chen YH, Han W, Wang FR, Wang JZ, Zhao XS, Qin YZ, Chang YJ, Liu KY, Huang XJ, Mo XD. Preemptive Interferon-alpha Therapy Could Protect Against Relapse and Improve Survival of Acute Myeloid Leukemia Patients After Allogeneic Hematopoietic Stem Cell Transplantation: Long-Term Results of Two Registry Studies. Front Immunol. 2022 Jan 28;13:757002. doi: 10.3389/fimmu.2022.757002. eCollection 2022.
PubMed 35154096Liu S, Luo X, Zhang X, Xu L, Wang Y, Yan C, Chen H, Chen Y, Han W, Wang F, Wang J, Liu K, Huang X, Mo X. Preemptive interferon-alpha treatment could protect against relapse and improve long-term survival of ALL patients after allo-HSCT. Sci Rep. 2020 Nov 19;10(1):20148. doi: 10.1038/s41598-020-77186-9.
PubMed 33214615Chang YJ, Wang Y, Xu LP, Zhang XH, Chen H, Chen YH, Wang FR, Wei-Han, Sun YQ, Yan CH, Tang FF, Mo XD, Liu YR, Liu KY, Huang XJ. Haploidentical donor is preferred over matched sibling donor for pre-transplantation MRD positive ALL: a phase 3 genetically randomized study. J Hematol Oncol. 2020 Mar 30;13(1):27. doi: 10.1186/s13045-020-00860-y.
PubMed 32228710Zhou YL, Wu LX, Peter Gale R, Wang ZL, Li JL, Jiang H, Jiang Q, Jiang B, Cao SB, Lou F, Sun Y, Wang CC, Liu YR, Wang Y, Chang YJ, Xu LP, Zhang XH, Liu KY, Ruan GR, Huang XJ. Mutation topography and risk stratification for de novo acute myeloid leukaemia with normal cytogenetics and no nucleophosmin 1 (NPM1) mutation or Fms-like tyrosine kinase 3 internal tandem duplication (FLT3-ITD). Br J Haematol. 2020 Jul;190(2):274-283. doi: 10.1111/bjh.16526. Epub 2020 Feb 26.
PubMed 32103499Mo XD, Zhang XH, Xu LP, Wang Y, Yan CH, Chen H, Chen YH, Han W, Wang FR, Wang JZ, Liu KY, Huang XJ. IFN-alpha Is Effective for Treatment of Minimal Residual Disease in Patients with Acute Leukemia after Allogeneic Hematopoietic Stem Cell Transplantation: Results of a Registry Study. Biol Blood Marrow Transplant. 2017 Aug;23(8):1303-1310. doi: 10.1016/j.bbmt.2017.04.023. Epub 2017 Apr 27.
PubMed 28457953
Study at a glance
From the registry record, last updated by the sponsor on 7 Jun 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Interferon α for the Therapy of Minimal Residual Disease Following Hematopoietic Stem Cell Transplantation
- ClinicalTrials.gov ID
- NCT02185261
- Acronym / sponsor ID
- 2014-02
- Conditions
- Leukemia
- Keywords
- Relapse, Minimal residual disease, Graft-versus-host disease, Acute leukemia, Interferon Alfa-2b
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 81 participants (estimated)
- Lead sponsor
- Peking University People's HospitalUniversity, hospital or other
- Study start
- Jun 2014
- Primary completion
- Jun 2021 (estimated)
- Study completion
- Jun 2021 (estimated)
- First posted
- 9 Jul 2014 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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
- Severe toxicity occurrence
- Cumulative incidence of relapse increased) (≥ 30%)
- Cumulative incidence of mortality increased (≥ 30%)
- Cumulative incidence of severe graft-versus-host disease increased (≥ 30%)
- Although large enough sample had been enrolled, it did not reach statistical significance
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| interferon Alfa-2b group | Experimental | Drug: Interferon Alfa-2bAcute leukemia patients who are minimal residual disease positive after hematopoietic stem cell transplantation receive interferon Alfa-2b |
Who may qualify
- Ages
- 1 year to 60 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (1 listed)
- Patients who had standard-risk acute myeloid leukemia(CR1 or CR2) had minimal residual disease positive after hematopoietic stem cell transplantation
Key exclusion criteria (1 listed)
- Patients with t(9;22)(q34; q11), t(15;17), inv(16)(p13q22), t(16;16)(p13; q22), or t(8;21)(q22; q22) cytogenetic abnormalities;active graft-versus-host disease; active infection; organ failure; exposure to donor lymphocyte infusion prior to enrollment
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Interferon Alfa-2bAlso: INF α-2bPatients who were deemed MRD-positive after day 60 post-transplantation receive interferon α-2b (subcutaneously at dosages of 3 million units 2-3 times per week) . Interferon treatment continues for 6 months in the absence of disease progression or unacceptable toxicity. | Drug | interferon Alfa-2b group |
Primary outcome
relapse rate
Time frame: participants will be followed for an expected average of 1 year
number of participants with morphologic relapse at one year
1 secondary outcome
The immunologic impact of subcutaneous interferon α-2b
Time frame: participants will be followed for an expected average of 1 year
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Jun 2018.
- Derived from this study: PubMed 35154096Shen MZ, Zhang XH, Xu LP, Wang Y, Yan CH, Chen H, Chen YH, Han W, Wang FR, Wang JZ, Zhao XS, Qin YZ, Chang YJ, Liu KY, Huang XJ, Mo XD. Preemptive Interferon-alpha Therapy Could Protect Against Relapse and Improve Survival of Acute Myeloid Leukemia Patients After Allogeneic Hematopoietic Stem Cell Transplantation: Long-Term Results of Two Registry Studies. Front Immunol. 2022 Jan 28;13:757002. doi: 10.3389/fimmu.2022.757002. eCollection 2022.
- Derived from this study: PubMed 33214615Liu S, Luo X, Zhang X, Xu L, Wang Y, Yan C, Chen H, Chen Y, Han W, Wang F, Wang J, Liu K, Huang X, Mo X. Preemptive interferon-alpha treatment could protect against relapse and improve long-term survival of ALL patients after allo-HSCT. Sci Rep. 2020 Nov 19;10(1):20148. doi: 10.1038/s41598-020-77186-9.
- Derived from this study: PubMed 32228710Chang YJ, Wang Y, Xu LP, Zhang XH, Chen H, Chen YH, Wang FR, Wei-Han, Sun YQ, Yan CH, Tang FF, Mo XD, Liu YR, Liu KY, Huang XJ. Haploidentical donor is preferred over matched sibling donor for pre-transplantation MRD positive ALL: a phase 3 genetically randomized study. J Hematol Oncol. 2020 Mar 30;13(1):27. doi: 10.1186/s13045-020-00860-y.
- Derived from this study: PubMed 32103499Zhou YL, Wu LX, Peter Gale R, Wang ZL, Li JL, Jiang H, Jiang Q, Jiang B, Cao SB, Lou F, Sun Y, Wang CC, Liu YR, Wang Y, Chang YJ, Xu LP, Zhang XH, Liu KY, Ruan GR, Huang XJ. Mutation topography and risk stratification for de novo acute myeloid leukaemia with normal cytogenetics and no nucleophosmin 1 (NPM1) mutation or Fms-like tyrosine kinase 3 internal tandem duplication (FLT3-ITD). Br J Haematol. 2020 Jul;190(2):274-283. doi: 10.1111/bjh.16526. Epub 2020 Feb 26.
- Derived from this study: PubMed 28457953Mo XD, Zhang XH, Xu LP, Wang Y, Yan CH, Chen H, Chen YH, Han W, Wang FR, Wang JZ, Liu KY, Huang XJ. IFN-alpha Is Effective for Treatment of Minimal Residual Disease in Patients with Acute Leukemia after Allogeneic Hematopoietic Stem Cell Transplantation: Results of a Registry Study. Biol Blood Marrow Transplant. 2017 Aug;23(8):1303-1310. doi: 10.1016/j.bbmt.2017.04.023. Epub 2017 Apr 27.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Xiao-Dong Mo, MD contact
Xiao-Jun Huang, MD principal investigator
Peking University Institute of Hematology
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Interferon Alfa-2b in people with Leukemia, run by Peking University People's Hospital at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 7 Jun 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Xiao-Dong Mo, MD (mxd453@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
relapse rate (time frame: participants will be followed for an expected average of 1 year). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02185261, which also lists 5 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 7 Jun 2018.