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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

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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

Study Description
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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.

Condition or disease Intervention/treatment Phase
Malignant Diseases Non-malignant Diseases Device: CliniMACS CD34+ cell enrichment and T-cell depletion Phase 2

Study Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 30 participants
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: 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
Study Start Date : May 2014
Estimated Primary Completion Date : December 2019
Estimated Study Completion Date : December 2020
Arms and Interventions
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Arm Intervention/treatment
Experimental: ARM A Malignant TBI
Malignant diseases Conditioning including total body irradiation and chemotherapy
 Device: CliniMACS CD34+ cell enrichment and T-cell depletion
Experimental: ARM B Malignant Non-TBI
Malignant diseases chemotherapy based conditioning
 Device: CliniMACS CD34+ cell enrichment and T-cell depletion
Experimental: ARM C Non-malignant
Non-malignant diseases Chemotherapy based conditioning
 Device: CliniMACS CD34+ cell enrichment and T-cell depletion


Outcome Measures
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Primary Outcome Measures :
  1. Incidence of severe (Grade III/IV) acute graft versus host disease [ Time Frame: Day 100 post transplant ]

Eligibility Criteria
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Ages Eligible for Study:   up to 35 Years   (Child, Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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.
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02162511


Locations
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United States, California
Stanford Children's Hospital Recruiting
Palo Alto, California, United States, 94305
Contact: Rajni Agarwal, MD    650-725-9250      
Contact: Leigh Shinn, RN    650-724-9179      
Principal Investigator: Rajni Agarwal, MD         
Sponsors and Collaborators
Rajni Agarwal
Investigators
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Principal Investigator: Rajni Agarwal, MD Stanford University
More Information
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Responsible Party: Rajni Agarwal, Principal Investigator, Stanford University
ClinicalTrials.gov Identifier: NCT02162511    
Other Study ID Numbers: 28663
First Posted: June 12, 2014    Key Record Dates
Last Update Posted: May 21, 2015
Last Verified: May 2015
Keywords provided by Rajni Agarwal, Stanford University:
Haplocompatible
Stem cell transplant
Borderline organ function
Alternative donor stem cell transplant