Selective Depletion of CD45RA+ T Cells From Allogeneic Peripheral Blood Stem Cell Grafts in Preventing GVHD in Children
NCT ID: NCT01858740
Last Updated: 2024-03-12
Study Results
Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.
View full resultsBasic Information
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
COMPLETED
PHASE2
20 participants
INTERVENTIONAL
2014-04-10
2023-07-30
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
Related Clinical Trials
Explore similar clinical trials based on study characteristics and research focus.
Selective Depletion of CD45RA+T Cells From Allogeneic Peripheral Blood Stem Cell Grafts for the Prevention of GVHD
NCT00914940
Selective Depletion of CD45RA+ T Cells From Allogeneic Peripheral Blood Stem Cell Grafts From HLA-Matched Related and Unrelated Donors in Preventing GVHD
NCT02220985
Naive T Cell Depletion for Preventing Chronic Graft-versus-Host Disease in Children and Young Adults With Blood Cancers Undergoing Donor Stem Cell Transplant
NCT03779854
Genetically Modified T-cell Infusion Following Peripheral Blood Stem Cell Transplant in Treating Patients With Recurrent or High-Risk Non-Hodgkin Lymphoma
NCT01815749
Phase 1/2: CD45RA Depleted Stem Cell Addback to Prevent Viral or Fungal Infections Post TCRab/CD19 Depleted HSCT
NCT06839456
Detailed Description
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
CONDITIONING REGIMEN: Patients undergo total body irradiation (TBI) twice daily (BID) on days -10 to -7, receive thiotepa intravenously (IV) over 4 hours on days -6 and -5 and fludarabine phosphate IV over 30 minutes on days -6 to -2.
TRANSPLANT: Patients undergo CD34+ enriched, CD45RA+ T cell-depleted allogeneic PBSCT on day 0.
POST-TRANSPLANT IMMUNOSUPPRESSION: Patients receive tacrolimus IV continuously or orally (PO) every 12 hours beginning on day -1 and continuing through day 50 with taper. Patients also receive methotrexate IV on days 1, 3, 6, and 11.
After completion of study treatment, patients are followed up for up to 5 years.
Conditions
See the medical conditions and disease areas that this research is targeting or investigating.
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
NA
SINGLE_GROUP
TREATMENT
NONE
Study Groups
Review each arm or cohort in the study, along with the interventions and objectives associated with them.
Treatment (CD45RA+ T cell depleted PBSCT)
CONDITIONING REGIMEN: Patients undergo TBI BID on days -10 to -7, receive thiotepa IV over 4 hours on days -6 and -5 and fludarabine phosphate IV over 30 minutes on days -6 to -2.
TRANSPLANT: Patients undergo CD34+ enriched, CD45RA+ T cell-depleted allogeneic PBSCT on day 0.
POST-TRANSPLANT IMMUNOSUPPRESSION: Patients receive tacrolimus IV continuously or PO every 12 hours beginning on day -1 and continuing through day 50 with taper. Patients also receive methotrexate IV on days 1, 3, 6, and 11.
Allogeneic Hematopoietic Stem Cell Transplantation
Undergo CD45RA+ T cell-depleted allogeneic peripheral blood stem cell transplant
Fludarabine Phosphate
Given IV
Laboratory Biomarker Analysis
Correlative studies
Methotrexate
Given IV
Peripheral Blood Stem Cell Transplantation
Undergo CD45RA+ T cell-depleted allogeneic peripheral blood stem cell transplant
T Cell-Depleted Hematopoietic Stem Cell Transplantation
Undergo CD45RA+ T cell-depleted allogeneic peripheral blood stem cell transplant
Tacrolimus
Given IV or PO
Thiotepa
Given IV
Total-Body Irradiation
Undergo TBI
Interventions
Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.
Allogeneic Hematopoietic Stem Cell Transplantation
Undergo CD45RA+ T cell-depleted allogeneic peripheral blood stem cell transplant
Fludarabine Phosphate
Given IV
Laboratory Biomarker Analysis
Correlative studies
Methotrexate
Given IV
Peripheral Blood Stem Cell Transplantation
Undergo CD45RA+ T cell-depleted allogeneic peripheral blood stem cell transplant
T Cell-Depleted Hematopoietic Stem Cell Transplantation
Undergo CD45RA+ T cell-depleted allogeneic peripheral blood stem cell transplant
Tacrolimus
Given IV or PO
Thiotepa
Given IV
Total-Body Irradiation
Undergo TBI
Other Intervention Names
Discover alternative or legacy names that may be used to describe the listed interventions across different sources.
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
* Acute lymphocytic leukemia in first or subsequent remission
* Acute myeloid leukemia in first or subsequent remission
* Acute lymphocytic leukemia in relapse or primary refractory disease with a circulating blast count of no more than 10,000/mm\^3
* Acute myeloid leukemia in relapse or primary refractory disease with a circulating blast count of no more than 10,000/mm\^3
* Refractory anemia with excess blasts (RAEB-1 and RAEB-2)
* Chronic myelogenous leukemia with a history of accelerated phase or blast crisis
* Other acute leukemia (including but not limited to 'biphenotypic', 'undifferentiated' or 'ambiguous lineage' acute leukemia)
* Patient with a human leukocyte antigen (HLA)-identical (HLA-A, B, C, and ribonucleic acid \[RNA\] binding motif protein 45 \[DRB1\] molecularly matched) unrelated donor or related donor capable of donating PBSC
* DONOR: HLA-matched unrelated donors (HLA-A, B, C, and DRB1 matched based on high-resolution typing) capable and willing to donate PBSC
* DONOR: HLA-matched related donors \>= 18 years and capable and willing to donate PBSC
Exclusion Criteria
* Patients on other experimental protocols for prevention of acute GVHD
* Patients who weigh \>= 70 kg must be discussed with the principal investigator prior to enrolling on the protocol
* Patients who are human immunodeficiency virus positive (HIV+)
* Patients with uncontrolled infections for whom myeloablative hematopoietic stem cell transplant (HCT) is considered contraindicated by the consulting infectious disease physician (upper respiratory tract viral infection does not constitute an uncontrolled infection in this context)
* Creatinine \> 1.5 mg/dl
* Cardiac ejection fraction \< 45%
* Patients who can perform pulmonary function tests will be excluded if they have a diffusing capacity of the lung for carbon monoxide (DLCO) (corrected for hemoglobin) of \< 60% predicted; patients who are unable to perform pulmonary function tests (for example, due to young age and/or developmental status) will be excluded if the oxygen (O2) saturation is \< 92% on room air
* Patients who have liver function test (LFTs) (including total bilirubin, aspartate aminotransferase \[AST\] and alanine aminotransferase \[ALT\]) \>= twice the upper limit of normal should be evaluated by a gastrointestinal (GI) physician unless there is a clear precipitating factor (such as an azole, methotrexate, Bactrim or another drug); if the GI physician considers that HCT on protocol 2660 is contraindicated for that patient the patient will be excluded from the protocol; patients with Gilbert's syndrome and no other known liver function abnormality and patients with reversible drug-related transaminitis do not necessarily require GI consultation and may be included on the protocol
* Patients with a life expectancy \< 3 months from co-existing disease other than the leukemia or RAEB
* Patients who are pregnant or breast-feeding
* Fertile patients of child bearing age unwilling to use contraception during and for 12 months post-transplant
* Patients with a significant other medical conditions that would make them unsuitable for transplant
* Patients with a known hypersensitivity to tacrolimus
* DONOR: Donors who are HIV-1, HIV-2, human T-lymphotropic virus (HTLV)-1, HTLV-2 seropositive or with active hepatitis B or hepatitis C virus infection
* DONOR: Donors who fail eligibility requirements for donation of cells or tissue per section 21 Code of Federal Regulations (CFR) 1271 for donation of a HCT/product (P) will be excluded unless use of the cells complies with 21 CFR 1271.65(b)(iii) (urgent medical need) or with 21 CFR 1271.65(b)(i) (allogeneic use in a first-degree or second-degree relative)
* DONOR: Unrelated donors donating outside of the United States of America (USA) or Germany
21 Years
ALL
No
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
National Cancer Institute (NCI)
NIH
National Heart, Lung, and Blood Institute (NHLBI)
NIH
Fred Hutchinson Cancer Center
OTHER
Responsible Party
Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.
Marie Bleakley
Professor
Principal Investigators
Learn about the lead researchers overseeing the trial and their institutional affiliations.
Marie Bleakley
Role: PRINCIPAL_INVESTIGATOR
Fred Hutch/University of Washington Cancer Consortium
Locations
Explore where the study is taking place and check the recruitment status at each participating site.
Fred Hutch/University of Washington Cancer Consortium
Seattle, Washington, United States
Countries
Review the countries where the study has at least one active or historical site.
References
Explore related publications, articles, or registry entries linked to this study.
Bleakley M, Sehgal A, Seropian S, Biernacki MA, Krakow EF, Dahlberg A, Persinger H, Hilzinger B, Martin PJ, Carpenter PA, Flowers ME, Voutsinas J, Gooley TA, Loeb K, Wood BL, Heimfeld S, Riddell SR, Shlomchik WD. Naive T-Cell Depletion to Prevent Chronic Graft-Versus-Host Disease. J Clin Oncol. 2022 Apr 10;40(11):1174-1185. doi: 10.1200/JCO.21.01755. Epub 2022 Jan 10.
Provided Documents
Download supplemental materials such as informed consent forms, study protocols, or participant manuals.
Document Type: Study Protocol and Statistical Analysis Plan
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
NCI-2013-00958
Identifier Type: REGISTRY
Identifier Source: secondary_id
2660
Identifier Type: -
Identifier Source: secondary_id
2660.00
Identifier Type: OTHER
Identifier Source: secondary_id
RG9213077
Identifier Type: OTHER
Identifier Source: secondary_id
2660.00
Identifier Type: -
Identifier Source: org_study_id
More Related Trials
Additional clinical trials that may be relevant based on similarity analysis.