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| ID | Type | Description | Link |
|---|---|---|---|
| 2014-000526-37 | EudraCT Number |
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| Name | Class |
|---|---|
| Karyopharm Therapeutics Inc | INDUSTRY |
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Acute Myeloid Leukemia (AML) is currently treated with chemotherapy by combining several drugs with different ways of inhibiting the cell growth. In this trial, standard chemotherapeutics that have proven their effectiveness for years, Ara-C and Idarubicin, will be combined with a new drug called Selinexor.
Selinexor inhibits the growth of cancer cells by keeping certain proteins in the nucleus which control the cell growth.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Cohort 1 / Selinexor 40 mg/m^2 in combination with cytarabine and idarubicin | Experimental | All enrolled patients are treated with cytarabine at a dose of 100 mg/m² continuous infusion (day 1-7) and idarubicin at a dose of 10 mg/m^2 iv (day 1,3,5) every 4 weeks and selinexor for up to 2 induction cycles. If a second cycle is applied idarubicin is only given on day 1 and 3. Selinexor is administered at a dose of 40 mg/m^2 twice weekly orally starting on day 2 (total of 8 doses per induction cycle). |
|
| Cohort 2 / Selinexor 60 mg flat dose in combination with cytarabine and idarubicin | Experimental | All enrolled patients are treated with cytarabine at a dose of 100 mg/m^2 continuous infusion (day 1-7) and idarubicin at a dose of 10 mg/m^2 iv (day 1,3,5) every 4 weeks and selinexor for up to 2 induction cycles. If a second cycle is applied idarubicin is only given on day 1 and 3. Selinexor is administered at a flat dose of 60 mg twice weekly orally in weeks 1-3 of a 4-week cycle starting on day 2 (total of 6 doses per induction cycle). |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Selinexor | Drug | Patients receive Selinexor as specified in arm/group description (8 doses of 40 mg/m^2 or 6 doses of 60 mg per induction cycle). |
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| Measure | Description | Time Frame |
|---|---|---|
| Number of Participants With CR/CRi = Overall Reponse Rate | Efficacy of selinexor in combination with standard chemotherapy in patients with relapsed/refractory AML by determination of rate of complete response (CR) or morphologic complete response with incomplete blood count recovery (CRi), as defined by the recommendations on diagnosis and management of AML in adults from an international expert panel, on behalf of the European LeukemiaNet: CR: Absolute Neutrophil count (ANC) >1.0x10^9/L, Platelet count >100x10^9/L, Bone marrow blasts <5%, no Auer rods, no evidence of extramedullary disease. CRi: Same as CR, but ANC may be <1.0x10^9/L and/or Platelet count <100x10^9/L. Patients with morphologic leukemia free-state (MLFS) were included in the group of responders. MLFS: Bone marrow blasts <5%, no Auer rods, no evidence of extramedullary disease. The best response after Selinexor treatment was analyzed, thus the best response after the induction cycle(s). | 1-2 induction cycles (4 - 8 weeks) |
| Measure | Description | Time Frame |
|---|---|---|
| Number of Participants With Partial Remission (PR) = Rate of PR | Efficacy of selinexor in combination with standard chemotherapy in patients with relapsed/refractory AML by determination of rate of partial remission(PR) as defined by the recommendations on diagnosis and management of AML in adults from an international expert panel, on behalf of the European LeukemiaNet: PR: Absolute Neutrophil count (ANC) >1.0x10^9/L, Platelet count >100x10^9/L, at least a 50% decrease in the percentage of marrow aspirate blasts to 5-25%, or marrow blasts <5% with persistent Auer rods. The best response after Selinexor treatment was analyzed, thus the best response after the induction cycle(s). |
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Inclusion Criteria:
Cytological or histological diagnosis of AML with the exception of promyelocytic leukemia (AML M3)
Patients must have relapsed/refractory disease (relapse after stem cell transplantation is permitted) as defined as:
Men and women aged ≥18 years and eligible for standard dose of chemotherapy (7+3);
A period of at least 3 weeks needs to have elapsed since last treatment (with the exception of hydroxyurea) before participating in this study. Hydroxyurea induction therapy to reduce peripheral blast counts is permitted prior to initiation of treatment on protocol. Treatment may begin in <3 weeks from last treatment if deemed in the best interest of the patient after discussion with the PI of the study;
ECOG performance status ≤ 2
Serum biochemical values with the following limits unless considered due to leukemia: creatinine ≤2 mg/dl; total bilirubin ≤2x ULN, unless increase is due to hemolysis or congenital disorder; transaminases (SGPT or SGOT) ≤2.5x ULN.
Ability to swallow and retain oral medication;
Ability to understand and provide signed informed consent;
Cardiac ejection fraction must be >/=50% (by echocardiography).
Willingness and ability to comply with scheduled visits, treatment plans, laboratory tests, and other study procedures.
Exclusion Criteria:
Treatment with any investigational agent within four weeks.
Cumulative anthracycline dose (daunorubicin or equivalent) >360 mg/m^2
HIV infection
Presence of any medical or psychiatric condition which may limit full compliance with the study, including but not limited to:
Presence of CNS leukemia
Unresolved toxicity from previous anti-cancer therapy or incomplete recovery from surgery.
For patients after SCT as part of prior treatment:
Any of the following within the 12 months prior to study drug administration: myocardial infarction, severe/unstable angina, coronary/peripheral artery bypass graft, symptomatic congestive heart failure, cerebrovascular accident or transient ischemic attack, pulmonary embolism, deep vein thrombosis, or other thromboembolic event.
Ongoing cardiac dysrhythmias of NCI CTCAE >/= Grade 2.
Other severe acute or chronic medical or psychiatric condition, or laboratory abnormality that may increase the risk associated with study participation or study drug administration, or may interfere with the interpretation of study results, and in the judgment of the investigator would make the patient inappropriate for entry into this study.
Clinically significant bleeding within 1 month
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Universitätsklinikum Frankfurt | Frankfurt am Main | Hesse | 60590 | Germany | ||
| Medizinische Hochschule Hannover |
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43 patients were registered in the clinical trial at 3 sites. One patient was a screening failure. Of the remaining 42 patients, the first 27 patients were treated in cohort 1 (Selinexor dosed by Body Surface Area [BSA] 40 mg/m^2 per dose) and the other 15 patients were treated in cohort 2 (flat dose of Selinexor of 60 mg per dose).
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| ID | Title | Description |
|---|---|---|
| FG000 | Cohort 1 / Selinexor 40 mg/m^2 in Combination With Cytarabine and Idarubicin | Induction cycle: All enrolled patients were treated with selinexor, cytarabine and idarubicin as follows: Selinexor: 40 mg/m^2 twice weekly orally starting on day 2 (total of 8 doses per 4-week induction cycle). Idarubcin: i.v. infusion, 10 mg/m^2, on days 1,3,5 in cycle 1 Cytarabine: continuous i.v. infusion day 1-7, 100 mg/m^2 Up to two induction cycles were administered. If a second cycle was applied idarubicin was only given on days 1 and 3. |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot | Yes | No | No | Study Protocol | Jan 13, 2017 | Apr 19, 2021 |
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In the initial protocol, 25 patients are included in the clinical trial on the schedule described as cohort 1. After an amendment 15 further patients are included on the schedule described as cohort 2.
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| Idarubicin | Drug | Infusion, iv, 10 mg/m^2, on days 1,3,5 in cycle 1, on days 1,3 in cycle 2 |
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| Cytarabine | Drug | Continuous infusion day 1 to 7, 100 mg/m^2, iv, |
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| 1-2 induction cycles (4 - 8 weeks) |
| Percentage of Patients Transplanted After Induction Therapy (Stem Cell Transplantation) | Percentage of patients being transplanted after induction therapy (stem cell transplantation) | 1-2 induction cycles (4 - 8 weeks) |
| Early Death Rate | Early death was defined as death before the end of the first induction cycle. | 1 induction cycle (4 weeks) |
| Overall Survival | Overall survival (OS) was calculated from the date of informed consent to the date of death. Patients still alive at the end of follow-up were censored at the last date of follow-up. | Time from registration to event, max 2 years |
| Relapse-Free Survival | Relapse-free survival (RFS) was calculated from the date of CR/CRi until death or relapse, whichever occurred first. Patients were censored on the date of the last follow-up if they were alive without relapse. | Time from registration to event, max 2 years |
| Event-Free Survival | Event-free survival (EFS) was calculated from the time of informed consent until death, not achieving CR/CRi or relapse after CR/CRi. | Time from registration to event, max 2 years |
| Progression-Free Survival | Progression-free survival (PFS) was calculated from the time of informed consent to the date of recurrence or death, whichever occurred first. Patients were censored at the date of the last follow-up visit if they were alive without relapse. Disease progression was defined as presence of >50% increase in bone marrow blasts to a level of at least 50% and/or a doubling of the percentage of peripheral blood blasts to a level of at least 50%. | Time from registration to event, max 2 years |
| Hanover |
| Lower Saxony |
| 30625 |
| Germany |
| Universitätsklinikum Hamburg-Eppendorf | Hamburg | 20246 | Germany |
| FG001 | Cohort 2 / Selinexor 60 mg Flat Dose in Combination With Cytarabine and Idarubicin | Induction cycle: All enrolled patients were treated with selinexor, cytarabine and idarubicin as follows: Selinexor: 60 mg flat dose twice weekly orally during weeks 1-3 of a 4-week cycle (day 2, 4, 9, 11, 16, 18; total of 6 doses per 4-week induction cycle). Idarubcin: i.v. infusion, 10 mg/m^2, on days 1,3,5 in cycle 1. Cytarabine: continuous i.v. infusion day 1-7, 100 mg/m^2 Up to two induction cycles were administered. If a second cycle was applied idarubicin was only given on days 1 and 3. |
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| NOT COMPLETED |
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| ID | Title | Description |
|---|---|---|
| BG000 | Cohort 1 / Selinexor 40 mg/m^2 in Combination With Cytarabine and Idarubicin | Induction cycle: All enrolled patients were treated with selinexor, cytarabine and idarubicin as follows: Selinexor: 40 mg/m^2 twice weekly orally starting on day 2 (total of 8 doses per 4-week induction cycle). Idarubcin: i.v. infusion, 10 mg/m^2, on days 1,3,5 in cycle 1 Cytarabine: continuous i.v. infusion day 1-7, 100 mg/m^2 Up to two induction cycles were administered. If a second cycle was applied idarubicin was only given on days 1 and 3. |
| BG001 | Cohort 2 / Selinexor 60 mg Flat Dose in Combination With Cytarabine and Idarubicin | Induction cycle: All enrolled patients were treated with selinexor, cytarabine and idarubicin as follows: Selinexor: 60 mg flat dose twice weekly orally during weeks 1-3 of a 4-week cycle (day 2, 4, 9, 11, 16, 18; total of 6 doses per 4-week induction cycle). Idarubcin: i.v. infusion, 10 mg/m^2, on days 1,3,5 in cycle 1. Cytarabine: continuous i.v. infusion day 1-7, 100 mg/m^2 Up to two induction cycles were administered. If a second cycle was applied idarubicin was only given on days 1 and 3. |
| BG002 | Total | Total of all reporting groups |
| Units | Counts |
|---|---|
| Participants |
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| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean | Standard Deviation | years |
| |||||||||||||||
| Sex: Female, Male | Count of Participants | Participants |
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| Race (NIH/OMB) | Count of Participants | Participants |
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| Region of Enrollment | Number | participants |
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| Leukemia diagnosis | Count of Participants | Participants |
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| Prior stem cell transplantation (SCT) | Count of Participants | Participants |
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| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Number of Participants With CR/CRi = Overall Reponse Rate | Efficacy of selinexor in combination with standard chemotherapy in patients with relapsed/refractory AML by determination of rate of complete response (CR) or morphologic complete response with incomplete blood count recovery (CRi), as defined by the recommendations on diagnosis and management of AML in adults from an international expert panel, on behalf of the European LeukemiaNet: CR: Absolute Neutrophil count (ANC) >1.0x10^9/L, Platelet count >100x10^9/L, Bone marrow blasts <5%, no Auer rods, no evidence of extramedullary disease. CRi: Same as CR, but ANC may be <1.0x10^9/L and/or Platelet count <100x10^9/L. Patients with morphologic leukemia free-state (MLFS) were included in the group of responders. MLFS: Bone marrow blasts <5%, no Auer rods, no evidence of extramedullary disease. The best response after Selinexor treatment was analyzed, thus the best response after the induction cycle(s). | All patients who have received study medication at least once and for whom post-baseline efficacy data upon treatment was available. | Posted | Count of Participants | Participants | 1-2 induction cycles (4 - 8 weeks) |
|
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| |||||||||||||||||||||||||||||
| Secondary | Number of Participants With Partial Remission (PR) = Rate of PR | Efficacy of selinexor in combination with standard chemotherapy in patients with relapsed/refractory AML by determination of rate of partial remission(PR) as defined by the recommendations on diagnosis and management of AML in adults from an international expert panel, on behalf of the European LeukemiaNet: PR: Absolute Neutrophil count (ANC) >1.0x10^9/L, Platelet count >100x10^9/L, at least a 50% decrease in the percentage of marrow aspirate blasts to 5-25%, or marrow blasts <5% with persistent Auer rods. The best response after Selinexor treatment was analyzed, thus the best response after the induction cycle(s). | All patients who have received study medication at least once and for whom post-baseline efficacy data upon treatment was available. | Posted | Count of Participants | Participants | 1-2 induction cycles (4 - 8 weeks) |
| |||||||||||||||||||||||||||||||
| Secondary | Percentage of Patients Transplanted After Induction Therapy (Stem Cell Transplantation) | Percentage of patients being transplanted after induction therapy (stem cell transplantation) | All patients who have received study medication at least once and for whom post-baseline efficacy data upon treatment was available. | Posted | Count of Participants | Participants | 1-2 induction cycles (4 - 8 weeks) |
| |||||||||||||||||||||||||||||||
| Secondary | Early Death Rate | Early death was defined as death before the end of the first induction cycle. | All patients who have received study medication at least once and for whom post-baseline efficacy data upon treatment was available. | Posted | Count of Participants | Participants | 1 induction cycle (4 weeks) |
| |||||||||||||||||||||||||||||||
| Secondary | Overall Survival | Overall survival (OS) was calculated from the date of informed consent to the date of death. Patients still alive at the end of follow-up were censored at the last date of follow-up. | All patients who have received study medication at least once and for whom post-baseline efficacy data upon treatment was available. | Posted | Median | 95% Confidence Interval | months | Time from registration to event, max 2 years |
| ||||||||||||||||||||||||||||||
| Secondary | Relapse-Free Survival | Relapse-free survival (RFS) was calculated from the date of CR/CRi until death or relapse, whichever occurred first. Patients were censored on the date of the last follow-up if they were alive without relapse. | All patients who have received study medication at least once and for whom post-baseline efficacy data upon treatment was available. | Posted | Median | 95% Confidence Interval | months | Time from registration to event, max 2 years |
| ||||||||||||||||||||||||||||||
| Secondary | Event-Free Survival | Event-free survival (EFS) was calculated from the time of informed consent until death, not achieving CR/CRi or relapse after CR/CRi. | All patients who have received study medication at least once and for whom post-baseline efficacy data upon treatment was available. | Posted | Median | 95% Confidence Interval | months | Time from registration to event, max 2 years |
| ||||||||||||||||||||||||||||||
| Secondary | Progression-Free Survival | Progression-free survival (PFS) was calculated from the time of informed consent to the date of recurrence or death, whichever occurred first. Patients were censored at the date of the last follow-up visit if they were alive without relapse. Disease progression was defined as presence of >50% increase in bone marrow blasts to a level of at least 50% and/or a doubling of the percentage of peripheral blood blasts to a level of at least 50%. | All patients who have received study medication at least once and for whom post-baseline efficacy data upon treatment was available. | Posted | Median | 95% Confidence Interval | months | Time from registration to event, max 2 years |
|
Throughout the treatment period from start of treatment until one month after the last dose of study mediation, on average 2 months.
All patients taking at least one dose of study medication were included in the safety population. This applied to all 42 patients included.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Cohort 1 / Selinexor 40 mg/m^2 in Combination With Cytarabine and Idarubicin | Induction cycle: All enrolled patients were treated with selinexor, cytarabine and idarubicin as follows: Selinexor: 40 mg/m^2 twice weekly orally starting on day 2 (total of 8 doses per 4-week induction cycle). Idarubcin: i.v. infusion, 10 mg/m^2, on days 1,3,5 in cycle 1 Cytarabine: continuous i.v. infusion day 1-7, 100 mg/m^2 Up to two induction cycles were administered. If a second cycle was applied idarubicin was only given on days 1 and 3. | 16 | 27 | 12 | 27 | 27 | 27 |
| EG001 | Cohort 2 / Selinexor 60 mg Flat Dose in Combination With Cytarabine and Idarubicin | Induction cycle: All enrolled patients were treated with selinexor, cytarabine and idarubicin as follows: Selinexor: 60 mg flat dose twice weekly orally during weeks 1-3 of a 4-week cycle (day 2, 4, 9, 11, 16, 18; total of 6 doses per 4-week induction cycle). Idarubcin: i.v. infusion, 10 mg/m^2, on days 1,3,5 in cycle 1. Cytarabine: continuous i.v. infusion day 1-7, 100 mg/m^2 Up to two induction cycles were administered. If a second cycle was applied idarubicin was only given on days 1 and 3. | 9 | 15 | 8 | 15 | 15 | 15 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Febrile neutropenia | Blood and lymphatic system disorders | NCI-CTCAE v4.03 | Systematic Assessment |
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| Anemia | Blood and lymphatic system disorders | NCI-CTCAE v4.03 | Systematic Assessment |
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| Bone marrow hypocellular | Blood and lymphatic system disorders | NCI-CTCAE v4.03 | Systematic Assessment | Bone marrow aplasia |
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| Asystole | Cardiac disorders | NCI-CTCAE v4.03 | Systematic Assessment |
| |
| Atrial fibrillation | Cardiac disorders | NCI-CTCAE v4.03 | Systematic Assessment |
| |
| Diarrhea | Gastrointestinal disorders | NCI-CTCAE v4.03 | Systematic Assessment |
| |
| Colitis | Gastrointestinal disorders | NCI-CTCAE v4.03 | Systematic Assessment |
| |
| Fever | General disorders | NCI-CTCAE v4.03 | Systematic Assessment |
| |
| General weakness | General disorders | NCI-CTCAE v4.03 | Systematic Assessment |
| |
| SIRS | General disorders | NCI-CTCAE v4.03 | Systematic Assessment | Systemic inflammatory response syndrome |
|
| GvHD | Immune system disorders | NCI-CTCAE v4.03 | Systematic Assessment | Graft-versus-host-disease |
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| Hemophagocytosis syndrome | Immune system disorders | NCI-CTCAE v4.03 | Systematic Assessment | Lymphohistiocytic syndrome, assessed as related to selinexor; cause of patient's death according to autopsy report: hemophagocytosis syndrome with acute cardiac decompensation |
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| Lung infection | Infections and infestations | NCI-CTCAE v4.03 | Systematic Assessment |
| |
| Sepsis | Infections and infestations | NCI-CTCAE v4.03 | Systematic Assessment |
| |
| Septic shock | Infections and infestations | NCI-CTCAE v4.03 | Systematic Assessment |
| |
| Fracture | Injury, poisoning and procedural complications | NCI-CTCAE v4.03 | Systematic Assessment |
| |
| Blood bilirubin increased | Investigations | NCI-CTCAE v4.03 | Systematic Assessment |
| |
| Neutrophil count decreased | Investigations | NCI-CTCAE v4.03 | Systematic Assessment | Neutropenia |
|
| Stroke | Nervous system disorders | NCI-CTCAE v4.03 | Systematic Assessment | Reported as Multiple Brain Infarctions |
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| Subarachnoidal hemorrhage | Nervous system disorders | NCI-CTCAE v4.03 | Systematic Assessment |
| |
| Hypotension | Vascular disorders | NCI-CTCAE v4.03 | Systematic Assessment |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Nausea | Gastrointestinal disorders | NCI-CTCAE v4.03 | Systematic Assessment |
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| Diarrhea | Gastrointestinal disorders | NCI-CTCAE v4.03 | Systematic Assessment |
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| Vomiting | Gastrointestinal disorders | NCI-CTCAE v4.03 | Systematic Assessment |
| |
| Anorexia | Metabolism and nutrition disorders | NCI-CTCAE v4.03 | Systematic Assessment |
| |
| Febrile neutropenia | Blood and lymphatic system disorders | NCI-CTCAE v4.03 | Systematic Assessment |
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| Fatigue | General disorders | NCI-CTCAE v4.03 | Systematic Assessment |
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| White blood cell decreased | Investigations | NCI-CTCAE v4.03 | Systematic Assessment |
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| Platelet count decreased | Investigations | NCI-CTCAE v4.03 | Systematic Assessment |
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| Anemia | Blood and lymphatic system disorders | NCI-CTCAE v4.03 | Systematic Assessment |
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| Hypokalemia | Metabolism and nutrition disorders | NCI-CTCAE v4.03 | Systematic Assessment |
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| Hypotension | Vascular disorders | NCI-CTCAE v4.03 | Systematic Assessment |
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| Neutrophil count decreased | Investigations | NCI-CTCAE v4.03 | Systematic Assessment |
| |
| Mucositis oral | Gastrointestinal disorders | NCI-CTCAE v4.03 | Systematic Assessment |
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| Epistaxis | Respiratory, thoracic and mediastinal disorders | NCI-CTCAE v4.03 | Systematic Assessment |
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| Dizziness | Nervous system disorders | NCI-CTCAE v4.03 | Systematic Assessment |
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| Constipation | Gastrointestinal disorders | NCI-CTCAE v4.03 | Systematic Assessment |
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| Injection site reaction | General disorders | NCI-CTCAE v4.03 | Systematic Assessment |
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| Lung infection | Infections and infestations | NCI-CTCAE v4.03 | Systematic Assessment |
| |
| Edema limbs | General disorders | NCI-CTCAE v4.03 | Systematic Assessment |
| |
| Abdominal pain | Gastrointestinal disorders | NCI-CTCAE v4.03 | Systematic Assessment |
| |
| Sepsis | Infections and infestations | NCI-CTCAE v4.03 | Systematic Assessment |
| |
| Depression | Psychiatric disorders | NCI-CTCAE v4.03 | Systematic Assessment |
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| Headache | Nervous system disorders | NCI-CTCAE v4.03 | Systematic Assessment |
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| Hyponatremia | Metabolism and nutrition disorders | NCI-CTCAE v4.03 | Systematic Assessment |
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| Dyspnea | Respiratory, thoracic and mediastinal disorders | NCI-CTCAE v4.03 | Systematic Assessment |
| |
| Hematoma | Vascular disorders | NCI-CTCAE v4.03 | Systematic Assessment |
| |
| Insomnia | Psychiatric disorders | NCI-CTCAE v4.03 | Systematic Assessment |
| |
| Fever | General disorders | NCI-CTCAE v4.03 | Systematic Assessment |
| |
| Sinus tachycardia | Cardiac disorders | NCI-CTCAE v4.03 | Systematic Assessment |
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| Syncope | Nervous system disorders | NCI-CTCAE v4.03 | Systematic Assessment |
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| Creatinine increased | Investigations | NCI-CTCAE v4.03 | Systematic Assessment |
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| Hyperglycemia | Metabolism and nutrition disorders | NCI-CTCAE v4.03 | Systematic Assessment |
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| Hypocalcemia | Metabolism and nutrition disorders | NCI-CTCAE v4.03 | Systematic Assessment |
| |
| Catheter related infection | Infections and infestations | NCI-CTCAE v4.03 | Systematic Assessment |
| |
| Fall | Injury, poisoning and procedural complications | NCI-CTCAE v4.03 | Systematic Assessment |
| |
| Hypertension | Vascular disorders | NCI-CTCAE v4.03 | Systematic Assessment |
| |
| Rash maculo-papular | Skin and subcutaneous tissue disorders | NCI-CTCAE v4.03 | Systematic Assessment |
| |
| Hearing impaired | Ear and labyrinth disorders | NCI-CTCAE v4.03 | Systematic Assessment |
| |
| Vertigo | Ear and labyrinth disorders | NCI-CTCAE v4.03 | Systematic Assessment |
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| Stomach pain | Gastrointestinal disorders | NCI-CTCAE v4.03 | Systematic Assessment |
| |
| Toothache | Gastrointestinal disorders | NCI-CTCAE v4.03 | Systematic Assessment |
| |
| Allergic reaction | Immune system disorders | NCI-CTCAE v4.03 | Systematic Assessment |
| |
| Weight loss | Metabolism and nutrition disorders | NCI-CTCAE v4.03 | Systematic Assessment |
| |
| Hypomagnesemia | Metabolism and nutrition disorders | NCI-CTCAE v4.03 | Systematic Assessment |
| |
| Pain in extremity | Musculoskeletal and connective tissue disorders | NCI-CTCAE v4.03 | Systematic Assessment |
| |
| Hematuria | Renal and urinary disorders | NCI-CTCAE v4.03 | Systematic Assessment |
| |
| Pleural effusion | Respiratory, thoracic and mediastinal disorders | NCI-CTCAE v4.03 | Systematic Assessment |
| |
| Left ventricular systolic dysfunction | Cardiac disorders | NCI-CTCAE v4.03 | Systematic Assessment |
| |
| Blurred vision | Eye disorders | NCI-CTCAE v4.03 | Systematic Assessment |
| |
| Dry eye | Eye disorders | NCI-CTCAE v4.03 | Systematic Assessment |
| |
| Colitis | Gastrointestinal disorders | NCI-CTCAE v4.03 | Systematic Assessment |
| |
| Dysphagia | Gastrointestinal disorders | NCI-CTCAE v4.03 | Systematic Assessment |
| |
| Oral hemorrhage | Gastrointestinal disorders | NCI-CTCAE v4.03 | Systematic Assessment |
| |
| Edema face | General disorders | NCI-CTCAE v4.03 | Systematic Assessment |
| |
| Sinusitis | Infections and infestations | NCI-CTCAE v4.03 | Systematic Assessment |
| |
| Weight gain | Investigations | NCI-CTCAE v4.03 | Systematic Assessment |
| |
| Hypophosphatemia | Metabolism and nutrition disorders | NCI-CTCAE v4.03 | Systematic Assessment |
| |
| Back pain | Musculoskeletal and connective tissue disorders | NCI-CTCAE v4.03 | Systematic Assessment |
| |
| Chest wall pain | Musculoskeletal and connective tissue disorders | NCI-CTCAE v4.03 | Systematic Assessment |
| |
| Dysgeusia | Nervous system disorders | NCI-CTCAE v4.03 | Systematic Assessment |
| |
| Presyncope | Nervous system disorders | NCI-CTCAE v4.03 | Systematic Assessment |
| |
| Urinary incontinence | Renal and urinary disorders | NCI-CTCAE v4.03 | Systematic Assessment |
| |
| Cough | Respiratory, thoracic and mediastinal disorders | NCI-CTCAE v4.03 | Systematic Assessment |
| |
| Alopecia | Skin and subcutaneous tissue disorders | NCI-CTCAE v4.03 | Systematic Assessment |
|
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr Anne L. Kranich | GSO mbH | +494044195460 | kranich@gsoglobal.com |
| Prot_000.pdf |
| SAP | No | Yes | No | Statistical Analysis Plan | Aug 25, 2017 | Apr 19, 2021 | SAP_001.pdf |
| ID | Term |
|---|---|
| D015470 | Leukemia, Myeloid, Acute |
| D012008 | Recurrence |
| ID | Term |
|---|---|
| D007951 | Leukemia, Myeloid |
| D007938 | Leukemia |
| D009370 | Neoplasms by Histologic Type |
| D009369 | Neoplasms |
| D006402 | Hematologic Diseases |
| D006425 | Hemic and Lymphatic Diseases |
| D020969 | Disease Attributes |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
Not provided
Not provided
| ID | Term |
|---|---|
| C585161 | selinexor |
| D015255 | Idarubicin |
| D003561 | Cytarabine |
| ID | Term |
|---|---|
| D003630 | Daunorubicin |
| D018943 | Anthracyclines |
| D009279 | Naphthacenes |
| D011084 | Polycyclic Aromatic Hydrocarbons |
| D006841 | Hydrocarbons, Aromatic |
| D006844 | Hydrocarbons, Cyclic |
| D006838 | Hydrocarbons |
| D009930 | Organic Chemicals |
| D011083 | Polycyclic Compounds |
| D000617 | Aminoglycosides |
| D006027 | Glycosides |
| D002241 | Carbohydrates |
| D003562 | Cytidine |
| D011741 | Pyrimidine Nucleosides |
| D011743 | Pyrimidines |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
| D001087 | Arabinonucleosides |
| D009705 | Nucleosides |
| D009706 | Nucleic Acids, Nucleotides, and Nucleosides |
Not provided
Not provided
| Male |
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| Asian |
|
| Native Hawaiian or Other Pacific Islander |
|
| Black or African American |
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| White |
|
| More than one race |
|
| Unknown or Not Reported |
|
| Therapy-induced AML |
|
| Secondary AML |
|
Induction cycle: All enrolled patients were treated with selinexor, cytarabine and idarubicin as follows: Selinexor: 60 mg flat dose twice weekly orally during weeks 1-3 of a 4-week cycle (day 2, 4, 9, 11, 16, 18; total of 6 doses per 4-week induction cycle). Idarubcin: i.v. infusion, 10 mg/m^2, on days 1,3,5 in cycle 1. Cytarabine: continuous i.v. infusion day 1-7, 100 mg/m^2 Up to two induction cycles were administered. If a second cycle was applied idarubicin was only given on days 1 and 3. |
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