Trial · NCT01998035

Romidepsin Plus Oral 5-Azacitidine in Relapsed/Refractory Lymphoid Malignancies

NCT01998035, Phase 1, Phase 2, Terminated, Columbia University; results first posted 2024-08-22

3 sourcestrials-2026-11-12-0.5.0

Cite this record

ConductScience Library. Romidepsin Plus Oral 5-Azacitidine in Relapsed/Refractory Lymphoid Malignancies. Trials, record NCT01998035. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT01998035

On this page

Trial

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

Title: Romidepsin Plus Oral 5-Azacitidine in Relapsed/Refractory Lymphoid Malignancies
NCT number: NCT01998035
Status: Terminated
Phases: Phase 1, Phase 2
Enrollment: 58 participants, actual
Lead sponsor: Columbia University
Conditions: Lymphoid Malignancies, Lymphoma, Hodgkin Lymphoma, Non-hodgkin Lymphoma
Interventions: RomiDEPsin 10 MG/M2, Oral 5-Azacitidine 100 MG, Romidepsin 14 MG/M2, Oral 5-Azacitidine 200 MG, Oral 5-Azacitidine 300 MG
First posted: 2013-11-28
Last updated: 2024-08-22
Results first posted: 2024-08-22

Source ClinicalTrials.gov

Registered outcomes4

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

List	Outcome	Time frame	Description
Primary	Phase I: Maximum Tolerated Dose (MTD) of the Combination of Oral 5-azacitidine in Combination With Romidepsin	up to 1.5 years	The highest dose of a drug or treatment that does not cause unacceptable side effects. The MTD is determined in clinical trials by testing increasing doses on different groups of people until the highest dose with acceptable side effects is found.
Primary	Phase I: Maximum Tolerated Dose (MTD) of Romidepsin in Combination With Oral 5-azacytidine	up to 1.5 years	The highest dose of a drug or treatment that does not cause unacceptable side effects. The MTD is determined in clinical trials by testing increasing doses on different groups of people until the highest dose with acceptable side effects is found.
Primary	Percentage of Patients Who Experienced Significant Toxicities in Phase 1	Up to 1.5 years	Patients receiving the combination of oral 5-azacitidine and romidepsin and experiencing grades 1-4 toxicities will be tallied based on events observed and assessed by a qualified investigator. This Outcome Measure is specifically for Phase 1 of the study.
Primary	Phase II: Overall Response Rate (ORR) (Complete + Partial Response) of the Combination of Oral 5-azacitidine and Romidepsin in Patients With Relapsed/Refractory T-Cell Lymphoma	Up to 3 years	The percentage of people in a study or treatment group who have a partial response or complete response to the treatment within a certain period of time. A partial response is a decrease in the size of a tumor or in the amount of cancer in the body, and a complete response is the disappearance of all signs of cancer in the body. In a clinical trial, measuring the ORR is one way to see how well a new treatment works.

Source ClinicalTrials.gov

Outcomes4

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

Type	Outcome	Time frame	Population	Units	Measured as
PRIMARY	Phase I: Maximum Tolerated Dose (MTD) of the Combination of Oral 5-azacitidine in Combination With Romidepsin	up to 1.5 years	This Outcome Measure is specific for Phase 1 of the study. This Outcome Measure was NOT applied to Phase 2, therefore data was only collected and reported for Phase 1.~26 participants received the study interventions in Phase 1.	mg	NUMBER
PRIMARY	Phase I: Maximum Tolerated Dose (MTD) of Romidepsin in Combination With Oral 5-azacytidine	up to 1.5 years	This Outcome Measure is specific for Phase 1 of the study. This Outcome Measure was NOT applied to Phase 2, therefore data was only collected and reported for Phase 1.~26 participants received the study interventions in Phase 1.	mg/m2	NUMBER
PRIMARY	Percentage of Patients Who Experienced Significant Toxicities in Phase 1	Up to 1.5 years	This Outcome Measure is specific for Phase 1 of the study. This Outcome Measure was NOT applied to Phase 2, therefore data was only collected and reported for Phase 1. Results were not collected per dose level and thus cannot be reported per dose level.~26 participants received the study interventions in Phase 1.	percentage of participants	NUMBER
PRIMARY	Phase II: Overall Response Rate (ORR) (Complete + Partial Response) of the Combination of Oral 5-azacitidine and Romidepsin in Patients With Relapsed/Refractory T-Cell Lymphoma	Up to 3 years	This Outcome Measure is specific for Phase 2 of the study, therefore data was only collected and reported for Phase 2. Results were not collected per dose level and thus cannot be reported per dose level.	percentage of participants	NUMBER

Source ClinicalTrials.gov

Results by group4

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

Outcome	Group	Value	Units
Phase I: Maximum Tolerated Dose (MTD) of the Combination of Oral 5-azacitidine in Combination With Romidepsin	Phase I	300	mg
Phase I: Maximum Tolerated Dose (MTD) of Romidepsin in Combination With Oral 5-azacytidine	Phase I	14	mg/m2
Percentage of Patients Who Experienced Significant Toxicities in Phase 1	Phase I	10	percentage of participants
Phase II: Overall Response Rate (ORR) (Complete + Partial Response) of the Combination of Oral 5-azacitidine and Romidepsin in Patients With Relapsed/Refractory T-Cell Lymphoma	Phase II	30	percentage of participants

Source ClinicalTrials.gov

Participant flow192

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

Period	Milestone	Group	Participants
Phase 1: Dose Level 1	STARTED	Phase 1, Dose Level 1: Oral 5-Azacitidine 100 mg and Romidepsin 10 mg/m2	6
Phase 1: Dose Level 1	STARTED	Phase 1, Dose Level 2: Oral 5-Azacitidine 200 mg and Romidepsin 10 mg/m2	0
Phase 1: Dose Level 1	STARTED	Phase 1, Dose Level 3: Oral 5-Azacitidine 200 mg and Romidepsin 10 mg/m2 (Extended Cycle)	0
Phase 1: Dose Level 1	STARTED	Phase 1, Dose Level 4: Oral 5-Azacitidine 300 mg and Romidepsin 10 mg/m2	0
Phase 1: Dose Level 1	STARTED	Phase 1, Dose Level 5: Oral 5-Azacitidine 300 mg and Romidepsin 14 mg/m2	0
Phase 1: Dose Level 1	STARTED	Phase 1, Dose Level 6: Oral 5-Azacitidine 300 mg and Romidepsin 14 mg/m2	0
Phase 1: Dose Level 1	STARTED	Phase 1, Dose Level 6 (MTD): Oral 5-Azacitidine 300 mg and Romidepsin 14 mg/m2	0
Phase 1: Dose Level 1	STARTED	Phase 2, MTD: Oral 5-Azacitidine 300 mg and Romidepsin 14 mg/m2	0
Phase 1: Dose Level 1	COMPLETED	Phase 1, Dose Level 1: Oral 5-Azacitidine 100 mg and Romidepsin 10 mg/m2	6
Phase 1: Dose Level 1	COMPLETED	Phase 1, Dose Level 2: Oral 5-Azacitidine 200 mg and Romidepsin 10 mg/m2	0

1 to 10 of 192Source ClinicalTrials.gov

See all 192 participant flow

Adverse events44

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	Fatigue	General disorders	Phase 1	10	26
other	Fatigue	General disorders	Phase 2	13	25
other	Nausea	General disorders	Phase 1	14	26
other	Nausea	General disorders	Phase 2	15	25
other	Vomiting	General disorders	Phase 1	12	26
other	Vomiting	General disorders	Phase 2	10	25
other	Creatinine elevation	Renal and urinary disorders	Phase 1	8	26
other	Creatinine elevation	Renal and urinary disorders	Phase 2	10	25
other	Diarrhea	Gastrointestinal disorders	Phase 1	7	26
other	Diarrhea	Gastrointestinal disorders	Phase 2	12	25

1 to 10 of 44Source ClinicalTrials.gov

See all 44 adverse events

Adverse event totals6

The totals the trial posted for each group.

Total	Group	Affected	At risk
Total, all-cause mortality	Phase 1	11	26
Total, all-cause mortality	Phase 2	0	25
Total, other adverse events	Phase 1	26	26
Total, other adverse events	Phase 2	25	25
Total, serious adverse events	Phase 1	11	26
Total, serious adverse events	Phase 2	12	25

Source ClinicalTrials.gov

Papers2

The papers the trial lists on ClinicalTrials.gov.

PMID	Listed as	Source
31471376	DERIVED	PubMed
33171487	DERIVED	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 comparisons2

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

Comparison	Source
Phase 1 vs Phase 2: deaths from any cause	Trial comparisons
Phase 1 vs Phase 2: 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/NCT01998035

GET https://conductscience.org/api/trials/v1/NCT01998035/flow?page=2

API reference For AI assistants