Working…
COVID-19 is an emerging, rapidly evolving situation.
Get the latest public health information from CDC: https://www.coronavirus.gov.

Get the latest research information from NIH: https://www.nih.gov/coronavirus.
ClinicalTrials.gov
ClinicalTrials.gov Menu

Stem Cell Transplant Therapy With Campath-1H for Treating Advanced Mycosis Fungoides and Sezary Syndrome

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT00047060
Recruitment Status : Completed
First Posted : January 27, 2003
Results First Posted : February 24, 2020
Last Update Posted : March 10, 2020
Sponsor:
Information provided by (Responsible Party):
National Institutes of Health Clinical Center (CC) ( National Heart, Lung, and Blood Institute (NHLBI) )

Study Type Interventional
Study Design Allocation: N/A;   Intervention Model: Single Group Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Conditions Mycosis Fungoides
Sezary Syndrome
Interventions Other: A matched peripheral donor stem cells
Drug: cyclosporine
Drug: fludarabine
Drug: Campath
Enrollment 5
Recruitment Details  
Pre-assignment Details  
Arm/Group Title Stem Cell Transplant Therapy With Campath-1H
Hide Arm/Group Description Subjects received a nonmyeloablative preparative regimen of alemtuzumab 30mg iv three times a week for two weeks followed by fludarabine 25mg/m2/day for five days followed by a PBPC graft targeted to deliver ≥ 5x106 CD34+ cells/kg. Cyclosporine A (CSA) for GVHD prophylaxis will be used initially with target CSA levels in the therapeutic range (200 -400 ng/ml)
Period Title: Overall Study
Started 5
Completed 3
Not Completed 2
Arm/Group Title Stem Cell Transplant Therapy With Campath-1H
Hide Arm/Group Description Subjects received a nonmyeloablative preparative regimen of alemtuzumab 30mg iv three times a week for two weeks followed by fludarabine 25mg/m2/day for five days followed by a PBPC graft targeted to deliver ≥ 5x106 CD34+ cells/kg. Cyclosporine A (CSA) for GVHD prophylaxis will be used initially with target CSA levels in the therapeutic range (200 -400 ng/ml)
Overall Number of Baseline Participants 5
Hide Baseline Analysis Population Description
[Not Specified]
Age, Categorical  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 5 participants
<=18 years
0
   0.0%
Between 18 and 65 years
5
 100.0%
>=65 years
0
   0.0%
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 5 participants
Female
2
  40.0%
Male
3
  60.0%
Ethnicity (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 5 participants
Hispanic or Latino
0
   0.0%
Not Hispanic or Latino
5
 100.0%
Unknown or Not Reported
0
   0.0%
Race (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 5 participants
American Indian or Alaska Native
0
   0.0%
Asian
0
   0.0%
Native Hawaiian or Other Pacific Islander
0
   0.0%
Black or African American
3
  60.0%
White
1
  20.0%
More than one race
0
   0.0%
Unknown or Not Reported
1
  20.0%
1.Primary Outcome
Title Efficacy of Nonmyeloablative Preparative Regimen
Hide Description Proportion of subjects achieving a complete response
Time Frame 36 months
Hide Outcome Measure Data
Hide Analysis Population Description
Received a nonmyeloablative preparative regimen of alemtuzumab 30mg iv 3x a week for 2 weeks followed by fludarabine 25mg/m2/day for five days followed by a PBPC graft targeted to deliver ≥ 5x106 CD34+ cells/kg. Cyclosporine A (CSA) for GVHD prophylaxis will be used initially w/target CSA levels in the therapeutic range (200 -400 ng/ml).
Arm/Group Title Stem Cell Transplant Therapy With Campath-1H
Hide Arm/Group Description:
Subjects received a nonmyeloablative preparative regimen of alemtuzumab 30mg iv three times a week for two weeks followed by fludarabine 25mg/m2/day for five days followed by a PBPC graft targeted to deliver ≥ 5x106 CD34+ cells/kg. Cyclosporine A (CSA) for GVHD prophylaxis will be used initially with target CSA levels in the therapeutic range (200 -400 ng/ml)
Overall Number of Participants Analyzed 5
Measure Type: Count of Participants
Unit of Measure: Participants
4
  80.0%
Time Frame 18 years
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Stem Cell Transplant Therapy With Campath-1H
Hide Arm/Group Description Subjects received a nonmyeloablative preparative regimen of alemtuzumab 30mg iv three times a week for two weeks followed by fludarabine 25mg/m2/day for five days followed by a PBPC graft targeted to deliver ≥ 5x106 CD34+ cells/kg. Cyclosporine A (CSA) for GVHD prophylaxis will be used initially with target CSA levels in the therapeutic range (200 -400 ng/ml).
All-Cause Mortality
Stem Cell Transplant Therapy With Campath-1H
Affected / at Risk (%)
Total   2/5 (40.00%) 
Hide Serious Adverse Events
Stem Cell Transplant Therapy With Campath-1H
Affected / at Risk (%)
Total   5/5 (100.00%) 
Blood and lymphatic system disorders   
Febrile Neutropenia   1/5 (20.00%) 
Eye disorders   
Eyelid disorder   1/5 (20.00%) 
Gastrointestinal disorders   
Abdominal pain   1/5 (20.00%) 
Vomiting   1/5 (20.00%) 
General disorders   
Disease Progression   2/5 (40.00%) 
Fatigue   1/5 (20.00%) 
Pain   2/5 (40.00%) 
Immune system disorders   
Acute graft versus host disease   1/5 (20.00%) 
chronic graft versus host disease   1/5 (20.00%) 
Infections and infestations   
Candida infection   1/5 (20.00%) 
Cytomegalovirus syndrome   3/5 (60.00%) 
Herpes Zoster   1/5 (20.00%) 
influenza   1/5 (20.00%) 
Pneumonia   1/5 (20.00%) 
Pneumonia bacterial   1/5 (20.00%) 
Sepsis   3/5 (60.00%) 
Skin infection   1/5 (20.00%) 
Urinary tract infection   1/5 (20.00%) 
Injury, poisoning and procedural complications   
Fall   1/5 (20.00%) 
Metabolism and nutrition disorders   
Dehydration   2/5 (40.00%) 
Hyponatremia   1/5 (20.00%) 
Neoplasms benign, malignant and unspecified (incl cysts and polyps)   
Haematological malignancy   1/5 (20.00%) 
Squamous cell carcinoma   2/5 (40.00%) 
Nervous system disorders   
Headache   1/5 (20.00%) 
Loss of consciousness   1/5 (20.00%) 
Psychiatric disorders   
Depression   1/5 (20.00%) 
Respiratory, thoracic and mediastinal disorders   
Pneumothorax   1/5 (20.00%) 
Vascular disorders   
Thromboembolic event   1/5 (20.00%) 
Indicates events were collected by systematic assessment
Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
Stem Cell Transplant Therapy With Campath-1H
Affected / at Risk (%)
Total   0/5 (0.00%) 
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: Aue, Georg
Organization: National Heart Lung and Blood Institute
Phone: +1 301 451 7141
EMail: aueg@nhlbi.nih.gov
Layout table for additonal information
Responsible Party: National Institutes of Health Clinical Center (CC) ( National Heart, Lung, and Blood Institute (NHLBI) )
ClinicalTrials.gov Identifier: NCT00047060    
Obsolete Identifiers: NCT00042640
Other Study ID Numbers: 020250
02-H-0250 ( Other Identifier: NIH - National Heart, Lung, and Blood Institute )
First Submitted: October 3, 2002
First Posted: January 27, 2003
Results First Submitted: February 14, 2020
Results First Posted: February 24, 2020
Last Update Posted: March 10, 2020