Haploidentical Donor Hematopoietic Progenitor Cell and NK Cell Transplantation for Hematologic Malignancy
NCT ID: NCT01807611
Last Updated: 2022-10-31
Study Results
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View full resultsBasic Information
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COMPLETED
PHASE2
82 participants
INTERVENTIONAL
2013-05-16
2021-09-27
Brief Summary
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The investigators anticipate enrollment of 75 donors and 75 recipients.
PRIMARY OBJECTIVE:
* To estimate the rate of successful engraftment at day +42 post-transplant in patients who receive haploidentical donor stem cell plus NK cell transplantation with TLI based conditioning regimen for high risk hematologic malignancy.
SECONDARY OBJECTIVES:
* Estimate the incidence of malignant relapse, event-free survival, and overall survival at one-year post-transplantation.
* Estimate incidence and severity of acute and chronic (GVHD).
* Estimate the rate of transplant related mortality (TRM) in the first 100 days after transplantation.
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Detailed Description
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The HPC products will be T-cell depleted (TCD) using the investigational CliniMACS device. CD34+ enrichment and CD45RA depletion will be utilized on sequential HPC grafts.
Participants will undergo a preparative regimen of total lymphoid irradiation, fludarabine, cyclophosphamide, granulocyte colony stimulating factor (G-CSF), thiotepa, and melphalan. This is followed by infusions of donor cells that have been prepared using the CliniMACS system: HPC,A (CD34+ selected), HPC,A (CD45RA depleted), and TC-NK.
Conditions
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Study Design
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NA
SINGLE_GROUP
TREATMENT
NONE
Study Groups
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Transplant Recipients
Participants undergo a preparative regimen of total lymphoid irradiation, fludarabine, cyclophosphamide, fludarabine, thiotepa, melphalan, and mycophenolate mofetil, followed by HPC,A infusion and TC-NK infusion. They also receive G-CSF and mesna.
Cells for infusion are prepared using the CliniMACS System.
Total Lymphoid Irradiation
Participants receive total lymphoid irradiation over four doses.
Fludarabine
Given IV.
Cyclophosphamide
Given IV.
Thiotepa
Given IV.
Melphalan
Given IV.
HPC,A Infusion
Participants received infusions of HPC,A (CD34+ selected) and HPC,A (CD45RA depleted).
TC-NK Infusion
Participants receive infusions of TC-NK.
G-CSF
Participants receive G-CSF subcutaneously or intravenously.
Donors receive G-CSF subcutaneously during cell mobilization.
Mesna
Mesna is generally dosed at approximately 25% of the cyclophosphamide dose. It is generally given intravenously prior to and again at 3, 6 and 9 hours following each dose of cyclophosphamide.
CliniMACS
The mechanism of action of the CliniMACS Cell Selection System is based on magnetic-activated cell sorting (MACS). The CliniMACS device is a powerful tool for the isolation of many cell types from heterogeneous cell mixtures, (e.g. apheresis products). These can then be separated in a magnetic field using an immunomagnetic label specific for the cell type of interest, such as CD3+ human T cells.
Mycophenolate mofetil
Given intravenously or orally.
Interventions
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Total Lymphoid Irradiation
Participants receive total lymphoid irradiation over four doses.
Fludarabine
Given IV.
Cyclophosphamide
Given IV.
Thiotepa
Given IV.
Melphalan
Given IV.
HPC,A Infusion
Participants received infusions of HPC,A (CD34+ selected) and HPC,A (CD45RA depleted).
TC-NK Infusion
Participants receive infusions of TC-NK.
G-CSF
Participants receive G-CSF subcutaneously or intravenously.
Donors receive G-CSF subcutaneously during cell mobilization.
Mesna
Mesna is generally dosed at approximately 25% of the cyclophosphamide dose. It is generally given intravenously prior to and again at 3, 6 and 9 hours following each dose of cyclophosphamide.
CliniMACS
The mechanism of action of the CliniMACS Cell Selection System is based on magnetic-activated cell sorting (MACS). The CliniMACS device is a powerful tool for the isolation of many cell types from heterogeneous cell mixtures, (e.g. apheresis products). These can then be separated in a magnetic field using an immunomagnetic label specific for the cell type of interest, such as CD3+ human T cells.
Mycophenolate mofetil
Given intravenously or orally.
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* Does not have a suitable MSD or volunteer MUD available in the necessary time for stem cell donation.
* Has a suitable single haplotype matched (≥ 3 of 6) and family member donor.
* High risk hematologic malignancy.
* If prior CNS leukemia, it must be treated and in CNS CR
* Does not have any other active malignancy other than the one for which this HCT is indicated.
* No prior allogeneic HCT, and no autologous HCT within the previous 12 months.
* Patient must fulfill pre-transplant evaluation
* At least single haplotype matched (≥ 3 of 6) family member
* At least 18 years of age.
* HIV negative.
* Not pregnant as confirmed by negative serum or urine pregnancy test within 14 days prior to enrollment (if female).
* Not breast feeding.
* Regarding eligibility, is identified as either: (1) Completed the process of donor eligibility determination as outlined in 21 CFR 1271 and agency guidance; OR (2) Does not meet 21 CFR 1271 eligibility requirements, but has a declaration of urgent medical need completed by the principal investigator or physician sub-investigator per 21 CFR 1271.
21 Years
ALL
No
Sponsors
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Assisi Foundation
OTHER
St. Jude Children's Research Hospital
OTHER
Responsible Party
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Principal Investigators
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Brandon M. Triplett, MD
Role: PRINCIPAL_INVESTIGATOR
St. Jude Children's Research Hospital
Locations
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St. Jude Children's Research Hospital
Memphis, Tennessee, United States
Countries
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References
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Naik S, Li Y, Talleur AC, Selukar S, Ashcraft E, Cheng C, Madden RM, Mamcarz E, Qudeimat A, Sharma A, Srinivasan A, Suliman AY, Epperly R, Obeng EA, Velasquez MP, Langfitt D, Schell S, Metais JY, Arnold PY, Hijano DR, Maron G, Merchant TE, Akel S, Leung W, Gottschalk S, Triplett BM. Memory T-cell enriched haploidentical transplantation with NK cell addback results in promising long-term outcomes: a phase II trial. J Hematol Oncol. 2024 Jun 27;17(1):50. doi: 10.1186/s13045-024-01567-0.
Provided Documents
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Document Type: Study Protocol and Statistical Analysis Plan
Document Type: Informed Consent Form
Related Links
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St. Jude Children's Research Hospital
Clinical Trials Open at St. Jude
Other Identifiers
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NCI-2013-00609
Identifier Type: REGISTRY
Identifier Source: secondary_id
HAPNK1
Identifier Type: -
Identifier Source: org_study_id
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