Trial · NCT01319851

Alefacept and Allogeneic Hematopoietic Stem Cell Transplantation

NCT01319851, Not applicable, Terminated, Emory University; results first posted 2015-03-09

3 sourcestrials-2026-11-12-0.5.0

Cite this record

ConductScience Library. Alefacept and Allogeneic Hematopoietic Stem Cell Transplantation. Trials, record NCT01319851. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT01319851

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Trial

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

Title: Alefacept and Allogeneic Hematopoietic Stem Cell Transplantation
NCT number: NCT01319851
Status: Terminated
Phases: Not applicable
Enrollment: 3 participants, actual
Lead sponsor: Emory University
Conditions: Thalassemia, Sickle Cell Disease, Glanzmann Thrombasthenia, Wiskott-Aldrich Syndrome, Chronic-granulomatous Disease, Severe Congenital Neutropenia, Leukocyte Adhesion Deficiency, Schwachman-Diamond Syndrome, Diamond-Blackfan Anemia, Fanconi Anemia, Dyskeratosis-congenita, Chediak-Higashi Syndrome, Severe Aplastic Anemia
Interventions: Alefacept
First posted: 2011-03-22
Last updated: 2017-07-27
Results first posted: 2015-03-09
Limitations and caveats: Production of alefacept was halted in 2011.

Source ClinicalTrials.gov

Registered outcomes7

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

List	Outcome	Time frame	Description
Primary	Feasibility of Alefacept Pre-conditioning, Measured by Number of Subjects With Full Donor Engraftment	Two years post-transplant	All subjects received alefacept prior to hematopoietic stem cell transplantation and were followed up to at least two years after transplantation to ensure successful engraftment.
Secondary	Number of Participants That Expressed Grade 2 or 3 Regimen-Related Toxicity	Day 42 post-transplant	Regimen-related toxicity was measured using the Bearman criteria. The Bearman criteria grades toxicity levels at Grade 1, Grade 2, Grade 3, and Grade 4. In this system, grade I toxicity is reversible without treatment and grade 2 is not life threatening, but requires treatment. Grade 3 requires life-support intervention and grade 4 is fatal. All regimen-related toxicities were determined to be unlikely attributable to the study drug.
Secondary	Number of Participants That Expressed Successful Neutrophil Engraftment	Day 100 post-transplant	Neutrophil engraftment was assessed with absolute neutrophils \>500\*10\^8/kg by 100 days post transplant. Neutrophils were counted by performing a complete blood cell count (CBC).
Secondary	Incidence of Greater Than or Equal to 85% CD3 Donor Chimerism	Day 30 post-transplant	CD3 chimerism was measured from peripheral blood lymphocytes 30 days post transplant. DNA chimerism analysis was performed by amplified fragment length polymorphism.
Secondary	Incidence of 100% CD33 Donor Chimerism	Day 30 post-transplant	CD33 chimerism was measured from peripheral blood lymphocytes 30 days post transplant. DNA chimerism analysis was performed by amplified fragment length polymorphism.
Secondary	Number of Participants Who Experienced Acute Graft-versus-host Disease (aGVHD), Measured by NIH Consensus Criteria (NCC) Score: Grade II-IV	Day 30 post-transplant	Cumulative Incidence of Grade II-IV aGVHD Score at 30 Days. The NIH Consensus grading and severity criteria includes physical assessments of skin, oral cavity, eyes, gynecological and laboratory data and patient reports. Each domain is scored from Grade 0 (no involvement) to Grade IV (severe involvement).
Secondary	Number of Participants Who Experienced Chronic Graft-versus-host Disease (cGVHD), Measured by the NIH Criteria Consensus (NCC)	Day 100 post-transplant	The severity criteria of chronic graft-versus-host disease (cGVHD) recommended by the NIH Criteria Consensus (NCC) was employed. The number of organs involved and the severity of the disease in these organs dictated the global summary score used to define the disease as mild, moderate, or severe. Mild disease indicates one or two organs involved each with a maximal score of 1. Moderate disease indicates three or more organs involved with a score of 2 in any individual organ, or lung involvement with a score of 1. Severe global GVHD is defined by a score of 3 in any organ, or a lung score of 2.

Source ClinicalTrials.gov

Outcomes7

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

Type	Outcome	Time frame	Units	Measured as
PRIMARY	Feasibility of Alefacept Pre-conditioning, Measured by Number of Subjects With Full Donor Engraftment	Two years post-transplant	participants	NUMBER
SECONDARY	Number of Participants That Expressed Grade 2 or 3 Regimen-Related Toxicity	Day 42 post-transplant	participants	NUMBER
SECONDARY	Number of Participants That Expressed Successful Neutrophil Engraftment	Day 100 post-transplant	participants	NUMBER
SECONDARY	Incidence of Greater Than or Equal to 85% CD3 Donor Chimerism	Day 30 post-transplant	participants	NUMBER
SECONDARY	Incidence of 100% CD33 Donor Chimerism	Day 30 post-transplant	participants	NUMBER
SECONDARY	Number of Participants Who Experienced Acute Graft-versus-host Disease (aGVHD), Measured by NIH Consensus Criteria (NCC) Score: Grade II-IV	Day 30 post-transplant	participants	NUMBER
SECONDARY	Number of Participants Who Experienced Chronic Graft-versus-host Disease (cGVHD), Measured by the NIH Criteria Consensus (NCC)	Day 100 post-transplant	participants	NUMBER

Source ClinicalTrials.gov

Results by group11

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

Outcome	Group	Category	Value	Units
Feasibility of Alefacept Pre-conditioning, Measured by Number of Subjects With Full Donor Engraftment	Alefacept		3	participants
Number of Participants That Expressed Grade 2 or 3 Regimen-Related Toxicity	Alefacept		2	participants
Number of Participants That Expressed Successful Neutrophil Engraftment	Alefacept		3	participants
Incidence of Greater Than or Equal to 85% CD3 Donor Chimerism	Alefacept		3	participants
Incidence of 100% CD33 Donor Chimerism	Alefacept		3	participants
Number of Participants Who Experienced Acute Graft-versus-host Disease (aGVHD), Measured by NIH Consensus Criteria (NCC) Score: Grade II-IV	Alefacept	Grade II	2	participants
Number of Participants Who Experienced Acute Graft-versus-host Disease (aGVHD), Measured by NIH Consensus Criteria (NCC) Score: Grade II-IV	Alefacept	Grade III	1	participants
Number of Participants Who Experienced Acute Graft-versus-host Disease (aGVHD), Measured by NIH Consensus Criteria (NCC) Score: Grade II-IV	Alefacept	Grade IV	0	participants
Number of Participants Who Experienced Chronic Graft-versus-host Disease (cGVHD), Measured by the NIH Criteria Consensus (NCC)	Alefacept	Mild cGVHD	0	participants
Number of Participants Who Experienced Chronic Graft-versus-host Disease (cGVHD), Measured by the NIH Criteria Consensus (NCC)	Alefacept	Moderate cGVHD	1	participants

1 to 10 of 11Source ClinicalTrials.gov

See all 11 results by group

Participant flow3

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

Period	Milestone	Group	Participants
Overall Study	STARTED	Alefacept	3
Overall Study	COMPLETED	Alefacept	3
Overall Study	NOT COMPLETED	Alefacept	0

Source ClinicalTrials.gov

Adverse events6

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	Pulmonary aspergillosis	Infections and infestations	Alefacept	1	3	1
other	Cytomegalovirus (CMV) Viremia	Infections and infestations	Alefacept	1	3	1
other	Sinusitis	Respiratory, thoracic and mediastinal disorders	Alefacept	1	3	1
other	Bacteremia	Blood and lymphatic system disorders	Alefacept	1	3	1
serious	Stomatitis	Gastrointestinal disorders	Alefacept	2	3	2
serious	Chronic graft versus host disease	Immune system disorders	Alefacept	2	3	3

Source ClinicalTrials.gov

Adverse event totals3

The totals the trial posted for each group.

Total	Group	Affected	At risk
Total, all-cause mortality	Alefacept
Total, other adverse events	Alefacept	2	3
Total, serious adverse events	Alefacept	2	3

Source ClinicalTrials.gov

Papers1

The papers the trial lists on ClinicalTrials.gov.

PMID	Listed as
26095669	DERIVED

Source 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 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.

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GET https://conductscience.org/api/trials/v1/NCT01319851/registered

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