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← refractory Myelodysplastic Syndromes

NCT00096122 · STUDY IN CONTEXT

Idarubicin, Cytarabine, and Tipifarnib in Treating Patients With Newly Diagnosed Myelodysplastic Syndromes or Acute Myeloid Leukemia

Draft scope assessment: unclear. Attached because the study's own record describes refractory disease. The study was not selected for this indication by its sponsor, and its eligibility has not been reconciled against this page in full. Found by searching ClinicalTrials.gov for this cancer type, restricted to studies that have posted results to the registry. No FDA notice, FDA label or NCI summary held by this site cites this study. Because the search asked for posted results, studies without posted results were never looked for, so their absence from this page means nothing.

Read the full study record and all posted results →

Linked outcomes

Measures are not ranked. Open each original source section for treatment groups, denominators, units and results.

primary · POSTED

Complete Response (CR) is required bone marrow blasts ≤5% and recovery of normal hematopoiesis with an absolute neutrophil count (ANC) of 1\*10\^9/L or more and platelet count of 100\*10\^9/L or more; and a complete response without platelets (CRp) is the same criteria as CR but with platelet counts from 20\*10\^9/L to less than 100\*10\^9/L.

Analysis was per protocol.

→

Reported safety

Serious events are not the same as severe events. Compare the original safety groups and their at-risk populations.

Open the study safety table →

Quality of life and patient-reported measures

No linked quality-of-life measure is recorded for this setting and study.

Full draft applicability and source-link record
trial
release id
clinical-indications-draft-1
disease state id
ds-myelodysplastic-syndromes-refractory-a84ec8fd
nct id
NCT00096122
trial label
Idarubicin, Cytarabine, and Tipifarnib in Treating Patients With Newly Diagnosed Myelodysplastic Syndromes or Acute Myeloid Leukemia
applicability
unclear
applicability note
Attached because the study's own record describes refractory disease. The study was not selected for this indication by its sponsor, and its eligibility has not been reconciled against this page in full.
curation status
draft
reviewed by
Source null
reviewed at
Source null
created at
2026-09-10T00:00:00Z
provenance class
registry-condition-search
discovery note
Found by searching ClinicalTrials.gov for this cancer type, restricted to studies that have posted results to the registry. No FDA notice, FDA label or NCI summary held by this site cites this study. Because the search asked for posted results, studies without posted results were never looked for, so their absence from this page means nothing.
outcome Count
1
harms Count
1
qol Count
0
outcomes
  1. release id
    clinical-indications-draft-1
    disease state id
    ds-myelodysplastic-syndromes-refractory-a84ec8fd
    nct id
    NCT00096122
    outcome key
    om-0000
    source section id
    NCT00096122-om-0000
    source outcome index
    0
    endpoint
    Number of Participants With Complete Response
    endpoint definition
    Complete Response (CR) is required bone marrow blasts ≤5% and recovery of normal hematopoiesis with an absolute neutrophil count (ANC) of 1\*10\^9/L or more and platelet count of 100\*10\^9/L or more; and a complete response without platelets (CRp) is the same criteria as CR but with platelet counts from 20\*10\^9/L to less than 100\*10\^9/L.
    time origin
    21 Day Cycle
    analysis role
    primary
    reporting status
    POSTED
    data cutoff
    Source null
    population note
    Analysis was per protocol.
    curation status
    draft
    reviewed by
    Source null
    reviewed at
    Source null
    created at
    2026-09-10T00:00:00Z
arms
  1. release id
    clinical-indications-draft-1
    disease state id
    ds-myelodysplastic-syndromes-refractory-a84ec8fd
    nct id
    NCT00096122
    outcome key
    om-0000
    arm key
    OG000
    arm label
    Idarubicin, Cytarabine + Tipifarnib
    regimen
    Cytarabine 1.5 g/m\^2 and Idarubicin 12 mg/m\^2 intravenous (IV) continuously on days 1-3 (or 1-4), with Oral Tipifarnib 200/300 twice daily on days 1-21, repeats every 21 days.
    analyzed count
    95
    analyzed unit
    Participants
    is comparator
    Source null
    source pointer
    NCT00096122-om-0000#groups/OG000
harms
  1. release id
    clinical-indications-draft-1
    disease state id
    ds-myelodysplastic-syndromes-refractory-a84ec8fd
    nct id
    NCT00096122
    harm key
    EG000
    source section id
    NCT00096122-ae
    event group key
    EG000
    event group label
    Idarubicin, Cytarabine + Tipifarnib
    serious affected
    46
    serious at risk
    95
    other affected
    95
    other at risk
    95
    frequency threshold
    5
    collection period
    5 years 4 months
    event definition
    Source null
    undenominated note
    Source null
    curation status
    draft
    reviewed by
    Source null
    reviewed at
    Source null
    created at
    2026-09-10T00:00:00Z
quality of life
    setting source links

      Preserved source evidence · Not medical advice