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CD34+ Cell Enriched and T Cell Depleted Allogeneic Stem Cell Transplantation for Patients With Mismatched Related Donors or Borderline Organ Function

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. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02162511
Recruitment Status : Recruiting
First Posted : June 12, 2014
Last Update Posted : May 21, 2015
Sponsor:
Information provided by (Responsible Party):
Rajni Agarwal, Stanford University

Tracking Information
First Submitted Date  ICMJE June 10, 2014
First Posted Date  ICMJE June 12, 2014
Last Update Posted Date May 21, 2015
Study Start Date  ICMJE May 2014
Estimated Primary Completion Date December 2019   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: June 11, 2014)
Incidence of severe (Grade III/IV) acute graft versus host disease [ Time Frame: Day 100 post transplant ]
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE Not Provided
Original Secondary Outcome Measures  ICMJE Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE CD34+ Cell Enriched and T Cell Depleted Allogeneic Stem Cell Transplantation for Patients With Mismatched Related Donors or Borderline Organ Function
Official Title  ICMJE An Expanded Access Study Using the CliniMACS System to Offer Therapeutic Manipulated Grafts That Are CD34 Cell Enriched and T Cell Depleted for Allogeneic Stem Cell Recipients With Mismatched Related Donors or Borderline Organ Function
Brief Summary The purpose of this protocol is to provide access to the CliniMACS® System to hematopoietic cell transplant (HSCT) patients who do not have a matched related donor. The CliniMACS system is currently approved for use in patients who have AML, and a genetically matched sibling donor. Through this protocol, the investigators will be able to offer potentially life-saving transplants to patients who have genetically mis-matched donor, who have no other options for treatment.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 2
Study Design  ICMJE Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE
  • Malignant Diseases
  • Non-malignant Diseases
Intervention  ICMJE Device: CliniMACS CD34+ cell enrichment and T-cell depletion
Study Arms  ICMJE
  • Experimental: ARM A Malignant TBI
    Malignant diseases Conditioning including total body irradiation and chemotherapy
    Intervention: Device: CliniMACS CD34+ cell enrichment and T-cell depletion
  • Experimental: ARM B Malignant Non-TBI
    Malignant diseases chemotherapy based conditioning
    Intervention: Device: CliniMACS CD34+ cell enrichment and T-cell depletion
  • Experimental: ARM C Non-malignant
    Non-malignant diseases Chemotherapy based conditioning
    Intervention: Device: CliniMACS CD34+ cell enrichment and T-cell depletion
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Recruiting
Estimated Enrollment  ICMJE
 (submitted: June 11, 2014)
30
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE December 2020
Estimated Primary Completion Date December 2019   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • Participant age is 0 (newborn) to 35 years-old.
  • Participant has a disorder affecting the hematopoietic system that are inherited, acquired, or a result from the myeloablative treatment that can benefit from alternative stem cell transplantation according to standard practice guidelines for including patients for transplant.
  • Participant's medical screening clears s/he for allogeneic transplantation as per current institutional SOP based on standards of foundation for accreditation of cellular therapy and stem cell transplantation (FACT);
  • Participant must lack a healthy, HLA-identical related or unrelated donor unless s/he has a borderline organ function that will preclude the recipient from receiving a curative therapy due to the need of post-HSCT immunosuppressive therapy.
  • Participant must have a matched or mismatched-related donor who is:
  • Able to receive granulocyte colony-stimulating factor (G-CSF) and undergo apheresis either through placement of catheters in antecubital veins or a temporary central venous catheter OR agrees on a bone marrow harvest;
  • Healthy as per donor selection screening (following current SOP based on standards of foundation for accreditation of cellular therapy and stem cell transplantation - FACT);
  • Willing to participate and sign consent.
  • Participant or Legal Authorized Representative is able to sign informed consent (and signed assent, if applicable) for transplant.

Exclusion Criteria:

  • Participant does not qualify for an allogeneic transplant due to medical screening, underlying disease, or lack of alternative donors.
  • Any condition that compromises compliance with the procedures of this protocol, as judged by the principal investigator.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE up to 35 Years   (Child, Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT02162511
Other Study ID Numbers  ICMJE 28663
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Rajni Agarwal, Stanford University
Study Sponsor  ICMJE Rajni Agarwal
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Rajni Agarwal, MD Stanford University
PRS Account Stanford University
Verification Date May 2015

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP