Trial · NCT01119066

HLA-Compatible Related or Unrelated Donors With CD34+ Enriched, T-cell Depleted Peripheral Blood Stem Cells Isolated by the CliniMACS System in the Treatment of Patients With Hematologic Malignancies

NCT01119066, Phase 2, Completed, Memorial Sloan Kettering Cancer Center; results first posted 2022-08-05

3 sourcestrials-2026-11-12-0.5.0

Cite this record

ConductScience Library. HLA-Compatible Related or Unrelated Donors With CD34+ Enriched, T-cell Depleted Peripheral Blood Stem Cells Isolated by the CliniMACS System in the Treatment of Patients With Hematologic Malignancies. Trials, record NCT01119066. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT01119066

On this page

Trial

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

Title: HLA-Compatible Related or Unrelated Donors With CD34+ Enriched, T-cell Depleted Peripheral Blood Stem Cells Isolated by the CliniMACS System in the Treatment of Patients With Hematologic Malignancies
NCT number: NCT01119066
Status: Completed
Phases: Phase 2
Enrollment: 422 participants, actual
Lead sponsor: Memorial Sloan Kettering Cancer Center
Conditions: Acute Lymphoblastic Leukemia, Acute Myelogenous Leukemia, Myelodysplastic Syndrome, Multiple Myeloma
Interventions: total body irradiation, Thiotepa, Cyclophosphamide, Busulfan, Melphalan, Fludarabine, Clofarabine, (CliniMACS) T-cell depleted PBSC Transplant
First posted: 2010-05-07
Last updated: 2022-08-05
Results first posted: 2022-08-05

Source ClinicalTrials.gov

Registered outcomes9

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

List	Outcome	Time frame	Description
Primary	The Incidence of Durable Hematopoietic Engraftment for T-cell Depleted Transplants Fractionated by the CliniMACS System Administered After Each of the Four Disease Targeted Cytoreduction Regimens.	3 years
Primary	Number of Participants With Acute and Chronic GVHD Following T-cell Depleted, CD34+ Progenitor Cell Enriched Transplants Fractionated by the CliniMACS System.	3 years	Standard BMT-CTN and IBMTR systems clinical criteria as defined by Rowlings, et al will be used to establish and grade acute GvHD. Chronic GvHD will be diagnosed and graded according to the criteria of Sullivan (CIBMTR).
Primary	Incidence of Non-relapse Mortality (Transplant-related Mortality) Following Each Cytoreduction Regimen and a Transplant Fractionated by the CliniMACS System.	3 years
Primary	Survival and Disease-free Survival (DFS)	at 6 months post transplant
Primary	Survival and Disease-free Survival (DFS)	1 year post transplant
Primary	Survival and Disease-free Survival (DFS)	2 years post transplant
Secondary	Proportion of Patients Receiving Optimal CD3+ (<1x10^5/kg) Cell Doses the Proportion of Patients Receiving CD3+ T-cell Doses > 1x10^5/kg.	Up to 3 years
Secondary	Proportion of Patients Receiving Optimal CD34+ (> 5x10^6/kg) Cell Doses the Proportion Recurring Suboptimal Doses (< 2x10^6/kg) CD34+ Cells	3 years
Secondary	Correlation of Doses of CD34+ Progenitors and CD3+ T Cells With Engraftment	3 years

Source ClinicalTrials.gov

Outcomes9

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

Type	Outcome	Time frame	Population	Units	Measured as
PRIMARY	The Incidence of Durable Hematopoietic Engraftment for T-cell Depleted Transplants Fractionated by the CliniMACS System Administered After Each of the Four Disease Targeted Cytoreduction Regimens.	3 years	Please note 13 participants were not evaluated in the data set as they received a second or third HCT on protocol.	Participants	COUNT_OF_PARTICIPANTS
PRIMARY	Number of Participants With Acute and Chronic GVHD Following T-cell Depleted, CD34+ Progenitor Cell Enriched Transplants Fractionated by the CliniMACS System.	3 years		participants	NUMBER
PRIMARY	Incidence of Non-relapse Mortality (Transplant-related Mortality) Following Each Cytoreduction Regimen and a Transplant Fractionated by the CliniMACS System.	3 years	Please note 13 participants were not evaluated in the data set as they received a second or third HCT on protocol.	Participants	COUNT_OF_PARTICIPANTS
PRIMARY	Survival and Disease-free Survival (DFS)	at 6 months post transplant	2 patients received 2 separate transplants on each Arm A and C	percentage of participants	NUMBER
PRIMARY	Survival and Disease-free Survival (DFS)	1 year post transplant	2 patients received 2 separate transplants on each Arm A and C	% of pts at 1 year post transplant	NUMBER
PRIMARY	Survival and Disease-free Survival (DFS)	2 years post transplant	2 patients received 2 separate transplants on each Arm A and C	% of pts at 2 years	NUMBER
SECONDARY	Proportion of Patients Receiving Optimal CD3+ (<1x10^5/kg) Cell Doses the Proportion of Patients Receiving CD3+ T-cell Doses > 1x10^5/kg.	Up to 3 years	2 patients received 2 separate transplants on each Arm A and C. Please note 13 participants were not evaluated in the data set as they received a second or third HCT on protocol.	Participants	COUNT_OF_PARTICIPANTS
SECONDARY	Proportion of Patients Receiving Optimal CD34+ (> 5x10^6/kg) Cell Doses the Proportion Recurring Suboptimal Doses (< 2x10^6/kg) CD34+ Cells	3 years	Please note 13 participants were not evaluated in the data set as they received a second or third HCT on protocol.	Participants	COUNT_OF_PARTICIPANTS
SECONDARY	Correlation of Doses of CD34+ Progenitors and CD3+ T Cells With Engraftment	3 years	Please note 13 participants were not evaluated in the data set as they received a second or third HCT on protocol.	Participants	COUNT_OF_PARTICIPANTS

Source ClinicalTrials.gov

Results by group120

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

Outcome	Group	Category	Value	Units
The Incidence of Durable Hematopoietic Engraftment for T-cell Depleted Transplants Fractionated by the CliniMACS System Administered After Each of the Four Disease Targeted Cytoreduction Regimens.	Total Body Irradiation, Thiotepa and Cyclophosphamide	Engrafted	118	Participants
The Incidence of Durable Hematopoietic Engraftment for T-cell Depleted Transplants Fractionated by the CliniMACS System Administered After Each of the Four Disease Targeted Cytoreduction Regimens.	Busulfan, Melphalan and Fludarabine	Engrafted	205	Participants
The Incidence of Durable Hematopoietic Engraftment for T-cell Depleted Transplants Fractionated by the CliniMACS System Administered After Each of the Four Disease Targeted Cytoreduction Regimens.	Clofarabine, Melphalan and Thiotepa	Engrafted	45	Participants
The Incidence of Durable Hematopoietic Engraftment for T-cell Depleted Transplants Fractionated by the CliniMACS System Administered After Each of the Four Disease Targeted Cytoreduction Regimens.	Melphalan, Fludarabine and Thiotepa	Engrafted	10	Participants
The Incidence of Durable Hematopoietic Engraftment for T-cell Depleted Transplants Fractionated by the CliniMACS System Administered After Each of the Four Disease Targeted Cytoreduction Regimens.	Total Body Irradiation, Thiotepa and Cyclophosphamide	Primary Graft Failure	0	Participants
The Incidence of Durable Hematopoietic Engraftment for T-cell Depleted Transplants Fractionated by the CliniMACS System Administered After Each of the Four Disease Targeted Cytoreduction Regimens.	Busulfan, Melphalan and Fludarabine	Primary Graft Failure	0	Participants
The Incidence of Durable Hematopoietic Engraftment for T-cell Depleted Transplants Fractionated by the CliniMACS System Administered After Each of the Four Disease Targeted Cytoreduction Regimens.	Clofarabine, Melphalan and Thiotepa	Primary Graft Failure	0	Participants
The Incidence of Durable Hematopoietic Engraftment for T-cell Depleted Transplants Fractionated by the CliniMACS System Administered After Each of the Four Disease Targeted Cytoreduction Regimens.	Melphalan, Fludarabine and Thiotepa	Primary Graft Failure	0	Participants
The Incidence of Durable Hematopoietic Engraftment for T-cell Depleted Transplants Fractionated by the CliniMACS System Administered After Each of the Four Disease Targeted Cytoreduction Regimens.	Total Body Irradiation, Thiotepa and Cyclophosphamide	Late graft failure	1	Participants
The Incidence of Durable Hematopoietic Engraftment for T-cell Depleted Transplants Fractionated by the CliniMACS System Administered After Each of the Four Disease Targeted Cytoreduction Regimens.	Busulfan, Melphalan and Fludarabine	Late graft failure	5	Participants

1 to 10 of 120Source ClinicalTrials.gov

See all 120 results by group

Participant flow12

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

Period	Milestone	Group	Participants	Units counted
Overall Study	STARTED	Total Body Irradiation, Thiotepa and Cyclophosphamide	132	1
Overall Study	STARTED	Busulfan, Melphalan and Fludarabine	227	0
Overall Study	STARTED	Clofarabine, Melphalan and Thiotepa	52	1
Overall Study	STARTED	Melphalan, Fludarabine and Thiotepa	11	0
Overall Study	COMPLETED	Total Body Irradiation, Thiotepa and Cyclophosphamide	125	1
Overall Study	COMPLETED	Busulfan, Melphalan and Fludarabine	213	0
Overall Study	COMPLETED	Clofarabine, Melphalan and Thiotepa	52	1
Overall Study	COMPLETED	Melphalan, Fludarabine and Thiotepa	11	0
Overall Study	NOT COMPLETED	Total Body Irradiation, Thiotepa and Cyclophosphamide	7	0
Overall Study	NOT COMPLETED	Busulfan, Melphalan and Fludarabine	14	0

1 to 10 of 12Source ClinicalTrials.gov

See all 12 participant flow

Adverse events184

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	Acidosis	Metabolism and nutrition disorders	Total Body Irradiation, Thiotepa and Cyclophosphamide	0	125
other	Acidosis	Metabolism and nutrition disorders	Busulfan, Melphalan and Fludarabine	1	213
other	Acidosis	Metabolism and nutrition disorders	Clofarabine, Melphalan and Thiotepa	0	52
other	Acidosis	Metabolism and nutrition disorders	Melphalan, Fludarabine and Thiotepa	0	11
other	Acute kidney injury	Renal and urinary disorders	Total Body Irradiation, Thiotepa and Cyclophosphamide	0	125
other	Acute kidney injury	Renal and urinary disorders	Busulfan, Melphalan and Fludarabine	1	213
other	Acute kidney injury	Renal and urinary disorders	Clofarabine, Melphalan and Thiotepa	1	52
other	Acute kidney injury	Renal and urinary disorders	Melphalan, Fludarabine and Thiotepa	0	11
other	Altered Mental Status	Psychiatric disorders	Total Body Irradiation, Thiotepa and Cyclophosphamide	1	125
other	Altered Mental Status	Psychiatric disorders	Busulfan, Melphalan and Fludarabine	0	213

1 to 10 of 184Source ClinicalTrials.gov

See all 184 adverse events

Adverse event totals12

The totals the trial posted for each group.

Total	Group	Affected	At risk
Total, all-cause mortality	Total Body Irradiation, Thiotepa and Cyclophosphamide	42	120
Total, all-cause mortality	Busulfan, Melphalan and Fludarabine	71	210
Total, all-cause mortality	Clofarabine, Melphalan and Thiotepa	18	47
Total, all-cause mortality	Melphalan, Fludarabine and Thiotepa	3	11
Total, other adverse events	Total Body Irradiation, Thiotepa and Cyclophosphamide	16	125
Total, other adverse events	Busulfan, Melphalan and Fludarabine	31	213
Total, other adverse events	Clofarabine, Melphalan and Thiotepa	9	52
Total, other adverse events	Melphalan, Fludarabine and Thiotepa	3	11
Total, serious adverse events	Total Body Irradiation, Thiotepa and Cyclophosphamide	13	125
Total, serious adverse events	Busulfan, Melphalan and Fludarabine	30	213

1 to 10 of 12Source ClinicalTrials.gov

See all 12 adverse event totals

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 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/NCT01119066

GET https://conductscience.org/api/trials/v1/NCT01119066/results?page=2

API reference For AI assistants