Trial · NCT00466921

Lenalidomide in Treating Patients With Relapsed Mycosis Fungoides/Sezary Syndrome

NCT00466921, Phase 2, Completed, Northwestern University; results first posted 2020-11-16

3 sourcestrials-2026-11-12-0.5.0

Cite this record

ConductScience Library. Lenalidomide in Treating Patients With Relapsed Mycosis Fungoides/Sezary Syndrome. Trials, record NCT00466921. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT00466921

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Trial

As registered on ClinicalTrials.gov, in the graph's capture of the registry.

Title: Lenalidomide in Treating Patients With Relapsed Mycosis Fungoides/Sezary Syndrome
NCT number: NCT00466921
Status: Completed
Phases: Phase 2
Enrollment: 33 participants, actual
Lead sponsor: Northwestern University
Conditions: Lymphoma
Interventions: lenalidomide
First posted: 2007-04-27
Last updated: 2020-12-01
Results first posted: 2020-11-16

Source ClinicalTrials.gov

Registered outcomes6

Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.

List	Outcome	Time frame	Description
Primary	Response to Treatment	After cycle 4 of treatment (1 cycle =28 days)	In general response to treatment is defined as either complete response (CR) or partial response (PR) assessed using Composite Assessment (CA) of index lesion disease severity and is defined as the following: CR =CA ratio=0/no evidence of new disease (abnormal or pathologically positive lymph nodes, cutaneous or other tumor manifestations, visceral disease) present over 4 weeks. Patients with Sézary Syndrome must have no evidence of circulating Sézary cells (\< 5% Sézary cells=not significant). Skin biopsy is required for documentation of CR. Confirmatory CT scans are required, if baseline CTs were abnormal. PR= CA ratio ≥0.5/no new clinically abnormal lymph nodes/no progression of existing clinically abnormal lymph nodes (\<25%)/no new cutaneous tumors/no new pathologically positive lymph nodes or visceral disease in an area previously documented as-ve for at least 4 weeks. In patients with circulating Sézary cells at least a 50% reduction of malignant lymphocytes is required.
Primary	Progression-free Survival (PFS)	From time of treatment initiation until progression or death from any cause (up to a possible maximum of approximately 6 years)	PFS is defined from the time of treatment initiation until documentation of progressive disease or death from any cause. Progressive disease is defined as (PD) ≥25% increase in CA ratio, ≥25% increase in no. or area of clinically abnormal lymph nodes/new tumors/new pathologically positive lymph nodes/visceral disease/an increase \>25% in no. of Sézary cells.
Primary	Duration of Response (DOR)	From time of initial response until progressive disease (up to approximately 1 year)	DOR is defined as time of initial documentation of response to the time of documentation of progression in patients who achieve either a complete response (CR) and partial response (PR)
Secondary	Number of Patients Who Experience Toxicity as Assessed by NCI CTCAE v3.0	From treatment initiation until up to 30 days post treatment with possible 4 cycles of initial treatment (1 cycle =28 days) and up to 2 further years of treatment permitted if meeting response criteria	Toxicity is defined as the number of patients who patients who experienced an adverse event that was determined to be at least possibly related to study drug and determined to be a grade 3 or higher in severity as assessed by the Common Terminology Criteria for Adverse Events v3.0 (CTCAE) where generally: Grade 1 Mild AE Grade 2 Moderate AE Grade 3 Severe AE Grade 4 Life-threatening or disabling AE Grade 5 Death related to AE
Other	Specific Immune Effector Cell Recruitment and Augmentation of Antitumor Response at Baseline and Day 15 of Course 1 (Northwestern University Only)	After all patients have completed thru day 15 of course 1.
Other	Correlation of Antiangiogenetic and Costimulatory Effects With Clinical Activity at Baseline and After Course 1	After all patients have completed 1 course

Source ClinicalTrials.gov

Outcomes6

Each outcome the trial posted results for, in ClinicalTrials.gov's words.

Type	Outcome	Time frame	Population	Units	Measured as
PRIMARY	Response to Treatment	After cycle 4 of treatment (1 cycle =28 days)	Patients considered not evaluable if they did not complete 1 cycle or were not evaluated for response	participants	NUMBER
PRIMARY	Progression-free Survival (PFS)	From time of treatment initiation until progression or death from any cause (up to a possible maximum of approximately 6 years)		months	MEDIAN
PRIMARY	Duration of Response (DOR)	From time of initial response until progressive disease (up to approximately 1 year)		months	MEDIAN
SECONDARY	Number of Patients Who Experience Toxicity as Assessed by NCI CTCAE v3.0	From treatment initiation until up to 30 days post treatment with possible 4 cycles of initial treatment (1 cycle =28 days) and up to 2 further years of treatment permitted if meeting response criteria		patients	NUMBER
OTHER_PRE_SPECIFIED	Specific Immune Effector Cell Recruitment and Augmentation of Antitumor Response at Baseline and Day 15 of Course 1 (Northwestern University Only)	After all patients have completed thru day 15 of course 1.
OTHER_PRE_SPECIFIED	Correlation of Antiangiogenetic and Costimulatory Effects With Clinical Activity at Baseline and After Course 1	After all patients have completed 1 course

Source ClinicalTrials.gov

Results by group7

Each measurement the trial posted, group by group, in the words and numbers it posted.

Outcome	Group	Category	Value	Spread	Units
Response to Treatment	Lenalidomide	CR	0		participants
Response to Treatment	Lenalidomide	PR	9		participants
Progression-free Survival (PFS)	Lenalidomide		8	95% Confidence Interval 3.7 to 26.1	months
Duration of Response (DOR)	Lenalidomide		10	95% Confidence Interval 1.1 to 11.0	months
Number of Patients Who Experience Toxicity as Assessed by NCI CTCAE v3.0	Lenalidomide	Fatigue (grade 3)	7		patients
Number of Patients Who Experience Toxicity as Assessed by NCI CTCAE v3.0	Lenalidomide	Infection (grade 3)	1		patients
Number of Patients Who Experience Toxicity as Assessed by NCI CTCAE v3.0	Lenalidomide	Leukopenia (grade 3)	1		patients

Source ClinicalTrials.gov

Participant flow16

How many started, completed or left each group, period by period.

Period	Milestone	Group	Participants
First 3 Cycles of Treatment	STARTED	Lenalidomide	33
First 3 Cycles of Treatment	Completed 1 Cycle	Lenalidomide	32
First 3 Cycles of Treatment	Started Cycle 2	Lenalidomide	31
First 3 Cycles of Treatment	Completed 3 Cycles	Lenalidomide	26
First 3 Cycles of Treatment	COMPLETED	Lenalidomide	26
First 3 Cycles of Treatment	NOT COMPLETED	Lenalidomide	7
Completed 4 Cycles/Reached 1st Response	STARTED	Lenalidomide	26
Completed 4 Cycles/Reached 1st Response	Completed 4 Cycles/1st Response	Lenalidomide	21
Completed 4 Cycles/Reached 1st Response	COMPLETED	Lenalidomide	21
Completed 4 Cycles/Reached 1st Response	NOT COMPLETED	Lenalidomide	5

1 to 10 of 16Source ClinicalTrials.gov

See all 16 participant flow

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
other	Allergic rhinitis (including sneezing,nasal stuffiness,postnasal drip)	General disorders	Lenalidomide	1	33
other	Hemoglobin (anemia)	Blood and lymphatic system disorders	Lenalidomide	14	33
other	Neutrophils (neutropenia)	Blood and lymphatic system disorders	Lenalidomide	4	33
other	Leukocytes (total WBC)	Blood and lymphatic system disorders	Lenalidomide	9	33
other	Increased white blood cells	Blood and lymphatic system disorders	Lenalidomide	1	33
other	Platelets (thrombocytopenia)	Blood and lymphatic system disorders	Lenalidomide	5	33
other	Hypotension	Cardiac disorders	Lenalidomide	2	33
other	Fatigue	General disorders	Lenalidomide	23	33
other	Fever	General disorders	Lenalidomide	1	33
other	Chills	General disorders	Lenalidomide	6	33

1 to 10 of 84Source ClinicalTrials.gov

See all 84 adverse events

Adverse event totals3

The totals the trial posted for each group.

Total	Group	Affected	At risk
Total, all-cause mortality	Lenalidomide	18	33
Total, other adverse events	Lenalidomide	33	33
Total, serious adverse events	Lenalidomide	10	33

Source ClinicalTrials.gov

Papers1

The papers the trial lists on ClinicalTrials.gov.

PMID	Listed as
24335103	DERIVED

Source PubMed

Grants1

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.

Project	Title	Principal investigators	Organization	Funder	Fiscal years
P30CA060553	The Robert H. Lurie Comprehensive Cancer Center	PLATANIAS, LEONIDAS C.	NORTHWESTERN UNIVERSITY	NATIONAL CANCER INSTITUTE	1993 to 2025

Source NIH RePORTER

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.

ClinicalTrials.gov: 2026-11-12; ClinicalTrials.gov
Results, from AACT: 2026-03-23; AACT
NIH grant links: 2026-11-13; NIH RePORTER

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/NCT00466921

GET https://conductscience.org/api/trials/v1/NCT00466921/events?page=2

API reference For AI assistants