Trial · NCT01121757

Epigenetic Modulation in Relapsed/Refractory Follicular Lymphoma and Marginal Zone Lymphoma

NCT01121757, Phase 2, Terminated, Duke University; results first posted 2015-05-07

3 sourcestrials-2026-11-12-0.5.0

Cite this record

ConductScience Library. Epigenetic Modulation in Relapsed/Refractory Follicular Lymphoma and Marginal Zone Lymphoma. Trials, record NCT01121757. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT01121757

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Trial

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

Title: Epigenetic Modulation in Relapsed/Refractory Follicular Lymphoma and Marginal Zone Lymphoma
NCT number: NCT01121757
Status: Terminated
Phases: Phase 2
Enrollment: 11 participants, actual
Lead sponsor: Duke University
Conditions: Follicular Lymphoma, Marginal Zone Lymphoma
Interventions: azacitidine, lenalidomide
First posted: 2010-05-12
Last updated: 2016-09-12
Results first posted: 2015-05-07

Source ClinicalTrials.gov

Registered outcomes6

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

List	Outcome	Time frame	Description
Primary	Response Predicted by Molecular Signatures Compared to True Response	approximately one year	The predicted response (response to therapy vs. no response to therapy) using gene sequencing will be compared to the overall "true" response (reported in Primary Outcome 2).
Primary	Overall Response	Response will be assessed after at least 4 months on first study drug.	Number of patients with a complete or partial response using Cheson criteria for lymphoma. A complete response is defined as a complete disappearance of all detectable clinical and radiographic evidence of disease and disappearance of all disease-related symptoms if present before therapy. A partial response is defined as a greater than or equal to 50% decrease in the sum of the products of the greatest diameters of 6 largest dominant nodes or nodal masses. No increase in size of nodes, liver or spleen and no new sites of disease. Patients who have been on study drug for at least 2 months will be considered evaluable for response as long as they have had repeat imaging to assess response or clear progression based on physical exam.
Primary	Overall Response	Response will be assessed after at least 4 months on second drug.	Number of patients with a complete or partial response using Cheson criteria for lymphoma. A complete response is defined as a complete disappearance of all detectable clinical and radiographic evidence of disease and disappearance of all disease-related symptoms if present before therapy. A partial response is defined as a greater than or equal to 50% decrease in the sum of the products of the greatest diameters of 6 largest dominant nodes or nodal masses. No increase in size of nodes, liver or spleen and no new sites of disease. Patients who have been on study drug for at least 2 months will be considered evaluable for response as long as they have had repeat imaging to assess response or clear progression based on physical exam.
Primary	Overall Response	Response will be assessed after at least 6 months on combination drug.	Number of patients with a complete or partial response using Cheson criteria for lymphoma. A complete response is defined as a complete disappearance of all detectable clinical and radiographic evidence of disease and disappearance of all disease-related symptoms if present before therapy. A partial response is defined as a greater than or equal to 50% decrease in the sum of the products of the greatest diameters of 6 largest dominant nodes or nodal masses. No increase in size of nodes, liver or spleen and no new sites of disease. Patients who have been on study drug for at least 2 months will be considered evaluable for response as long as they have had repeat imaging to assess response or clear progression based on physical exam.
Secondary	Number of Participants With Grade 3 and 4 Toxicities	While taking the study drug and 30 days after the last dose	Evaluate the safety of lenalidomide, azacitidine and the combination of azacitidine + lenalidomide in patients with lymphoma; grading the adverse events using Common Toxicity Criteria for Adverse Events (CTCAE) version 4.0
Other	Serum Markers Measured on the First Day of Cycle 1 and on the First Day of Cycle 3	Within 4 months of taking single agent and 6 months of taking the combination

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 Predicted by Molecular Signatures Compared to True Response	approximately one year	The number of participants who were evaluated for a response were analyzed to see if the prediction of response vs. no response through gene expression matched the true response.	participants	NUMBER
PRIMARY	Overall Response	Response will be assessed after at least 4 months on first study drug.	Everyone who started the first drug regimen	participants	NUMBER
PRIMARY	Overall Response	Response will be assessed after at least 4 months on second drug.	Everyone who started the second drug regimen	participants	NUMBER
PRIMARY	Overall Response	Response will be assessed after at least 6 months on combination drug.	Only subjects that completed combination drug will be included in analysis.
SECONDARY	Number of Participants With Grade 3 and 4 Toxicities	While taking the study drug and 30 days after the last dose		participants	NUMBER
OTHER_PRE_SPECIFIED	Serum Markers Measured on the First Day of Cycle 1 and on the First Day of Cycle 3	Within 4 months of taking single agent and 6 months of taking the combination

Source ClinicalTrials.gov

Results by group14

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

Outcome	Group	Category	Value	Units
Response Predicted by Molecular Signatures Compared to True Response	1a-Azacitidine Followed by Lenalidomide	Predicted: Response; Actual: Response	1	participants
Response Predicted by Molecular Signatures Compared to True Response	1b-Lenalidomide Followed by Azacitidine	Predicted: Response; Actual: Response	0	participants
Response Predicted by Molecular Signatures Compared to True Response	1a-Azacitidine Followed by Lenalidomide	Predicted: No Response; Actual: No Response	2	participants
Response Predicted by Molecular Signatures Compared to True Response	1b-Lenalidomide Followed by Azacitidine	Predicted: No Response; Actual: No Response	3	participants
Response Predicted by Molecular Signatures Compared to True Response	1a-Azacitidine Followed by Lenalidomide	Predicted: Response; Actual: No Response	3	participants
Response Predicted by Molecular Signatures Compared to True Response	1b-Lenalidomide Followed by Azacitidine	Predicted: Response; Actual: No Response	0	participants
Overall Response	1a-Azacitidine Followed by Lenalidomide		1	participants
Overall Response	1b-Lenalidomide Followed by Azacitidine		0	participants
Overall Response	1a-Azacitidine Followed by Lenalidomide		2	participants
Overall Response	1b-Lenalidomide Followed by Azacitidine		0	participants

1 to 10 of 14Source ClinicalTrials.gov

See all 14 results by group

Participant flow18

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

Period	Milestone	Group	Participants
First Drug	STARTED	1a-Azacitidine Followed by Lenalidomide	6
First Drug	STARTED	1b-Lenalidomide Followed by Azacitidine	3
First Drug	COMPLETED	1a-Azacitidine Followed by Lenalidomide	5
First Drug	COMPLETED	1b-Lenalidomide Followed by Azacitidine	1
First Drug	NOT COMPLETED	1a-Azacitidine Followed by Lenalidomide	1
First Drug	NOT COMPLETED	1b-Lenalidomide Followed by Azacitidine	2
Second Drug	STARTED	1a-Azacitidine Followed by Lenalidomide	4
Second Drug	STARTED	1b-Lenalidomide Followed by Azacitidine	1
Second Drug	COMPLETED	1a-Azacitidine Followed by Lenalidomide	4
Second Drug	COMPLETED	1b-Lenalidomide Followed by Azacitidine	1

1 to 10 of 18Source ClinicalTrials.gov

See all 18 participant flow

Adverse events172

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	Anemia	Blood and lymphatic system disorders	1a-Azacitidine Followed by Lenalidomide	3	6	8
other	Anemia	Blood and lymphatic system disorders	1b-Lenalidomide Followed by Azacitidine	0	3	0
other	Leukocytosis	Blood and lymphatic system disorders	1a-Azacitidine Followed by Lenalidomide	1	6	1
other	Leukocytosis	Blood and lymphatic system disorders	1b-Lenalidomide Followed by Azacitidine	1	3	1
other	Atrial flutter	Cardiac disorders	1a-Azacitidine Followed by Lenalidomide	1	6	1
other	Atrial flutter	Cardiac disorders	1b-Lenalidomide Followed by Azacitidine	0	3	0
other	Ear pain	Ear and labyrinth disorders	1a-Azacitidine Followed by Lenalidomide	1	6	2
other	Ear pain	Ear and labyrinth disorders	1b-Lenalidomide Followed by Azacitidine	0	3	0
other	Middle ear inflammation	Ear and labyrinth disorders	1a-Azacitidine Followed by Lenalidomide	2	6	3
other	Middle ear inflammation	Ear and labyrinth disorders	1b-Lenalidomide Followed by Azacitidine	0	3	0

1 to 10 of 172Source ClinicalTrials.gov

See all 172 adverse events

Adverse event totals6

The totals the trial posted for each group.

Total	Group	Affected	At risk
Total, all-cause mortality	1a-Azacitidine Followed by Lenalidomide
Total, all-cause mortality	1b-Lenalidomide Followed by Azacitidine
Total, other adverse events	1a-Azacitidine Followed by Lenalidomide	6	6
Total, other adverse events	1b-Lenalidomide Followed by Azacitidine	3	3
Total, serious adverse events	1a-Azacitidine Followed by Lenalidomide	2	6
Total, serious adverse events	1b-Lenalidomide Followed by Azacitidine	2	3

Source ClinicalTrials.gov

Papers0

The papers the trial lists on ClinicalTrials.gov.

None in this release.

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 comparisons3

Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.

Comparison	Source
1a-Azacitidine Followed by Lenalidomide vs 1b-Lenalidomide Followed by Azacitidine: Overall Response	Trial comparisons
1a-Azacitidine Followed by Lenalidomide vs 1b-Lenalidomide Followed by Azacitidine: Overall Response	Trial comparisons
1a-Azacitidine Followed by Lenalidomide vs 1b-Lenalidomide Followed by Azacitidine: serious adverse events	Trial comparisons

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/NCT01121757

GET https://conductscience.org/api/trials/v1/NCT01121757/events?page=2

API reference For AI assistants