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← Ruxience: refractory Non-Hodgkin's Lymphoma (first-line) after prior therapy

NCT00274651 · STUDY IN CONTEXT

A Phase II Clinical Trial of PXD101 in Patients With Recurrent or Refractory Cutaneous and Peripheral T-Cell Lymphomas

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.

post-hoc · POSTED

Tumor response was assessed using Cheson (Cheson 2007) and SWAT criteria. The SWAT score represents the product of the percentage total body surface area (TBSA) involvement of each lesion type (patch, plaque, and tumor or ulceration), multiplied by a weighting factor.

At termination OR was noted in 1/13 patients (Simon Stage 1). With 29 patients in the CTCL arm the demand for expansion to Simon Stage 2 lacked 5 patients and the study was stopped. Instead OR was done as secondary efficacy analysis (ITT and PP (per protocol)) with OR calculated without accounting for Simon design and with 95% confidence intervals

→

primary · POSTED

Tumor response was assessed using Cheson (Cheson 2007) and SWAT criteria. The SWAT score represents the product of the percentage total body surface area (TBSA) involvement of each lesion type (patch, plaque, and tumor or ulceration), multiplied by a weighting factor.

At termination OR was noted in 1/13 patients (Simon Stage 1). With 29 patients in the CTCL arm the demand for expansion to Simon Stage 2 lacked 5 patients and the study was stopped. Instead OR was done as secondary efficacy analysis (ITT and PP (per protocol)) with OR calculated without accounting for Simon design and with 95% confidence intervals

→

primary · POSTED

Tumor response was assessed using the revised criteria of Cheson (Cheson 2007).Tumor assessments were done using conventional radiographic methods, e.g. CT or CT/PET.

Primary efficacy analysis is based on the ITT analysis set, where the OR are calculated, and the proportion ± 80% CI (confidence interval) specified by Koyama \& Chen (2008) are presented

→

secondary · POSTED

Time to progression was defined as the interval between the first date of treatment and the first notation of disease progression.

Time to Progression (ITT population) was estimated using the Kaplan-Meier method for CTCL and PTCL arms. As progression was not observed in six patients in Arm A and 10 patients in Arm B, a total of 37 patients progressed, and the the median time to progression and the full range (days) are presented.

→

secondary · POSTED

Time to response was defined as the interval between the first date of treatment and the first notation of response.

Time to response (ITT population) was estimated using the Kaplan-Meier method for CTCL and PTCL arms. For 4 patients with CTCL and 6 patients with PTCL, response was recorded. The median time to response and the full range (days) are presented.

→

secondary · POSTED

Duration of response was defined as the time from first notation of response until the time of first notation of disease progression.

Duration of response (ITT population) was estimated by Kaplan-Meier method for CTCL/PTCL arms. 2 CTCL and 2 PTCL patients did not progress and were censored. Median duration of response and full range (days) are presented for 2 patients with CTCL and 4 patients with PTCL. The 2 CTCL patients being evaluable had response durations of 56 and 129 days

→

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

FACT · Objective Response Rate in Patients With Recurrent or Refractory Cutaneous T-cell Lymphoma (CTCL)

Score direction: Not stated by the study. Direction is never inferred from an instrument name.

release id
clinical-indications-draft-1
disease state id
ds-non-hodgkin-lymphoma-ruxience-816f4f4a
nct id
NCT00274651
qol key
qol-0000
source section id
NCT00274651-om-0000
source outcome index
0
instrument
FACT
instrument basis
matched 'factor' in the study's own wording
scale title
Objective Response Rate in Patients With Recurrent or Refractory Cutaneous T-cell Lymphoma (CTCL)
measure definition
Tumor response was assessed using Cheson (Cheson 2007) and SWAT criteria. The SWAT score represents the product of the percentage total body surface area (TBSA) involvement of each lesion type (patch, plaque, and tumor or ulceration), multiplied by a weighting factor.
time frame
throughout the study, or for a maximum of 2 years
analysis role
primary
reporting status
POSTED
higher is better
Source null
direction quote
Source null
population note
At termination OR was noted in 1/13 patients (Simon Stage 1). With 29 patients in the CTCL arm the demand for expansion to Simon Stage 2 lacked 5 patients and the study was stopped. Instead OR was done as secondary efficacy analysis (ITT and PP (per protocol)) with OR calculated without accounting for Simon design and with 95% confidence intervals
curation status
draft
reviewed by
Source null
reviewed at
Source null
created at
2026-09-10T00:00:00Z
Open the exact result →
FACT · Objective Response Rate in Patients With Recurrent or Refractory Cutaneous T-cell Lymphoma (CTCL)

Score direction: Not stated by the study. Direction is never inferred from an instrument name.

release id
clinical-indications-draft-1
disease state id
ds-non-hodgkin-lymphoma-ruxience-816f4f4a
nct id
NCT00274651
qol key
qol-0005
source section id
NCT00274651-om-0005
source outcome index
5
instrument
FACT
instrument basis
matched 'factor' in the study's own wording
scale title
Objective Response Rate in Patients With Recurrent or Refractory Cutaneous T-cell Lymphoma (CTCL)
measure definition
Tumor response was assessed using Cheson (Cheson 2007) and SWAT criteria. The SWAT score represents the product of the percentage total body surface area (TBSA) involvement of each lesion type (patch, plaque, and tumor or ulceration), multiplied by a weighting factor.
time frame
throughout the study, or for a maximum of 2 years
analysis role
post-hoc
reporting status
POSTED
higher is better
Source null
direction quote
Source null
population note
At termination OR was noted in 1/13 patients (Simon Stage 1). With 29 patients in the CTCL arm the demand for expansion to Simon Stage 2 lacked 5 patients and the study was stopped. Instead OR was done as secondary efficacy analysis (ITT and PP (per protocol)) with OR calculated without accounting for Simon design and with 95% confidence intervals
curation status
draft
reviewed by
Source null
reviewed at
Source null
created at
2026-09-10T00:00:00Z
Open the exact result →
Full draft applicability and source-link record
trial
release id
clinical-indications-draft-1
disease state id
ds-non-hodgkin-lymphoma-ruxience-816f4f4a
nct id
NCT00274651
trial label
A Phase II Clinical Trial of PXD101 in Patients With Recurrent or Refractory Cutaneous and Peripheral T-Cell Lymphomas
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
6
harms Count
2
qol Count
2
outcomes
  1. release id
    clinical-indications-draft-1
    disease state id
    ds-non-hodgkin-lymphoma-ruxience-816f4f4a
    nct id
    NCT00274651
    outcome key
    om-0005
    source section id
    NCT00274651-om-0005
    source outcome index
    5
    endpoint
    Objective Response Rate in Patients With Recurrent or Refractory Cutaneous T-cell Lymphoma (CTCL)
    endpoint definition
    Tumor response was assessed using Cheson (Cheson 2007) and SWAT criteria. The SWAT score represents the product of the percentage total body surface area (TBSA) involvement of each lesion type (patch, plaque, and tumor or ulceration), multiplied by a weighting factor.
    time origin
    throughout the study, or for a maximum of 2 years
    analysis role
    post-hoc
    reporting status
    POSTED
    data cutoff
    Source null
    population note
    At termination OR was noted in 1/13 patients (Simon Stage 1). With 29 patients in the CTCL arm the demand for expansion to Simon Stage 2 lacked 5 patients and the study was stopped. Instead OR was done as secondary efficacy analysis (ITT and PP (per protocol)) with OR calculated without accounting for Simon design and with 95% confidence intervals
    curation status
    draft
    reviewed by
    Source null
    reviewed at
    Source null
    created at
    2026-09-10T00:00:00Z
  2. release id
    clinical-indications-draft-1
    disease state id
    ds-non-hodgkin-lymphoma-ruxience-816f4f4a
    nct id
    NCT00274651
    outcome key
    om-0000
    source section id
    NCT00274651-om-0000
    source outcome index
    0
    endpoint
    Objective Response Rate in Patients With Recurrent or Refractory Cutaneous T-cell Lymphoma (CTCL)
    endpoint definition
    Tumor response was assessed using Cheson (Cheson 2007) and SWAT criteria. The SWAT score represents the product of the percentage total body surface area (TBSA) involvement of each lesion type (patch, plaque, and tumor or ulceration), multiplied by a weighting factor.
    time origin
    throughout the study, or for a maximum of 2 years
    analysis role
    primary
    reporting status
    POSTED
    data cutoff
    Source null
    population note
    At termination OR was noted in 1/13 patients (Simon Stage 1). With 29 patients in the CTCL arm the demand for expansion to Simon Stage 2 lacked 5 patients and the study was stopped. Instead OR was done as secondary efficacy analysis (ITT and PP (per protocol)) with OR calculated without accounting for Simon design and with 95% confidence intervals
    curation status
    draft
    reviewed by
    Source null
    reviewed at
    Source null
    created at
    2026-09-10T00:00:00Z
  3. release id
    clinical-indications-draft-1
    disease state id
    ds-non-hodgkin-lymphoma-ruxience-816f4f4a
    nct id
    NCT00274651
    outcome key
    om-0001
    source section id
    NCT00274651-om-0001
    source outcome index
    1
    endpoint
    Objective Response Rate in Patients With Recurrent or Refractory Peripheral T-cell Lymphoma (PTCL))
    endpoint definition
    Tumor response was assessed using the revised criteria of Cheson (Cheson 2007).Tumor assessments were done using conventional radiographic methods, e.g. CT or CT/PET.
    time origin
    throughout the study, or for a maximum of 2 years
    analysis role
    primary
    reporting status
    POSTED
    data cutoff
    Source null
    population note
    Primary efficacy analysis is based on the ITT analysis set, where the OR are calculated, and the proportion ± 80% CI (confidence interval) specified by Koyama \& Chen (2008) are presented
    curation status
    draft
    reviewed by
    Source null
    reviewed at
    Source null
    created at
    2026-09-10T00:00:00Z
  4. release id
    clinical-indications-draft-1
    disease state id
    ds-non-hodgkin-lymphoma-ruxience-816f4f4a
    nct id
    NCT00274651
    outcome key
    om-0002
    source section id
    NCT00274651-om-0002
    source outcome index
    2
    endpoint
    Time to Progression
    endpoint definition
    Time to progression was defined as the interval between the first date of treatment and the first notation of disease progression.
    time origin
    throughout the study, or for a maximum of 2 years
    analysis role
    secondary
    reporting status
    POSTED
    data cutoff
    Source null
    population note
    Time to Progression (ITT population) was estimated using the Kaplan-Meier method for CTCL and PTCL arms. As progression was not observed in six patients in Arm A and 10 patients in Arm B, a total of 37 patients progressed, and the the median time to progression and the full range (days) are presented.
    curation status
    draft
    reviewed by
    Source null
    reviewed at
    Source null
    created at
    2026-09-10T00:00:00Z
  5. release id
    clinical-indications-draft-1
    disease state id
    ds-non-hodgkin-lymphoma-ruxience-816f4f4a
    nct id
    NCT00274651
    outcome key
    om-0003
    source section id
    NCT00274651-om-0003
    source outcome index
    3
    endpoint
    Time to Response
    endpoint definition
    Time to response was defined as the interval between the first date of treatment and the first notation of response.
    time origin
    throughout the study, or for a maximum of 2 years
    analysis role
    secondary
    reporting status
    POSTED
    data cutoff
    Source null
    population note
    Time to response (ITT population) was estimated using the Kaplan-Meier method for CTCL and PTCL arms. For 4 patients with CTCL and 6 patients with PTCL, response was recorded. The median time to response and the full range (days) are presented.
    curation status
    draft
    reviewed by
    Source null
    reviewed at
    Source null
    created at
    2026-09-10T00:00:00Z
  6. release id
    clinical-indications-draft-1
    disease state id
    ds-non-hodgkin-lymphoma-ruxience-816f4f4a
    nct id
    NCT00274651
    outcome key
    om-0004
    source section id
    NCT00274651-om-0004
    source outcome index
    4
    endpoint
    Duration of Response
    endpoint definition
    Duration of response was defined as the time from first notation of response until the time of first notation of disease progression.
    time origin
    throughout the study, or for a maximum of 2 years
    analysis role
    secondary
    reporting status
    POSTED
    data cutoff
    Source null
    population note
    Duration of response (ITT population) was estimated by Kaplan-Meier method for CTCL/PTCL arms. 2 CTCL and 2 PTCL patients did not progress and were censored. Median duration of response and full range (days) are presented for 2 patients with CTCL and 4 patients with PTCL. The 2 CTCL patients being evaluable had response durations of 56 and 129 days
    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-non-hodgkin-lymphoma-ruxience-816f4f4a
    nct id
    NCT00274651
    outcome key
    om-0000
    arm key
    OG000
    arm label
    Arm A (CTCL, ITT Population)
    regimen
    CTCL patients will receive 1000 mg/m2 of PXD101 IV belinostat: 1000 mg/m2 for 5 days every 21 days; IV
    analyzed count
    0
    analyzed unit
    Participants
    is comparator
    Source null
    source pointer
    NCT00274651-om-0000#groups/OG000
  2. release id
    clinical-indications-draft-1
    disease state id
    ds-non-hodgkin-lymphoma-ruxience-816f4f4a
    nct id
    NCT00274651
    outcome key
    om-0001
    arm key
    OG000
    arm label
    PTCL (ITT Population)
    regimen
    PTCL patients will receive 1000 mg/m2 of PXD101 IV belinostat: 1000 mg/m2 for 5 days every 21 days; IV
    analyzed count
    24
    analyzed unit
    Participants
    is comparator
    Source null
    source pointer
    NCT00274651-om-0001#groups/OG000
  3. release id
    clinical-indications-draft-1
    disease state id
    ds-non-hodgkin-lymphoma-ruxience-816f4f4a
    nct id
    NCT00274651
    outcome key
    om-0002
    arm key
    OG000
    arm label
    Arm A (CTCL, ITT Population)
    regimen
    CTCL patients will receive 1000 mg/m2 of PXD101 IV belinostat: 1000 mg/m2 for 5 days every 21 days; IV
    analyzed count
    23
    analyzed unit
    Participants
    is comparator
    Source null
    source pointer
    NCT00274651-om-0002#groups/OG000
  4. release id
    clinical-indications-draft-1
    disease state id
    ds-non-hodgkin-lymphoma-ruxience-816f4f4a
    nct id
    NCT00274651
    outcome key
    om-0002
    arm key
    OG001
    arm label
    Arm B (PTCL, ITT Population)
    regimen
    PTCL patients will receive 1000 mg/m2 of PXD101 IV belinostat: 1000 mg/m2 for 5 days every 21 days; IV
    analyzed count
    14
    analyzed unit
    Participants
    is comparator
    Source null
    source pointer
    NCT00274651-om-0002#groups/OG001
  5. release id
    clinical-indications-draft-1
    disease state id
    ds-non-hodgkin-lymphoma-ruxience-816f4f4a
    nct id
    NCT00274651
    outcome key
    om-0003
    arm key
    OG000
    arm label
    Arm A (CTCL, ITT Population)
    regimen
    CTCL patients will receive 1000 mg/m2 of PXD101 IV belinostat: 1000 mg/m2 for 5 days every 21 days; IV
    analyzed count
    4
    analyzed unit
    Participants
    is comparator
    Source null
    source pointer
    NCT00274651-om-0003#groups/OG000
  6. release id
    clinical-indications-draft-1
    disease state id
    ds-non-hodgkin-lymphoma-ruxience-816f4f4a
    nct id
    NCT00274651
    outcome key
    om-0003
    arm key
    OG001
    arm label
    Arm B (PTCL, ITT Population)
    regimen
    PTCL patients will receive 1000 mg/m2 of PXD101 IV belinostat: 1000 mg/m2 for 5 days every 21 days; IV
    analyzed count
    6
    analyzed unit
    Participants
    is comparator
    Source null
    source pointer
    NCT00274651-om-0003#groups/OG001
  7. release id
    clinical-indications-draft-1
    disease state id
    ds-non-hodgkin-lymphoma-ruxience-816f4f4a
    nct id
    NCT00274651
    outcome key
    om-0004
    arm key
    OG000
    arm label
    Arm A (CTCL, ITT Population)
    regimen
    CTCL patients will receive 1000 mg/m2 of PXD101 IV belinostat: 1000 mg/m2 for 5 days every 21 days; IV
    analyzed count
    2
    analyzed unit
    Participants
    is comparator
    Source null
    source pointer
    NCT00274651-om-0004#groups/OG000
  8. release id
    clinical-indications-draft-1
    disease state id
    ds-non-hodgkin-lymphoma-ruxience-816f4f4a
    nct id
    NCT00274651
    outcome key
    om-0004
    arm key
    OG001
    arm label
    Arm B (PTCL, ITT Population)
    regimen
    PTCL patients will receive 1000 mg/m2 of PXD101 IV belinostat: 1000 mg/m2 for 5 days every 21 days; IV
    analyzed count
    4
    analyzed unit
    Participants
    is comparator
    Source null
    source pointer
    NCT00274651-om-0004#groups/OG001
  9. release id
    clinical-indications-draft-1
    disease state id
    ds-non-hodgkin-lymphoma-ruxience-816f4f4a
    nct id
    NCT00274651
    outcome key
    om-0005
    arm key
    OG000
    arm label
    Arm A (CTCL, ITT Population)
    regimen
    CTCL patients will receive 1000 mg/m2 of PXD101 IV belinostat: 1000 mg/m2 for 5 days every 21 days; IV
    analyzed count
    29
    analyzed unit
    Participants
    is comparator
    Source null
    source pointer
    NCT00274651-om-0005#groups/OG000
harms
  1. release id
    clinical-indications-draft-1
    disease state id
    ds-non-hodgkin-lymphoma-ruxience-816f4f4a
    nct id
    NCT00274651
    harm key
    EG000
    source section id
    NCT00274651-ae
    event group key
    EG000
    event group label
    Arm A (CTCL, ITT Population)
    serious affected
    7
    serious at risk
    29
    other affected
    29
    other at risk
    29
    frequency threshold
    5
    collection period
    Throughout study, up to 4 weeks after last drug administration
    event definition
    Follow-up of the AE (adverse event) was required during the study and after completion, withdrawal or discontinuation of the study if the event was still ongoing. The Investigator was to continuously monitor patients with AEs until the event had returned to baseline or ≤ Grade 1 or until the patient started another type of antineoplastic therapy.
    undenominated note
    Source null
    curation status
    draft
    reviewed by
    Source null
    reviewed at
    Source null
    created at
    2026-09-10T00:00:00Z
  2. release id
    clinical-indications-draft-1
    disease state id
    ds-non-hodgkin-lymphoma-ruxience-816f4f4a
    nct id
    NCT00274651
    harm key
    EG001
    source section id
    NCT00274651-ae
    event group key
    EG001
    event group label
    Arm B (PTCL, ITT Population)
    serious affected
    8
    serious at risk
    24
    other affected
    23
    other at risk
    24
    frequency threshold
    5
    collection period
    Throughout study, up to 4 weeks after last drug administration
    event definition
    Follow-up of the AE (adverse event) was required during the study and after completion, withdrawal or discontinuation of the study if the event was still ongoing. The Investigator was to continuously monitor patients with AEs until the event had returned to baseline or ≤ Grade 1 or until the patient started another type of antineoplastic therapy.
    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
  1. release id
    clinical-indications-draft-1
    disease state id
    ds-non-hodgkin-lymphoma-ruxience-816f4f4a
    nct id
    NCT00274651
    qol key
    qol-0000
    source section id
    NCT00274651-om-0000
    source outcome index
    0
    instrument
    FACT
    instrument basis
    matched 'factor' in the study's own wording
    scale title
    Objective Response Rate in Patients With Recurrent or Refractory Cutaneous T-cell Lymphoma (CTCL)
    measure definition
    Tumor response was assessed using Cheson (Cheson 2007) and SWAT criteria. The SWAT score represents the product of the percentage total body surface area (TBSA) involvement of each lesion type (patch, plaque, and tumor or ulceration), multiplied by a weighting factor.
    time frame
    throughout the study, or for a maximum of 2 years
    analysis role
    primary
    reporting status
    POSTED
    higher is better
    Source null
    direction quote
    Source null
    population note
    At termination OR was noted in 1/13 patients (Simon Stage 1). With 29 patients in the CTCL arm the demand for expansion to Simon Stage 2 lacked 5 patients and the study was stopped. Instead OR was done as secondary efficacy analysis (ITT and PP (per protocol)) with OR calculated without accounting for Simon design and with 95% confidence intervals
    curation status
    draft
    reviewed by
    Source null
    reviewed at
    Source null
    created at
    2026-09-10T00:00:00Z
  2. release id
    clinical-indications-draft-1
    disease state id
    ds-non-hodgkin-lymphoma-ruxience-816f4f4a
    nct id
    NCT00274651
    qol key
    qol-0005
    source section id
    NCT00274651-om-0005
    source outcome index
    5
    instrument
    FACT
    instrument basis
    matched 'factor' in the study's own wording
    scale title
    Objective Response Rate in Patients With Recurrent or Refractory Cutaneous T-cell Lymphoma (CTCL)
    measure definition
    Tumor response was assessed using Cheson (Cheson 2007) and SWAT criteria. The SWAT score represents the product of the percentage total body surface area (TBSA) involvement of each lesion type (patch, plaque, and tumor or ulceration), multiplied by a weighting factor.
    time frame
    throughout the study, or for a maximum of 2 years
    analysis role
    post-hoc
    reporting status
    POSTED
    higher is better
    Source null
    direction quote
    Source null
    population note
    At termination OR was noted in 1/13 patients (Simon Stage 1). With 29 patients in the CTCL arm the demand for expansion to Simon Stage 2 lacked 5 patients and the study was stopped. Instead OR was done as secondary efficacy analysis (ITT and PP (per protocol)) with OR calculated without accounting for Simon design and with 95% confidence intervals
    curation status
    draft
    reviewed by
    Source null
    reviewed at
    Source null
    created at
    2026-09-10T00:00:00Z
setting source links

    Preserved source evidence · Not medical advice