Trial · NCT00943592

Clofarabine-Melphalan-Alemtuzumab Conditioning in Patients With Advanced Hematologic Malignancies

NCT00943592, Phase 1, Phase 2, Completed, University of Chicago; results first posted 2014-02-27

3 sourcestrials-2026-11-12-0.5.0

Cite this record

ConductScience Library. Clofarabine-Melphalan-Alemtuzumab Conditioning in Patients With Advanced Hematologic Malignancies. Trials, record NCT00943592. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT00943592

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Trial

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

Title: Clofarabine-Melphalan-Alemtuzumab Conditioning in Patients With Advanced Hematologic Malignancies
NCT number: NCT00943592
Status: Completed
Phases: Phase 1, Phase 2
Enrollment: 82 participants, actual
Lead sponsor: University of Chicago
Conditions: Advanced Hematologic Malignancies, Leukemia, Preleukemia
Interventions: Clofarabine, Melphalan, Campath, Stem Cell Transplant
First posted: 2009-07-22
Last updated: 2014-02-27
Results first posted: 2014-02-27

Source ClinicalTrials.gov

Registered outcomes8

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

List	Outcome	Time frame	Description
Primary	Number of Participants With Hepatic Adverse Events During the Conditioning Regimen Prior to Stem Cell Transplantation	Day 7 until Day 30	Toxicity was scored according to NCI/CTC version 3
Primary	Number of Participants With Renal Adverse Events During the Conditioning Regimen Prior to Stem Cell Transplantation	Day 7 until Day 30	Toxicity was scored according to NCI/CTC version 3
Primary	Number of Participants With Skin Adverse Events During the Conditioning Regimen Prior to Stem Cell Transplantation	Day 7 until Day 30	Toxicity was scored according to NCI/CTC version 3
Primary	Number of Participants With Other Adverse Events During the Conditioning Regimen Prior to Stem Cell Transplantation	Day 7 until Day 30	Toxicity was scored according to NCI/CTC version 3
Secondary	Overall Survival (OS)	1 year
Secondary	Progression-free Survival (PFS)	1 year	Progression is defined from stem cell infusion to disease relapse, i.e., recurrence of hematologic malignancy and/or need for treatment after transplant for disease or death from any cause, whichever occurred first.
Secondary	Treatment-related Mortality (TRM)	1 year
Secondary	Relapse Rate	1 year

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	Number of Participants With Hepatic Adverse Events During the Conditioning Regimen Prior to Stem Cell Transplantation	Day 7 until Day 30		participants	NUMBER
SECONDARY	Overall Survival (OS)	1 year	74 patients received the Maximum Tolerated Dose of clofarabine 40 mg/m2 IV daily x 5 days, melphalan 140 mg/m2 x 1 day, and alemtuzumab 20 mg IV daily x 5 days	percentage of participants	NUMBER
PRIMARY	Number of Participants With Renal Adverse Events During the Conditioning Regimen Prior to Stem Cell Transplantation	Day 7 until Day 30		participants	NUMBER
PRIMARY	Number of Participants With Skin Adverse Events During the Conditioning Regimen Prior to Stem Cell Transplantation	Day 7 until Day 30		participants	NUMBER
PRIMARY	Number of Participants With Other Adverse Events During the Conditioning Regimen Prior to Stem Cell Transplantation	Day 7 until Day 30		participants	NUMBER
SECONDARY	Progression-free Survival (PFS)	1 year	74 patients received the Maximum Tolerated Dose of clofarabine 40 mg/m2 IV daily x 5 days, melphalan 140 mg/m2 x 1 day, and alemtuzumab 20 mg IV daily x 5 days	percentage of participants	NUMBER
SECONDARY	Treatment-related Mortality (TRM)	1 year	74 patients received the Maximum Tolerated Dose of clofarabine 40 mg/m2 IV daily x 5 days, melphalan 140 mg/m2 x 1 day, and alemtuzumab 20 mg IV daily x 5 days	percentage of participants	NUMBER
SECONDARY	Relapse Rate	1 year	74 patients received the Maximum Tolerated Dose of clofarabine 40 mg/m2 IV daily x 5 days, melphalan 140 mg/m2 x 1 day, and alemtuzumab 20 mg IV daily x 5 days	percentage of participants	NUMBER

Source ClinicalTrials.gov

Results by group14

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

Outcome	Group	Category	Value	Spread	Units
Number of Participants With Hepatic Adverse Events During the Conditioning Regimen Prior to Stem Cell Transplantation	Clofarabine, Melphalan, and Alemtuzumab	Grade 1-2	48		participants
Number of Participants With Hepatic Adverse Events During the Conditioning Regimen Prior to Stem Cell Transplantation	Clofarabine, Melphalan, and Alemtuzumab	Grade 3-4	30		participants
Overall Survival (OS)	Clofarabine, Melphalan, and Alemtuzumab		59	95% Confidence Interval 47 to 71	percentage of participants
Number of Participants With Renal Adverse Events During the Conditioning Regimen Prior to Stem Cell Transplantation	Clofarabine, Melphalan, and Alemtuzumab	Grade 1-2	26		participants
Number of Participants With Renal Adverse Events During the Conditioning Regimen Prior to Stem Cell Transplantation	Clofarabine, Melphalan, and Alemtuzumab	Grade 3-4	13		participants
Number of Participants With Renal Adverse Events During the Conditioning Regimen Prior to Stem Cell Transplantation	Clofarabine, Melphalan, and Alemtuzumab	Grade 5	3		participants
Number of Participants With Skin Adverse Events During the Conditioning Regimen Prior to Stem Cell Transplantation	Clofarabine, Melphalan, and Alemtuzumab	Grade 1-2	6		participants
Number of Participants With Skin Adverse Events During the Conditioning Regimen Prior to Stem Cell Transplantation	Clofarabine, Melphalan, and Alemtuzumab	Grade 3-4	8		participants
Number of Participants With Other Adverse Events During the Conditioning Regimen Prior to Stem Cell Transplantation	Clofarabine, Melphalan, and Alemtuzumab	Grade 1-2	12		participants
Number of Participants With Other Adverse Events During the Conditioning Regimen Prior to Stem Cell Transplantation	Clofarabine, Melphalan, and Alemtuzumab	Grade 3-4	7		participants

1 to 10 of 14Source ClinicalTrials.gov

See all 14 results by group

Participant flow4

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

Period	Milestone	Group	Participants
Overall Study	STARTED	Clofarabine, Melphalan, and Alemtuzumab	82
Overall Study	Maximum Tolerated Dose	Clofarabine, Melphalan, and Alemtuzumab	74
Overall Study	COMPLETED	Clofarabine, Melphalan, and Alemtuzumab	79
Overall Study	NOT COMPLETED	Clofarabine, Melphalan, and Alemtuzumab	3

Source ClinicalTrials.gov

Adverse events22

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	Anxiety	Psychiatric disorders	Clofarabine, Melphalan, and Alemtuzumab	1	82	1
other	Atrial flutter	Cardiac disorders	Clofarabine, Melphalan, and Alemtuzumab	1	82	1
other	Confusion	Psychiatric disorders	Clofarabine, Melphalan, and Alemtuzumab	1	82	1
other	Hepatobiliary disease NOS	Hepatobiliary disorders	Clofarabine, Melphalan, and Alemtuzumab	48	82	48
other	Mucositis	General disorders	Clofarabine, Melphalan, and Alemtuzumab	3	82	3
other	Palmar-plantar erythrodysesthesia syndrome	Skin and subcutaneous tissue disorders	Clofarabine, Melphalan, and Alemtuzumab	6	82	6
other	Pancreatitis	Gastrointestinal disorders	Clofarabine, Melphalan, and Alemtuzumab	2	82	2
other	Renal disorder NOS	Renal and urinary disorders	Clofarabine, Melphalan, and Alemtuzumab	26	82	26
other	Diarrhea	Gastrointestinal disorders	Clofarabine, Melphalan, and Alemtuzumab	1	82	1
other	Pseudotumor cerebri	Nervous system disorders	Clofarabine, Melphalan, and Alemtuzumab	1	82	1

1 to 10 of 22Source ClinicalTrials.gov

See all 22 adverse events

Adverse event totals3

The totals the trial posted for each group.

Total	Group	Affected	At risk
Total, all-cause mortality	Clofarabine, Melphalan, and Alemtuzumab
Total, other adverse events	Clofarabine, Melphalan, and Alemtuzumab	62	82
Total, serious adverse events	Clofarabine, Melphalan, and Alemtuzumab	44	82

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/NCT00943592

GET https://conductscience.org/api/trials/v1/NCT00943592/events?page=2

API reference For AI assistants