Trial · NCT02426086
Study to Evaluate Activity of 2 Dose Levels of Imetelstat in Participants With Intermediate-2 or High-Risk Myelofibrosis (MF) Previously Treated With Janus Kinase (JAK) Inhibitor
NCT02426086, Phase 2, Completed, Geron Corporation; results first posted 2021-09-14
3 sourcestrials-2026-11-12-0.5.0
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ConductScience Library. Study to Evaluate Activity of 2 Dose Levels of Imetelstat in Participants With Intermediate-2 or High-Risk Myelofibrosis (MF) Previously Treated With Janus Kinase (JAK) Inhibitor. Trials, record NCT02426086. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT02426086
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Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Study to Evaluate Activity of 2 Dose Levels of Imetelstat in Participants With Intermediate-2 or High-Risk Myelofibrosis (MF) Previously Treated With Janus Kinase (JAK) Inhibitor
- NCT number
- NCT02426086
- Status
- Completed
- Phases
- Phase 2
- Enrollment
- 107 participants, actual
- Lead sponsor
- Geron Corporation
- Conditions
- Myelofibrosis
- Interventions
- Imetelstat 4.7 mg/kg, Imetelstat 9.4 mg/kg
- First posted
- 2015-04-24
- Last updated
- 2021-09-14
- Other registries' IDs
- eudract:2015-000946-41
- Results first posted
- 2021-09-14
Source ClinicalTrials.gov
Registered outcomes22
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Percentage of Participants With Spleen Response | Week 24 | Spleen response rate is defined as the percentage of participants who achieved ≥ 35% reduction in spleen volume at Week 24 from baseline performed by the IRC using magnetic resonance imaging (MRI). |
| Primary | Percentage of Participants With Symptom Response | Week 24 | Symptom response rate is defined as percentage of participants who achieved ≥ 50% reduction in total symptom score (TSS) at Week 24 from baseline as measured by the modified Myelofibrosis Symptom Assessment Form (MFSAF) version 2.0 diary. The MFSAF assessed following symptoms due to Myelofibrosis (MF): night sweats, itchiness, abdominal discomfort, pain under ribs on left side, feeling of fullness, bone or muscle pain and degree of inactivity. Each item is scored on a scale of 0 (absent) to 10 (worst imaginable) with higher scores indicating more severe symptoms and greater inactivity. The total score ranges from 0-70, where 0 indicates absent/as good as it can be and 70 indicates worst imaginable/as bad as it can be. |
| Secondary | Percentage of Participants With Overall Response as Per Modified 2013 International Working Group - Myeloproliferative Neoplasms Research and Treatment (IWG-MRT) Criteria | Every 12 weeks up to Week 48 then every 24 weeks (approximately up to 2.3 years) | Overall Response Rate: % of participants with complete remission (CR) or partial remission (PR) per modified IWG-MRT.CR: bone marrow: normocellular \<5% blasts, ≤Grade 1 fibrosis; immature myeloid cells in peripheral blood (PB):\<2%;hemoglobin (Hb):10 g/dL-upper limit of normal (ULN); neutrophils:1\*10\^9/L-ULN; platelets: 100\*10\^9/L-ULN; spleen:not palpable and ≤350ml volume; extramedullary hematopoiesis (EMH): no non-hepato-splenic EMH; symptoms: \>70% improvement in symptom score per modified MFSAF v2.0 TSS. PR: bone marrow: normocellular: \<5% blasts ≤ Grade 1 fibrosis or not meeting bone marrow remission criteria; Immature myeloid cells in PB: \<2%; Hb: 8.5 -\<10 g/dL-ULN or 10 g/dL-ULN; neutrophils: 1\*10\^9/L-ULN; platelets: 50 -\<100\*10\^9/L-ULN; spleen: ≥35% splenic volumetric reduction by MRI or not palpable; EMH: no non-hepato-splenic EMH;symptoms: \>50% improvement in symptom score per modified MFSAF v2.0 TSS. All response categories, benefit must last \>12 weeks to qualify as response. |
| Secondary | Percentage of Participants With Clinical Improvement (CI) Per Modified 2013 IWG-MRT Criteria | Every 12 weeks up to Week 48 then every 24 weeks (approximately up to 2.3 years) | CI per the modified 2013 IWG-MRT criteria defined as the achievement of anemia, spleen or symptoms response without progressive disease or increase in severity of anemia, thrombocytopenia, or neutropenia (Increase in severity of anemia constitutes the occurrence of new transfusion dependency or a ≥ 2.0 g/dL decrease in hemoglobin level from pretreatment baseline that lasts for at least 12 weeks. Increase in severity of thrombocytopenia or neutropenia is defined as a 2-grade decline, from pretreatment baseline, in platelet count or ANC, according to the Common Terminology Criteria for Adverse Events (CTCAE) Version 4.03. In addition, assignment to CI requires a minimum platelet count of ≥ 25,000\*10\^9/L and ANC of ≥ 0.5\*10\^9/L.) For all response categories, benefit must last for \>12 weeks to qualify as a response. |
| Secondary | Percentage of Participants With Clinical Response Per Modified 2013 IWG-MRT | Every 12 weeks up to Week 48 then every 24 weeks (approximately up to 2.3 years) | Clinical response rate (CRR) was defined as percentage of participants who achieved CR, PR, or CI per modified 2013 IWG-MRT criteria. CR: bone marrow: normocellular \<5% blasts, ≤Grade 1 fibrosis; immature myeloid cells in PB: \<2%; Hb: 10 g/dL-ULN; neutrophils: 1\*10\^9/L-ULN; platelets: 100\*10\^9/L-ULN; spleen: not palpable and ≤350ml volume; EMH: no non-hepato-splenic EMH; symptoms: \>70% improvement in symptom score per modified MFSAF v2.0 TSS. PR: bone marrow: normocellular: \<5% blasts ≤ Grade 1 fibrosis or not meeting bone marrow remission criteria; Immature myeloid cells in PB: \<2%; Hb: 8.5 -\<10 g/dL-ULN or 10 g/dL-ULN; neutrophils: 1\*10\^9/L-ULN; platelets: 50 -\<100\*10\^9/L-ULN; spleen: ≥35% splenic volumetric reduction by MRI or not palpable; EMH: no non-hepato-splenic EMH; symptoms: \>50% improvement in symptom score per modified MFSAF v2.0 TSS. CI: achievement of anemia, spleen or symptoms response without PD or increase in severity of anemia, thrombocytopenia, or neutropenia. |
| Secondary | Percentage of Participants With Spleen Response Per Modified 2013 IWG-MRT Criteria | Every 12 weeks up to Week 48 then every 24 weeks (approximately up to 2.3 years) | Spleen response per modified 2013 IWG-MRT criteria. Spleen response: a baseline splenomegaly that is palpable at 5-10 cm, below the left costal margin (LCM), becomes not palpable or a baseline splenomegaly that is palpable at \>10 cm, below the LCM, decreases by ≥50%; A spleen response requires confirmation by MRI showing \>35% spleen volume reduction (SVR). For response categories, benefit must last for \>12 weeks to qualify as a response. Participants who achieved CI per modified IWG-MRT criteria considered as response with clinical improvement. Participants who met criteria for spleen response but had worsening cytopenias (and therefore did not meet criteria for clinical improvement) were considered to have a response without clinical improvement. The clinical improvement in IWG-MRT is defined as the achievement of anemia, spleen or symptoms response without progressive disease or increase in severity of anemia, thrombocytopenia, or neutropenia. |
| Secondary | Percentage of Participants With Symptoms Response Per Modified 2013 IWG-MRT Criteria | Every 12 weeks up to Week 48 then every 24 weeks (approximately up to 2.3 years) | Symptoms response per modified 2013 IWG-MRT criteria. Symptoms Response: a ≥50% reduction in the modified MFSAF v2.0 TSS. For response category, benefit must last for \>12 weeks to qualify as a response. Participants who achieved CI per modified IWG-MRT criteria considered as response with clinical improvement. Participants who met criteria for symptom response but had worsening cytopenias (and therefore did not meet criteria for clinical improvement) were considered to have a response without clinical improvement. The clinical improvement in IWG-MRT is defined as the achievement of anemia, spleen or symptoms response without progressive disease or increase in severity of anemia, thrombocytopenia, or neutropenia. |
| Secondary | Percentage of Participants With Anemia Response Per Modified 2013 IWG-MRT Criteria | Every 12 weeks up to Week 48 then every 24 weeks (approximately up to 2.3 years) | Anemia response per modified 2013 IWG-MRT criteria. Anemia response is defined as participants with baseline Hb \<10 g/dL but not meeting strict criteria for transfusion dependency: a ≥ 2 g/dL increase in Hb; Transfusion dependent participants at baseline: becoming transfusion independent. Transfusion independence is defined as absence of any pRBC transfusions for at least 12 "rolling" weeks. For response categories, benefit must last for \>12 weeks to qualify as a response. Participants who achieved CI per modified IWG-MRT criteria considered as response with clinical improvement. Participants who met criteria for anemia response but had worsening cytopenias (and therefore did not meet criteria for clinical improvement) were considered to have a response without clinical improvement. The clinical improvement in IWG-MRT is defined as the achievement of anemia, spleen or symptoms response without progressive disease or increase in severity of anemia, thrombocytopenia, or neutropenia. |
| Secondary | Duration of Response (PR/CI/RWCI) as Per IWG-MRT Criteria | From date of initial documentation of a response to the date of first documented evidence of PD or death, whichever occurs first (approximately up to 2.3 years) | Duration of response (PR/CI/RWCI) is the duration from the date of initial documentation of a response to date of first documented evidence of PD or death, whichever occurs first. PR: BM: normocellular: \<5% blasts ≤Grade 1 fibrosis/not meeting BM remission criteria; IMC in PB: \<2%; Hb: 8.5 -\<10 g/dL-ULN or 10 g/dL- ULN; neutrophils: 1\*10\^9/L-ULN; platelets: 50 -\<100\*10\^9/L-ULN; spleen: ≥35% splenic volumetric reduction by MRI/not palpable; EMH: no non-hepato-splenic EMH; symptoms: \>50% improvement in symptom score. CI: achievement of anemia, spleen or symptoms response without PD or increase in severity of anemia, thrombocytopenia, neutropenia. RWCI: Participants who met criteria for response but had worsening cytopenias. PD: Splenomegaly requires MRI showing ≥25% increase in spleen volume. |
| Secondary | Overall Survival | Day 1 of Cycle 1 (each cycle was of 21 days), up to the date of the participant's death (approximately up to 4.1 years) | Overall Survival is measured from the date of Cycle 1, Day 1 to the date of the participants death. If the participant's was alive or the vital status was unknown, OS was censored at the date that the participant is last known to be alive. |
1 to 10 of 22Source ClinicalTrials.gov
See all 22 registered outcomesOutcomes22
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Percentage of Participants With Spleen Response | Week 24 | Treated analysis set included all participants who received at least 1 dose of study drug. | percentage of participants | NUMBER |
| PRIMARY | Percentage of Participants With Symptom Response | Week 24 | Treated analysis set included all participants who received at least 1 dose of study drug. | percentage of participants | NUMBER |
| SECONDARY | Percentage of Participants With Overall Response as Per Modified 2013 International Working Group - Myeloproliferative Neoplasms Research and Treatment (IWG-MRT) Criteria | Every 12 weeks up to Week 48 then every 24 weeks (approximately up to 2.3 years) | Treated analysis set included all participants who received at least 1 dose of study drug. | percentage of participants | NUMBER |
| SECONDARY | Percentage of Participants With Clinical Improvement (CI) Per Modified 2013 IWG-MRT Criteria | Every 12 weeks up to Week 48 then every 24 weeks (approximately up to 2.3 years) | Treated analysis set included all participants who received at least 1 dose of study drug. | percentage of participants | NUMBER |
| SECONDARY | Percentage of Participants With Clinical Response Per Modified 2013 IWG-MRT | Every 12 weeks up to Week 48 then every 24 weeks (approximately up to 2.3 years) | Treated analysis set included all participants who received at least 1 dose of study drug. | percentage of participants | NUMBER |
| SECONDARY | Percentage of Participants With Spleen Response Per Modified 2013 IWG-MRT Criteria | Every 12 weeks up to Week 48 then every 24 weeks (approximately up to 2.3 years) | Treated analysis set included all participants who received at least 1 dose of study drug. All treated participants were evaluated for each response. | percentage of participants | NUMBER |
| SECONDARY | Percentage of Participants With Symptoms Response Per Modified 2013 IWG-MRT Criteria | Every 12 weeks up to Week 48 then every 24 weeks (approximately up to 2.3 years) | Treated analysis set included all participants who received at least 1 dose of study drug. All treated participants were evaluated for each response. | percentage of participants | NUMBER |
| SECONDARY | Percentage of Participants With Anemia Response Per Modified 2013 IWG-MRT Criteria | Every 12 weeks up to Week 48 then every 24 weeks (approximately up to 2.3 years) | Treated analysis set included all participants who received at least 1 dose of study drug. All treated participants were evaluated for each response. | percentage of participants | NUMBER |
| SECONDARY | Duration of Response (PR/CI/RWCI) as Per IWG-MRT Criteria | From date of initial documentation of a response to the date of first documented evidence of PD or death, whichever occurs first (approximately up to 2.3 years) | Treated analysis set included all participants who received at least 1 dose of study drug. Here, overall number of participants analyzed signifies participants who were responders (PR/CI/RWCI) at any time. | weeks | MEDIAN |
| SECONDARY | Overall Survival | Day 1 of Cycle 1 (each cycle was of 21 days), up to the date of the participant's death (approximately up to 4.1 years) | Treated analysis set included all participants who received at least 1 dose of study drug. | months | MEDIAN |
1 to 10 of 22Source ClinicalTrials.gov
See all 22 outcomesResults by group74
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Percentage of Participants With Spleen Response | Imetelstat 4.7 mg/kg | 0 | 95% Confidence Interval 0 to 7.4 | percentage of participants | |
| Percentage of Participants With Spleen Response | Imetelstat 9.4 mg/kg | 10.2 | 95% Confidence Interval 3.8 to 20.8 | percentage of participants | |
| Percentage of Participants With Symptom Response | Imetelstat 4.7 mg/kg | 6.3 | 95% Confidence Interval 1.3 to 17.2 | percentage of participants | |
| Percentage of Participants With Symptom Response | Imetelstat 9.4 mg/kg | 32.2 | 95% Confidence Interval 20.6 to 45.6 | percentage of participants | |
| Percentage of Participants With Overall Response as Per Modified 2013 International Working Group - Myeloproliferative Neoplasms Research and Treatment (IWG-MRT) Criteria | Imetelstat 4.7 mg/kg | 0 | 95% Confidence Interval NA to NA | percentage of participants | |
| Percentage of Participants With Overall Response as Per Modified 2013 International Working Group - Myeloproliferative Neoplasms Research and Treatment (IWG-MRT) Criteria | Imetelstat 9.4 mg/kg | 1.7 | 95% Confidence Interval 0.0 to 9.1 | percentage of participants | |
| Percentage of Participants With Clinical Improvement (CI) Per Modified 2013 IWG-MRT Criteria | Imetelstat 4.7 mg/kg | 16.7 | percentage of participants | ||
| Percentage of Participants With Clinical Improvement (CI) Per Modified 2013 IWG-MRT Criteria | Imetelstat 9.4 mg/kg | 25.4 | percentage of participants | ||
| Percentage of Participants With Clinical Response Per Modified 2013 IWG-MRT | Imetelstat 4.7 mg/kg | 16.7 | 95% Confidence Interval 7.5 to 30.2 | percentage of participants | |
| Percentage of Participants With Clinical Response Per Modified 2013 IWG-MRT | Imetelstat 9.4 mg/kg | 27.1 | 95% Confidence Interval 16.4 to 40.3 | percentage of participants |
1 to 10 of 74Source ClinicalTrials.gov
See all 74 results by groupParticipant flow8
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | Imetelstat 4.7 mg/kg | 48 | |
| Overall Study | STARTED | Imetelstat 9.4 mg/kg | 59 | |
| Overall Study | Treated | Imetelstat 4.7 mg/kg | 48 | |
| Overall Study | Treated | Imetelstat 9.4 mg/kg | 59 | |
| Overall Study | COMPLETED | Imetelstat 4.7 mg/kg | 0 | |
| Overall Study | COMPLETED | Imetelstat 9.4 mg/kg | 0 | |
| Overall Study | NOT COMPLETED | Imetelstat 4.7 mg/kg | 48 | |
| Overall Study | NOT COMPLETED | Imetelstat 9.4 mg/kg | 59 |
Source ClinicalTrials.gov
Adverse events471
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
| Type | Event | Organ system | Group | Affected | At risk | Events |
|---|---|---|---|---|---|---|
| other | Anaemia | Blood and lymphatic system disorders | Imetelstat 4.7 mg/kg | 15 | 48 | |
| other | Anaemia | Blood and lymphatic system disorders | Imetelstat 9.4 mg/kg | 26 | 59 | |
| other | Anaemia | Blood and lymphatic system disorders | Imetelstat Dose Escalated From 4.7 mg/kg to 9.4 mg/kg | 5 | 12 | |
| other | Leukocytosis | Blood and lymphatic system disorders | Imetelstat 4.7 mg/kg | 3 | 48 | |
| other | Leukocytosis | Blood and lymphatic system disorders | Imetelstat 9.4 mg/kg | 2 | 59 | |
| other | Leukocytosis | Blood and lymphatic system disorders | Imetelstat Dose Escalated From 4.7 mg/kg to 9.4 mg/kg | 0 | 12 | |
| other | Leukopenia | Blood and lymphatic system disorders | Imetelstat 4.7 mg/kg | 3 | 48 | |
| other | Leukopenia | Blood and lymphatic system disorders | Imetelstat 9.4 mg/kg | 8 | 59 | |
| other | Leukopenia | Blood and lymphatic system disorders | Imetelstat Dose Escalated From 4.7 mg/kg to 9.4 mg/kg | 2 | 12 | |
| other | Neutropenia | Blood and lymphatic system disorders | Imetelstat 4.7 mg/kg | 5 | 48 |
1 to 10 of 471Source ClinicalTrials.gov
See all 471 adverse eventsAdverse event totals9
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Imetelstat 4.7 mg/kg | 34 | 48 |
| Total, all-cause mortality | Imetelstat 9.4 mg/kg | 36 | 59 |
| Total, all-cause mortality | Imetelstat Dose Escalated From 4.7 mg/kg to 9.4 mg/kg | 1 | 12 |
| Total, other adverse events | Imetelstat 4.7 mg/kg | 47 | 48 |
| Total, other adverse events | Imetelstat 9.4 mg/kg | 59 | 59 |
| Total, other adverse events | Imetelstat Dose Escalated From 4.7 mg/kg to 9.4 mg/kg | 12 | 12 |
| Total, serious adverse events | Imetelstat 4.7 mg/kg | 24 | 48 |
| Total, serious adverse events | Imetelstat 9.4 mg/kg | 21 | 59 |
| Total, serious adverse events | Imetelstat Dose Escalated From 4.7 mg/kg to 9.4 mg/kg | 4 | 12 |
Source ClinicalTrials.gov
Papers1
The papers the trial lists on ClinicalTrials.gov.
| PMID | Listed as |
|---|---|
| 34138638 | DERIVED |
Source PubMed
Grants0
The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.
None in this release.
Trial comparisons1
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
| Comparison |
|---|
| Imetelstat 4.7 mg/kg vs Imetelstat 9.4 mg/kg: Number of Participants With Treatment-emergent Adverse Events (TEAEs) |
Source Trial comparisons
Tests0
The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.
None in this release.
Data dates
The day each source was copied for this release.
Sources 3
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNo license stated
- NIH RePORTER's clinical studies and project filesPublic domain
Each source's terms
- ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
- ClinicalTrials.govnone stated
- NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)
ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
For software
Read this trial from software.
The record and each of its lists are JSON, twenty rows a page. No key.
GET https://conductscience.org/api/trials/v1/NCT02426086
GET https://conductscience.org/api/trials/v1/NCT02426086/registered?page=2