Trial · NCT01724177

A Phase 2 Study of Lenalidomide in Patients With Relapsed or Recurrent Adult T-cell Leukemia-lymphoma

NCT01724177, Phase 2, Completed, Celgene; results first posted 2016-01-05

3 sourcestrials-2026-11-12-0.5.0

Cite this record

ConductScience Library. A Phase 2 Study of Lenalidomide in Patients With Relapsed or Recurrent Adult T-cell Leukemia-lymphoma. Trials, record NCT01724177. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT01724177

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Trial

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

Title: A Phase 2 Study of Lenalidomide in Patients With Relapsed or Recurrent Adult T-cell Leukemia-lymphoma
NCT number: NCT01724177
Status: Completed
Phases: Phase 2
Enrollment: 26 participants, actual
Lead sponsor: Celgene
Conditions: Adult T-Cell Leukemia-Lymphoma
Interventions: Lenalidomide
First posted: 2012-11-09
Last updated: 2018-05-29
Results first posted: 2016-01-05

Source ClinicalTrials.gov

Registered outcomes8

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

List	Outcome	Time frame	Description
Primary	Percentage of Participants Who Achieved a Complete Response, Unconfirmed Complete Response, or Partial Response as Assessed by the Efficacy-Safety Evaluation Committee (ESEC)	From day 1 of study treatment to date of first documented CR, CRU or PR; Up to data cut-off date of 19 May 2017; maximum study duration was 134.1 weeks	ORR is a Complete Response (CR) + Complete Response unconfirmed (CRu) + Partial Response (PR). A CR requires that target lesions have regressed to normal; nodal non-target lesions have regressed to normal; extranodal non-target lesions have disappeared; hepatomegaly/splenomegaly has disappeared; skin findings are GR 0; peripheral blood is normal; Bone marrow (BM) infiltration is negative and no new lesions. A CRu requires the sum of the product diameters (SPD) of target lesions have decreased by at least 75% from baseline; nodal non-target lesions have regressed to normal size; extranodal non-target lesions have disappeared; hepatomegaly/splenomegaly has disappeared; skin findings are Grade 0; peripheral blood is normal; BM infiltration is "negative" and no new lesions. A PR requires the SPD of target lesions has decreased by at least 50% from baseline; all nodal non-target lesions have regressed to normal or show no increase in size; all extranodal non-target lesions have disappeared
Secondary	Kaplan Meier Estimate of Progression Free Survival (PFS) as Assessed by the ESEC	From day 1 of study treatment to the date of disease progression; up to data cut date of date of 19 May 2017; maximum study duration was 134.1 weeks	PFS was defined as the time from the first dose of study treatment to progressive disease (PD) or death due to any cause on study or within 28 days after study discontinuation, whichever occurred earlier.
Secondary	Kaplan-Meier Estimate of Time to Progression (TTP)	From day 1 of study treatment to the date of disease progression; up to data cut date of 19 May 2017; maximum study duration was 134.1 weeks	Time to progression was calculated as the time from the first dosing of study treatment to the first documented PD and assessed by the ESEC
Secondary	Number of Participants With Treatment Emergent Adverse Events	From the date of the first dose of study drug up to 28 days after the last dose of study drug; up to data cutoff date of 19 May 2017; maximum treatment duration was 130.1 weeks	Treatment Emergent Adverse Event (TEAE) was defined as any AE occurring on or after the start of study treatment and within 28 days after the last dose. Severity was assessed using National Cancer Institute Common Terminology Criteria for Adverse Events version 4.0 (NCI CTCAE v4.0): Grade 1= Mild Grade 2= Moderate Grade 3= Severe Grade 4= Life-threatening and Grade 5= Death related to AE. Serious AEs (SAEs) were those that resulted in death, were life-threatening, required or prolonged inpatient hospitalization, resulted in persistent or significant disability/incapacity, congenital anomaly, or resulted in an important medical event that may have jeopardized the patient or required medical or surgical intervention to prevent one of the outcomes listed above.
Secondary	Kaplan-Meier Estimate of Duration of Response (DOR) for Responders as Assessed by the ESEC	From day 1 of study treatment to first documented response; up to data cut-off date of 19 May 2017; Maximum study duration was 134.1 Weeks	The response duration in participants with an objective response was measured from the date of the first Complete Response or Complete Response unconfirmed or Partial Response to the first date of Relapsed Disease or Progressive Disease (PD). For participants who did not progress during the study, DOR was censored at the last adequate response assessment not showing evidence of PD.
Secondary	Percentage of Participants Who Achieved a Complete Response, Unconfirmed Complete Response (CRu), Partial Response or Stable Disease (SD) as Assessed by the ESEC	From day 1 of study treatment to first documented response; up to data cut-off date of 19 May 2017; maximum study duration was 134.1 weeks	The tumor control rate was measured for those with a response of Complete Remission, + CRu, + PR + Stable Disease (SD) in the EE population based on the best response.
Secondary	Kaplan-Meier Estimate for Overall Survival	From Day 1 of study treatment to disease progression or death; up to final data cut-off date of 19 May 2017; maximum surivival time was 197.9 weeks	Overall Survival was defined as the time from the start of study treatment to the death due to any cause. For participants who were still alive at the time of the data cutoff, survival data were censored at the latest available date the participant was known to be alive.
Other	Time to Response	From day 1 of study treatment to first documented response; up to data cut-off date of 19 May 2017; maximum study duration was 134.1 weeks	Time to Response was defined as the time from the first dose of study treatment to the initial documented response (CR or CRu, or PR)

Source ClinicalTrials.gov

Outcomes8

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

Type	Outcome	Time frame	Population	Units	Measured as
PRIMARY	Percentage of Participants Who Achieved a Complete Response, Unconfirmed Complete Response, or Partial Response as Assessed by the Efficacy-Safety Evaluation Committee (ESEC)	From day 1 of study treatment to date of first documented CR, CRU or PR; Up to data cut-off date of 19 May 2017; maximum study duration was 134.1 weeks	The Efficacy Evaluable (EE) population consisted of all participants who met basic protocol requirements (all eligibility criteria) and were evaluated after receiving at least one dose of lenalidomide	percentage of participants	NUMBER
SECONDARY	Kaplan Meier Estimate of Progression Free Survival (PFS) as Assessed by the ESEC	From day 1 of study treatment to the date of disease progression; up to data cut date of date of 19 May 2017; maximum study duration was 134.1 weeks	The EE population consisted of all participants who met basic protocol requirements (all eligibility criteria) and were evaluated after receiving at least one dose of lenalidomide	weeks	MEDIAN
SECONDARY	Kaplan-Meier Estimate of Time to Progression (TTP)	From day 1 of study treatment to the date of disease progression; up to data cut date of 19 May 2017; maximum study duration was 134.1 weeks	The EE population consisted of all participants who met basic protocol requirements (all eligibility criteria) and were evaluated after receiving at least one dose of lenalidomide	weeks	MEDIAN
SECONDARY	Number of Participants With Treatment Emergent Adverse Events	From the date of the first dose of study drug up to 28 days after the last dose of study drug; up to data cutoff date of 19 May 2017; maximum treatment duration was 130.1 weeks	Safety population was defined as all participants who received at least one dose of lenalidomide. All safety analyses were based on the safety population.	participants	NUMBER
SECONDARY	Kaplan-Meier Estimate of Duration of Response (DOR) for Responders as Assessed by the ESEC	From day 1 of study treatment to first documented response; up to data cut-off date of 19 May 2017; Maximum study duration was 134.1 Weeks	The EE population who had a documented response and consisted of participants who met basic protocol requirements (all eligibility criteria) and were evaluated after receiving at least one dose of lenalidomide	weeks	NUMBER
OTHER_PRE_SPECIFIED	Time to Response	From day 1 of study treatment to first documented response; up to data cut-off date of 19 May 2017; maximum study duration was 134.1 weeks	Participants with a response of PR or better.	weeks	MEDIAN
SECONDARY	Percentage of Participants Who Achieved a Complete Response, Unconfirmed Complete Response (CRu), Partial Response or Stable Disease (SD) as Assessed by the ESEC	From day 1 of study treatment to first documented response; up to data cut-off date of 19 May 2017; maximum study duration was 134.1 weeks	The EE population with a response (CR, CRu, PR or SD) and consisted of all participants who met basic protocol requirements (all eligibility criteria) and were evaluated after receiving at least one dose of lenalidomide	percentage of participants	NUMBER
SECONDARY	Kaplan-Meier Estimate for Overall Survival	From Day 1 of study treatment to disease progression or death; up to final data cut-off date of 19 May 2017; maximum surivival time was 197.9 weeks	The EE population consisted of all participants who met basic protocol requirements (all eligibility criteria) and were evaluated after receiving at least one dose of lenalidomide.	weeks	MEDIAN

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
Percentage of Participants Who Achieved a Complete Response, Unconfirmed Complete Response, or Partial Response as Assessed by the Efficacy-Safety Evaluation Committee (ESEC)	Lenalidomide		42.3	95% Confidence Interval 23.352 to 63.082	percentage of participants
Kaplan Meier Estimate of Progression Free Survival (PFS) as Assessed by the ESEC	Lenalidomide		16.30	95% Confidence Interval 8.100 to 24.000	weeks
Kaplan-Meier Estimate of Time to Progression (TTP)	Lenalidomide		16.30	95% Confidence Interval 8.100 to 24.000	weeks
Number of Participants With Treatment Emergent Adverse Events	Lenalidomide	≥ 1 TEAE	26		participants
Number of Participants With Treatment Emergent Adverse Events	Lenalidomide	≥ 1 TEAE Related to Lenalidomide	26		participants
Number of Participants With Treatment Emergent Adverse Events	Lenalidomide	≥ 1 NCI CTCAE Grade (GR) 3 or Greater TEAE	25		participants
Number of Participants With Treatment Emergent Adverse Events	Lenalidomide	≥ 1 NCI CTCAE ≥ GR 3 TEAE Related to Lenalidomide	25		participants
Number of Participants With Treatment Emergent Adverse Events	Lenalidomide	≥ 1 Serious TEAE	11		participants
Number of Participants With Treatment Emergent Adverse Events	Lenalidomide	≥ 1 Serious TEAE Related to Lenalidomide	9		participants
Number of Participants With Treatment Emergent Adverse Events	Lenalidomide	≥ 1 TEAE Leading to Discontinuation	8		participants

1 to 10 of 18Source ClinicalTrials.gov

See all 18 results by group

Participant flow4

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

Period	Milestone	Group	Participants
Overall Study	STARTED	Lenalidomide	26
Overall Study	Safety Population	Lenalidomide	26
Overall Study	COMPLETED	Lenalidomide	0
Overall Study	NOT COMPLETED	Lenalidomide	26

Source ClinicalTrials.gov

Adverse events93

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	Thrombocytopenia	Blood and lymphatic system disorders	Lenalidomide	20	26
other	Neutropenia	Blood and lymphatic system disorders	Lenalidomide	19	26
other	Lymphopenia	Blood and lymphatic system disorders	Lenalidomide	18	26
other	Anaemia	Blood and lymphatic system disorders	Lenalidomide	15	26
other	Leukopenia	Blood and lymphatic system disorders	Lenalidomide	13	26
other	Leukocytosis	Blood and lymphatic system disorders	Lenalidomide	5	26
other	Basophilia	Blood and lymphatic system disorders	Lenalidomide	3	26
other	Eosinophilia	Blood and lymphatic system disorders	Lenalidomide	3	26
other	Disseminated intravascular coagulation	Blood and lymphatic system disorders	Lenalidomide	2	26
other	Hypoalbuminaemia	Metabolism and nutrition disorders	Lenalidomide	9	26

1 to 10 of 93Source ClinicalTrials.gov

See all 93 adverse events

Adverse event totals3

The totals the trial posted for each group.

Total	Group	Affected	At risk
Total, all-cause mortality	Lenalidomide	22	26
Total, other adverse events	Lenalidomide	26	26
Total, serious adverse events	Lenalidomide	11	26

Source ClinicalTrials.gov

Papers1

The papers the trial lists on ClinicalTrials.gov.

PMID	Listed as
27621400	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.

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/NCT01724177

GET https://conductscience.org/api/trials/v1/NCT01724177/events?page=2

API reference For AI assistants