- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05583552
Study to Evaluate Imetelstat in Patients With High-Risk MDS or AML Failing HMA-based Therapy (IMpress)
A Phase II Study Evaluating the Efficacy and Safety of Imetelstat in Patients With HR Myelodysplastic Syndromes or AML Failing HMA-based Therapy
Study Overview
Status
Conditions
Intervention / Treatment
Study Type
Enrollment (Estimated)
Phase
- Phase 2
Contacts and Locations
Study Contact
- Name: Andreas Beust, Dr.
- Phone Number: +49 (0) 421 89 67 66 11
- Email: germany@gcp-service.com
Study Locations
-
-
-
Adelaide, Australia
- Recruiting
- Royal Adelaide Hospital
-
Contact:
- Deepak Singhal, Dr.
-
Brisbane, Australia
- Recruiting
- Royal Brisbane and Women's Hospitals
-
Contact:
- Steven Lane, Prof. Dr.
-
Hobart, Australia
- Not yet recruiting
- Royal Hobart Hospital
-
Contact:
- Rosie Harrup, Dr.
-
Nedlands, Australia
- Recruiting
- Linear Clinical Research
-
Contact:
- Carolyn Grove, Dr.
-
-
-
-
-
Nantes, France
- Recruiting
- CHU Nantes - Hotel Dieu
-
Contact:
- Alice Garnier, Dr.
-
Nice, France
- Recruiting
- Hôpital Archet 1
-
Contact:
- Thomas Cluzeau, Prof.
-
Paris, France
- Recruiting
- Hôpital Saint-Louis
-
Contact:
- Lionel Adès, Prof.
-
Toulouse, France
- Recruiting
- CHU de Toulouse
-
Contact:
- Odile Rauzy, Prof.
-
-
-
-
-
Düsseldorf, Germany
- Recruiting
- Marien Hospital Dusseldorf
-
Contact:
- Aristoteles Giagounidis, Prof. Dr.
-
Jena, Germany
- Recruiting
- Universität Jena, Medizinische Fakultät
-
Contact:
- Sebastian Scholl, Prof. Dr.
-
Leipzig, Germany
- Recruiting
- Universität Leipzig, Medizinische Fakultät
-
Contact:
- Uwe Platzbecker, Prof. Dr.
-
München, Germany
- Recruiting
- Klinikum rechts der Isar
-
Contact:
- Katharina Götze, Prof. Dr.
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Description
Inclusion Criteria:
- Signed written informed consent
- Male and female ≥ 18 years at the first screening
- Must be able to adhere to the study visit schedule and other protocol requirements
- Initial diagnosis of AML or MDS according to WHO 2016 classification
- At least one cytopenia
- Failure to achieve complete or partial response or hematological improvement observed after at least six azacitidine monotherapy or four decitabine monotherapy based 4-week treatment cycles administered during the past two years OR Failure to achieve complete or partial response or hematological improvement observed after at least two 4-week treatment cycles with azacitidine plus venetoclax or with decitabine plus venetoclax during the past two years OR Relapse after initial complete or partial response or hematological improvement observed after at least six (azacitidine) or four (decitabine) based 4-week treatment cycles administered during the past two years OR Relapse after initial complete or partial response or hematological improvement observed after at least two 4-week treatment cycles with azacitidine plus venetoclax or with decitabine plus venetoclax during the past two years OR Intolerance to treatment with HMA-based therapy during the past two years
- Not eligible for allogeneic stem cell transplantation
- ≥ 5% bone marrow blasts at screening
- Off all other treatments for AML/MDS for at least 14 days; granulocyte colony-stimulating factor (G-CSF) and erythropoietin are allowed before and during the study as clinically indicated
- Eastern Cooperative Oncology Group (ECOG) performance status of 0-2
- Biochemical laboratory test values must be within the defined limits.
- Availability of blood counts and transfusion events for previous 16 weeks
- Women of childbearing potential and practicing a highly effective method of birth control consistent with local regulations regarding the use of birth control methods for subjects participating in clinical studies. For females, these restrictions apply for 3 months after the end of dosing.
- A woman of childbearing potential must have a negative serum or urine pregnancy test at screening and agree to be tested on day 1 of every cycle and at End of Treatment (EOT)
- A man who is sexually active with a woman of childbearing potential and has not had a vasectomy must agree to use a barrier method of birth control. For males, these restrictions apply for 3 months after the end of dosing
Exclusion Criteria:
- Chemotherapy within the 14 days prior to the first dose of imetelstat being administered (other than hydroxyurea)
- Participant has known allergies, hypersensitivity, or intolerance to imetelstat or its excipients (refer to the Investigators Brochure (IB))
- Participant has received an experimental or investigational drug or used an invasive investigational medical device within 30 days prior to day 1 of Cycle 1
- Prior treatment with imetelstat
- Prior history of intensive chemotherapy or hematopoietic stem cell transplant
- Major surgery within 4 weeks prior to day 1 of Cycle 1 (excluding the placement of vascular access and other minor surgical procedures)
- Diagnosed or treated for malignancy other than MDS or AML, except:
Malignancy treated with curative intent and with no known active disease present for 3 years before day 1 of Cycle 1 Adequately treated non-melanoma skin cancer or lentigo maligna without evidence of disease Adequately treated cervical carcinoma in situ without evidence of disease
- Clinically significant cardiovascular disease such as uncontrolled or symptomatic arrhythmias, congestive heart failure, or myocardial infarction within 6 months of day 1 of Cycle 1, or any Class 3 (moderate) or Class 4 (severe) cardiac disease as defined by the New York Heart Association Functional Classification
- Known history of human immunodeficiency virus (HIV) or any uncontrolled active systemic infection requiring IV antibiotics
- Active systemic hepatitis infection requiring treatment (carriers of hepatitis virus are permitted to enter the study), or known acute or chronic liver disease including cirrhosis
- Any life-threatening illness, medical condition, or organ system dysfunction which, in the investigator's opinion, could compromise the participant 's safety, interfere with the imetelstat metabolism, or put the study outcomes at undue risk; Participant has any condition for which, in the opinion of the investigator, participation would not be in the best interest of the participant (eg, compromise the well-being) or that could prevent, limit, or confound the protocol-specified assessments
- Females who are pregnant or are currently breastfeeding or planning to become pregnant while enrolled in this study or within 3 months after the end of dosing
- Participant is a man who plans to father a child while enrolled in this study or within 3 months after the end of dosing
- Other:
Participant is in custody by order of an authority or a court of law Participation in another interventional clinical study within the last 3 months prior to signing the Informed consent form (ICF) or simultaneous participation in other interventional clinical studies Previous assignment to treatment during this study Close affiliation with the investigator (e.g., a close relative) or persons working at the study site Participant is an employee of the sponsor or involved Contract Research Organization (CRO) Criteria which in the opinion of the investigator preclude participation for scientific reasons, for reasons of compliance, or for reasons of the Participant's safety
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Single-arm imetelstat
|
Intravenous injection
Other Names:
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Overall Hematological Response Rate of Participants after Treatment with Imetelstat
Time Frame: After 4 Months of Treatment
|
The combined response assessment criteria for MDS and AML based on IWG 2018 criteria (MDS) and the criteria of the European LeukemiaNet (AML) will be used to define responders. The response rate is calculated as number of responders divided by the number of all participants of the analysis set. |
After 4 Months of Treatment
|
Collaborators and Investigators
Collaborators
Investigators
- Principal Investigator: Uwe Platzbecker, MD, Universitätsklinikum Leipzig
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Estimated)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- IMpress_001
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
product manufactured in and exported from the U.S.
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Acute Myeloid Leukemia
-
University of PennsylvaniaActive, not recruitingAcute Myeloid Leukemia, in Relapse | Acute Myeloid Leukemia, Refractory | Acute Myeloid Leukemia, PediatricUnited States
-
National Cancer Institute (NCI)RecruitingAcute Myeloid Leukemia | Secondary Acute Myeloid Leukemia | Recurrent Acute Myeloid Leukemia | Refractory Acute Myeloid LeukemiaUnited States
-
Massachusetts General HospitalExelixisCompletedRefractory Acute Myeloid Leukemia | Relapsed Acute Myeloid LeukemiaUnited States
-
Terrence J Bradley, MDImago BioSciences, Inc., a subsidiary of Merck & Co., Inc., (Rahway, New...RecruitingAcute Myeloid Leukemia | Refractory Acute Myeloid Leukemia | Acute Myeloid Leukemia, in RelapseUnited States
-
Jacqueline Garcia, MDEli Lilly and CompanyCompletedCombination Merestinib and LY2874455 for Patients With Relapsed or Refractory Acute Myeloid LeukemiaRelapsed Adult Acute Myeloid Leukemia | Refractory Adult Acute Myeloid LeukemiaUnited States
-
University of NebraskaNational Cancer Institute (NCI)Active, not recruitingSecondary Acute Myeloid Leukemia | Therapy-Related Acute Myeloid Leukemia | Adult Acute Myeloid LeukemiaUnited States
-
Bhavana BhatnagarCTI BioPharmaCompletedRecurrent Adult Acute Myeloid Leukemia | Secondary Acute Myeloid Leukemia | Untreated Adult Acute Myeloid Leukemia | Therapy-Related Acute Myeloid LeukemiaUnited States
-
Washington University School of MedicineWithdrawnRefractory Acute Myeloid Leukemia | Relapsed Acute Myeloid LeukemiaUnited States
-
C. Babis AndreadisGateway for Cancer Research; AVEO Pharmaceuticals, Inc.TerminatedAcute Myeloid Leukemia | Refractory Acute Myeloid Leukemia | Relapsed Acute Myeloid LeukemiaUnited States
-
Advesya SASNot yet recruitingAcute Myeloid Leukemia, in Relapse | Acute Myeloid Leukemia RefractoryFrance, Sweden, Spain, Germany
Clinical Trials on Imetelstat
-
Geron CorporationCompletedMultiple MyelomaUnited States
-
Geron CorporationCompletedSolid Tumor MalignanciesUnited States
-
Geron CorporationCompleted
-
Geron CorporationCompletedMyelofibrosisUnited States, France, Italy, United Kingdom, Belgium, Germany, Taiwan, Spain, Israel, Korea, Republic of, Canada
-
Pediatric Brain Tumor ConsortiumNational Cancer Institute (NCI)TerminatedGlioblastoma | Gliosarcoma | Ependymoma | Anaplastic Astrocytoma | Oligodendroglioma | Anaplastic Ependymoma | Giant Cell Glioblastoma | Astrocytoma, Grade II | Brainstem TumorsUnited States
-
Children's Oncology GroupNational Cancer Institute (NCI)CompletedLymphoma | Unspecified Childhood Solid Tumor, Protocol Specific | Small Intestine Cancer | Brain and Central Nervous System Tumors | Lymphoproliferative DisorderUnited States, Canada
-
Indiana UniversityBreast Cancer Research Foundation; Geron CorporationCompletedBreast NeoplasmsUnited States
-
Children's Oncology GroupNational Cancer Institute (NCI)WithdrawnRhabdomyosarcoma | Recurrent Neuroblastoma | Recurrent Osteosarcoma | Hepatoblastoma | Recurrent Childhood Rhabdomyosarcoma | Previously Treated Childhood Rhabdomyosarcoma | Recurrent Ewing Sarcoma/Peripheral Primitive Neuroectodermal Tumor | Recurrent Childhood Liver Cancer
-
Geron CorporationCompletedMultiple MyelomaUnited States