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Reduced Intensity Preparative Regimen Followed by Stem Cell Transplant (FAB)

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ClinicalTrials.gov Identifier: NCT00579111
Recruitment Status : Terminated (slow accrual)
First Posted : December 21, 2007
Results First Posted : August 9, 2012
Last Update Posted : May 4, 2016
Sponsor:
Collaborators:
Center for Cell and Gene Therapy, Baylor College of Medicine
The Methodist Hospital System
Information provided by (Responsible Party):
Rammurti Kamble, Baylor College of Medicine

Study Type Interventional
Study Design Allocation: Non-Randomized;   Intervention Model: Parallel Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Conditions Myelodysplastic and Myeloproliferative Disorders
Acute Myelogenous Leukemia
Acute Lymphoblastic Leukemia
Chronic Myelogenous Leukemia
Multiple Myeloma
Plasma Cell Dyscrasia
Lymphoproliferative Disorders
Hematologic Diseases
Interventions Drug: Campath
Drug: Busulfan
Drug: Fludarabine
Procedure: Hematopoietic stem cell infusion
Drug: FK-506
Enrollment 4
Recruitment Details  
Pre-assignment Details  
Arm/Group Title HLA-identical Sibling Transplant Unrelated Matched or Single Antigen Mismatched Transplant
Hide Arm/Group Description Recipients of HLA identical sibling stem cell transplants Recipients of unrelated matched or single antigen mismatched donor stem cell transplant or single antigen mismatched family donor stem cell transplants
Period Title: Overall Study
Started 3 1
Completed 1 0
Not Completed 2 1
Arm/Group Title HLA-identical Sibling Transplant Unrelated Matched or Single Antigen Mismatched Transplant Total
Hide Arm/Group Description Recipients of HLA identical sibling stem cell transplants Recipients of unrelated matched or single antigen mismatched donor stem cell transplant or single antigen mismatched family donor stem cell transplants Total of all reporting groups
Overall Number of Baseline Participants 3 1 4
Hide Baseline Analysis Population Description
[Not Specified]
Age, Customized  
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 3 participants 1 participants 4 participants
Between 50 and 65 years 3 0 3
>=65 years 0 1 1
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 3 participants 1 participants 4 participants
Female
1
  33.3%
0
   0.0%
1
  25.0%
Male
2
  66.7%
1
 100.0%
3
  75.0%
1.Primary Outcome
Title Number of Patients With Successful Donor Engraftment
Hide Description Each patient will be classified as a success or failure. A success will be defined as engraftment of at least 35% of cells 100 days after transplant.
Time Frame 100 days
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title HLA-identical Sibling Transplant Unrelated Matched or Single Antigen Mismatched Transplant
Hide Arm/Group Description:
Recipients of HLA identical sibling stem cell transplants
Recipients of unrelated matched or single antigen mismatched donor stem cell transplant or single antigen mismatched family donor stem cell transplants
Overall Number of Participants Analyzed 3 1
Measure Type: Number
Unit of Measure: participants
2 1
2.Secondary Outcome
Title Number of Patients With Treatment Related Grade III or IV Non-hematological Toxicity
Hide Description [Not Specified]
Time Frame 100 days
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title HLA-identical Sibling Transplant Unrelated Matched or Single Antigen Mismatched Transplant
Hide Arm/Group Description:
Recipients of HLA identical sibling stem cell transplants
Recipients of unrelated matched or single antigen mismatched donor stem cell transplant or single antigen mismatched family donor stem cell transplants
Overall Number of Participants Analyzed 3 1
Measure Type: Number
Unit of Measure: participants
1 0
Time Frame [Not Specified]
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title HLA-identical Sibling Transplant Unrelated Matched or Single Antigen Mismatched Transplant
Hide Arm/Group Description Recipients of HLA identical sibling stem cell transplants Recipients of unrelated matched or single antigen mismatched donor stem cell transplant or single antigen mismatched family donor stem cell transplants
All-Cause Mortality
HLA-identical Sibling Transplant Unrelated Matched or Single Antigen Mismatched Transplant
Affected / at Risk (%) Affected / at Risk (%)
Total   --/--      --/--    
Hide Serious Adverse Events
HLA-identical Sibling Transplant Unrelated Matched or Single Antigen Mismatched Transplant
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   2/3 (66.67%)      0/1 (0.00%)    
Blood and lymphatic system disorders     
Blood/Bone Marrow - Other: Engraftment Failure   1/3 (33.33%)  1 0/1 (0.00%)  0
Infections and infestations     
Infection (documented clinically or microbiologically) with Grade 3 or 4 neutrophils (ANC <1.0 x 10e   1/3 (33.33%)  2 0/1 (0.00%)  0
Indicates events were collected by systematic assessment
Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
HLA-identical Sibling Transplant Unrelated Matched or Single Antigen Mismatched Transplant
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   0/3 (0.00%)      0/1 (0.00%)    
Certain Agreements
All Principal Investigators ARE employed by the organization sponsoring the study.
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: Rammurti Kamble, MD
Organization: Baylor
Phone: 713-394-6252
EMail: rtkamble@tmhs.org
Layout table for additonal information
Responsible Party: Rammurti Kamble, Baylor College of Medicine
ClinicalTrials.gov Identifier: NCT00579111    
Obsolete Identifiers: NCT00625144
Other Study ID Numbers: 19386
FAB
First Submitted: December 19, 2007
First Posted: December 21, 2007
Results First Submitted: July 3, 2012
Results First Posted: August 9, 2012
Last Update Posted: May 4, 2016