ENDURE - Efficacy and Safety of AOP2014 With CML Patients in Remission

NCT03117816

PHASE3INTERVENTIONAL

Philipps University Marburg

214 participants

Started 2017-05-04 · Completed 2022-12-12

Status: Completed (as of 12-23-2025)

Conditions

Chronic Myeloid Leukemia in Remission

Interventions

DRUG: AOP2014 / Pegylated-Proline-interferon alpha-2b OTHER: Surveillance

Linked Papers (from SciSciNet-V2)

Total Papers60

Background

11

Result

0

Derived

0

Unknown

49

View on ClinicalTrials.gov

Total Citations Per Year

Brief Summary

A randomized, open-label assessor blinded, multi-center, controlled phase III Trial to evaluate the efficacy of AOP2014 administered bi-weekly subcutaneously (s.c.) in preventing molecular relapse (loss of MMR) in CML patients, who discontinue ABL tyrosine kinase inhibitor therapy (TKI) in deep molecular remission of MR4 or better (MR4.5, or MR5).

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Background Papers22

European LeukemiaNet recommendations for the management of chronic myeloid leukemia: 2013

1,881 citations

European LeukemiaNet recommendations for the management of chronic myeloid leukemia: 2013

1,881 citations

Human chronic myeloid leukemia stem cells are insensitive to imatinib despite inhibition of BCR-ABL activity

Human chronic myeloid leukemia stem cells are insensitive to imatinib despite inhibition of BCR-ABL activity

Chronic myeloid leukemia: mechanisms of blastic transformation

Chronic myeloid leukemia: mechanisms of blastic transformation

Early response with dasatinib or imatinib in chronic myeloid leukemia: 3-year follow-up from a randomized phase 3 trial (DASISION)

Early response with dasatinib or imatinib in chronic myeloid leukemia: 3-year follow-up from a randomized phase 3 trial (DASISION)

The concept of treatment-free remission in chronic myeloid leukemia

The concept of treatment-free remission in chronic myeloid leukemia

Chronic myelogenous leukemia shapes host immunity by selective deletion of high-avidity leukemia-specific T cells

Chronic myelogenous leukemia shapes host immunity by selective deletion of high-avidity leukemia-specific T cells

Chronic Myeloid Leukemia Patients in Prolonged Remission following Interferon-α Monotherapy Have Distinct Cytokine and Oligoclonal Lymphocyte Profile

Chronic Myeloid Leukemia Patients in Prolonged Remission following Interferon-α Monotherapy Have Distinct Cytokine and Oligoclonal Lymphocyte Profile

Gene Expression Profiling Reveals Similarities between theIn vitroandIn vivoResponses of Immune Effector Cells to IFN-α

Gene Expression Profiling Reveals Similarities between theIn vitroandIn vivoResponses of Immune Effector Cells to IFN-α

Genetic analysis of interferon induced thyroiditis (IIT): Evidence for a key role for MHC and apoptosis related genes and pathways

Genetic analysis of interferon induced thyroiditis (IIT): Evidence for a key role for MHC and apoptosis related genes and pathways

HIV/Hepatitis C Virus−Coinfected Virologic Responders to Pegylated Interferon and Ribavirin Therapy More Frequently Incur Interferon-Related Adverse Events Than Nonresponders Do

HIV/Hepatitis C Virus−Coinfected Virologic Responders to Pegylated Interferon and Ribavirin Therapy More Frequently Incur Interferon-Related Adverse Events Than Nonresponders Do

Gene Expression Profiles Predict Emergence of Psychiatric Adverse Events in HIV/HCV-Coinfected Patients on Interferon-Based HCV Therapy

Gene Expression Profiles Predict Emergence of Psychiatric Adverse Events in HIV/HCV-Coinfected Patients on Interferon-Based HCV Therapy

Result Papers0

No result papers linked

Derived Papers0

No derived papers linked

Unknown Papers49

Induction of Chronic Myelogenous Leukemia in Mice by the P210 ^bcr/abl Gene of the Philadelphia Chromosome

2,207 citations

Tutorial in biostatistics: competing risks and multi‐state models

2,045 citations

Discontinuation of imatinib in patients with chronic myeloid leukaemia who have maintained complete molecular remission for at least 2 years: the prospective, multicentre Stop Imatinib (STIM) trial

1,484 citations

Frequency of Major Molecular Responses to Imatinib or Interferon Alfa plus Cytarabine in Newly Diagnosed Chronic Myeloid Leukemia

1,253 citations

Primitive, quiescent, Philadelphia-positive stem cells from patients with chronic myeloid leukemia are insensitive to STI571 in vitro

1,194 citations

Prognostic discrimination in "good-risk" chronic granulocytic leukemia

Six-year follow-up of patients receiving imatinib for the first-line treatment of chronic myeloid leukemia

A New Prognostic Score for Survival of Patients With Chronic Myeloid Leukemia Treated With Interferon Alfa Writing Committee for the Collaborative CML Prognostic Factors Project Group

The Chronic Myelogenous Leukemia-Specific P210 Protein Is the Product of the bcr / abl Hybrid Gene

Evidence that specific T lymphocytes may participate in the elimination of chronic myelogenous leukemia

Hematologic Remission and Cytogenetic Improvement Induced by Recombinant Human Interferon Alpha_Ain Chronic Myelogenous Leukemia

Safety and efficacy of imatinib cessation for CML patients with stable undetectable minimal residual disease: results from the TWISTER study

Interferon Alfa-2b Combined with Cytarabine versus Interferon Alone in Chronic Myelogenous Leukemia

Imatinib mesylate discontinuation in patients with chronic myelogenous leukemia in complete molecular remission for more than 2 years

Chronic Myelogenous Leukemia: Biology and Therapy

Predicting complete cytogenetic response and subsequent progression-free survival in 2060 patients with CML on imatinib treatment: the EUTOS score

Randomized comparison of interferon-alpha with busulfan and hydroxyurea in chronic myelogenous leukemia. The German CML Study Group [see comments]

Nilotinib vs imatinib in patients with newly diagnosed Philadelphia chromosome-positive chronic myeloid leukemia in chronic phase: ENESTnd 3-year follow-up

Loss of Major Molecular Response As a Trigger for Restarting Tyrosine Kinase Inhibitor Therapy in Patients With Chronic-Phase Chronic Myelogenous Leukemia Who Have Stopped Imatinib After Durable Undetectable Disease

Imatinib plus Peginterferon Alfa-2a in Chronic Myeloid Leukemia

Standardized definitions of molecular response in chronic myeloid leukemia

Clinical investigation of human alpha interferon in chronic myelogenous leukemia

Chronic myeloid leukemia and interferon-α: a study of complete cytogenetic responders

Tolerability-Adapted Imatinib 800 mg/d Versus 400 mg/d Versus 400 mg/d Plus Interferon-α in Newly Diagnosed Chronic Myeloid Leukemia

Discontinuation of dasatinib or nilotinib in chronic myeloid leukemia: interim analysis of the STOP 2G-TKI study

Deep Molecular Response Is Reached by the Majority of Patients Treated With Imatinib, Predicts Survival, and Is Achieved More Quickly by Optimized High-Dose Imatinib: Results From the Randomized CML-Study IV

Prognosis of long-term survival considering disease-specific death in patients with chronic myeloid leukemia

Complete cytogenetic and molecular responses to interferon‐α‐based therapy for chronic myelogenous leukemia are associated with excellent long‐term prognosis

Allogeneic hematopoietic stem cell transplantation (allo SCT) for chronic myeloid leukemia in the imatinib era: evaluation of its impact within a subgroup of the randomized German CML Study IV

Harmonization of molecular monitoring of CML therapy in Europe

Molecular heterogeneity in complete cytogenetic responders after interferon-α therapy for chronic myelogenous leukemia: low levels of minimal residual disease are associated with continuing remission

Combination of pegylated IFN-α2b with imatinib increases molecular response rates in patients with low- or intermediate-risk chronic myeloid leukemia

Sustained Molecular Response With Interferon Alfa Maintenance After Induction Therapy With Imatinib Plus Interferon Alfa in Patients With Chronic Myeloid Leukemia

A randomized study of interferon-α versus interferon-α and low-dose arabinosyl cytosine in chronic myeloid leukemia

Early molecular response and female sex strongly predict stable undetectable BCR-ABL1, the criteria for imatinib discontinuation in patients with CML

Divergent clinical outcome in two CML patients who discontinued imatinib therapy after achieving a molecular remission

Interferon-α, but not the ABL-kinase inhibitor imatinib (STI571), induces expression of myeloblastin and a specific T-cell response in chronic myeloid leukemia

Follow-Up of Complete Cytogenetic Remission in Patients With Chronic Myeloid Leukemia After Cessation of Interferon Alfa

Outcome of four patients with chronic myeloid leukemia after imatinib mesylate discontinuation.

Imatinib and pegylated human recombinant interferon-α2b in early chronic-phase chronic myeloid leukemia

Recommendations to meet statistical challenges arising from endpoints beyond overall survival in clinical trials on chronic myeloid leukemia

Interferon alpha 2 maintenance therapy may enable high rates of treatment discontinuation in chronic myeloid leukemia

Phase II, randomized, multicenter, comparative study of peginterferon–α–2a (40 kD) (Pegasys®)versusinterferon α-2a (Roferon®-A) in patients with treatment-naïve, chronic-phase chronic myelogenous leukemia

Nilotinib and peginterferon alfa-2a for newly diagnosed chronic-phase chronic myeloid leukaemia (NiloPeg): a multicentre, non-randomised, open-label phase 2 study

Prognostic scores for patients with chronic myeloid leukemia under particular consideration of competing causes of death

Correction of Abnormal T-Cell Receptor Repertoire During Interferon-α Therapy in Patients With Hairy Cell Leukemia

Expression Profiling of Peripheral‐Blood Mononuclear Cells from Patients with Chronic Hepatitis C Undergoing Interferon Therapy

Imatinib and pegylated <scp>IFN</scp>‐α2b discontinuation in first‐line chronic myeloid leukemia patients following a major molecular response