NCT01772420 · OUTCOME
Number of Patients With Hematologic Improvement in Neutrophil Counts (HI-N)
Results reported by the registry submitting party. Population, time horizon, units and missing values must be read together.
- Measure
- COUNT_OF_PARTICIPANTS
- Unit
- Participants
- Interval / dispersion
- Not reported
- Time frame
- 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
What was measured
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.
Analysis population: Intention to treat population study design.
Groups in this outcome
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
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
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
| Group | Source count |
|---|---|
| Arm A (Platelets > 50,000 k/uL) LEN Initiation | 16 |
| Arm B (Platelets < 50,000 k/uL) ELT Initiation With Potential LEN Combination | 15 |
| Arm C (Platelets < 50,000 k/uL) ELT Monotherapy | 21 |
Reported measurements
Source class 1
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Arm A (Platelets > 50,000 k/uL) LEN Initiation | 0 | Not reported | Not reported | Not reported | Not reported |
| Arm B (Platelets < 50,000 k/uL) ELT Initiation With Potential LEN Combination | 1 | Not reported | Not reported | Not reported | Not reported |
| Arm C (Platelets < 50,000 k/uL) ELT Monotherapy | 2 | Not reported | Not reported | Not reported | Not reported |
Complete source fields
- classes
- categories
- measurements
- group Id
- OG000
- value
- 0
- group Id
- OG001
- value
- 1
- group Id
- OG002
- value
- 2
- denoms
- counts
- group Id
- OG000
- value
- 16
- group Id
- OG001
- value
- 15
- group Id
- OG002
- value
- 21
- units
- Participants
- description
- 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.
- groups
- description
- 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
- id
- OG000
- title
- Arm A (Platelets > 50,000 k/uL) LEN Initiation
- description
- 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
- id
- OG001
- title
- Arm B (Platelets < 50,000 k/uL) ELT Initiation With Potential LEN Combination
- description
- 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
- id
- OG002
- title
- Arm C (Platelets < 50,000 k/uL) ELT Monotherapy
- param Type
- COUNT_OF_PARTICIPANTS
- population Description
- Intention to treat population study design.
- reporting Status
- POSTED
- time Frame
- 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
- title
- Number of Patients With Hematologic Improvement in Neutrophil Counts (HI-N)
- type
- SECONDARY
- unit Of Measure
- Participants
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Preserved source evidence · Not medical advice
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