NCT01858740 · REGISTRY CONDITION SEARCH

Selective Depletion of CD45RA+ T Cells From Allogeneic Peripheral Blood Stem Cell Grafts in Preventing GVHD in Children

Found through the registry condition index, not selected as a treatment recommendation. This discovery collection was restricted to studies with posted results.

Phase: PHASE2
Status at capture: COMPLETED
Registry last update: 2024-03-12

This phase II trial studies how well T cell depleted donor peripheral blood stem cell transplant works in preventing graft-versus-host disease in younger patients with high risk hematologic malignancies. Giving chemotherapy and total-body irradiation before a donor peripheral blood stem cell transplant helps stop the growth of cancer cells. It may also stop the patient's immune system from rejecting the donor's stem cells. When the healthy stem cells from a donor are infused into the patient they may help the patient's bone marrow make stem cells, red blood cells, white blood cells, and platelets. Sometimes the transplanted cells from a donor can make an immune response against the body's normal cells. Removing a subset of the T cells from the donor cells before transplant may stop this from happening.

Open the original ClinicalTrials.gov record → · Download preserved record

What did the study report?

Outcomes, safety and baseline populations are separate source sections. Quality-of-life measures appear under their original outcome titles.

flow

Participant flow

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baseline

Baseline characteristics

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outcome · POSTED

Graft Failure

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outcome · POSTED

Time to Discontinuation of Systemic Immunosuppression

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outcome · POSTED

Time to Platelet Count > 50,000/uL for 3 Days Without Transfusion

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outcome · POSTED

Time to Platelet Count > 20,000/uL for 3 Days Without Transfusion

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outcome · POSTED

Time to ANC of > 1,000/uL

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outcome · POSTED

Time to ANC of > 500/uL

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outcome · POSTED

Occurrence of Chronic GHVD Meeting NIH Criteria and Requiring Systemic Pharmacological Immunosuppression

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outcome · POSTED

Acute GVHD Grade III-IV

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outcome · POSTED

Acute GVHD Grades II-IV

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outcome · POSTED

Steroid Refractory Acute GVHD

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outcome · POSTED

Relapse Post-transplant

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outcome · POSTED

Transplant Related Mortality

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outcome · POSTED

Use of Additional Immune Suppressive Agents to Treat Chronic GVHD

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adverse events

Adverse events

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more info

Limitations, agreements, and source contact

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Who could take part

eligibility Criteria: Inclusion Criteria: * Patients who are considered appropriate candidates for allogeneic hematopoietic stem cell transplantation and have one of the following diagnoses: * 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 with central nervous system (CNS) involvement refractory to intrathecal chemotherapy and/or standard cranial-spinal radiation * 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
healthy Volunteers: false
maximum Age: 21 Years
sex: ALL
std Ages: CHILD
ADULT

Treatment arms and interventions

arm Groups

description
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.
intervention Names
Procedure: Allogeneic Hematopoietic Stem Cell Transplantation
Drug: Fludarabine Phosphate
Other: Laboratory Biomarker Analysis
Drug: Methotrexate
Procedure: Peripheral Blood Stem Cell Transplantation
Biological: T Cell-Depleted Hematopoietic Stem Cell Transplantation
Drug: Tacrolimus
Drug: Thiotepa
Radiation: Total-Body Irradiation
label
Treatment (CD45RA+ T cell depleted PBSCT)
type
EXPERIMENTAL

interventions

arm Group Labels
Treatment (CD45RA+ T cell depleted PBSCT)
description
Undergo CD45RA+ T cell-depleted allogeneic peripheral blood stem cell transplant
name
Allogeneic Hematopoietic Stem Cell Transplantation
other Names
allogeneic stem cell transplantation
HSC
HSCT
type
PROCEDURE
arm Group Labels
Treatment (CD45RA+ T cell depleted PBSCT)
description
Given IV
name
Fludarabine Phosphate
other Names
2-F-ara-AMP
9H-Purin-6-amine, 2-fluoro-9-(5-O-phosphono-.beta.-D-arabinofuranosyl)-
Beneflur
Fludara
SH T 586
type
DRUG
arm Group Labels
Treatment (CD45RA+ T cell depleted PBSCT)
description
Correlative studies
name
Laboratory Biomarker Analysis
type
OTHER
arm Group Labels
Treatment (CD45RA+ T cell depleted PBSCT)
description
Given IV
name
Methotrexate
other Names
Abitrexate
Alpha-Methopterin
Amethopterin
Brimexate
CL 14377
CL-14377
Emtexate
Emthexat
Emthexate
Farmitrexat
Fauldexato
Folex
type
DRUG
arm Group Labels
Treatment (CD45RA+ T cell depleted PBSCT)
description
Undergo CD45RA+ T cell-depleted allogeneic peripheral blood stem cell transplant
name
Peripheral Blood Stem Cell Transplantation
other Names
PBPC transplantation
Peripheral Blood Progenitor Cell Transplantation
Peripheral Stem Cell Support
Peripheral Stem Cell Transplant
Peripheral Stem Cell Transplantation
type
PROCEDURE
arm Group Labels
Treatment (CD45RA+ T cell depleted PBSCT)
description
Undergo CD45RA+ T cell-depleted allogeneic peripheral blood stem cell transplant
name
T Cell-Depleted Hematopoietic Stem Cell Transplantation
type
BIOLOGICAL
arm Group Labels
Treatment (CD45RA+ T cell depleted PBSCT)
description
Given IV or PO
name
Tacrolimus
other Names
FK 506
Fujimycin
Hecoria
Prograf
Protopic
type
DRUG
arm Group Labels
Treatment (CD45RA+ T cell depleted PBSCT)
description
Given IV
name
Thiotepa
other Names
1,1',1''-Phosphinothioylidynetrisaziridine
Girostan
N,N', N''-Triethylenethiophosphoramide
Oncotiotepa
STEPA
Tepadina
TESPA
Tespamin
Tespamine
Thio-Tepa
Thiofosfamide
Thiofozil
type
DRUG
arm Group Labels
Treatment (CD45RA+ T cell depleted PBSCT)
description
Undergo TBI
name
Total-Body Irradiation
other Names
TOTAL BODY IRRADIATION
Whole-Body Irradiation
type
RADIATION

Study design

allocation

intervention Model

SINGLE_GROUP

masking Info

masking: NONE

primary Purpose

TREATMENT

Enrollment

count: 20
type: ACTUAL

Registered outcome plans (not posted results)

primary Outcomes

description
Graft failure defined as failure to reach ANC of \>500/uL for 3 consecutive days by day 28, or irreversible decrease in ANC to \<100 after an established donor graft. A reduction in ANC as result of relapse is not considered graft failure
measure
Graft Failure
time Frame
Up to 5 years
description
Measure the number of days to discontinuation of systemic immunosuppression (both including and excluding calcineurin inhibitors) in pediatric recipients of CD45RA+ T cell-depleted PBSCT. Possible outcomes range from no systemic immunosuppression (best outcome) to 5 years on immunosuppression (poor outcome)
measure
Time to Discontinuation of Systemic Immunosuppression
time Frame
5 years post transplant

secondary Outcomes

description
Number of days post-transplant without transfusion where platelet count is \>50,000/uL. Measured as the first of three days
measure
Time to Platelet Count > 50,000/uL for 3 Days Without Transfusion
time Frame
Up to 5 years
description
Number of days post transplant until platelet count is \>20,000/uL for three consecutive days without transfusion, counted as the first of three days
measure
Time to Platelet Count > 20,000/uL for 3 Days Without Transfusion
time Frame
Up to 5 years
description
Time (in days) to ANC of \> 1,000/uL, counted as the first of three consecutive days post-transplant
measure
Time to ANC of > 1,000/uL
time Frame
Up to 5 years
description
Time (in days) to ANC of \> 500/uL, counted as the first of three consecutive days post-transplant
measure
Time to ANC of > 500/uL
time Frame
Up to 5 years
description
Number of patients with chronic GVHD defined using NIH criteria. Incidents requiring only calcineurin inhibitors will not be counted. If patients do not develop cGVHD after transplant but then relapse and then receive a donor lymphocyte infusion or antigen specific T cells as treatment, they will no longer be evaluable for the cGVHD endpoint.
measure
Occurrence of Chronic GHVD Meeting NIH Criteria and Requiring Systemic Pharmacological Immunosuppression
time Frame
Up to 5 years
description
Number of patients with acute GVHD grade III-IV
measure
Acute GVHD Grade III-IV
time Frame
Up to day 100
description
Number of patients with acute GVHD grades II-IV
measure
Acute GVHD Grades II-IV
time Frame
Up to day 100
description
Presence of steroid refractory acute GVHD within the first 100 days post transplant
measure
Steroid Refractory Acute GVHD
time Frame
Up to day 100
description
Relapse defined by the presence of malignant cells in marrow, peripheral blood, or extramedullary sites by histopathology
measure
Relapse Post-transplant
time Frame
Up to 5 years
description
Transplant related mortality defined as mortality in any patient for whom there has not been a diagnosis of relapse
measure
Transplant Related Mortality
time Frame
Up to 5 years
description
Use of additional immune suppressive agents to treat chronic GVHD other than first line therapy. First line therapy is considered prednisone and tacrolimus/cyclosporin.
measure
Use of Additional Immune Suppressive Agents to Treat Chronic GVHD
time Frame
Up to 5 years

Full study description

brief Summary: This phase II trial studies how well T cell depleted donor peripheral blood stem cell transplant works in preventing graft-versus-host disease in younger patients with high risk hematologic malignancies. Giving chemotherapy and total-body irradiation before a donor peripheral blood stem cell transplant helps stop the growth of cancer cells. It may also stop the patient's immune system from rejecting the donor's stem cells. When the healthy stem cells from a donor are infused into the patient they may help the patient's bone marrow make stem cells, red blood cells, white blood cells, and platelets. Sometimes the transplanted cells from a donor can make an immune response against the body's normal cells. Removing a subset of the T cells from the donor cells before transplant may stop this from happening.
detailed Description: OUTLINE: 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.

Source references

references

citation
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.
pmid
35007144
type
DERIVED

Source notices and limitations

Discovery and provenance

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Preserved source evidence · Not medical advice