NCT02135874 · STUDY IN CONTEXT

Clofarabine, Idarubicin, Cytarabine, Vincristine Sulfate, and Dexamethasone in Treating Patients With Newly Diagnosed or Relapsed Mixed Phenotype Acute Leukemia

Draft scope assessment: narrower. Linked by condition-string match at the cancer-entity level. The study's eligibility - stage, biomarker, treatment line and prior therapy - has not been reconciled against this page's definition, so its population is narrower than this page in ways not yet recorded. The condition was transformed or resolved through the terminology hierarchy to reach this cancer type, so the link itself is a candidate a reviewer must confirm. 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

Response is Complete Response (CR) is Neutrophil count \>/= 1.0 x 10\^9/L, . Platelet count \>/= 100 x 10\^9/L, Bone marrow aspirate \< 5% blasts, No extramedullary leukemia.

Source null

→

secondary · POSTED

Number of participants who died after 4 weeks of treatment.

Source null

→

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-acute-undifferentiated-leukemia
nct id: NCT02135874
trial label: Clofarabine, Idarubicin, Cytarabine, Vincristine Sulfate, and Dexamethasone in Treating Patients With Newly Diagnosed or Relapsed Mixed Phenotype Acute Leukemia
applicability: narrower
applicability note: Linked by condition-string match at the cancer-entity level. The study's eligibility - stage, biomarker, treatment line and prior therapy - has not been reconciled against this page's definition, so its population is narrower than this page in ways not yet recorded. The condition was transformed or resolved through the terminology hierarchy to reach this cancer type, so the link itself is a candidate a reviewer must confirm.
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: 2
harms Count: 1
qol Count: 0

outcomes

release id
clinical-indications-draft-1
disease state id
ds-acute-undifferentiated-leukemia
nct id
NCT02135874
outcome key
om-0000
source section id
NCT02135874-om-0000
source outcome index
0
endpoint
Participants Complete Response
endpoint definition
Response is Complete Response (CR) is Neutrophil count \>/= 1.0 x 10\^9/L, . Platelet count \>/= 100 x 10\^9/L, Bone marrow aspirate \< 5% blasts, No extramedullary leukemia.
time origin
Up to 2 months
analysis role
primary
reporting status
POSTED
data cutoff
Source null
population note
Source null
curation status
draft
reviewed by
Source null
reviewed at
Source null
created at
2026-09-10T00:00:00Z
release id
clinical-indications-draft-1
disease state id
ds-acute-undifferentiated-leukemia
nct id
NCT02135874
outcome key
om-0001
source section id
NCT02135874-om-0001
source outcome index
1
endpoint
4-week Mortality Rate
endpoint definition
Number of participants who died after 4 weeks of treatment.
time origin
At 4 weeks
analysis role
secondary
reporting status
POSTED
data cutoff
Source null
population note
Source null
curation status
draft
reviewed by
Source null
reviewed at
Source null
created at
2026-09-10T00:00:00Z

arms

release id
clinical-indications-draft-1
disease state id
ds-acute-undifferentiated-leukemia
nct id
NCT02135874
outcome key
om-0000
arm key
OG000
arm label
Treatment (Combination Chemotherapy)
regimen
See Detailed Description. Clofarabine: Given IV Cytarabine: Given IV Dexamethasone: Given IV Idarubicin: Given IV Rituximab: Given IV Sorafenib: Given PO Sorafenib Tosylate: Given PO Vincristine: Given IV Vincristine Sulfate: Given IV
analyzed count
16
analyzed unit
Participants
is comparator
Source null
source pointer
NCT02135874-om-0000#groups/OG000
release id
clinical-indications-draft-1
disease state id
ds-acute-undifferentiated-leukemia
nct id
NCT02135874
outcome key
om-0001
arm key
OG000
arm label
Treatment (Combination Chemotherapy)
regimen
See Detailed Description. Clofarabine: Given IV Cytarabine: Given IV Dexamethasone: Given IV Idarubicin: Given IV Rituximab: Given IV Sorafenib: Given PO Sorafenib Tosylate: Given PO Vincristine: Given IV Vincristine Sulfate: Given IV
analyzed count
16
analyzed unit
Participants
is comparator
Source null
source pointer
NCT02135874-om-0001#groups/OG000

harms

release id
clinical-indications-draft-1
disease state id
ds-acute-undifferentiated-leukemia
nct id
NCT02135874
harm key
EG000
source section id
NCT02135874-ae
event group key
EG000
event group label
Treatment (Combination Chemotherapy)
serious affected
11
serious at risk
16
other affected
16
other at risk
16
frequency threshold
5
collection period
Up to 8 years
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