Trial · NCT02730299

Stem Cell Transplantation With NiCord® (Omidubicel) vs Standard UCB in Patients With Leukemia, Lymphoma, and MDS

NCT02730299, Phase 3, Completed, Gamida Cell ltd; results first posted 2022-10-25

3 sourcestrials-2026-11-12-0.5.0

Cite this record

ConductScience Library. Stem Cell Transplantation With NiCord® (Omidubicel) vs Standard UCB in Patients With Leukemia, Lymphoma, and MDS. Trials, record NCT02730299. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT02730299

On this page

Trial

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

Title: Stem Cell Transplantation With NiCord® (Omidubicel) vs Standard UCB in Patients With Leukemia, Lymphoma, and MDS
NCT number: NCT02730299
Status: Completed
Phases: Phase 3
Enrollment: 125 participants, actual
Lead sponsor: Gamida Cell ltd
Conditions: Hematological Malignancies, Acute Lymphoblastic Leukemia (ALL), Acute Myelogenous Leukemia (AML), Chronic Myelogenous Leukemia (CML), Myelodysplastic Syndrome (MDS), Lymphoma, Acute Leukemia
Interventions: NiCord® (omidubicel), Cord Blood Unit
First posted: 2016-04-06
Last updated: 2026-02-25
Results first posted: 2022-10-25
Limitations and caveats: The analyses of the long term follow-up sub-study were descriptive only and the study was not powered to detect statistical differences between the treatment groups.

Source ClinicalTrials.gov

Registered outcomes8

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

List	Outcome	Time frame	Description
Primary	Time to Neutrophil Engraftment	post-transplant up to 42 days	The time to engraftment of neutrophils \>500/μl was defined as per Center for International Blood and Marrow Transplant Research (CIBMTR) standards, requiring donor chimerism for neutrophil engraftment.
Secondary	First Grade 2/3 Bacterial or Invasive Fungal Infections by 100 Days Following Transplantation	100 days post-transplant	First Bacterial Infection Grades 2-3 or Invasive Fungal Infection by 100 Days following Transplantation for the Intent to Treat Population
Secondary	Days Alive and Out of Hospital in the First 100 Days Post-transplantation	100 days post-transplantation	Days alive and out of hospital in the first 100 Days post-transplantation for the Intent to Treat Population
Secondary	Number of Participants With Platelet Engraftment by 42 Days Post-transplantation	42 days post-transplantation	Platelet engraftment defined as the first day of a minimum of three consecutive measurements on different days such that the patient has achieved a platelet count \> 20 × 10\^9/L with no platelet transfusions during the preceding seven days (counting day of engraftment as one of the preceding seven days) for the Intent to Treat Population
Other	LTF Chimerism	By 5 years post-transplant	Kaplan Meier probability of donor chimerism \<95%
Other	LTF Overall Survival	By 5 years post-transplant	Kaplan Meier probability of overall survival
Other	LTF Disease Progression/Relapse	By 5 years post-transplant	Number of patients with relapse during the long-term follow-up period
Other	LTF Chronic GvHD	By 5 years post-transplant	Cumulative Incidence of Chronic GvHD

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	Time to Neutrophil Engraftment	post-transplant up to 42 days	intent to treat	days	MEDIAN
SECONDARY	First Grade 2/3 Bacterial or Invasive Fungal Infections by 100 Days Following Transplantation	100 days post-transplant	Intent to Treat Population	Participants	COUNT_OF_PARTICIPANTS
SECONDARY	Days Alive and Out of Hospital in the First 100 Days Post-transplantation	100 days post-transplantation	Intent to Treat Population	Days	MEDIAN
SECONDARY	Number of Participants With Platelet Engraftment by 42 Days Post-transplantation	42 days post-transplantation	Intent to Treat Population	Participants	COUNT_OF_PARTICIPANTS
OTHER_PRE_SPECIFIED	LTF Chimerism	By 5 years post-transplant	Patients who were transplanted, alive at Year 1 post-transplant (end of main study) and provided consent to participate in the optional long-term follow-up sub-study	Kaplan Meier probability	NUMBER
OTHER_PRE_SPECIFIED	LTF Overall Survival	By 5 years post-transplant	Patients who were transplanted, alive at Year 1 post-transplant (end of main study) and provided consent to participate in the optional long-term follow-up sub-study	KM probability	NUMBER
OTHER_PRE_SPECIFIED	LTF Disease Progression/Relapse	By 5 years post-transplant	Patients who were transplanted, alive at Year 1 post-transplant (end of main study) and provided consent to participate in the optional long-term follow-up sub-study	Patients with relapse	NUMBER
OTHER_PRE_SPECIFIED	LTF Chronic GvHD	By 5 years post-transplant	Patients who were transplanted, alive at Year 1 post-transplant (end of main study) and provided consent to participate in the optional long-term follow-up sub-study	Proportion	NUMBER

Source ClinicalTrials.gov

Results by group16

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

Outcome	Group	Value	Spread	Units
Time to Neutrophil Engraftment	NiCord® (Omidubicel)	12	95% Confidence Interval 10 to 14	days
Time to Neutrophil Engraftment	Unmanipulated Cord Blood Unit(s)	22	95% Confidence Interval 19 to 25	days
First Grade 2/3 Bacterial or Invasive Fungal Infections by 100 Days Following Transplantation	NiCord® (Omidubicel)	24		Participants
First Grade 2/3 Bacterial or Invasive Fungal Infections by 100 Days Following Transplantation	Unmanipulated CBU(s)	38		Participants
Days Alive and Out of Hospital in the First 100 Days Post-transplantation	NiCord® (Omidubicel)	60.5	Full Range 0 to 89	Days
Days Alive and Out of Hospital in the First 100 Days Post-transplantation	Unmanipulated CBU(s)	48	Full Range 0 to 79	Days
Number of Participants With Platelet Engraftment by 42 Days Post-transplantation	NiCord® (Omidubicel)	34		Participants
Number of Participants With Platelet Engraftment by 42 Days Post-transplantation	Unmanipulated CBU(s)	22		Participants
LTF Chimerism	LTF NiCord Recipients	0.97		Kaplan Meier probability
LTF Chimerism	LTF Unmanipulated CBU(s)	0.91		Kaplan Meier probability

1 to 10 of 16Source ClinicalTrials.gov

See all 16 results by group

Participant flow6

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

Period	Milestone	Group	Participants
Overall Study	STARTED	NiCord® (Omidubicel)	62
Overall Study	STARTED	Unmanipulated CBU(s)	63
Overall Study	COMPLETED	NiCord® (Omidubicel)	62
Overall Study	COMPLETED	Unmanipulated CBU(s)	63
Overall Study	NOT COMPLETED	NiCord® (Omidubicel)	0
Overall Study	NOT COMPLETED	Unmanipulated CBU(s)	0

Source ClinicalTrials.gov

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	Febrile Neutropenia	Blood and lymphatic system disorders	Omidubicel	4	52	4
other	Febrile Neutropenia	Blood and lymphatic system disorders	Unmanipulated CBU(s)	5	56	8
other	Thrombotic microangiopathy	Blood and lymphatic system disorders	Omidubicel	1	52	1
other	Thrombotic microangiopathy	Blood and lymphatic system disorders	Unmanipulated CBU(s)	5	56	5
other	Diarrhea	Gastrointestinal disorders	Omidubicel	1	52	1
other	Diarrhea	Gastrointestinal disorders	Unmanipulated CBU(s)	3	56	3
other	Dysphagia	Gastrointestinal disorders	Omidubicel	17	52	18
other	Dysphagia	Gastrointestinal disorders	Unmanipulated CBU(s)	21	56	22
other	Gastrointestinal Hemorrhage	Gastrointestinal disorders	Omidubicel	0	52	0
other	Gastrointestinal Hemorrhage	Gastrointestinal disorders	Unmanipulated CBU(s)	3	56	3

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	Omidubicel	19	52
Total, all-cause mortality	Unmanipulated CBU(s)	24	56
Total, other adverse events	Omidubicel	52	52
Total, other adverse events	Unmanipulated CBU(s)	56	56
Total, serious adverse events	Omidubicel	47	52
Total, serious adverse events	Unmanipulated CBU(s)	51	56

Source ClinicalTrials.gov

Papers4

The papers the trial lists on ClinicalTrials.gov.

PMID	Listed as	Source
33811823	DERIVED	PubMed
34157093	DERIVED	PubMed
37120136	DERIVED	PubMed
37703995	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 comparisons4

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

Comparison	Source
NiCord® (Omidubicel) vs Unmanipulated CBU(s): First Grade 2/3 Bacterial or Invasive Fungal Infections by 100 Days Following Transplantation	Trial comparisons
Omidubicel vs Unmanipulated CBU(s): deaths from any cause	Trial comparisons
NiCord® (Omidubicel) vs Unmanipulated CBU(s): Number of Participants With Platelet Engraftment by 42 Days Post-transplantation	Trial comparisons
Omidubicel vs Unmanipulated CBU(s): 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/NCT02730299

GET https://conductscience.org/api/trials/v1/NCT02730299/events?page=2

API reference For AI assistants