Clinical trial · Interventional
Peg Interferon α-2b for Relapsed Hematological Malignancies After Allo-HSCT
Induction of Graft Versus Tumor Effect of Pegylated Interferon Alpha-2b for Patients With Relapsed Hematological Malignancies After Allogeneic Stem Cell Transplantation
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (2)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Hematological Neoplasms | Hematopoietic and Lymphoid Cell Neoplasm | ALIAS | 0.90 |
| Recurrence | — | UNRESOLVED | — |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Peg interferon alfa-2b | Drug | Peginterferon Alfa-2b | ALIAS |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- Peg interferon alfa-2b
- description
- 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.
- interventionNames
- Drug: Peg interferon alfa-2b
Primary outcomes (1)
- measure
- response rate of Peg interferon alpha-2b
- timeFrame
- 90 days
- description
- the percentage of patients acquiring complete remission and partial remission to Peg interferon alpha-2b in 90 days after treatment
Secondary outcomes (2)
- measure
- overall survival after relapsing
- timeFrame
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 14 Years
- Maximum age
- 60 Years
Show eligibility criteria text
Inclusion Criteria: 1. Age 14-60 years, male or female 2. Allo-HSCT recipients with malignant hematological diseases 3. Disease relapse after allo-HSCT, including hematological relapse, molecular relapse 4. Able to provide written informed consent and to comply with all study procedures Exclusion Criteria: 1. Pregnant or nursing woman 2. Cardiac ejection factor \< normal lower limit 3. Active acute or chronic GVHD with immunosuppressant treatment 4. Known hypersensitivity or allergy to interferon 5. Patient might develop serious complications according to investigator's experiences 6. Patient is undergoing other experimental medication
References
Publications (2)
- BACKGROUNDGupta 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. PMID 16939523
- BACKGROUNDBejanyan 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. PMID 25460355