Trial · NCT01010217

Mismatched Transplantation Using High-dose Post-transplant Cyclophosphamide

NCT01010217, Phase 2, Completed, M.D. Anderson Cancer Center; results first posted 2020-01-07

3 sourcestrials-2026-11-12-0.5.0

Cite this record

ConductScience Library. Mismatched Transplantation Using High-dose Post-transplant Cyclophosphamide. Trials, record NCT01010217. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT01010217

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Trial

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

Title: Mismatched Transplantation Using High-dose Post-transplant Cyclophosphamide
NCT number: NCT01010217
Status: Completed
Phases: Phase 2
Enrollment: 176 participants, actual
Lead sponsor: M.D. Anderson Cancer Center
Conditions: Blood Stem Cell Transplant Failure, Leukemia, Hematologic Malignancies
Interventions: Cyclophosphamide, Fludarabine, Melphalan, Mesna, Rituximab, Stem Cell Transplantation, Thiotepa, Tacrolimus, Mycofenolate mofetil, G-CSF
First posted: 2009-11-09
Last updated: 2020-03-25
Results first posted: 2020-01-07

Source ClinicalTrials.gov

Registered outcomes6

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

List	Outcome	Time frame	Description
Primary	Number of Participants With Non-relapse Mortality (NRM)	At 100 days	Non-relapse mortality (NRM) is defined as death from any cause other than relapse disease. Bayesian monitoring scheme described in Thall, Simon, and Estey (1996) employed to perform interim monitoring of the data during the course of the trial separately within each group.
Secondary	Number of Participants With Non Related Mortality (NRM)	six months	Non-relapse mortality (NRM) is defined as death from any cause other than relapse disease.
Secondary	Engraftments	Day 28
Secondary	Grade III-IV aGVHD	100 days	Acute Graft vs host disease
Secondary	cGVHD	1 year	Chronic graft vs host disease
Secondary	Disease Free Survival	1 year	Participants who have survived without their original disease.

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	Number of Participants With Non-relapse Mortality (NRM)	At 100 days	Second Transplant and Myelofibrosis was not evaluated due to low accrual.	Participants	COUNT_OF_PARTICIPANTS
SECONDARY	Number of Participants With Non Related Mortality (NRM)	six months	Second Transplant and Myelofibrosis was not evaluated due to low accrual.	Participants	COUNT_OF_PARTICIPANTS
SECONDARY	Engraftments	Day 28	Second Transplant and Myelofibrosis was not evaluated due to low accrual.	Participants	COUNT_OF_PARTICIPANTS
SECONDARY	Grade III-IV aGVHD	100 days	Second Transplant and Myelofibrosis was not evaluated due to low accrual	Participants	COUNT_OF_PARTICIPANTS
SECONDARY	cGVHD	1 year	Second Transplant and Myelofibrosis was not evaluated due to low accrual.	Participants	COUNT_OF_PARTICIPANTS
SECONDARY	Disease Free Survival	1 year	Second Transplant and Myelofibrosis was not evaluated due to low accrual.	Participants	COUNT_OF_PARTICIPANTS

Source ClinicalTrials.gov

Results by group30

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

Outcome	Group	Value	Units
Number of Participants With Non-relapse Mortality (NRM)	Haplo Arm	8	Participants
Number of Participants With Non-relapse Mortality (NRM)	1AgMM Related/Unrelated Donors	7	Participants
Number of Participants With Non-relapse Mortality (NRM)	MUD Donor	2	Participants
Number of Participants With Non-relapse Mortality (NRM)	Second Transplant	0	Participants
Number of Participants With Non-relapse Mortality (NRM)	Myelofibrosis	0	Participants
Number of Participants With Non Related Mortality (NRM)	Haplo Arm	17	Participants
Number of Participants With Non Related Mortality (NRM)	1AgMM Related/Unrelated Donors	15	Participants
Number of Participants With Non Related Mortality (NRM)	MUD Donor	4	Participants
Number of Participants With Non Related Mortality (NRM)	Second Transplant	0	Participants
Number of Participants With Non Related Mortality (NRM)	Myelofibrosis	0	Participants

1 to 10 of 30Source ClinicalTrials.gov

See all 30 results by group

Participant flow15

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

Period	Milestone	Group	Participants
Overall Study	STARTED	Haplo Arm	89
Overall Study	STARTED	1AgMM Related/Unrelated Donors	56
Overall Study	STARTED	MUD Donor	22
Overall Study	STARTED	Second Transplant	6
Overall Study	STARTED	Myelofibrosis	3
Overall Study	COMPLETED	Haplo Arm	84
Overall Study	COMPLETED	1AgMM Related/Unrelated Donors	51
Overall Study	COMPLETED	MUD Donor	21
Overall Study	COMPLETED	Second Transplant	0
Overall Study	COMPLETED	Myelofibrosis	0

1 to 10 of 15Source ClinicalTrials.gov

See all 15 participant flow

Adverse events435

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	Acute renal failure	Renal and urinary disorders	Haplo Arm	4	84
other	Acute renal failure	Renal and urinary disorders	1AgMM Related/Unrelated Donors	5	51
other	Acute renal failure	Renal and urinary disorders	MUD Donor	3	21
other	Acute renal failure	Renal and urinary disorders	Second Transplant	0	6
other	Acute renal failure	Renal and urinary disorders	Myelofibrosis	1	3
other	Altered mental status	Nervous system disorders	Haplo Arm	4	84
other	Altered mental status	Nervous system disorders	1AgMM Related/Unrelated Donors	3	51
other	Altered mental status	Nervous system disorders	MUD Donor	2	21
other	Altered mental status	Nervous system disorders	Second Transplant	0	6
other	Altered mental status	Nervous system disorders	Myelofibrosis	0	3

1 to 10 of 435Source ClinicalTrials.gov

See all 435 adverse events

Adverse event totals15

The totals the trial posted for each group.

Total	Group	Affected	At risk
Total, all-cause mortality	Haplo Arm	22	84
Total, all-cause mortality	1AgMM Related/Unrelated Donors	21	51
Total, all-cause mortality	MUD Donor	9	21
Total, all-cause mortality	Second Transplant	2	6
Total, all-cause mortality	Myelofibrosis	2	3
Total, other adverse events	Haplo Arm	84	84
Total, other adverse events	1AgMM Related/Unrelated Donors	51	51
Total, other adverse events	MUD Donor	21	21
Total, other adverse events	Second Transplant	6	6
Total, other adverse events	Myelofibrosis	3	3

1 to 10 of 15Source ClinicalTrials.gov

See all 15 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/NCT01010217

GET https://conductscience.org/api/trials/v1/NCT01010217/results?page=2

API reference For AI assistants