TriangleNCT01780662 · OUTCOME
The Number of Patients With Relapsed or Refractory HL Who Achieved Complete Response (CR)
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
- After 4 cycles (21 days per cycle) of protocol therapy
What was measured
The number of patients who experienced complete Response (CR) within the first four cycles. By modern response criteria, those with partial response (PR) or stable disease with all target lesions with Deauville scores \<=3 after cycle 4 are also considered as CR. Patients were assessed after treatment with four cycles of gemcitabine with brentuximab vedotin. CR was only reported for Dose level 2 across both phases of study.
Analysis population: All eligible patients (N=42) at Dose Level 2 (brentuximab vedotin 1.8 mg/kg with gemcitabine). 4 patients were excluded. 3 patients did not receive dose level 2 and 1 patient was ineligible due to exceeding the prescribed interval between disease evaluation and study entry.
Groups in this outcome
Treatment (Brentuximab Vedotin, Gemcitabine Hydrochloride)
Patients receive brentuximab vedotin IV over 30 minutes on day 1 and gemcitabine hydrochloride IV over 100 minutes on days 1 and 8. Treatment repeats every 21 days for up to 15 more courses in the absence of disease progression or unacceptable toxicity. Patients with CR after any course may go off protocol therapy for stem cell transplant. Brentuximab Vedotin: Given IV Gemcitabine Hydrochloride: Given IV
| Group | Source count |
|---|---|
| Treatment (Brentuximab Vedotin, Gemcitabine Hydrochloride) | 42 |
Reported measurements
Source class 1
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Treatment (Brentuximab Vedotin, Gemcitabine Hydrochloride) | 28 | Not reported | Not reported | Not reported | Not reported |
Complete source fields
- classes
- categories
- measurements
- group Id
- OG000
- value
- 28
- denoms
- counts
- group Id
- OG000
- value
- 42
- units
- Participants
- description
- The number of patients who experienced complete Response (CR) within the first four cycles. By modern response criteria, those with partial response (PR) or stable disease with all target lesions with Deauville scores \<=3 after cycle 4 are also considered as CR. Patients were assessed after treatment with four cycles of gemcitabine with brentuximab vedotin. CR was only reported for Dose level 2 across both phases of study.
- groups
- description
- Patients receive brentuximab vedotin IV over 30 minutes on day 1 and gemcitabine hydrochloride IV over 100 minutes on days 1 and 8. Treatment repeats every 21 days for up to 15 more courses in the absence of disease progression or unacceptable toxicity. Patients with CR after any course may go off protocol therapy for stem cell transplant. Brentuximab Vedotin: Given IV Gemcitabine Hydrochloride: Given IV
- id
- OG000
- title
- Treatment (Brentuximab Vedotin, Gemcitabine Hydrochloride)
- param Type
- COUNT_OF_PARTICIPANTS
- population Description
- All eligible patients (N=42) at Dose Level 2 (brentuximab vedotin 1.8 mg/kg with gemcitabine). 4 patients were excluded. 3 patients did not receive dose level 2 and 1 patient was ineligible due to exceeding the prescribed interval between disease evaluation and study entry.
- reporting Status
- POSTED
- time Frame
- After 4 cycles (21 days per cycle) of protocol therapy
- title
- The Number of Patients With Relapsed or Refractory HL Who Achieved Complete Response (CR)
- type
- PRIMARY
- unit Of Measure
- Participants
Download exact source JSON → · Snapshot ctgov-results-191f4516d4760045304b24a0
Preserved source evidence · Not medical advice