Trial · NCT00582933

Phase II Trial of a Chemotherapy Alone Regimen of IV Busulfan (Busulfex), Melphalan and Fludarabine as Myeloablative Regimen Followed by an Allogeneic T-Cell Depleted Hematopoietic Stem Cell Transplant From an HLA-Identical, or HLA-Non Identical Related or Unrelated Donor

NCT00582933, Phase 2, Completed, Memorial Sloan Kettering Cancer Center; results first posted 2016-02-01

3 sourcestrials-2026-11-12-0.5.0

Cite this record

ConductScience Library. Phase II Trial of a Chemotherapy Alone Regimen of IV Busulfan (Busulfex), Melphalan and Fludarabine as Myeloablative Regimen Followed by an Allogeneic T-Cell Depleted Hematopoietic Stem Cell Transplant From an HLA-Identical, or HLA-Non Identical Related or Unrelated Donor. Trials, record NCT00582933. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT00582933

On this page

Trial

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

Title: Phase II Trial of a Chemotherapy Alone Regimen of IV Busulfan (Busulfex), Melphalan and Fludarabine as Myeloablative Regimen Followed by an Allogeneic T-Cell Depleted Hematopoietic Stem Cell Transplant From an HLA-Identical, or HLA-Non Identical Related or Unrelated Donor
NCT number: NCT00582933
Status: Completed
Phases: Phase 2
Enrollment: 96 participants, actual
Lead sponsor: Memorial Sloan Kettering Cancer Center
Conditions: Leukemia, Myelodysplastic Syndrome, Non-Hodgkin's Lymphoma, Allogeneic Marrow Transplant
Interventions: BUSULFAN, MELPHALAN, FLUDARABINE, G-CSF, BUSULFAN, MELPHALAN, FLUDARABINE, G-CSF, BUSULFAN, MELPHALAN, FLUDARABINE, G-CSF
First posted: 2007-12-28
Last updated: 2016-02-01
Results first posted: 2016-02-01

Source ClinicalTrials.gov

Registered outcomes1

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

List	Outcome	Time frame	Description
Primary	Death From GVHD	2 years	To establish the early transplant-related severe morbidity and mortality and 3-the incidence and severity of GvHD.

Source ClinicalTrials.gov

Outcomes1

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

Type	Outcome	Time frame	Population	Units	Measured as
PRIMARY	Death From GVHD	2 years		participants	NUMBER

Source ClinicalTrials.gov

Results by group1

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

Outcome	Group	Category	Value	Spread	Units
Death From GVHD	Transplant Patients		4		participants

Source ClinicalTrials.gov

Participant flow3

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

Period	Milestone	Group	Participants
Overall Study	STARTED	Transplant Patients	95
Overall Study	COMPLETED	Transplant Patients	92
Overall Study	NOT COMPLETED	Transplant Patients	3

Source ClinicalTrials.gov

Adverse events31

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	Alkaline phosphatase	Metabolism and nutrition disorders	Transplant Patients	15	92	15
other	Bilirubin	Metabolism and nutrition disorders	Transplant Patients	17	92	17
other	Creatinine	Metabolism and nutrition disorders	Transplant Patients	14	92	14
other	Hemoglobin (Hgb)	Blood and lymphatic system disorders	Transplant Patients	89	92	89
other	Hyperglycemia	Metabolism and nutrition disorders	Transplant Patients	48	92	48
other	Hyperkalemia	Metabolism and nutrition disorders	Transplant Patients	18	92	18
other	Hypocalcemia	Metabolism and nutrition disorders	Transplant Patients	33	92	33
other	Hypokalemia	Metabolism and nutrition disorders	Transplant Patients	48	92	48
other	Hyponatremia	Metabolism and nutrition disorders	Transplant Patients	23	92	23
other	Hypophosphatemia	Metabolism and nutrition disorders	Transplant Patients	49	92	49

1 to 10 of 31Source ClinicalTrials.gov

See all 31 adverse events

Adverse event totals3

The totals the trial posted for each group.

Total	Group	Affected	At risk
Total, all-cause mortality	Transplant Patients
Total, other adverse events	Transplant Patients	92	92
Total, serious adverse events	Transplant Patients	16	92

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 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/NCT00582933

GET https://conductscience.org/api/trials/v1/NCT00582933/events?page=2

API reference For AI assistants