Trial · NCT00655668
A Phase II Study of Single-Agent Lenalidomide in Subjects With Relapsed Or Refractory T-Cell Non-Hodgkin's Lymphoma
NCT00655668, Phase 2, Terminated, Celgene; results first posted 2012-01-05
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. A Phase II Study of Single-Agent Lenalidomide in Subjects With Relapsed Or Refractory T-Cell Non-Hodgkin's Lymphoma. Trials, record NCT00655668. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT00655668
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- A Phase II Study of Single-Agent Lenalidomide in Subjects With Relapsed Or Refractory T-Cell Non-Hodgkin's Lymphoma
- NCT number
- NCT00655668
- Status
- Terminated
- Phases
- Phase 2
- Enrollment
- 54 participants, actual
- Lead sponsor
- Celgene
- Conditions
- T-cell Non-Hodgkin's Lymphoma
- Interventions
- Lenalidomide
- First posted
- 2008-04-10
- Last updated
- 2019-11-25
- Other registries' IDs
- eudract:2007-002171-13
- Results first posted
- 2012-01-05
Source ClinicalTrials.gov
Registered outcomes5
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Participants Categorized by Best Response as Determined by Investigator | Up to 24 months | Participant response assessed by investigator; criteria by B. Cheson in Journal of Clinical Oncology, 1999 (see article for more detail): * Complete Response(CR): Complete disappearance of all detectable disease * Complete Response Unconfirmed(CRu): CR, but indeterminate bone marrow * Partial Response(PR): \>50% decrease in six largest nodes/nodal masses * Stable Disease(SD): Less than PR, but not progressive disease * Relapsed Disease: In CR/CRu Patients, new lesions seen or increased by \>=50% in previous sites * Progressive Disease(PD): \>=50% increase from low in PR/Non-Responders |
| Secondary | Duration of Response | Up to 24 months | Kaplan-Meier Estimate of duration of response calculated as the time from first computed tomography (CT) Scan or magnetic resonance imaging (MRI) that demonstrates at least a partial response to the first documentation of disease progression, including death due to Non-Hodgkin's Lymphoma. |
| Secondary | Time-to-Progression | Up to 24 months | Kaplan-Meier estimate of time-to-progression is calculated as the time from the start of study drug therapy to the first documentation of progressive disease. |
| Secondary | Progression-Free Survival | Up to 24 months | Kaplan-Meier estimate of progression-free survival is defined as the start of study drug therapy to the first observation of disease progression or death due to any cause. |
| Secondary | Safety | Up to 24 months | Summary of Treatment-Emergent Events in Safety Population (participants with at least one dose of study drug). Events assessed using National Cancer Institute, Common Terminology Criteria for Adverse Events (NCI CTCAE, Version 3: Following is the scale: Grade 1=Mild Adverse Event (AE), Grade 2=Moderate AE, Grade 3=Severe and Undesirable AE, Grade 4=Life-threatening or Disabling AE, and Grade 5=Death Related to AE.) |
Source ClinicalTrials.gov
Outcomes5
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Participants Categorized by Best Response as Determined by Investigator | Up to 24 months | Intent-to-treat (ITT) Population | Participants | NUMBER |
| SECONDARY | Duration of Response | Up to 24 months | Intent-to-treat (ITT) Population | Months | MEDIAN |
| SECONDARY | Time-to-Progression | Up to 24 months | Due to early termination of study, data not analyzed. See outcome #4 for progression-free survival. | ||
| SECONDARY | Progression-Free Survival | Up to 24 months | Intent-to-treat (ITT) Population | Months | MEDIAN |
| SECONDARY | Safety | Up to 24 months | Safety Population (received at least one dose of study drug) | Participants | NUMBER |
Source ClinicalTrials.gov
Results by group18
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Participants Categorized by Best Response as Determined by Investigator | Single Agent Lenalidomide | Complete Response (CR) | 4 | Participants | |
| Participants Categorized by Best Response as Determined by Investigator | Single Agent Lenalidomide | Complete Response Unconfirmed (CRu) | 2 | Participants | |
| Participants Categorized by Best Response as Determined by Investigator | Single Agent Lenalidomide | Partial Response (PR) | 6 | Participants | |
| Participants Categorized by Best Response as Determined by Investigator | Single Agent Lenalidomide | Stable Disease (SD) | 16 | Participants | |
| Participants Categorized by Best Response as Determined by Investigator | Single Agent Lenalidomide | Progressive Disease (PD) | 16 | Participants | |
| Participants Categorized by Best Response as Determined by Investigator | Single Agent Lenalidomide | No Response Assessment | 9 | Participants | |
| Participants Categorized by Best Response as Determined by Investigator | Single Agent Lenalidomide | Other | 1 | Participants | |
| Participants Categorized by Best Response as Determined by Investigator | Single Agent Lenalidomide | Tumor Control (CR+CRu+PR+SD) | 28 | Participants | |
| Duration of Response | Single Agent Lenalidomide | 3.55 | 95% Confidence Interval 3.1562 to 7.6274 | Months | |
| Progression-Free Survival | Single Agent Lenalidomide | 2.53 | 95% Confidence Interval 1.7753 to 4.6356 | Months |
1 to 10 of 18Source ClinicalTrials.gov
See all 18 results by groupParticipant flow3
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | Single Agent Lenalidomide | 54 | |
| Overall Study | COMPLETED | Single Agent Lenalidomide | 0 | |
| Overall Study | NOT COMPLETED | Single Agent Lenalidomide | 54 |
Source ClinicalTrials.gov
Adverse events84
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 | Anaemia | Blood and lymphatic system disorders | Single Agent Lenalidomide | 7 | 54 | |
| other | Neutropenia | Blood and lymphatic system disorders | Single Agent Lenalidomide | 9 | 54 | |
| other | Thrombocytopenia | Blood and lymphatic system disorders | Single Agent Lenalidomide | 10 | 54 | |
| other | Abdominal Pain | Gastrointestinal disorders | Single Agent Lenalidomide | 5 | 54 | |
| other | Constipation | Gastrointestinal disorders | Single Agent Lenalidomide | 12 | 54 | |
| other | Diarrhoea | Gastrointestinal disorders | Single Agent Lenalidomide | 8 | 54 | |
| other | Dry Mouth | Gastrointestinal disorders | Single Agent Lenalidomide | 3 | 54 | |
| other | Dysphagia | Gastrointestinal disorders | Single Agent Lenalidomide | 6 | 54 | |
| other | Nausea | Gastrointestinal disorders | Single Agent Lenalidomide | 7 | 54 | |
| other | Rectal Haemorrhage | Gastrointestinal disorders | Single Agent Lenalidomide | 3 | 54 |
1 to 10 of 84Source ClinicalTrials.gov
See all 84 adverse eventsAdverse event totals3
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Single Agent Lenalidomide | ||
| Total, other adverse events | Single Agent Lenalidomide | 53 | 54 |
| Total, serious adverse events | Single Agent Lenalidomide | 29 | 54 |
Source ClinicalTrials.gov
Papers1
The papers the trial lists on ClinicalTrials.gov.
| PMID | Listed as |
|---|---|
| 23731832 | RESULT |
Source PubMed
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/NCT00655668
GET https://conductscience.org/api/trials/v1/NCT00655668/events?page=2