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AlloSCT for Malignant and Non-malignant Hematologic Diseases Utilizing Alpha/Beta T Cell and CD19+ B Cell Depletion

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ClinicalTrials.gov Identifier: NCT04099966
Recruitment Status : Not yet recruiting
First Posted : September 23, 2019
Last Update Posted : February 27, 2020
Sponsor:
Information provided by (Responsible Party):
Mitchell Cairo, New York Medical College

Tracking Information
First Submitted Date  ICMJE September 18, 2019
First Posted Date  ICMJE September 23, 2019
Last Update Posted Date February 27, 2020
Estimated Study Start Date  ICMJE April 1, 2020
Estimated Primary Completion Date December 31, 2023   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: September 20, 2019)
incidence of adverse events related to administration of α/β CD3+/CD19+ cell depleted stem cells [ Time Frame: 1 year ]
patients will be monitored for any adverse events related to administration of α/β CD3+/CD19+ cell depleted stem cells
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: September 20, 2019)
  • incidence of hematpoitic engraftment following Allogeneic stem cell transplantation (AlloSCT) utilizing α/β CD3+/CD19+ cell depletion [ Time Frame: 1 year ]
    patients will have routine chimerism performed to monitoring engraftment of donor cells
  • incidence of GVHD following Allogeneic stem cell transplantation (AlloSCT) utilizing α/β CD3+/CD19+ cell depletion [ Time Frame: 1 year ]
    patients will be monitored post transplant for signs of acute and chronic GVHD
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE AlloSCT for Malignant and Non-malignant Hematologic Diseases Utilizing Alpha/Beta T Cell and CD19+ B Cell Depletion
Official Title  ICMJE Allogeneic Stem Cell Transplantation for Malignant and Non-malignant Hematologic Diseases Utilizing Alpha/Beta T Cell and CD19+ B Cell Depletion - NYMC 588
Brief Summary Children, adolescents, and young adults with malignant and non-malignant conditionsundergoing an allogeneic stem cell transplantation (AlloSCT) will have the stem cells selected utilizing α/β CD3+/CD19+ cell depletion. All other treatment is standard of care.
Detailed Description

Patients wiith selected malignant or non-malignant conditions meeting eligibility criteria will be enrolled on this study. Patients will receive one of either full intensity, reduced intensity, or reduced toxicity conditioning appropriate based on disease, disease status, organ function and performance status and will undergo α/β T-cell and CD 19+ B cell depleted alloSCT.

Patients will be following for engraftment, chimerism, immune reconstitution, GVHD and QOL.

Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 2
Study Design  ICMJE Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE
  • Acute Leukemia
  • Severe Aplastic Anemia
  • Non-hodgkin Lymphoma
  • Hodgkin Lymphoma
  • Kostmann
  • Diamond Blackfan Anemia
  • Amegakaryocytic Thrombocytopenia
  • Sickle Cell Disease
  • Beta-Thalassemia
Intervention  ICMJE Drug: alpha beta depletion
donor cells will be collected and subsequently undergo α/β CD3+/CD19+ cell depletion.
Other Name: α/β CD3+/CD19+ cell depletion
Study Arms  ICMJE Experimental: alpha beta cell depletion
Matched allogeneic donor stem cells will be processed utilizing α/β CD3+/CD19+ cell depletion with the Prodigy system. Standard pre-conditioning and post-transplant motioning will be given.
Intervention: Drug: alpha beta 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 Not yet recruiting
Estimated Enrollment  ICMJE
 (submitted: September 20, 2019)
20
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE December 31, 2024
Estimated Primary Completion Date December 31, 2023   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  1. ALL:ALL high risk including one or more of the following: (t(9;22) or 11q23 chromosomal abnormality, primary induction failure (<15% blasts at time of registration), mixed phenotype acute leukemia (MPAL), persistent MRD (<0.01% by flow or persistent abnormal karyotype detected by cytogenetics) or hypodiploidy (44 chromosomes)) in first remission ' ALL in second remission and beyond;
  2. AML: History of AML induction/reinduction Failure (<15% blasts at time of registration); AML in CR1 with poor cytogenetics (i.e. 12p, 5a, -7, FLT3 mutation/duplication, t(9;11) and others); AML with persistent minimal residual disease (MRD) in CR1(<0.01% on flow or persistent abnormal karyotype detected by cytogenetics); AML CR2 or beyond; AML in refractory relapse but ≤15% bone marrow leukemia blasts; Therapy-related AML
  3. High Risk Myelodysplastic syndrome (MDS) 4 Lymphoma: Hodgkin (HL) or Non-Hodgkin (NHL): HL or NHL in induction failure; HL or NHL in PR1 or PR2 ; HL or NHL in CR2 or subsequent remission

5. Bone marrow failure syndromes: Kostmann syndrome refractory or intolerant to granulocyte colony-33stimulating factor; Diamond-Blackfan anemia refractory or intolerant to corticosteroids and/or cyclosporine'; amegakaryocytic thrombocytopenia 6. Sickle Cell Disease (Homozygous Hemoglobin S Disease, or Hemoglobin S β 0/+ thalassemia, or Hemoglobin SC Disease) 7. age 0-30 years 8. adequate organ function

Exclusion Criteria:

  1. Females who are pregnant or breast-feeding are not eligible.
  2. Patients with documented uncontrolled infection at the time of study entry are not eligible.
  3. Karnofsky/Lansky (age appropriate) Performance Score <60
  4. Demonstrated lack of compliance with medical care
  5. Patients who have received allogeneic HSCT within 6 months, unless being done as a boost.
  6. Patients with active <Grade 2 GVHD.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE up to 30 Years   (Child, Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE
Contact: Mitchell S Cairo, MD 9145942150 mitchell_cairo@nymc.edu
Contact: Lauren Harrison, RN 6172857844 lauren_harrison@nymc.edu
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT04099966
Other Study ID Numbers  ICMJE NYMC 588
Has Data Monitoring Committee No
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Responsible Party Mitchell Cairo, New York Medical College
Study Sponsor  ICMJE Mitchell Cairo
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Chair: Mitchell S Cairo New York Medical College
PRS Account New York Medical College
Verification Date February 2020

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