TriangleNCT00007345 · STUDY IN CONTEXT
Depsipeptide to Treat Patients With Cutaneous T-Cell Lymphoma and Peripheral T-Cell Lymphoma
Draft scope assessment: unclear. Attached because the study's own record describes recurrent 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 because this study's registry identifier is printed in an FDA approval notice, an FDA product label or an NCI summary held by this site. The citing document and the exact position of the identifier inside it are recorded. Being cited is not a statement that the study supports this treatment.
Read the full study record and all posted results →
Linked outcomes
A rigorous composite assessment was employed with uni-dimensional measurements of skin and visceral disease sites assessed by the Response Evaluation Criteria in Solid Tumors (RECIST). Complete response (CR) required clearing of all known disease sites. Partial response (PR) required documented response in skin (≥ 30% per RECIST) or lymph nodes (≥ 50% per the International Working Group (IWG) criteria, with response in both compartments for a determination of PR, IWG guidelines. Stable disease (SD) is neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for PD. Progressive disease (PD) is at least a 20% increase in the sum of the target lesions, or the appearance of one or more new lesions. Lymph node disease was assessed bi-dimensionally using the IWG criteria. Bone marrow involvement, as recommended by IWG criteria, and presence of circulating malignant T-cells ascertained by flow cytometry.
DOR is defined as the date response was noted until disease was no longer considered to be responding. Response was assessed by the Response Evaluation Criteria in Solid Tumors (RECIST) criteria and the International Working Group Criteria (IWG).Complete response (CR) required clearing of all known disease sites. Partial response (PR) required documented response in skin (≥ 30% per RECIST) or lymph nodes (≥ 50% per the International Working Group (IWG) criteria, with response in both compartments for a determination of PR, IWG guidelines. Stable disease (SD) is neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for PD. Progressive disease (PD) is at least a 20% increase in the sum of the target lesions, or the appearance of one or more new lesions. Lymph node disease was assessed bi-dimensionally using the IWG criteria. Bone marrow involvement, as recommended by IWG criteria, and presence of circulating malignant T-cells ascertained by flow cytometry.
Here is the number of participants with adverse events. For a detailed list of adverse events, see the adverse event module.
Participants were administered Depsipeptide and cycles (each cycle is 21 days) were monitored from the prescribed dose or higher to determine reductions (if needed) to maintain tolerability.
Time to progression is defined from the first day of therapy until documentation of progressive disease. Progressive disease (PD) is at least a 20% increase in the sum of the target lesions, or the appearance of one or more new lesions. Lymph node disease was assessed bi-dimensionally using the International Working Group (IWG) criteria. Bone marrow involvement, as recommended by IWG criteria, and presence of circulating malignant T-cells ascertained by flow cytometry.
Fold change is calculated by dividing the level of histone acetylation in a treated sample (at 4, 24, and 48 hours) measured as intensity on a dot blot immunoassay, divided by the intensity in the pre-treatment sample. We considered a ≥ 2-fold change a measurable difference, and indicative of successful HDAC inhibition by romidepsin (depsipeptide).
Reported safety
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-cutaneous-t-cell-lymphomas-recurrent-c41d0ac8
- nct id
- NCT00007345
- trial label
- Depsipeptide to Treat Patients With Cutaneous T-Cell Lymphoma and Peripheral T-Cell Lymphoma
- applicability
- unclear
- applicability note
- Attached because the study's own record describes recurrent 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
- regulator-cited
- discovery note
- Found because this study's registry identifier is printed in an FDA approval notice, an FDA product label or an NCI summary held by this site. The citing document and the exact position of the identifier inside it are recorded. Being cited is not a statement that the study supports this treatment.
- outcome Count
- 6
- harms Count
- 2
- qol Count
- 0
- outcomes
- release id
- clinical-indications-draft-1
- disease state id
- ds-cutaneous-t-cell-lymphomas-recurrent-c41d0ac8
- nct id
- NCT00007345
- outcome key
- om-0000
- source section id
- NCT00007345-om-0000
- source outcome index
- 0
- endpoint
- Number of Participants With a Response
- endpoint definition
- A rigorous composite assessment was employed with uni-dimensional measurements of skin and visceral disease sites assessed by the Response Evaluation Criteria in Solid Tumors (RECIST). Complete response (CR) required clearing of all known disease sites. Partial response (PR) required documented response in skin (≥ 30% per RECIST) or lymph nodes (≥ 50% per the International Working Group (IWG) criteria, with response in both compartments for a determination of PR, IWG guidelines. Stable disease (SD) is neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for PD. Progressive disease (PD) is at least a 20% increase in the sum of the target lesions, or the appearance of one or more new lesions. Lymph node disease was assessed bi-dimensionally using the IWG criteria. Bone marrow involvement, as recommended by IWG criteria, and presence of circulating malignant T-cells ascertained by flow cytometry.
- time origin
- up to 56.5 days
- analysis role
- primary
- reporting status
- POSTED
- data cutoff
- Source null
- population note
- Two participants were excluded. After further analysis it was determined that the participants did not have PTCL but a different form of lymphoma that was not known at the onset of enrollment.
- 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-cutaneous-t-cell-lymphomas-recurrent-c41d0ac8
- nct id
- NCT00007345
- outcome key
- om-0001
- source section id
- NCT00007345-om-0001
- source outcome index
- 1
- endpoint
- Duration of Response (DOR)
- endpoint definition
- DOR is defined as the date response was noted until disease was no longer considered to be responding. Response was assessed by the Response Evaluation Criteria in Solid Tumors (RECIST) criteria and the International Working Group Criteria (IWG).Complete response (CR) required clearing of all known disease sites. Partial response (PR) required documented response in skin (≥ 30% per RECIST) or lymph nodes (≥ 50% per the International Working Group (IWG) criteria, with response in both compartments for a determination of PR, IWG guidelines. Stable disease (SD) is neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for PD. Progressive disease (PD) is at least a 20% increase in the sum of the target lesions, or the appearance of one or more new lesions. Lymph node disease was assessed bi-dimensionally using the IWG criteria. Bone marrow involvement, as recommended by IWG criteria, and presence of circulating malignant T-cells ascertained by flow cytometry.
- time origin
- up to 127 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-cutaneous-t-cell-lymphomas-recurrent-c41d0ac8
- nct id
- NCT00007345
- outcome key
- om-0002
- source section id
- NCT00007345-om-0002
- source outcome index
- 2
- endpoint
- Number of Participants With Adverse Events
- endpoint definition
- Here is the number of participants with adverse events. For a detailed list of adverse events, see the adverse event module.
- time origin
- 147 months and 5 days
- 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
- release id
- clinical-indications-draft-1
- disease state id
- ds-cutaneous-t-cell-lymphomas-recurrent-c41d0ac8
- nct id
- NCT00007345
- outcome key
- om-0003
- source section id
- NCT00007345-om-0003
- source outcome index
- 3
- endpoint
- Median Number of Cycles of Depsipeptide Administered
- endpoint definition
- Participants were administered Depsipeptide and cycles (each cycle is 21 days) were monitored from the prescribed dose or higher to determine reductions (if needed) to maintain tolerability.
- time origin
- 83 cycles (i.e., each cycle is 21 days)
- 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
- release id
- clinical-indications-draft-1
- disease state id
- ds-cutaneous-t-cell-lymphomas-recurrent-c41d0ac8
- nct id
- NCT00007345
- outcome key
- om-0004
- source section id
- NCT00007345-om-0004
- source outcome index
- 4
- endpoint
- Time to Progression
- endpoint definition
- Time to progression is defined from the first day of therapy until documentation of progressive disease. Progressive disease (PD) is at least a 20% increase in the sum of the target lesions, or the appearance of one or more new lesions. Lymph node disease was assessed bi-dimensionally using the International Working Group (IWG) criteria. Bone marrow involvement, as recommended by IWG criteria, and presence of circulating malignant T-cells ascertained by flow cytometry.
- time origin
- Until disease progression, or 30 days following off study date
- 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
- release id
- clinical-indications-draft-1
- disease state id
- ds-cutaneous-t-cell-lymphomas-recurrent-c41d0ac8
- nct id
- NCT00007345
- outcome key
- om-0005
- source section id
- NCT00007345-om-0005
- source outcome index
- 5
- endpoint
- Fold Change in Histone Acetylation
- endpoint definition
- Fold change is calculated by dividing the level of histone acetylation in a treated sample (at 4, 24, and 48 hours) measured as intensity on a dot blot immunoassay, divided by the intensity in the pre-treatment sample. We considered a ≥ 2-fold change a measurable difference, and indicative of successful HDAC inhibition by romidepsin (depsipeptide).
- time origin
- 4 hours, 24 hours, and 48 hours after Romidepsin
- analysis role
- secondary
- reporting status
- POSTED
- data cutoff
- Source null
- population note
- Global histone acetylation of all samples at pretreatment was designated as 1; values at other time points for each patient were calculated relative to the corresponding pretreatment value.
- 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-cutaneous-t-cell-lymphomas-recurrent-c41d0ac8
- nct id
- NCT00007345
- outcome key
- om-0000
- arm key
- OG000
- arm label
- Peripheral T-cell Lymphoma (PTCL)
- regimen
- Participants received at least one protocol prescribed dose or higher of Romidepsin intravenously at 14mg/m\^2 and at 17.5 mg/m\^2 on days 1, 8, and 15 of a 28 day cycle.
- analyzed count
- 45
- analyzed unit
- Participants
- is comparator
- Source null
- source pointer
- NCT00007345-om-0000#groups/OG000
- release id
- clinical-indications-draft-1
- disease state id
- ds-cutaneous-t-cell-lymphomas-recurrent-c41d0ac8
- nct id
- NCT00007345
- outcome key
- om-0000
- arm key
- OG001
- arm label
- Cutaneous T-cell Lymphoma (CTCL)
- regimen
- Participants received at least one protocol prescribed dose or higher of Romidepsin intravenously at 14mg/m\^2 and at 17.5 mg/m\^2 on days 1, 8, and 15 of a 28 day cycle.
- analyzed count
- 84
- analyzed unit
- Participants
- is comparator
- Source null
- source pointer
- NCT00007345-om-0000#groups/OG001
- release id
- clinical-indications-draft-1
- disease state id
- ds-cutaneous-t-cell-lymphomas-recurrent-c41d0ac8
- nct id
- NCT00007345
- outcome key
- om-0001
- arm key
- OG000
- arm label
- Peripheral T-cell Lymphoma (PTCL)
- regimen
- Participants received at least one protocol prescribed dose or higher of Romidepsin intravenously at 14mg/m\^2 and at 17.5 mg/m\^2 on days 1, 8, and 15 of a 28 day cycle.
- analyzed count
- 47
- analyzed unit
- Participants
- is comparator
- Source null
- source pointer
- NCT00007345-om-0001#groups/OG000
- release id
- clinical-indications-draft-1
- disease state id
- ds-cutaneous-t-cell-lymphomas-recurrent-c41d0ac8
- nct id
- NCT00007345
- outcome key
- om-0001
- arm key
- OG001
- arm label
- Cutaneous T-cell Lymphoma (CTCL)
- regimen
- Participants received at least one protocol prescribed dose or higher of Romidepsin intravenously at 14mg/m\^2 and at 17.5 mg/m\^2 on days 1, 8, and 15 of a 28 day cycle.
- analyzed count
- 84
- analyzed unit
- Participants
- is comparator
- Source null
- source pointer
- NCT00007345-om-0001#groups/OG001
- release id
- clinical-indications-draft-1
- disease state id
- ds-cutaneous-t-cell-lymphomas-recurrent-c41d0ac8
- nct id
- NCT00007345
- outcome key
- om-0002
- arm key
- OG000
- arm label
- Peripheral T-cell Lymphoma (PTCL)
- regimen
- Participants received at least one protocol prescribed dose or higher of Romidepsin intravenously at 14mg/m\^2 and at 17.5 mg/m\^2 on days 1, 8, and 15 of a 28 day cycle.
- analyzed count
- 47
- analyzed unit
- Participants
- is comparator
- Source null
- source pointer
- NCT00007345-om-0002#groups/OG000
- release id
- clinical-indications-draft-1
- disease state id
- ds-cutaneous-t-cell-lymphomas-recurrent-c41d0ac8
- nct id
- NCT00007345
- outcome key
- om-0002
- arm key
- OG001
- arm label
- Cutaneous T-cell Lymphoma (CTCL)
- regimen
- Participants received at least one protocol prescribed dose or higher of Romidepsin intravenously at 14mg/m\^2 and at 17.5 mg/m\^2 on days 1, 8, and 15 of a 28 day cycle.
- analyzed count
- 84
- analyzed unit
- Participants
- is comparator
- Source null
- source pointer
- NCT00007345-om-0002#groups/OG001
- release id
- clinical-indications-draft-1
- disease state id
- ds-cutaneous-t-cell-lymphomas-recurrent-c41d0ac8
- nct id
- NCT00007345
- outcome key
- om-0003
- arm key
- OG000
- arm label
- Peripheral T-cell Lymphoma (PTCL)
- regimen
- Participants received at least one protocol prescribed dose or higher of Romidepsin intravenously at 14mg/m\^2 and at 17.5 mg/m\^2 on days 1, 8, and 15 of a 28 day cycle.
- analyzed count
- 47
- analyzed unit
- Participants
- is comparator
- Source null
- source pointer
- NCT00007345-om-0003#groups/OG000
- release id
- clinical-indications-draft-1
- disease state id
- ds-cutaneous-t-cell-lymphomas-recurrent-c41d0ac8
- nct id
- NCT00007345
- outcome key
- om-0003
- arm key
- OG001
- arm label
- Cutaneous T-cell Lymphoma (CTCL)
- regimen
- Participants received at least one protocol prescribed dose or higher of Romidepsin intravenously at 14mg/m\^2 and at 17.5 mg/m\^2 on days 1, 8, and 15 of a 28 day cycle.
- analyzed count
- 84
- analyzed unit
- Participants
- is comparator
- Source null
- source pointer
- NCT00007345-om-0003#groups/OG001
- release id
- clinical-indications-draft-1
- disease state id
- ds-cutaneous-t-cell-lymphomas-recurrent-c41d0ac8
- nct id
- NCT00007345
- outcome key
- om-0004
- arm key
- OG000
- arm label
- Peripheral T-cell Lymphoma (PTCL)
- regimen
- Participants received at least one protocol prescribed dose or higher of Romidepsin intravenously at 14mg/m\^2 and at 17.5 mg/m\^2 on days 1, 8, and 15 of a 28 day cycle.
- analyzed count
- 47
- analyzed unit
- Participants
- is comparator
- Source null
- source pointer
- NCT00007345-om-0004#groups/OG000
- release id
- clinical-indications-draft-1
- disease state id
- ds-cutaneous-t-cell-lymphomas-recurrent-c41d0ac8
- nct id
- NCT00007345
- outcome key
- om-0004
- arm key
- OG001
- arm label
- Cutaneous T-cell Lymphoma (CTCL)
- regimen
- Participants received at least one protocol prescribed dose or higher of Romidepsin intravenously at 14mg/m\^2 and at 17.5 mg/m\^2 on days 1, 8, and 15 of a 28 day cycle.
- analyzed count
- 94
- analyzed unit
- Participants
- is comparator
- Source null
- source pointer
- NCT00007345-om-0004#groups/OG001
- release id
- clinical-indications-draft-1
- disease state id
- ds-cutaneous-t-cell-lymphomas-recurrent-c41d0ac8
- nct id
- NCT00007345
- outcome key
- om-0005
- arm key
- OG000
- arm label
- Peripheral T-cell Lymphoma (PTCL)
- regimen
- Participants received at least one protocol prescribed dose or higher of Romidepsin intravenously at 14mg/m\^2 and at 17.5 mg/m\^2 on days 1, 8, and 15 of a 28 day cycle.
- analyzed count
- 18
- analyzed unit
- Participants
- is comparator
- Source null
- source pointer
- NCT00007345-om-0005#groups/OG000
- release id
- clinical-indications-draft-1
- disease state id
- ds-cutaneous-t-cell-lymphomas-recurrent-c41d0ac8
- nct id
- NCT00007345
- outcome key
- om-0005
- arm key
- OG001
- arm label
- Cutaneous T-cell Lymphoma (CTCL)
- regimen
- Participants received at least one protocol prescribed dose or higher of Romidepsin intravenously at 14mg/m\^2 and at 17.5 mg/m\^2 on days 1, 8, and 15 of a 28 day cycle.
- analyzed count
- 29
- analyzed unit
- Participants
- is comparator
- Source null
- source pointer
- NCT00007345-om-0005#groups/OG001
- harms
- release id
- clinical-indications-draft-1
- disease state id
- ds-cutaneous-t-cell-lymphomas-recurrent-c41d0ac8
- nct id
- NCT00007345
- harm key
- EG000
- source section id
- NCT00007345-ae
- event group key
- EG000
- event group label
- Peripheral T-cell Lymphoma (PTCL)
- serious affected
- 20
- serious at risk
- 47
- other affected
- 47
- other at risk
- 47
- frequency threshold
- 0
- collection period
- 147 months and 5 days
- event definition
- Although 7 cohorts were written in the protocol, the cohorts were consolidated for submission to the Food and Drug Administration (FDA) into the peripheral T-cell lymphoma (PTCL) and cutaneous T-cell lymphoma (CTCL) groups, thus they are presented in this format.
- undenominated 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-cutaneous-t-cell-lymphomas-recurrent-c41d0ac8
- nct id
- NCT00007345
- harm key
- EG001
- source section id
- NCT00007345-ae
- event group key
- EG001
- event group label
- Cutaneous T-cell Lymphoma (CTCL)
- serious affected
- 38
- serious at risk
- 84
- other affected
- 83
- other at risk
- 84
- frequency threshold
- 0
- collection period
- 147 months and 5 days
- event definition
- Although 7 cohorts were written in the protocol, the cohorts were consolidated for submission to the Food and Drug Administration (FDA) into the peripheral T-cell lymphoma (PTCL) and cutaneous T-cell lymphoma (CTCL) groups, thus they are presented in this format.
- 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