Clinical trial · Observational
Follow-up of Ph+ Chronic Myleoid Leukemia Patients in Complete Cytogenetic Response With Interferon Based Therapy
Long Term Follow-up of Ph+ CML Patients Achieving Complete Cytogenetic Remission With Interferon Based Therapy
- 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)
Objectives This is an observational study aimed at updating the overall survival (OS), the progression free survival (PFS) to accelerated-blastic (AB) phase and the complete cytogenetic response (CCgR) duration of the CML patients who between 1986 and 2001 were treated with an IFN based therapy (either alone or in combination) and who obtained a CCgR. It also aims at analysing the clinical and biological features of this selected cohort of patients with persisting CCgR after treatment with IFN. Study design This study is an observational retrospective multicenter study. Assessment and Follow-up Patients' demographic data and retrospective collection of CML cytogenetic and molecular data will be reported in the "Assessment and Follow-up FORM". In this FORM the events related to therapy, disease and survival will also be reported. Duration of the study: The recruitment period is estimated in approximately 2 years.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Chronic Myeloid Leukemia | Chronic Myeloid Leukemia, BCR-ABL1 Positive | ALIAS | 0.90 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Interpheron alpha | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- label
- CML and interpheron alpha
- description
- Adult Ph+CML pts in CCgR after IFN alpha.
- interventionNames
- Drug: Interpheron alpha
Primary outcomes (3)
- measure
- Progression Free Survival
- timeFrame
- From date of enrollment until the date of first documented progression, assessed up to 240 months
- description
- One primary outcome measure is the PFS of the CML patients who between 1986 and 2001 were treated with IFN based therapy (either alone or in combination) and who obtained the CCgR.
- measure
- Duration of Complete Cytogenetic Response (CCgR)
- timeFrame
- From date of enrollment until the date of first documented loss of CCgR, assessed up to 240 months
- description
- One primary outcome measure is the duration of CCgR of the CML patients who between 1986 and 2001 were treated with IFN based therapy (either alone or in combination) and who obtained the CCgR.
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion criteria * Age \> 18 years * Ph+/BCR-ABL+ CML in CP * Treatment with IFN alpha alone or in combination ( i.e HU, Ara-C, YNK01, ASCT ), either within or outside national Study Protocols. * Complete cytogenetic response (CCgR) (0% Ph+ cells) * Written informed consent prior to any study procedures being performed. Exclusion Criteria: * Patients with Ph+ CML in accelerated/blastic phase (AP/BP) * No treatment with Interferon-alpha * No written informed consent prior to any study procedures being performed.
References
Publications (0)
Data not yet available