Hematological NeoplasmsPhase 2/3NCT02634294
Peg Interferon α-2b for Relapsed Hematological Malignancies After Allo-HSCT
A Phase 2/3 study testing Peg interferon alfa-2b in people with Hematological Neoplasms and Recurrence, run by Shanghai General Hospital, Shanghai Jiao Tong University School of Medicine at 1 site in China.
Trial summary
Aim: to observe the graft versus tumor effect of Pegylated Interferonα-2b in patients with hematological malignancies relapsed after allogeneic hematopoietic stem cell transplantation (alloHSCT) Patients: patients relapsed after alloHSCT, men and women aged 14-60 years, without vital organ dysfunction or ongoing… Read more about this study
- Who is it for?
- Ages 14 to 60 years
- Conditions the study is for
- Hematological Neoplasms, Recurrence
- What is being tested?
- Peg interferon alfa-2b
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteChina
- Study dates
- Aug 2015to Dec 2021
- Phase
- Phase 2/3
- 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 14 to 60 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- Age 14-60 years, male or female
- Allo-HSCT recipients with malignant hematological diseases
- Disease relapse after allo-HSCT, including hematological relapse, molecular relapse
- Able to provide written informed consent and to comply with all study procedures
Who cannot join
- Pregnant or nursing woman
- Cardiac ejection factor < normal lower limit
- Active acute or chronic GVHD with immunosuppressant treatment
- Known hypersensitivity or allergy to interferon
- Patient might develop serious complications according to investigator's experiences
- Patient is undergoing other experimental medication
Trial locations and contacts
1 site in 1 country.
China1 site
Shanghai Jiao Tong University Affilated First People's Hospital
Shanghai, Shanghai Municipality, 200080
About this study
Official title: Induction of Graft Versus Tumor Effect of Pegylated Interferon Alpha-2b for Patients With Relapsed Hematological Malignancies After Allogeneic Stem Cell Transplantation
Aim: to observe the graft versus tumor effect of Pegylated Interferonα-2b in patients with hematological malignancies relapsed after allogeneic hematopoietic stem cell transplantation (alloHSCT) Patients: patients relapsed after alloHSCT, men and women aged 14-60 years, without vital organ dysfunction or ongoing graft-verus-host disease (GVHD).
Number of subjects: 50, Single center, one group, prospective. Drug: pegylated interferon alpha-2b (Peg Intron®; Schering-Plough) 1~1.5ug/kg qw, until occurrence of grade II or higher grade of acute GVHD, or no response to treatment after 8 doses of treatments.
Read the detailed description
Eligible patients were age 14 to 60 years with molecular, hematological or radiography relapsed hematological malignancies post allogeneic hematopoietic stem cell transplantation.
Molecular relapse was defined as reappearance or 1 log increase of molecular markers or decreasing donor chimerism by more than 5%; Hematological relapse was defined as reappearance of blast in bone marrow smear by more than 5%; radiography relapse was defined as enlargement of lymph nodes by more than 25% or infiltration of tumor cells in other sites.
Patients were excluded if they need immunosuppressant treatment for ongoing grade II～IV acute GVHD or moderate to severe chronic GVHD.
Eligible patients were treated with pegylated interferon alpha-2b (Peg Intron®; Schering-Plough (Brinny) Company, Innishannon, County Cork, Ireland) 1~1.5ug/kg qw, until occurrence of grade II or higher grade of acute GVHD, or no response to treatment after 8 doses of treatments. Patients were followed up every week. Physical exams and blood tests including complete blood count (CBC), chemical were performed every week. Disease status evaluation was performed every month.
Number of subjects: 50 Single center, one group, prospective.
- Conditions
- Hematological Neoplasms, Recurrence
- Being tested
- Peg interferon alfa-2b
- Keywords
- Hematological Neoplasms, recurrence, Hematopoietic Stem Cell Transplantation, peginterferon alfa-2b, Graft vs Host Disease
- Medical subject headings
- Hematologic Neoplasms, Recurrence, Graft vs Host Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Peg interferon alfa-2bDrug
Also called PEG INTRON®
Eligible patients were treated with pegylated interferon alpha-2b (Peg Intron®; Schering-Plough (Brinny) Company, Innishannon, County Cork, Ireland) 1~1.5ug/kg qw, until occurrence of grade II or higher grade of acute graft versus host disease, or no response to treatment after 8 doses of treatments.
| Study group | Role | What they receive |
|---|---|---|
| Peg interferon alfa-2b | Experimental | Pegylated Interferon α-2b (PEG INTRON®) , 1~1.5μg/kg qw, subcutaneous injection, 1 to 12 months, until occurrence of grade II or higher grade of acute graft versus host disease, or no response to treatment after 8 doses of treatments. Receives: Drug: Peg interferon alfa-2b |
What is being measured
The primary outcome is the main question the study is designed to answer.
response rate of Peg interferon alpha-2b
the percentage of patients acquiring complete remission and partial remission to Peg interferon alpha-2b in 90 days after treatment
Measured: 90 days
Secondary outcomes (2)
overall survival after relapsing
the percentage of patients still alive after 1 year
Measured: one year
disease free survival after relapsing
the percentage of patients still alive and disease free after 1 year
Measured: one year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Dec 2015 (estimated)
- Study startAug 2015
- Primary completionDec 2021
- Study completionDec 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Hematological NeoplasmsStudies of the same condition, open and under way.
- More trials run by Shanghai General Hospital, Shanghai Jiao Tong University School of MedicineThe 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 2/3
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 30 participants (actual)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Chun Wang, Shanghai General Hospital, Shanghai Jiao Tong University School of Medicine
- Investigators
- Chun Wang, M.D., Ph.D., Principal investigator, Shanghai General Hospital, Shanghai Jiao Tong University School of Medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02634294
- Sponsor's protocol ID
- Shanghai1st
- Status last verified
- Mar 2023
- First submitted
- 5 Dec 2015
- Last updated
- 16 Mar 2023
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No: There is no plan to make individual participant date available before publication
Publications
Gupta S, Jen J, Kolz K, Cutler D. Dose selection and population pharmacokinetics of PEG-Intron in patients with chronic myelogenous leukaemia. Br J Clin Pharmacol. 2007 Mar;63(3):292-9. doi: 10.1111/j.1365-2125.2006.02757.x. Epub 2006 Aug 30.
PubMed 16939523Bejanyan N, Weisdorf DJ, Logan BR, Wang HL, Devine SM, de Lima M, Bunjes DW, Zhang MJ. Survival of patients with acute myeloid leukemia relapsing after allogeneic hematopoietic cell transplantation: a center for international blood and marrow transplant research study. Biol Blood Marrow Transplant. 2015 Mar;21(3):454-9. doi: 10.1016/j.bbmt.2014.11.007. Epub 2014 Nov 15.
PubMed 25460355
Study at a glance
From the registry record, last updated by the sponsor on 16 Mar 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Induction of Graft Versus Tumor Effect of Pegylated Interferon Alpha-2b for Patients With Relapsed Hematological Malignancies After Allogeneic Stem Cell Transplantation
- ClinicalTrials.gov ID
- NCT02634294
- Acronym / sponsor ID
- Shanghai1st
- Conditions
- Hematological Neoplasms, Recurrence
- Keywords
- Hematological Neoplasms, recurrence, Hematopoietic Stem Cell Transplantation, peginterferon alfa-2b, Graft vs Host Disease
- Phase
- Phase 2/3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 30 participants (actual)
- Lead sponsor
- Shanghai General Hospital, Shanghai Jiao Tong University School of MedicineUniversity, hospital or other
- Study start
- Aug 2015
- Primary completion
- Dec 2021 (actual)
- Study completion
- Dec 2021 (actual)
- First posted
- 18 Dec 2015 (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.
Aim: to observe the graft versus tumor effect of Pegylated Interferonα-2b in patients with hematological malignancies relapsed after allogeneic hematopoietic stem cell transplantation (alloHSCT) Patients: patients relapsed after alloHSCT, men and women aged 14-60 years, without vital organ dysfunction or ongoing graft-verus-host disease (GVHD).
Number of subjects: 50, Single center, one group, prospective. Drug: pegylated interferon alpha-2b (Peg Intron®; Schering-Plough) 1~1.5ug/kg qw, until occurrence of grade II or higher grade of acute GVHD, or no response to treatment after 8 doses of treatments.
Detailed description
Eligible patients were age 14 to 60 years with molecular, hematological or radiography relapsed hematological malignancies post allogeneic hematopoietic stem cell transplantation.
Molecular relapse was defined as reappearance or 1 log increase of molecular markers or decreasing donor chimerism by more than 5%; Hematological relapse was defined as reappearance of blast in bone marrow smear by more than 5%; radiography relapse was defined as enlargement of lymph nodes by more than 25% or infiltration of tumor cells in other sites.
Patients were excluded if they need immunosuppressant treatment for ongoing grade II～IV acute GVHD or moderate to severe chronic GVHD.
Eligible patients were treated with pegylated interferon alpha-2b (Peg Intron®; Schering-Plough (Brinny) Company, Innishannon, County Cork, Ireland) 1~1.5ug/kg qw, until occurrence of grade II or higher grade of acute GVHD, or no response to treatment after 8 doses of treatments. Patients were followed up every week. Physical exams and blood tests including complete blood count (CBC), chemical were performed every week. Disease status evaluation was performed every month.
Number of subjects: 50 Single center, one group, prospective.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Peg interferon alfa-2b | Experimental | Drug: Peg interferon alfa-2bPegylated Interferon α-2b (PEG INTRON®) , 1~1.5μg/kg qw, subcutaneous injection, 1 to 12 months, until occurrence of grade II or higher grade of acute graft versus host disease, or no response to treatment after 8 doses of treatments. |
Who may qualify
- Ages
- 14 to 60 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (4 listed)
- Age 14-60 years, male or female
- Allo-HSCT recipients with malignant hematological diseases
- Disease relapse after allo-HSCT, including hematological relapse, molecular relapse
- Able to provide written informed consent and to comply with all study procedures
Key exclusion criteria (6 listed)
- Pregnant or nursing woman
- Cardiac ejection factor < normal lower limit
- Active acute or chronic GVHD with immunosuppressant treatment
- Known hypersensitivity or allergy to interferon
- Patient might develop serious complications according to investigator's experiences
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 |
|---|---|---|
| Peg interferon alfa-2bAlso: PEG INTRON®Eligible patients were treated with pegylated interferon alpha-2b (Peg Intron®; Schering-Plough (Brinny) Company, Innishannon, County Cork, Ireland) 1~1.5ug/kg qw, until occurrence of grade II or higher grade of acute graft versus host disease, or no response to treatment after 8 doses of treatments. | Drug | Peg interferon alfa-2b |
Primary outcome
response rate of Peg interferon alpha-2b
Time frame: 90 days
the percentage of patients acquiring complete remission and partial remission to Peg interferon alpha-2b in 90 days after treatment
2 secondary outcomes
overall survival after relapsing
Time frame: one year
disease free survival after relapsing
Time frame: one year
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Mar 2023.
- Background: PubMed 16939523Gupta S, Jen J, Kolz K, Cutler D. Dose selection and population pharmacokinetics of PEG-Intron in patients with chronic myelogenous leukaemia. Br J Clin Pharmacol. 2007 Mar;63(3):292-9. doi: 10.1111/j.1365-2125.2006.02757.x. Epub 2006 Aug 30.
- Background: PubMed 25460355Bejanyan N, Weisdorf DJ, Logan BR, Wang HL, Devine SM, de Lima M, Bunjes DW, Zhang MJ. Survival of patients with acute myeloid leukemia relapsing after allogeneic hematopoietic cell transplantation: a center for international blood and marrow transplant research study. Biol Blood Marrow Transplant. 2015 Mar;21(3):454-9. doi: 10.1016/j.bbmt.2014.11.007. Epub 2014 Nov 15.
- Individual participant dataSharing planned: No. There is no plan to make individual participant date available before publication
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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.
Chun Wang, M.D., Ph.D. principal investigator
Shanghai General Hospital, Shanghai Jiao Tong University School of Medicine
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2/3 study testing Peg interferon alfa-2b in people with Hematological Neoplasms and Recurrence, run by Shanghai General Hospital, Shanghai Jiao Tong University School of Medicine 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 4 inclusion and 6 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: finished, as of the sponsor's last update on 16 Mar 2023. 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.
What does this combined phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
response rate of Peg interferon alpha-2b (time frame: 90 days). 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 NCT02634294, which also lists 2 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 16 Mar 2023; AzTrials last refreshed its copy on 3 Nov 2026.