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| ID | Type | Description | Link |
|---|---|---|---|
| NCI-2013-01219 | Registry Identifier | CTRP (Clinical Trial Reporting Program) | |
| P30CA013330 | U.S. NIH Grant/Contract | View source | |
| 115479 | Other Identifier | GlaxoSmithKline Tracking Number | |
| RV--MDS-PI-0645 | Other Identifier | Celgene Tracking Number |
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| Name | Class |
|---|---|
| National Cancer Institute (NCI) | NIH |
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This phase II trial studies how well lenalidomide (LEN) and eltrombopag olamine (ELT) work in treating patients with symptomatic anemia in low or intermediate myelodysplastic syndrome (MDS). Lenalidomide may stimulate the immune system in different ways and stop cancer cells from growing. Eltrombopag olamine may increase the number of white blood cells and platelets found in bone marrow or peripheral blood. Giving lenalidomide and eltrombopag olamine may be an effective treatment for myelodysplastic syndrome.
PRIMARY OBJECTIVES (not Outcome Measures):
I. To evaluate the rate of hematologic improvement of the eltrombopag (eltrombopag olamine)/lenalidomide combination (as per Modified International Working Group [IWG] criteria).
II. To evaluate the safety and tolerability of the combination.
SECONDARY OBJECTIVES (not Outcome Measures):
I. To compare the time to hematologic improvement. II. To evaluate the duration of hematologic improvement III. To evaluate the effect of combination treatment on platelet counts, platelet transfusions and bleeding events.
IV. To evaluate the frequency of bone marrow response (complete response [CR] + partial response [PR]) and cytogenetic response.
V. To evaluate the relationship between mutations in bone marrow stem cells and response.
VI. To evaluate the relationship between various stem and progenitor alterations and response.
OUTLINE: Patients are initially assigned to 1 of 2 treatment arms.
ARM A: Patients with platelet counts >= 50,000 receive lenalidomide orally (PO) daily or every other day (QOD) on days 1-21. If platelet counts fall below 50,000, patients discontinue lenalidomide and receive eltrombopag olamine PO daily or QOD until platelet count is maintained above 50,000 for 2 weeks. Patients then resume lenalidomide PO daily or QOD. If platelets fall below 50,000 again, patients receive eltrombopag olamine as before. When platelet counts are maintained above 50,000 for 2 weeks, patients resume lenalidomide concurrently with eltrombopag for all subsequent courses.
ARM B: Patients with platelet counts < 50,000 receive eltrombopag olamine PO daily or QOD on days 1-28 until platelet counts is maintained above 50,000 for 2 weeks. Patients then receive treatment as in Arm A.
In both arms, treatment repeats every 28 days for 4 courses in the absence of disease progression or unacceptable toxicity.
After completion of study treatment, patients are followed up every 3 months for 2 years, every 6 months for 3 years, and then every 12 months for 5 years.
Eligible patients with a diagnosis of MDS or non-proliferative chronic myelomonocytic leukemia (CMML) (WBC ≤ 12,000/mL) of at least 3-month duration according to WHO criteria and International Prognostic Scoring System categories of low or intermediate-1-risk disease. Patients either had symptomatic anemia untransfused with hemoglobin ≤ 10 g/dL in the 8 weeks before starting the study or had RBC transfusion dependence (i.e., ≥ 2 units/mo) confirmed 8 weeks before starting the study and/or PLTs <50,000 k/uL with hemoglobin >10.0 g/dL. Patients must not have received prior therapy with LEN (for > 2 months) nor ELT
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Arm A (lenalidomide, eltrombopag olamine) | Experimental | Patients with baseline platelet counts >= 50,000 receive lenalidomide PO daily or QOD on days 1-21. If platelet counts fall below 50,000, patients discontinue lenalidomide and receive eltrombopag olamine PO daily or QOD until platelet count is maintained above 50,000 for 2 weeks. Patients then resume lenalidomide PO daily or QOD. If platelets fall below 50,000 again, patients receive eltrombopag olamine as before. When platelet counts are maintained above 50,000 for 2 weeks, patients resume lenalidomide concurrently with eltrombopag for all subsequent courses. Treatment repeats every 28 days for 4 courses in the absence of disease progression or unacceptable toxicity. |
|
| Arm B (eltrombopag olamine, lenalidomide) | Experimental | Patients with baseline platelet counts < 50,000 receive eltrombopag olamine PO daily or QOD on days 1-28 until platelet count is maintained above 50,000 for 2 weeks. Patients then receive treatment as in Arm A. Treatment repeats every 28 days for 4 courses in the absence of disease progression or unacceptable toxicity. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Eltrombopag Olamine | Drug | Given PO |
|
| Measure | Description | Time Frame |
|---|---|---|
| Number of Patients Demonstrating Overall Hematologic Improvement (HI) | The number of patients demonstrating overall Hematologic Improvement (HI) was assessed based on the MDS 2006 IWG criteria. The IWG criteria for HI define specific responses of cytopenia in the 3 hematopoietic lineages: erythroid (HI-E), platelet (HI-P), and neutrophil (HI-N) as demonstrated in corresponding outcome measures. Responses must have sustained for at minimum of 8 weeks for the participant to be included in the tally. | Periodic evaluation (weekly up to a month, followed by 4x28 day cycles = 16weeks) with additional cycles and titrations depending upon treatment response; up to 2 years |
| Measure | Description | Time Frame |
|---|---|---|
| Number of Patients With Hematologic Improvement in Platelet Counts (HI-P) | The Number of Patients with Hematologic Improvement in Platelet Counts (HI-P) was assessed based on the MDS 2006 IWG criteria. Patients demonstrating an absolute increase of ≥ 30 × 10^9/L (for those patients starting with > 20 × 10^9/L platelets) or an increase from < 20 × 10^9/L to > 20 × 10^9/L along with an increase of at least 100%, were deemed to have demonstrated HI-P improvement. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Amit K Verma | Albert Einstein College of Medicine | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Kansas Cancer Center | Kansas City | Kansas | 66160 | United States | ||
| Albert Einstein College of Medicine |
From October 2012 through January 2020, 52 patients were enrolled in this multicenter study.
Not provided
Not provided
| ID | Title | Description |
|---|---|---|
| FG000 | Arm A (Platelets > 50,000 k/uL) LEN Initiation | Patients with baseline platelet counts >50,000 k/uL received lenalidomide (LEN) PO daily or QOD on days 1-21. If platelet counts fell below 50,000 k/uL during treatment, patients discontinued LEN and received eltrombopag olamine (ELT) PO daily or QOD until platelet counts > 50,000 k/uL were achieved, and then maintained for 2 weeks thereafter. If a platelet count >50,000 k/uL was maintained, patients discontinued ELT and resumed only LEN as a single agent (PO daily or QOD). If platelets fell below 50,000 k/uL a second time, LEN was stopped and ELT was re-initiated at the dose last given to the patient. Once platelet counts were >50,000 k/uL and maintained for 2 weeks, patients resumed LEN concurrently with ELT for all subsequent courses. Treatment repeated every 28 days for 4 courses in the absence of disease progression or unacceptable toxicity. Eltrombopag Olamine: Given PO Laboratory Biomarker Analysis: Correlative studies Lenalidomide: Given PO |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
|
Not provided
Not provided
Not provided
| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | May 16, 2016 |
Not provided
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Not provided
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| Laboratory Biomarker Analysis | Other | Correlative studies |
|
| Lenalidomide | Drug | Given PO |
|
|
| Periodic evaluation (weekly up to a month, followed by 4x28 day cycles = 16weeks) with additional cycles and titrations depending upon treatment response; up to 2 years |
| Number of Patients With Hematologic Improvement in Erythrocyte Counts (HI-E) | The Number of Patients with Hematologic Improvement in Erythrocyte Counts (HI-E) was assessed based on the MDS 2006 IWG criteria. Patients demonstrating an Hgb increase by ≥ 1.5 g/dL were deemed to have improvement in HI-E. Only transfusions given for a Hgb of ≤ 9.0 g/dL pretreatment were counted in the RBC transfusion response. | Periodic evaluation (weekly up to a month, followed by 4x28 day cycles = 16weeks) with additional cycles and titrations depending upon treatment response; up to 2 years |
| Number of Patients With Hematologic Improvement in Neutrophil Counts (HI-N) | The Number of Patients with Hematologic Improvement in Neutrophil Counts (HI-N) was assessed based on the MDS 2006 IWG criteria. Patients demonstrating an increase of at least 100% and an absolute increase > 0.5 × 10^9/L were determined to have shown an improvement in HI-N. | Periodic evaluation (weekly up to a month, followed by 4x28 day cycles = 16weeks) with additional cycles and titrations depending upon treatment response; up to 2 years |
| Time to Attain Hematologic Improvement (HI) | Time to hematologic improvement as determined by median time required to achieve HI response. | Periodic evaluation (weekly up to a month, followed by 4x28 day cycles = 16weeks) with additional cycles and titrations depending upon treatment response; up to 2 years |
| Duration of Hematologic Improvement (HI) | Duration to hematologic improvement as determined by median duration of HI response. | Time to progression/relapse following hematologic improvement, at completion of final cycle and treatment discontinuation; up to 6 years |
| Number of Patients With Clinically Significant Bleeding Events | Number of Patients With Clinically Significant Bleeding Events | Treatment initiation through study completion, up to 2 years |
| The Bronx |
| New York |
| 10461 |
| United States |
| FG001 | Arm B (Platelets < 50,000 k/uL) ELT Initiation With Potential LEN Combination | Patients with baseline platelet counts <50,000 k/uL received eltrombopag olamine (ELT) PO daily or QOD on days 1-28 until a platelet count >50,000 k/uL was achieved. Once a platelet count>50,000 k/uL was achieved the ELT dose was maintained for two weeks. After two weeks ELT was discontinued and LEN was started as in Arm A (i.e., eltrombopag olamine discontinued and lenalidomide started). Patients in Arm B were permitted to stay on ELT alone if a hematologic response on ELT was achieved as defined by the 2006 International Working Group (IWG) consensus criteria, or if baseline hemoglobin was >10.0 g/dL and didn't decrease while on study drug. Treatment repeated every 28 days for 4 courses in the absence of disease progression or unacceptable toxicity. Eltrombopag Olamine: Given PO Laboratory Biomarker Analysis: Correlative studies Lenalidomide: Given PO |
| FG002 | Arm C (Platelets < 50,000 k/uL) ELT Monotherapy | Patients in Arm B were permitted to stay on ELT alone if a hematologic response on ELT was achieved as defined by the 2006 International Working Group (IWG) consensus criteria, or if baseline hemoglobin was >10.0 g/dL and didn't decrease while on study drug. Treatment repeated every 28 days for 4 courses in the absence of disease progression or unacceptable toxicity. Eltrombopag Olamine: Given PO Laboratory Biomarker Analysis: Correlative studies |
| COMPLETED |
|
| NOT COMPLETED |
|
Not provided
| ID | Title | Description |
|---|---|---|
| BG000 | Arm A (Platelets > 50,000 k/uL) LEN Initiation | Patients with baseline platelet counts >50,000 k/uL received lenalidomide (LEN) PO daily or QOD on days 1-21. If platelet counts fell below 50,000 k/uL during treatment, patients discontinued LEN and received eltrombopag olamine (ELT) PO daily or QOD until platelet counts > 50,000 k/uL were achieved, and then maintained for 2 weeks thereafter. If a platelet count >50,000 k/uL was maintained, patients discontinued ELT and resumed only LEN as a single agent (PO daily or QOD). If platelets fell below 50,000 k/uL a second time, LEN was stopped and ELT was re-initiated at the dose last given to the patient. Once platelet counts were >50,000 k/uL and maintained for 2 weeks, patients resumed LEN concurrently with ELT for all subsequent courses. Treatment repeated every 28 days for 4 courses in the absence of disease progression or unacceptable toxicity. Eltrombopag Olamine: Given PO Laboratory Biomarker Analysis: Correlative studies Lenalidomide: Given PO |
| BG001 | Arm B (Platelets < 50,000 k/uL) ELT Initiation With Potential LEN Combination | Patients with baseline platelet counts <50,000 k/uL received eltrombopag olamine (ELT) PO daily or QOD on days 1-28 until a platelet count >50,000 k/uL was achieved. Once a platelet count>50,000 k/uL was achieved the ELT dose was maintained for two weeks. After two weeks ELT was discontinued and LEN was started as in Arm A (i.e., eltrombopag olamine discontinued and lenalidomide started). Patients in Arm B were permitted to stay on ELT alone if a hematologic response on ELT was achieved as defined by the 2006 International Working Group (IWG) consensus criteria, or if baseline hemoglobin was >10.0 g/dL and didn't decrease while on study drug. Treatment repeated every 28 days for 4 courses in the absence of disease progression or unacceptable toxicity. Eltrombopag Olamine: Given PO Laboratory Biomarker Analysis: Correlative studies Lenalidomide: Given PO |
| BG002 | Arm C (Platelets < 50,000 k/uL) ELT Monotherapy | Patients in Arm B were permitted to stay on ELT alone if a hematologic response on ELT was achieved as defined by the 2006 International Working Group (IWG) consensus criteria, or if baseline hemoglobin was >10.0 g/dL and didn't decrease while on study drug. Treatment repeated every 28 days for 4 courses in the absence of disease progression or unacceptable toxicity. Eltrombopag Olamine: Given PO Laboratory Biomarker Analysis: Correlative studies |
| BG003 | Total | Total of all reporting groups |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean | Full Range | years |
| |||||||||||||||
| Sex: Female, Male | Count of Participants | Participants |
| ||||||||||||||||
| Race/Ethnicity, Customized | Count of Participants | Participants |
| ||||||||||||||||
| Region of Enrollment | Number | participants |
| ||||||||||||||||
| Baseline Hemoglobin | Mean | Full Range | g/dL |
| |||||||||||||||
| Baseline Platelet | Mean | Full Range | platelets x10^9/L |
| |||||||||||||||
| Blast Count | Mean | Full Range | percentage of blasts in bone marrow cell |
| |||||||||||||||
| Myelodysplastic Syndrome (MDS) | Count of Participants | Participants |
| ||||||||||||||||
| Chronic Myelomonocytic Leukemia (CMML) | Count of Participants | Participants |
| ||||||||||||||||
| Revised International Prognostic Scoring System (IPSS-R) for Myelodysplastic Syndrome (MDS) | Count of Participants | Participants |
| ||||||||||||||||
| Number of Prior Treatments | Mean | Full Range | Prior Treatments |
|
| 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 Patients Demonstrating Overall Hematologic Improvement (HI) | The number of patients demonstrating overall Hematologic Improvement (HI) was assessed based on the MDS 2006 IWG criteria. The IWG criteria for HI define specific responses of cytopenia in the 3 hematopoietic lineages: erythroid (HI-E), platelet (HI-P), and neutrophil (HI-N) as demonstrated in corresponding outcome measures. Responses must have sustained for at minimum of 8 weeks for the participant to be included in the tally. | Intention to treat population study design. | Posted | Count of Participants | Participants | Periodic evaluation (weekly up to a month, followed by 4x28 day cycles = 16weeks) with additional cycles and titrations depending upon treatment response; up to 2 years |
|
|
| ||||||||||||||||||||||||||||||||
| Secondary | Number of Patients With Hematologic Improvement in Platelet Counts (HI-P) | The Number of Patients with Hematologic Improvement in Platelet Counts (HI-P) was assessed based on the MDS 2006 IWG criteria. Patients demonstrating an absolute increase of ≥ 30 × 10^9/L (for those patients starting with > 20 × 10^9/L platelets) or an increase from < 20 × 10^9/L to > 20 × 10^9/L along with an increase of at least 100%, were deemed to have demonstrated HI-P improvement. | Intention to treat population study design. | Posted | Count of Participants | Participants | Periodic evaluation (weekly up to a month, followed by 4x28 day cycles = 16weeks) with additional cycles and titrations depending upon treatment response; up to 2 years |
| ||||||||||||||||||||||||||||||||||
| Secondary | Number of Patients With Hematologic Improvement in Erythrocyte Counts (HI-E) | The Number of Patients with Hematologic Improvement in Erythrocyte Counts (HI-E) was assessed based on the MDS 2006 IWG criteria. Patients demonstrating an Hgb increase by ≥ 1.5 g/dL were deemed to have improvement in HI-E. Only transfusions given for a Hgb of ≤ 9.0 g/dL pretreatment were counted in the RBC transfusion response. | Intention to treat population study design. | Posted | Count of Participants | Participants | Periodic evaluation (weekly up to a month, followed by 4x28 day cycles = 16weeks) with additional cycles and titrations depending upon treatment response; up to 2 years |
| ||||||||||||||||||||||||||||||||||
| Secondary | Number of Patients With Hematologic Improvement in Neutrophil Counts (HI-N) | The Number of Patients with Hematologic Improvement in Neutrophil Counts (HI-N) was assessed based on the MDS 2006 IWG criteria. Patients demonstrating an increase of at least 100% and an absolute increase > 0.5 × 10^9/L were determined to have shown an improvement in HI-N. | Intention to treat population study design. | Posted | Count of Participants | Participants | Periodic evaluation (weekly up to a month, followed by 4x28 day cycles = 16weeks) with additional cycles and titrations depending upon treatment response; up to 2 years |
| ||||||||||||||||||||||||||||||||||
| Secondary | Time to Attain Hematologic Improvement (HI) | Time to hematologic improvement as determined by median time required to achieve HI response. | Intention to treat population study design. | Posted | Median | Full Range | number of weeks | Periodic evaluation (weekly up to a month, followed by 4x28 day cycles = 16weeks) with additional cycles and titrations depending upon treatment response; up to 2 years |
| |||||||||||||||||||||||||||||||||
| Secondary | Duration of Hematologic Improvement (HI) | Duration to hematologic improvement as determined by median duration of HI response. | Intention to treat population study design. | Posted | Median | Full Range | number of weeks | Time to progression/relapse following hematologic improvement, at completion of final cycle and treatment discontinuation; up to 6 years |
| |||||||||||||||||||||||||||||||||
| Secondary | Number of Patients With Clinically Significant Bleeding Events | Number of Patients With Clinically Significant Bleeding Events | Intention to treat population study design. | Posted | Count of Participants | Participants | Treatment initiation through study completion, up to 2 years |
|
Through study completion, up to 2 years
Adverse events categorized based on the Common Terminology Criteria for Adverse Events (CTCAE) Version 5.0
Not provided
| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Arm A (Platelets > 50,000 k/uL) LEN Initiation | Patients with baseline platelet counts >50,000 k/uL received lenalidomide (LEN) PO daily or QOD on days 1-21. If platelet counts fell below 50,000 k/uL during treatment, patients discontinued LEN and received eltrombopag olamine (ELT) PO daily or QOD until platelet counts > 50,000 k/uL were achieved, and then maintained for 2 weeks thereafter. If a platelet count >50,000 k/uL was maintained, patients discontinued ELT and resumed only LEN as a single agent (PO daily or QOD). If platelets fell below 50,000 k/uL a second time, LEN was stopped and ELT was re-initiated at the dose last given to the patient. Once platelet counts were >50,000 k/uL and maintained for 2 weeks, patients resumed LEN concurrently with ELT for all subsequent courses. Treatment repeated every 28 days for 4 courses in the absence of disease progression or unacceptable toxicity. Eltrombopag Olamine: Given PO Laboratory Biomarker Analysis: Correlative studies Lenalidomide: Given PO | 1 | 16 | 8 | 16 | 15 | 16 |
| EG001 | Arm B (Platelets < 50,000 k/uL) ELT Initiation With Potential LEN Combination | Patients with baseline platelet counts <50,000 k/uL received eltrombopag olamine (ELT) PO daily or QOD on days 1-28 until a platelet count >50,000 k/uL was achieved. Once a platelet count>50,000 k/uL was achieved the ELT dose was maintained for two weeks. After two weeks ELT was discontinued and LEN was started as in Arm A (i.e., eltrombopag olamine discontinued and lenalidomide started). Patients in Arm B were permitted to stay on ELT alone if a hematologic response on ELT was achieved as defined by the 2006 International Working Group (IWG) consensus criteria, or if baseline hemoglobin was >10.0 g/dL and didn't decrease while on study drug. Treatment repeated every 28 days for 4 courses in the absence of disease progression or unacceptable toxicity. Eltrombopag Olamine: Given PO Laboratory Biomarker Analysis: Correlative studies Lenalidomide: Given PO Treatment repeated every 28 days for 4 courses in the absence of disease progression or unacceptable toxicity. Eltrombopag Olamine: Given PO Laboratory Biomarker Analysis: Correlative studies Lenalidomide: Given PO | 2 | 15 | 5 | 15 | 9 | 15 |
| EG002 | Arm C (Platelets < 50,000 k/uL) ELT Monotherapy | Patients in Arm B were permitted to stay on ELT alone if a hematologic response on ELT was achieved as defined by the 2006 International Working Group (IWG) consensus criteria, or if baseline hemoglobin was >10.0 g/dL and didn't decrease while on study drug. Treatment repeated every 28 days for 4 courses in the absence of disease progression or unacceptable toxicity. Eltrombopag Olamine: Given PO Laboratory Biomarker Analysis: Correlative studies | 0 | 21 | 0 | 21 | 4 | 21 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Sepsis | Infections and infestations | CTCAE (Version 5.0) | Systematic Assessment |
| |
| Neutropenia | Blood and lymphatic system disorders | CTCAE (Unspecified) | Systematic Assessment |
| |
| Febrile Neutropenia | Blood and lymphatic system disorders | CTCAE (Version 5.0) | Systematic Assessment |
| |
| Thrombocytopenia (severe) | Blood and lymphatic system disorders | CTCAE (4.0) | Systematic Assessment | Severe thrombocytopenia |
|
| Lung Infection | Infections and infestations | CTCAE (Version 5.0) | Systematic Assessment | Pneumonia |
|
| Gall Bladder Cancer | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | CTCAE (Version 5.0) | Systematic Assessment |
|
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Blood Bilirubin Increased | Investigations | CTCAE (Version 5.0) | Systematic Assessment | Hyperbilirubinemia from development of bone marrow fibrosis |
|
| Acute Cholecystitis | Investigations | CTCAE (Version 5.0) | Systematic Assessment | AST/ALT elevation, reversible increase in peripheral blasts |
|
| Hematoma | Vascular disorders | CTCAE (Version 5.0) | Systematic Assessment | Right Arm Hematoma |
|
| Upper Gastrointestinal Hemorrhage | Gastrointestinal disorders | CTCAE (Version 5.0) | Systematic Assessment |
| |
| Anemia | Blood and lymphatic system disorders | CTCAE (Version 5.0) | Systematic Assessment |
| |
| Neutropenia | Blood and lymphatic system disorders | CTCAE (4.0) | Systematic Assessment |
| |
| Thrombocytopenia | Blood and lymphatic system disorders | CTCAE (Unspecified) | Systematic Assessment |
| |
| Acute Kidney Injury | Renal and urinary disorders | CTCAE (Version 5.0) | Systematic Assessment |
| |
| Diarrhea | Gastrointestinal disorders | CTCAE (Version 5.0) | Systematic Assessment |
| |
| Rash | Skin and subcutaneous tissue disorders | CTCAE (4.0) | Systematic Assessment |
| |
| Arthralgia | Musculoskeletal and connective tissue disorders | CTCAE (Version 5.0) | Systematic Assessment |
|
Not provided
Not provided
Not provided
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. Amit K. Verma | Albert Einstein College of Medicine | 718-430-8761 | amit.verma@einsteinmed.edu |
| May 22, 2023 |
| Prot_SAP_000.pdf |
| ID | Term |
|---|---|
| D000754 | Anemia, Refractory, with Excess of Blasts |
| D000740 | Anemia |
| D015477 | Leukemia, Myelomonocytic, Chronic |
| ID | Term |
|---|---|
| D000753 | Anemia, Refractory |
| D006402 | Hematologic Diseases |
| D006425 | Hemic and Lymphatic Diseases |
| D009190 | Myelodysplastic Syndromes |
| D001855 | Bone Marrow Diseases |
| D007951 | Leukemia, Myeloid |
| D007938 | Leukemia |
| D009370 | Neoplasms by Histologic Type |
| D009369 | Neoplasms |
| D054437 | Myelodysplastic-Myeloproliferative Diseases |
| D002908 | Chronic Disease |
| D020969 | Disease Attributes |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
Not provided
Not provided
| ID | Term |
|---|---|
| C520809 | eltrombopag |
| D000077269 | Lenalidomide |
| ID | Term |
|---|---|
| D010797 | Phthalimides |
| D010795 | Phthalic Acids |
| D000146 | Acids, Carbocyclic |
| D002264 | Carboxylic Acids |
| D009930 | Organic Chemicals |
| D010881 | Piperidones |
| D010880 | Piperidines |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
| D054833 | Isoindoles |
| D006574 | Heterocyclic Compounds, 2-Ring |
| D000072471 | Heterocyclic Compounds, Fused-Ring |
Not provided
Not provided
| Male |
|
| Non-Hispanic Black |
|
| Hispanic |
|
| Asian |
|
| Unknown (Not Documented) |
|
| Low Risk |
|
| Intermediate Risk |
|
| OG001 | Arm B (Platelets < 50,000 k/uL) ELT Initiation With Potential LEN Combination | Patients with baseline platelet counts <50,000 k/uL received eltrombopag olamine (ELT) PO daily or QOD on days 1-28 until a platelet count >50,000 k/uL was achieved. Once a platelet count>50,000 k/uL was achieved the ELT dose was maintained for two weeks. After two weeks ELT was discontinued and LEN was started as in Arm A (i.e., eltrombopag olamine discontinued and lenalidomide started). Patients in Arm B were permitted to stay on ELT alone if a hematologic response on ELT was achieved as defined by the 2006 International Working Group (IWG) consensus criteria, or if baseline hemoglobin was >10.0 g/dL and didn't decrease while on study drug. Treatment repeated every 28 days for 4 courses in the absence of disease progression or unacceptable toxicity. Eltrombopag Olamine: Given PO Laboratory Biomarker Analysis: Correlative studies Lenalidomide: Given PO |
| OG002 | Arm C (Platelets < 50,000 k/uL) ELT Monotherapy | Patients in Arm B were permitted to stay on ELT alone if a hematologic response on ELT was achieved as defined by the 2006 International Working Group (IWG) consensus criteria, or if baseline hemoglobin was >10.0 g/dL and didn't decrease while on study drug. Treatment repeated every 28 days for 4 courses in the absence of disease progression or unacceptable toxicity. Eltrombopag Olamine: Given PO Laboratory Biomarker Analysis: Correlative studies |
|
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| OG001 | Arm B (Platelets < 50,000 k/uL) ELT Initiation With Potential LEN Combination | Patients with baseline platelet counts <50,000 k/uL received eltrombopag olamine (ELT) PO daily or QOD on days 1-28 until a platelet count >50,000 k/uL was achieved. Once a platelet count>50,000 k/uL was achieved the ELT dose was maintained for two weeks. After two weeks ELT was discontinued and LEN was started as in Arm A (i.e., eltrombopag olamine discontinued and lenalidomide started). Patients in Arm B were permitted to stay on ELT alone if a hematologic response on ELT was achieved as defined by the 2006 International Working Group (IWG) consensus criteria, or if baseline hemoglobin was >10.0 g/dL and didn't decrease while on study drug. Treatment repeated every 28 days for 4 courses in the absence of disease progression or unacceptable toxicity. Eltrombopag Olamine: Given PO Laboratory Biomarker Analysis: Correlative studies Lenalidomide: Given PO |
| OG002 | Arm C (Platelets < 50,000 k/uL) ELT Monotherapy | Patients in Arm B were permitted to stay on ELT alone if a hematologic response on ELT was achieved as defined by the 2006 International Working Group (IWG) consensus criteria, or if baseline hemoglobin was >10.0 g/dL and didn't decrease while on study drug. Treatment repeated every 28 days for 4 courses in the absence of disease progression or unacceptable toxicity. Eltrombopag Olamine: Given PO Laboratory Biomarker Analysis: Correlative studies |
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| OG001 | Arm B (Platelets < 50,000 k/uL) ELT Initiation With Potential LEN Combination | Patients with baseline platelet counts <50,000 k/uL received eltrombopag olamine (ELT) PO daily or QOD on days 1-28 until a platelet count >50,000 k/uL was achieved. Once a platelet count>50,000 k/uL was achieved the ELT dose was maintained for two weeks. After two weeks ELT was discontinued and LEN was started as in Arm A (i.e., eltrombopag olamine discontinued and lenalidomide started). Patients in Arm B were permitted to stay on ELT alone if a hematologic response on ELT was achieved as defined by the 2006 International Working Group (IWG) consensus criteria, or if baseline hemoglobin was >10.0 g/dL and didn't decrease while on study drug. Treatment repeated every 28 days for 4 courses in the absence of disease progression or unacceptable toxicity. Eltrombopag Olamine: Given PO Laboratory Biomarker Analysis: Correlative studies Lenalidomide: Given PO |
| OG002 | Arm C (Platelets < 50,000 k/uL) ELT Monotherapy | Patients in Arm B were permitted to stay on ELT alone if a hematologic response on ELT was achieved as defined by the 2006 International Working Group (IWG) consensus criteria, or if baseline hemoglobin was >10.0 g/dL and didn't decrease while on study drug. Treatment repeated every 28 days for 4 courses in the absence of disease progression or unacceptable toxicity. Eltrombopag Olamine: Given PO Laboratory Biomarker Analysis: Correlative studies |
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Patients with baseline platelet counts <50,000 k/uL received eltrombopag olamine (ELT) PO daily or QOD on days 1-28 until a platelet count >50,000 k/uL was achieved. Once a platelet count>50,000 k/uL was achieved the ELT dose was maintained for two weeks. After two weeks ELT was discontinued and LEN was started as in Arm A (i.e., eltrombopag olamine discontinued and lenalidomide started). Patients in Arm B were permitted to stay on ELT alone if a hematologic response on ELT was achieved as defined by the 2006 International Working Group (IWG) consensus criteria, or if baseline hemoglobin was >10.0 g/dL and didn't decrease while on study drug. Treatment repeated every 28 days for 4 courses in the absence of disease progression or unacceptable toxicity. Eltrombopag Olamine: Given PO Laboratory Biomarker Analysis: Correlative studies Lenalidomide: Given PO |
| OG002 | Arm C (Platelets < 50,000 k/uL) ELT Monotherapy | Patients in Arm B were permitted to stay on ELT alone if a hematologic response on ELT was achieved as defined by the 2006 International Working Group (IWG) consensus criteria, or if baseline hemoglobin was >10.0 g/dL and didn't decrease while on study drug. Treatment repeated every 28 days for 4 courses in the absence of disease progression or unacceptable toxicity. Eltrombopag Olamine: Given PO Laboratory Biomarker Analysis: Correlative studies |
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Patients with baseline platelet counts <50,000 k/uL received eltrombopag olamine (ELT) PO daily or QOD on days 1-28 until a platelet count >50,000 k/uL was achieved. Once a platelet count>50,000 k/uL was achieved the ELT dose was maintained for two weeks. After two weeks ELT was discontinued and LEN was started as in Arm A (i.e., eltrombopag olamine discontinued and lenalidomide started). Patients in Arm B were permitted to stay on ELT alone if a hematologic response on ELT was achieved as defined by the 2006 International Working Group (IWG) consensus criteria, or if baseline hemoglobin was >10.0 g/dL and didn't decrease while on study drug.
Treatment repeated every 28 days for 4 courses in the absence of disease progression or unacceptable toxicity.
Eltrombopag Olamine: Given PO
Laboratory Biomarker Analysis: Correlative studies
Lenalidomide: Given PO
| OG002 | Arm C (Platelets < 50,000 k/uL) ELT Monotherapy | Patients in Arm B were permitted to stay on ELT alone if a hematologic response on ELT was achieved as defined by the 2006 International Working Group (IWG) consensus criteria, or if baseline hemoglobin was >10.0 g/dL and didn't decrease while on study drug. Treatment repeated every 28 days for 4 courses in the absence of disease progression or unacceptable toxicity. Eltrombopag Olamine: Given PO Laboratory Biomarker Analysis: Correlative studies |
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| OG002 | Arm C (Platelets < 50,000 k/uL) ELT Monotherapy | Patients in Arm B were permitted to stay on ELT alone if a hematologic response on ELT was achieved as defined by the 2006 International Working Group (IWG) consensus criteria, or if baseline hemoglobin was >10.0 g/dL and didn't decrease while on study drug. Treatment repeated every 28 days for 4 courses in the absence of disease progression or unacceptable toxicity. Eltrombopag Olamine: Given PO Laboratory Biomarker Analysis: Correlative studies |
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