18 and older, any sex, with Hodgkin Lymphoma. Patients with the condition only — healthy volunteers not accepted.
Results — posted to ClinicalTrials.gov
Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.
Progression-Free Survival According to the Cheson Criteria by Kaplan-Meier Analysis Following Orally Administered PLX3397 in Adults With Relapsed or Refractory Hodgkin Lymphoma (Modified Intent-to-Treat Population)Primary· Baseline to 1 year postdose
Progression-free survival was assessed by Kaplan Meier analysis and was defined as the number of days from the first day of treatment to the date of first documented disease progression or date of death (whichever occurred first).
Group
Value
95% CI
PLX3397
56
54 – 57
Summary of Overall Tumor Response and By Cycle Following Orally Administered PLX3397 in Adults With Relapsed or Refractory Hodgkin Lymphoma (Modified Intent-to-Treat Population)Primary· Baseline to Cycles 3, 5, 7, 10, and 13, up to 1 year postdose
Subjects were monitored for response and disease progression with contrast Computed tomography (CT) /18Fluorodeoxyglucose (FDG)-positron emission tomography (PET) scans every two cycles. Each cycle is 28 days. Response to treatment as defined by Cheson criteria was reported via descriptive statistics. Target tumor response is Complete Response (CR) + Partial Response (PR) and target tumor disease control rate (CR + PR + Stable Disease (SD)) are reported. Per Cheson Criteria, CR is disappearance of all evidence of disease; Partial Response is regression of measurable disease and no new sites (≥
Overall: Target tumor response (CR+PR)
Group
Value
95% CI
PLX3397
1
Overall: Target tumor DCR (CR+PR+SD)
Group
Value
95% CI
PLX3397
4
Overall: Complete response (CR)
Group
Value
95% CI
PLX3397
0
Overall: Partial response (PR)
Group
Value
95% CI
PLX3397
1
Overall: Stable disease (SD)
Group
Value
95% CI
PLX3397
3
Overall: Relapsed disease or progressive disease
Group
Value
95% CI
PLX3397
13
Cycle 3: Target tumor response (CR+PR)
Group
Value
95% CI
PLX3397
0
Cycle 3: Target tumor DCR (CR+PR+SD)
Group
Value
95% CI
PLX3397
4
Participants With Treatment-Emergent Adverse Events Occurring at a Frequency of ≥10% in Any Preferred Term (Safety Population)Primary· Baseline to 1 year post-dose
At least 1 adverse event
Group
Value
95% CI
PLX3397
20
Anaemia
Group
Value
95% CI
PLX3397
6
Thrombocytopenia
Group
Value
95% CI
PLX3397
6
Diarrhoea
Group
Value
95% CI
PLX3397
2
Nausea
Group
Value
95% CI
PLX3397
2
Vomiting
Group
Value
95% CI
PLX3397
2
Chills
Group
Value
95% CI
PLX3397
2
Fatigue
Group
Value
95% CI
PLX3397
8
Participants With at Least Grade 2 Severity Adverse Events by Preferred Term (Safety Population)Primary· Baseline to 1 year postdose
Grade 2 adverse events were defined as events that were moderate; minimal, local or noninvasive intervention indicated; limiting age-appropriate instrumental activities of daily living (ADL).
At least 1 Grade 2 adverse event
Group
Value
95% CI
PLX3397
13
At least 1 Grade 3 adverse event
Group
Value
95% CI
PLX3397
5
Grade 2 Anaemia
Group
Value
95% CI
PLX3397
6
Grade 2 Neutropenia
Group
Value
95% CI
PLX3397
1
Grade 3 Neutropenia
Group
Value
95% CI
PLX3397
1
Grade 2 Thrombocytopenia
Group
Value
95% CI
PLX3397
1
Grade 3 Thrombocytopenia
Group
Value
95% CI
PLX3397
1
Grade 2 Fatigue
Group
Value
95% CI
PLX3397
5
Adverse events — posted to ClinicalTrials.gov
Time frame: Adverse events were collected from study enrollment up to 1 year post dose..
Reporting threshold: 5%.
Adverse-event reports describe events observed during the trial — not all are caused by the drug.
PLX3397 is a selective inhibitor of Fms, Kit, and oncogenic Flt3 activity.The primary objective of this study is to evaluate the efficacy, as measured by overall response rate, of orally administered PLX3397 in patients with relapsed or refractory classical Hodgkin lymphoma (HL). Secondary objectives include safety, the duration of response, the disease control rate, progression free survival, and how the drug affects your body.
Publications & conference data
8 peer-reviewed publications reference this trial (live from Europe PMC):
NCT02975700 — A Study of PLX3397 in Patients With Unresectable or Metastatic KIT-mutated Melanoma
· NA
· completed
NCT02452424 — A Combination Clinical Study of PLX3397 and Pembrolizumab To Treat Advanced Melanoma and Other Solid Tumors
· Phase 1, PHASE2
· terminated
NCT01826448 — A Phase 1b Open Label, Dose Escalation Study of PLX3397 in Combination With Vemurafenib in V600-mutated BRAF Melanoma
· Phase 1
· terminated
NCT01790503 — A Phase 1b/2 Study of PLX3397 + Radiation Therapy + Temozolomide in Patients With Newly Diagnosed Glioblastoma
· Phase 1, PHASE2
· completed
NCT01596751 — Phase Ib/II Study of PLX 3397 and Eribulin in Patients With Metastatic Breast Cancer
· Phase 1, PHASE2
· completed
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Publications: Europe PMC API search by NCT ID, retrieved 10 June 2026
Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
Sponsor: as reported to ClinicalTrials.gov by Daiichi Sankyo
Last refreshed: 30 June 2020
Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT01217229.