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Trial record 16 of 18 for:    "Acute Promyelocytic Leukemia" | "Methotrexate"

Alemtuzumab, Busulfan, and Cyclophosphamide Followed By a Donor Stem Cell Transplant in Treating Patients With Hematologic Cancer

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ClinicalTrials.gov Identifier: NCT00555048
Recruitment Status : Terminated (Low accrual)
First Posted : November 7, 2007
Results First Posted : May 24, 2017
Last Update Posted : May 24, 2017
Sponsor:
Collaborator:
National Cancer Institute (NCI)
Information provided by (Responsible Party):
Ann Woolfrey, Fred Hutchinson Cancer Research Center

Study Type Interventional
Study Design Primary Purpose: Treatment
Conditions Graft Versus Host Disease
Leukemia
Myelodysplastic Syndromes
Myelodysplastic/Myeloproliferative Diseases
Interventions Biological: alemtuzumab
Drug: busulfan
Drug: cyclophosphamide
Drug: methotrexate
Drug: tacrolimus
Procedure: allogeneic hematopoietic stem cell transplantation
Procedure: peripheral blood stem cell transplantation
Enrollment 1
Recruitment Details  
Pre-assignment Details  
Arm/Group Title Alemtuzumab
Hide Arm/Group Description

Alemtuzumab given together with busulfan and cyclophosphamide followed by a donor stem cell transplant.

alemtuzumab

busulfan

cyclophosphamide

methotrexate

tacrolimus

allogeneic hematopoietic stem cell transplantation

peripheral blood stem cell transplantation

Period Title: Overall Study
Started 1
Completed 1
Not Completed 0
Arm/Group Title Alemtuzumab
Hide Arm/Group Description

Alemtuzumab given together with busulfan and cyclophosphamide followed by a donor stem cell transplant.

alemtuzumab

busulfan

cyclophosphamide

methotrexate

tacrolimus

allogeneic hematopoietic stem cell transplantation

peripheral blood stem cell transplantation

Overall Number of Baseline Participants 1
Hide Baseline Analysis Population Description
[Not Specified]
Age, Continuous  
Median (Full Range)
Unit of measure:  Years
Number Analyzed 1 participants
47
(47 to 47)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 1 participants
Female
0
   0.0%
Male
1
 100.0%
1.Primary Outcome
Title Lowest Dose of Alemtuzumab Associated With Transplant-related Mortality
Hide Description Lowest dose of alemtuzumab associated with transplant-related mortality at day 180
Time Frame Up to day 180
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Alemtuzumab
Hide Arm/Group Description:

Alemtuzumab given together with busulfan and cyclophosphamide followed by a donor stem cell transplant.

alemtuzumab

busulfan

cyclophosphamide

methotrexate

tacrolimus

allogeneic hematopoietic stem cell transplantation

peripheral blood stem cell transplantation

Overall Number of Participants Analyzed 1
Measure Type: Number
Unit of Measure: mg total dose
40
2.Secondary Outcome
Title Life-threatening Infection
Hide Description [Not Specified]
Time Frame Up to 180 days
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Alemtuzumab
Hide Arm/Group Description:

Alemtuzumab given together with busulfan and cyclophosphamide followed by a donor stem cell transplant.

alemtuzumab

busulfan

cyclophosphamide

methotrexate

tacrolimus

allogeneic hematopoietic stem cell transplantation

peripheral blood stem cell transplantation

Overall Number of Participants Analyzed 1
Measure Type: Count of Participants
Unit of Measure: Participants
0
   0.0%
3.Secondary Outcome
Title Grades III-IV Acute Graft-vs-host Disease (GVHD)
Hide Description [Not Specified]
Time Frame Up to 100 days
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Alemtuzumab
Hide Arm/Group Description:

Alemtuzumab given together with busulfan and cyclophosphamide followed by a donor stem cell transplant.

alemtuzumab

busulfan

cyclophosphamide

methotrexate

tacrolimus

allogeneic hematopoietic stem cell transplantation

peripheral blood stem cell transplantation

Overall Number of Participants Analyzed 1
Measure Type: Count of Participants
Unit of Measure: Participants
0
   0.0%
4.Secondary Outcome
Title Overall Survival
Hide Description Count of surviving participants at 1 year
Time Frame Up to 1 year
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Alemtuzumab
Hide Arm/Group Description:

Alemtuzumab given together with busulfan and cyclophosphamide followed by a donor stem cell transplant.

alemtuzumab

busulfan

cyclophosphamide

methotrexate

tacrolimus

allogeneic hematopoietic stem cell transplantation

peripheral blood stem cell transplantation

Overall Number of Participants Analyzed 1
Measure Type: Count of Participants
Unit of Measure: Participants
1
 100.0%
5.Secondary Outcome
Title Disease Relapse
Hide Description Count of participants with disease relapse at 1 year
Time Frame Up to 1 year
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Alemtuzumab
Hide Arm/Group Description:

Alemtuzumab given together with busulfan and cyclophosphamide followed by a donor stem cell transplant.

alemtuzumab

busulfan

cyclophosphamide

methotrexate

tacrolimus

allogeneic hematopoietic stem cell transplantation

peripheral blood stem cell transplantation

Overall Number of Participants Analyzed 1
Measure Type: Count of Participants
Unit of Measure: Participants
0
   0.0%
6.Secondary Outcome
Title Extensive Chronic GVHD
Hide Description Count of participants with extensive chronic GVHD at 1 year
Time Frame Up to 1 year
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Alemtuzumab
Hide Arm/Group Description:

Alemtuzumab given together with busulfan and cyclophosphamide followed by a donor stem cell transplant.

alemtuzumab

busulfan

cyclophosphamide

methotrexate

tacrolimus

allogeneic hematopoietic stem cell transplantation

peripheral blood stem cell transplantation

Overall Number of Participants Analyzed 1
Measure Type: Count of Participants
Unit of Measure: Participants
1
 100.0%
7.Secondary Outcome
Title Graft Failure
Hide Description Count of participants with graft failure at day 100
Time Frame Up to day 100
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Alemtuzumab
Hide Arm/Group Description:

Alemtuzumab given together with busulfan and cyclophosphamide followed by a donor stem cell transplant.

alemtuzumab

busulfan

cyclophosphamide

methotrexate

tacrolimus

allogeneic hematopoietic stem cell transplantation

peripheral blood stem cell transplantation

Overall Number of Participants Analyzed 1
Measure Type: Count of Participants
Unit of Measure: Participants
0
   0.0%
Time Frame [Not Specified]
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Alemtuzumab
Hide Arm/Group Description

Alemtuzumab given together with busulfan and cyclophosphamide followed by a donor stem cell transplant.

alemtuzumab

busulfan

cyclophosphamide

methotrexate

tacrolimus

allogeneic hematopoietic stem cell transplantation

peripheral blood stem cell transplantation

All-Cause Mortality
Alemtuzumab
Affected / at Risk (%)
Total   --/-- 
Show Serious Adverse Events Hide Serious Adverse Events
Alemtuzumab
Affected / at Risk (%)
Total   0/1 (0.00%) 
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
Alemtuzumab
Affected / at Risk (%)
Total   0/1 (0.00%) 
Certain Agreements
All Principal Investigators ARE employed by the organization sponsoring the study.
Results Point of Contact
Name/Title: Ann Woolfrey, MD
Organization: Fred Hutchinson Cancer Research Center
Phone: 206-667-4453
Responsible Party: Ann Woolfrey, Fred Hutchinson Cancer Research Center
ClinicalTrials.gov Identifier: NCT00555048     History of Changes
Other Study ID Numbers: 1981.00
P30CA015704 ( U.S. NIH Grant/Contract )
FHCRC-1981.00
CDR0000574145 ( Registry Identifier: PDQ )
First Submitted: November 6, 2007
First Posted: November 7, 2007
Results First Submitted: April 17, 2017
Results First Posted: May 24, 2017
Last Update Posted: May 24, 2017