Trial · NCT00082017
UCN-01 (7-Hydroxystaurosporine) to Treat Relapsed T-Cell Lymphomas
NCT00082017, Phase 2, Terminated, National Cancer Institute (NCI); results first posted 2012-08-29
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. UCN-01 (7-Hydroxystaurosporine) to Treat Relapsed T-Cell Lymphomas. Trials, record NCT00082017. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT00082017
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- UCN-01 (7-Hydroxystaurosporine) to Treat Relapsed T-Cell Lymphomas
- NCT number
- NCT00082017
- Status
- Terminated
- Phases
- Phase 2
- Enrollment
- 20 participants, actual
- Lead sponsor
- National Cancer Institute (NCI)
- Conditions
- Lymphoma, Large-Cell, Ki-1, Lymphoma, T-Cell
- Interventions
- UCN-01 (7-hydroxystaurosporine)
- First posted
- 2004-04-28
- Last updated
- 2017-05-15
- Results first posted
- 2012-08-29
Source ClinicalTrials.gov
Registered outcomes7
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Clinical Response Rate | 74.5 months | Clinical Response Rate is the percentage of participants with a response assessed by the International Workshop to Standardize Response Criteria. Complete response (CR) is complete disappearance of all detectable clinical and radiographic evidence of disease. Complete response unconfirmed (CRu) is per CR criteria except that if a residual node is \>1.5cm, it must have regressed by \>75%. Partial response (PR) is no increase in size of nodes, liver or spleen. Progressive disease (PD) is a greater than or equal to 50% increase from nadir. Details re: response criteria, see the protocol link module |
| Primary | Progression Free Survival (PFS) | 3.6 months | PFS is defined as the time interval from start of treatment to documented evidence of disease progression. Disease progression is assessed by the International Workshop to Standardize Response Criteria for non-Hodgkin's Lymphomas and is defined as a ≥50% increase from nadir in the sum of the products of the greatest diameters of any previously identified abnormal node for partial response's or non-responders or appearance of any new lesion during or at the end of therapy. |
| Primary | Overall Survival (OS) | 55 months | OS is defined as the date of on-study to the date of death from any cause or last follow up. |
| Secondary | Number of Participants With Adverse Events | 76 months | Here is the number of participants with adverse events. For a detailed list of adverse events, see the adverse event module. |
| Other | Effect of UCN-01 on Soluble TAC Cluster of Differentiation 25 (CD25) | Day 3-5 after drug administration | Soluble TAC (CD25) levels will be assessed in patients with anaplastic large cell lymphoma. |
| Other | Evaluation of Mature T-cell Lymphoma Cells by Complementary Double-Stranded Deoxyribonucleic Acid (cDNA) Microarray | Day 3-5 after drug administration | Mature T-cells will be analyzed to identify gene expression changes that correlate with loss of a tumor suppressor gene in a human melanoma cell line. |
| Other | Effect of UCN-01 on Anaplastic Lymphoma Kinase (ALK) Expression in ALCL | Day 3-5 after drug administration | Gene expression patterns in participants ALK positive tumors will be assessed. |
Source ClinicalTrials.gov
Outcomes7
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Clinical Response Rate | 74.5 months | Percentage of participants | NUMBER | |
| PRIMARY | Progression Free Survival (PFS) | 3.6 months | months | MEDIAN | |
| PRIMARY | Overall Survival (OS) | 55 months | months | MEDIAN | |
| SECONDARY | Number of Participants With Adverse Events | 76 months | Participants | NUMBER | |
| OTHER_PRE_SPECIFIED | Effect of UCN-01 on Soluble TAC Cluster of Differentiation 25 (CD25) | Day 3-5 after drug administration | This outcome measure was not done because data were insufficient to assess for possible effects on soluble TAC (CD25) levels. | ||
| OTHER_PRE_SPECIFIED | Evaluation of Mature T-cell Lymphoma Cells by Complementary Double-Stranded Deoxyribonucleic Acid (cDNA) Microarray | Day 3-5 after drug administration | This outcome measure was not done because there were inadequate samples to evaluate mature T cell lymphoma malignant cells by cDNA microarray. | ||
| OTHER_PRE_SPECIFIED | Effect of UCN-01 on Anaplastic Lymphoma Kinase (ALK) Expression in ALCL | Day 3-5 after drug administration | This outcome measure was not done because data were insufficient to assess for possible effects of UCN-01 on ALK expression. |
Source ClinicalTrials.gov
Results by group17
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Clinical Response Rate | UCN-01 for T-cell Lymphomas - Cohort 1 Every 28 Days | Complete response | 18 | Percentage of participants | |
| Clinical Response Rate | UCN-01 for T-cell Lymphomas - Cohort 2 Every 21 Days | Complete response | 0 | Percentage of participants | |
| Clinical Response Rate | UCN-01 for T-cell Lymphomas - Cohort 1 Every 28 Days | Complete response unconfirmed | 0 | Percentage of participants | |
| Clinical Response Rate | UCN-01 for T-cell Lymphomas - Cohort 2 Every 21 Days | Complete response unconfirmed | 0 | Percentage of participants | |
| Clinical Response Rate | UCN-01 for T-cell Lymphomas - Cohort 1 Every 28 Days | Partial response | 9 | Percentage of participants | |
| Clinical Response Rate | UCN-01 for T-cell Lymphomas - Cohort 2 Every 21 Days | Partial response | 0 | Percentage of participants | |
| Clinical Response Rate | UCN-01 for T-cell Lymphomas - Cohort 1 Every 28 Days | Progressive disease | 55 | Percentage of participants | |
| Clinical Response Rate | UCN-01 for T-cell Lymphomas - Cohort 2 Every 21 Days | Progressive disease | 45 | Percentage of participants | |
| Clinical Response Rate | UCN-01 for T-cell Lymphomas - Cohort 1 Every 28 Days | Stable disease | 9 | Percentage of participants | |
| Clinical Response Rate | UCN-01 for T-cell Lymphomas - Cohort 2 Every 21 Days | Stable disease | 33 | Percentage of participants |
1 to 10 of 17Source ClinicalTrials.gov
See all 17 results by groupParticipant flow6
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | UCN-01 for T-cell Lymphomas - Cohort 1-Every 28 Days | 11 | |
| Overall Study | STARTED | UCN-01 for T-cell Lymphomas - Cohort 2 Every 21 Days | 9 | |
| Overall Study | COMPLETED | UCN-01 for T-cell Lymphomas - Cohort 1-Every 28 Days | 11 | |
| Overall Study | COMPLETED | UCN-01 for T-cell Lymphomas - Cohort 2 Every 21 Days | 9 | |
| Overall Study | NOT COMPLETED | UCN-01 for T-cell Lymphomas - Cohort 1-Every 28 Days | 0 | |
| Overall Study | NOT COMPLETED | UCN-01 for T-cell Lymphomas - Cohort 2 Every 21 Days | 0 |
Source ClinicalTrials.gov
Adverse events146
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
| Type | Event | Organ system | Group | Affected | At risk | Events |
|---|---|---|---|---|---|---|
| other | abdominal pain | Gastrointestinal disorders | UCN-01 for T-cell Lymphomas - Cohort 1&2 | 4 | 20 | 5 |
| other | Activated partial thromboplastin time prolonged | Investigations | UCN-01 for T-cell Lymphomas - Cohort 1&2 | 3 | 20 | 6 |
| other | Agitation | Psychiatric disorders | UCN-01 for T-cell Lymphomas - Cohort 1&2 | 1 | 20 | 1 |
| other | Alanine aminotransferase increased | Investigations | UCN-01 for T-cell Lymphomas - Cohort 1&2 | 2 | 20 | 6 |
| other | Alkaline phosphatase increased | Investigations | UCN-01 for T-cell Lymphomas - Cohort 1&2 | 3 | 20 | 3 |
| other | Allergic rhinitis | Immune system disorders | UCN-01 for T-cell Lymphomas - Cohort 1&2 | 1 | 20 | 1 |
| other | Anemia | Blood and lymphatic system disorders | UCN-01 for T-cell Lymphomas - Cohort 1&2 | 3 | 20 | 3 |
| other | Arthralgia | Musculoskeletal and connective tissue disorders | UCN-01 for T-cell Lymphomas - Cohort 1&2 | 1 | 20 | 1 |
| other | Ascites | Gastrointestinal disorders | UCN-01 for T-cell Lymphomas - Cohort 1&2 | 1 | 20 | 1 |
| other | Aspartate aminotransferase increased | Investigations | UCN-01 for T-cell Lymphomas - Cohort 1&2 | 4 | 20 | 8 |
1 to 10 of 146Source ClinicalTrials.gov
See all 146 adverse eventsAdverse event totals3
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | UCN-01 for T-cell Lymphomas - Cohort 1&2 | 1 | 20 |
| Total, other adverse events | UCN-01 for T-cell Lymphomas - Cohort 1&2 | 18 | 20 |
| Total, serious adverse events | UCN-01 for T-cell Lymphomas - Cohort 1&2 | 19 | 20 |
Source ClinicalTrials.gov
Papers3
The papers the trial lists on ClinicalTrials.gov.
Grants0
The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.
None in this release.
Trial comparisons0
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
None in this release.
Tests0
The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.
None in this release.
Data dates
The day each source was copied for this release.
Sources 3
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNo license stated
- NIH RePORTER's clinical studies and project filesPublic domain
Each source's terms
- ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
- ClinicalTrials.govnone stated
- NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)
ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
For software
Read this trial from software.
The record and each of its lists are JSON, twenty rows a page. No key.
GET https://conductscience.org/api/trials/v1/NCT00082017
GET https://conductscience.org/api/trials/v1/NCT00082017/events?page=2