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NCT01772420 · OUTCOME

Number of Patients Demonstrating Overall Hematologic Improvement (HI)

Phase II Study of Lenalidomide and Eltrombopag in Patients With Symptomatic Anemia · Source last updated 2023-07-27

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 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.

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 identifiers and denominators belong to this outcome only. They may differ in another outcome or in safety reporting.

Analysis denominator · Participants

GroupSource count
Arm A (Platelets > 50,000 k/uL) LEN Initiation16
Arm B (Platelets < 50,000 k/uL) ELT Initiation With Potential LEN Combination15
Arm C (Platelets < 50,000 k/uL) ELT Monotherapy21

Reported measurements

Source class 1
Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Arm A (Platelets > 50,000 k/uL) LEN Initiation6Not reportedNot reportedNot reportedNot reported
Arm B (Platelets < 50,000 k/uL) ELT Initiation With Potential LEN Combination5Not reportedNot reportedNot reportedNot reported
Arm C (Platelets < 50,000 k/uL) ELT Monotherapy7Not reportedNot reportedNot reportedNot reported
Complete source fields
classes
  1. categories
    1. measurements
      1. group Id
        OG000
        value
        6
      2. group Id
        OG001
        value
        5
      3. group Id
        OG002
        value
        7
denoms
  1. counts
    1. group Id
      OG000
      value
      16
    2. group Id
      OG001
      value
      15
    3. group Id
      OG002
      value
      21
    units
    Participants
description
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.
groups
  1. 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
  2. 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
  3. 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 Demonstrating Overall Hematologic Improvement (HI)
type
PRIMARY
unit Of Measure
Participants

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Preserved source evidence · Not medical advice