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Donor Peripheral Blood Stem Cell Transplant in Treating Patients With Hematologic Malignancies

Primary Purpose

Acute Biphenotypic Leukemia, Acute Erythroid Leukemia in Remission, Acute Leukemia in Remission

Status
Terminated
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
Cyclophosphamide
Filgrastim
Fludarabine Phosphate
Mycophenolate Mofetil
Nonmyeloablative Allogeneic Hematopoietic Stem Cell Transplantation
Peripheral Blood Stem Cell Transplantation
Tacrolimus
Total-Body Irradiation
Sponsored by
Fred Hutchinson Cancer Center
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Acute Biphenotypic Leukemia

Eligibility Criteria

undefined - undefined (Child, Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • Molecular based human leukocyte antigen (HLA) typing will be performed for the HLA-A, -B, -Cw, -DRB1 and -DQB1 loci to the resolution adequate to establish haplo-identity; a minimum match of 5/10 is required; an unrelated donor search is not required for a patient to be eligible for this protocol if the clinical situation dictates an urgent transplant; clinical urgency is defined as 6-8 weeks from referral or low-likelihood of finding a matched, unrelated donor
  • Acute leukemias (includes T lymphoblastic lymphoma); remission is defined as < 5% blasts with no morphological characteristics of acute leukemia (e.g., Auer rods) in a bone marrow with > 20% cellularity, peripheral blood counts showing ANC > 1000/ul, including patients in complete remission with incomplete platelet recovery (CRp); if the marrow has < 20% cellularity due to treatment related cytotoxicity, but still has < 5% blasts, an exception may be made to include this patient up to principal investigator (PI) discretion
  • Acute lymphoblastic leukemia in high risk first complete remission (CR1) as defined by at least one of the following:

    • Adverse cytogenetics including but not limited to t(9;22), t(1;19), t(4;11), mixed lineage leukemia (MLL) rearrangements
    • White blood cell counts > 30,000/mcL
    • Patients over 30 years of age
    • Time to complete remission > 4 weeks
    • Presence of extramedullary disease
    • Minimal residual disease
    • Other risk factors determined by the patient's attending physician to be high risk features requiring transplantation
  • Acute myelogenous leukemia in high risk CR1 as defined by at least one of the following:

    • Greater than 1 cycle of induction therapy required to achieve remission
    • Preceding myelodysplastic syndrome (MDS)
    • Presence of fms-like tyrosine kinase receptor-3 (Flt3) abnormalities
    • French-American-British (FAB) M6 or M7 leukemia, or
    • Adverse cytogenetics for overall survival such as:

      • Those associated with MDS
      • Complex karyotype (>= 3 abnormalities); or
      • Any of the following: inv(3) or t(3;3), t(6;9), t(6;11), + 8 [alone or with other abnormalities except for t(8;21), t(9;11), inv(16) or t(16;16)], t(11;19)(q23;p13.1)]
    • Other risk factors determined by the patient's attending physician to be high risk features requiring transplantation
  • Acute leukemias in second (2nd) or subsequent remission
  • Biphenotypic/undifferentiated leukemias in first (1st) or subsequent complete remission (CR)
  • High-risk MDS status-post cytotoxic chemotherapy
  • Burkitt's lymphoma: second or subsequent CR
  • Chemotherapy-sensitive (at least stable disease) large cell, mantle cell or Hodgkin's lymphomas that have failed at least 1 prior regimen of multi-agent chemotherapy and are ineligible for an autologous transplant
  • Marginal zone B-cell lymphoma or follicular lymphoma that has progressed after at least two prior therapies (excluding single agent Rituxan)
  • Multiple myeloma (MM) stage II or III patients who have progressed after an initial response to chemotherapy or autologous hematopoietic stem cell transplantation (HSCT) or MM patients with refractory disease who may benefit from tandem autologous-nonmyeloablative allogeneic transplant
  • Left ventricular ejection fraction at rest must be >= 35%
  • Bilirubin =< 2.5 mg/dL
  • Alanine aminotransferase (ALT) < 5 x upper limit of normal (ULN)
  • Aspartate aminotransferase (AST) < 5 x ULN
  • Alkaline phosphatase < 5 x ULN
  • Serum creatinine within normal range for age, or if serum creatinine outside normal range for age, then renal function (creatinine clearance or glomerular filtration rate [GFR]) > 40 mL/min/1.73m^2
  • Forced expiratory volume in one second (FEV1), forced vital capacity (FVC), diffusion capacity of carbon monoxide (DLCO) (diffusion capacity) >= 40% predicted (corrected for hemoglobin); if unable to perform pulmonary function tests, then oxygen (O2) saturation > 92% on room air
  • Karnofsky/Lansky score >= 60%
  • Patients who have received a prior allogeneic HSCT and who have either rejected their grafts or who have become tolerant of their grafts with no active GVHD requiring immunosuppressive therapy
  • Patients will undergo standard pre-transplant work-up as dictated by standard practice guidelines the results of which may be used for screening for this study
  • DONOR: Donors must be HLA-haploidentical first-degree relatives of the patient; eligible donors include biological parents, siblings, or children, or half-siblings
  • DONOR: Age >= 12 years
  • DONOR: Weight >= 40 kg
  • DONOR: Ability of donors < 18 years of age to undergo apheresis without use of a vascular access device; vein check must be performed and verified by an apheresis nurse prior to arrival at the Seattle Cancer Care Alliance (SCCA)
  • DONOR: Donors must meet the selection criteria as defined by the Foundation for the Accreditation of Cell Therapy (FACT) and will be screened per the American Association of Blood Banks (AABB) guidelines

Exclusion Criteria:

  • HLA-matched or single allele-mismatched donor able to donate
  • Pregnancy or breast-feeding
  • Current uncontrolled bacterial, viral or fungal infection (currently taking medication with evidence of progression of clinical symptoms or radiologic findings)
  • Patients with primary idiopathic myelofibrosis
  • DONOR: Positive anti-donor HLA antibody

Sites / Locations

  • Fred Hutch/University of Washington Cancer Consortium

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Treatment (nonmyeloablative HCT, TBI)

Arm Description

Patients receive fludarabine IV over 30-60 minutes daily on days -6 through -2 and cyclophosphamide IV over 1-2 hours on days -6, -5, and 3-4. Patients undergo total-body irradiation on day -1. Patients undergo donor peripheral blood stem cell transplant on day 0. Patients then receive tacrolimus IV once daily or PO BID on days 5-180 (may be continued if active GvHD is present), mycophenolate mofetil IV or PO TID on days 5-35 (may be continued if GvHD present), and filgrastim IV beginning on day 5 until the ANC is >= 1,000/mm^3 for three consecutive days.

Outcomes

Primary Outcome Measures

Non-relapse Mortality at 1 Year
Cumulative incidence of death without evidence of disease progression at 1 year
Percentage of Participants With Chronic Graft Versus Host Disease
Scored according to the National Cancer Institute criteria. Mild-to-severe chronic GVHD at 2 years.
Incidence of Grades III/IV Acute Graft Versus Host Disease
Grading determined by organ system stages. Grade III/IV acute graft versus host disease is defined as skin: stage IV, liver: stages II-IV, and/or gastrointestinal tract: stages II-IV.
Relapse of Malignancy After Transplantation
Defined by either morphological or cytogenetic evidence of acute leukemia consistent with pre-transplant features, or radiologic evidence of lymphoma progression. When in doubt, the diagnosis of recurrent or progressive lymphoma should be documented by tissue biopsy.

Secondary Outcome Measures

Time to Neutrophil Recovery
Achievement of an absolute neutrophil count greater or equal to 500/mm^3 for three consecutive measurements on different days. The first of the three days will be designated the day of neutrophil recovery.
Time to Platelet Recovery
The first day of a sustained platelet count > 20,000/mm^3 with no platelet transfusions in the preceding seven days.
Incidence of Primary Graft Failure
Defined as < 5% donor CD3 chimerism. Chimerism will be measured by short tandem repeat-polymerase chain reaction on peripheral blood sorted into CD3 and CD33 cell fractions.
Disease-free Survival
Defined as being alive and in remission by < 5% blasts by bone marrow morphology for patients with myeloid malignancies and CT or PET imaging for patients with lymphoid malignancies at the time of the assessment
Toxicity of Treatment Regimen Determined by Number of Adverse Events Per Organ System
Assessed by Common Terminology Criteria for Adverse Events version 3.0. The incidence of all adverse events greater or equal to grade 3 was determined.
Number of Red Blood Cell Transfusions
Number of units of RBCs given to the patient between day 0 and day 100 post transplant
Number of Platelet Transfusions
Number platelet transfusions given to the patient between day 0 and day 100 post transplant
Point Estimate of Overall Survival at 3 Years
Kaplan Meier estimate of the percentage of participants with overall survival at 3 years

Full Information

First Posted
December 8, 2009
Last Updated
January 4, 2023
Sponsor
Fred Hutchinson Cancer Center
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1. Study Identification

Unique Protocol Identification Number
NCT01028716
Brief Title
Donor Peripheral Blood Stem Cell Transplant in Treating Patients With Hematologic Malignancies
Official Title
Nonmyeloablative Hematopoietic Cell Transplantation (HCT) for Patients With Hematologic Malignancies Using Related, HLA-Haploidentical Donors: A Phase II Trial of Peripheral Blood Stem Cells (PBSC) as the Donor Source
Study Type
Interventional

2. Study Status

Record Verification Date
January 2023
Overall Recruitment Status
Terminated
Why Stopped
The study experienced lower accrual rates after the onset of COVID. Upon review of the collected data it was deemed that an adequate amount of subjects has been enrolled to date to assess study aims.
Study Start Date
May 19, 2010 (Actual)
Primary Completion Date
October 7, 2021 (Actual)
Study Completion Date
October 7, 2021 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Fred Hutchinson Cancer Center

4. Oversight

Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

Brief Summary
This phase II trial studies how well donor peripheral blood stem cell (PBSC) transplant works in treating patients with hematologic malignancies. Cyclophosphamide when added to tacrolimus and mycophenolate mofetil is safe and effective in preventing severe graft-versus-host disease (GVHD) in most patients with hematologic malignancies undergoing transplantation of bone marrow from half-matched (haploidentical) donors. This approach has extended the transplant option to patients who do not have matched related or unrelated donors, especially for patients from ethnic minority groups. The graft contains cells of the donor's immune system which potentially can recognize and destroy the patient's cancer cells (graft-versus-tumor effect). Rejection of the donor's cells by the patient's own immune system is prevented by giving low doses of chemotherapy (fludarabine phosphate and cyclophosphamide) and total-body irradiation before transplant. Patients can experience low blood cell counts after transplant. Using stem cells and immune cells collected from the donor's circulating blood may result in quicker recovery of blood counts and may be more effective in treating the patient's disease than using bone marrow.
Detailed Description
PRIMARY OBJECTIVES: I. To demonstrate that use of PBSC in place of marrow as the source of lymphocytes and stem cells for nonmyeloablative transplants from related, haploidentical donors will not result in unacceptable rates of high-grade acute or chronic GVHD, non-relapse mortality or relapse compared to historical data on nonmyeloablative transplants from unrelated donors. SECONDARY OBJECTIVES: I. Estimates of the rates of neutrophil and platelet recovery, number of red blood cell (RBC) and platelet transfusions, incidences of graft failure, transplant-related toxicities, disease-free survival and overall survival. OUTLINE: Patients receive fludarabine intravenously (IV) over 30-60 minutes daily on days -6 through -2 and cyclophosphamide IV over 1-2 hours on days -6, -5, and 3-4. Patients undergo total-body irradiation on day -1. Patients undergo donor peripheral blood stem cell transplant on day 0. Patients then receive tacrolimus IV once daily or orally (PO) twice daily (BID) on days 5-180 (may be continued if active GVHD is present), mycophenolate mofetil IV or PO thrice daily (TID) on days 5-35 (may be continued if GVHD present), and filgrastim IV beginning on day 5 until the absolute neutrophil count (ANC) is >= 1,000/mm^3 for three consecutive days. Treatment continues in the absence of disease progression or unacceptable toxicity.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Acute Biphenotypic Leukemia, Acute Erythroid Leukemia in Remission, Acute Leukemia in Remission, Acute Lymphoblastic Leukemia in Remission, Acute Myeloid Leukaemia With Prior Myelodysplastic Syndrome, Acute Myeloid Leukemia in Remission, Acute Myeloid Leukemia With FLT3/ITD Mutation, Acute Myeloid Leukemia With Inv(3)(Q21Q26.2); RPN1-EVI1, Acute Myeloid Leukemia With Multilineage Dysplasia, Acute Myeloid Leukemia With t(6;9), Acute Undifferentiated Leukemia, Adult Acute Lymphoblastic Leukemia in Complete Remission, B Acute Lymphoblastic Leukemia With T(1;19)(Q23;P13.3); E2A-PBX1 (TCF3-PBX1), Ph+ ALL, Burkitt Lymphoma, Childhood Acute Lymphoblastic Leukemia in Complete Remission, DS Stage II Plasma Cell Myeloma, DS Stage III Plasma Cell Myeloma, Myelodysplastic Syndrome, Recurrent Anaplastic Large Cell Lymphoma, Blasts Under 5 Percent of Bone Marrow Nucleated Cells, Recurrent Follicular Lymphoma, Recurrent Hodgkin Lymphoma, Recurrent Mantle Cell Lymphoma, Recurrent Marginal Zone Lymphoma, Recurrent Plasma Cell Myeloma, Refractory Plasma Cell Myeloma, Secondary Acute Myeloid Leukemia, T Lymphoblastic Lymphoma, Hematopoietic Cell Transplant Recipient

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
46 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Treatment (nonmyeloablative HCT, TBI)
Arm Type
Experimental
Arm Description
Patients receive fludarabine IV over 30-60 minutes daily on days -6 through -2 and cyclophosphamide IV over 1-2 hours on days -6, -5, and 3-4. Patients undergo total-body irradiation on day -1. Patients undergo donor peripheral blood stem cell transplant on day 0. Patients then receive tacrolimus IV once daily or PO BID on days 5-180 (may be continued if active GvHD is present), mycophenolate mofetil IV or PO TID on days 5-35 (may be continued if GvHD present), and filgrastim IV beginning on day 5 until the ANC is >= 1,000/mm^3 for three consecutive days.
Intervention Type
Drug
Intervention Name(s)
Cyclophosphamide
Other Intervention Name(s)
(-)-Cyclophosphamide, 2H-1,3,2-Oxazaphosphorine, 2-[bis(2-chloroethyl)amino]tetrahydro-, 2-oxide, monohydrate, Carloxan, Ciclofosfamida, Ciclofosfamide, Cicloxal, Clafen, Claphene, CP monohydrate, CTX, CYCLO-cell, Cycloblastin, Cycloblastine, Cyclophospham, Cyclophosphamid monohydrate, Cyclophosphamidum, Cyclophosphan, Cyclophosphane, Cyclophosphanum, Cyclostin, Cyclostine, Cytophosphan, Cytophosphane, Cytoxan, Fosfaseron, Genoxal, Genuxal, Ledoxina, Mitoxan, Neosar, Revimmune, Syklofosfamid, WR- 138719
Intervention Description
Given IV
Intervention Type
Biological
Intervention Name(s)
Filgrastim
Other Intervention Name(s)
Filgrastim XM02, Filgrastim-sndz, G-CSF, Neupogen, r-metHuG-CSF, Recombinant Methionyl Human Granulocyte Colony Stimulating Factor, rG-CSF, Tbo-filgrastim, Tevagrastim, Zarxio
Intervention Description
Given SQ
Intervention Type
Drug
Intervention Name(s)
Fludarabine Phosphate
Other Intervention Name(s)
2-F-ara-AMP, 9H-Purin-6-amine, 2-fluoro-9-(5-O-phosphono-.beta.-D-arabinofuranosyl)-, Beneflur, Fludara, SH T 586
Intervention Description
Given IV
Intervention Type
Drug
Intervention Name(s)
Mycophenolate Mofetil
Other Intervention Name(s)
Cellcept, MMF
Intervention Description
Given PO
Intervention Type
Procedure
Intervention Name(s)
Nonmyeloablative Allogeneic Hematopoietic Stem Cell Transplantation
Other Intervention Name(s)
Non-myeloablative allogeneic transplant, Nonmyeloablative Stem Cell Transplantation, NST
Intervention Description
Undergo PBSC
Intervention Type
Procedure
Intervention Name(s)
Peripheral Blood Stem Cell Transplantation
Other Intervention Name(s)
PBPC transplantation, Peripheral Blood Progenitor Cell Transplantation, Peripheral Stem Cell Support, Peripheral Stem Cell Transplant, Peripheral Stem Cell Transplantation
Intervention Description
Undergo PBSC
Intervention Type
Drug
Intervention Name(s)
Tacrolimus
Other Intervention Name(s)
FK 506, Fujimycin, Hecoria, Prograf, Protopic
Intervention Description
Given IV or PO
Intervention Type
Radiation
Intervention Name(s)
Total-Body Irradiation
Other Intervention Name(s)
TOTAL BODY IRRADIATION, Whole-Body Irradiation
Intervention Description
Undergo total-body irradiation (TBI)
Primary Outcome Measure Information:
Title
Non-relapse Mortality at 1 Year
Description
Cumulative incidence of death without evidence of disease progression at 1 year
Time Frame
Up to 1 year
Title
Percentage of Participants With Chronic Graft Versus Host Disease
Description
Scored according to the National Cancer Institute criteria. Mild-to-severe chronic GVHD at 2 years.
Time Frame
Up to 2 years post-transplant
Title
Incidence of Grades III/IV Acute Graft Versus Host Disease
Description
Grading determined by organ system stages. Grade III/IV acute graft versus host disease is defined as skin: stage IV, liver: stages II-IV, and/or gastrointestinal tract: stages II-IV.
Time Frame
At day 84
Title
Relapse of Malignancy After Transplantation
Description
Defined by either morphological or cytogenetic evidence of acute leukemia consistent with pre-transplant features, or radiologic evidence of lymphoma progression. When in doubt, the diagnosis of recurrent or progressive lymphoma should be documented by tissue biopsy.
Time Frame
Up to 7 years
Secondary Outcome Measure Information:
Title
Time to Neutrophil Recovery
Description
Achievement of an absolute neutrophil count greater or equal to 500/mm^3 for three consecutive measurements on different days. The first of the three days will be designated the day of neutrophil recovery.
Time Frame
Up to day 84 post-transplant
Title
Time to Platelet Recovery
Description
The first day of a sustained platelet count > 20,000/mm^3 with no platelet transfusions in the preceding seven days.
Time Frame
Up to day 84 post-transplant
Title
Incidence of Primary Graft Failure
Description
Defined as < 5% donor CD3 chimerism. Chimerism will be measured by short tandem repeat-polymerase chain reaction on peripheral blood sorted into CD3 and CD33 cell fractions.
Time Frame
At day 84
Title
Disease-free Survival
Description
Defined as being alive and in remission by < 5% blasts by bone marrow morphology for patients with myeloid malignancies and CT or PET imaging for patients with lymphoid malignancies at the time of the assessment
Time Frame
3 years from the date of transplant
Title
Toxicity of Treatment Regimen Determined by Number of Adverse Events Per Organ System
Description
Assessed by Common Terminology Criteria for Adverse Events version 3.0. The incidence of all adverse events greater or equal to grade 3 was determined.
Time Frame
Up to day 90
Title
Number of Red Blood Cell Transfusions
Description
Number of units of RBCs given to the patient between day 0 and day 100 post transplant
Time Frame
Day 0-100
Title
Number of Platelet Transfusions
Description
Number platelet transfusions given to the patient between day 0 and day 100 post transplant
Time Frame
Day 0-100
Title
Point Estimate of Overall Survival at 3 Years
Description
Kaplan Meier estimate of the percentage of participants with overall survival at 3 years
Time Frame
3 years

10. Eligibility

Sex
All
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Molecular based human leukocyte antigen (HLA) typing will be performed for the HLA-A, -B, -Cw, -DRB1 and -DQB1 loci to the resolution adequate to establish haplo-identity; a minimum match of 5/10 is required; an unrelated donor search is not required for a patient to be eligible for this protocol if the clinical situation dictates an urgent transplant; clinical urgency is defined as 6-8 weeks from referral or low-likelihood of finding a matched, unrelated donor Acute leukemias (includes T lymphoblastic lymphoma); remission is defined as < 5% blasts with no morphological characteristics of acute leukemia (e.g., Auer rods) in a bone marrow with > 20% cellularity, peripheral blood counts showing ANC > 1000/ul, including patients in complete remission with incomplete platelet recovery (CRp); if the marrow has < 20% cellularity due to treatment related cytotoxicity, but still has < 5% blasts, an exception may be made to include this patient up to principal investigator (PI) discretion Acute lymphoblastic leukemia in high risk first complete remission (CR1) as defined by at least one of the following: Adverse cytogenetics including but not limited to t(9;22), t(1;19), t(4;11), mixed lineage leukemia (MLL) rearrangements White blood cell counts > 30,000/mcL Patients over 30 years of age Time to complete remission > 4 weeks Presence of extramedullary disease Minimal residual disease Other risk factors determined by the patient's attending physician to be high risk features requiring transplantation Acute myelogenous leukemia in high risk CR1 as defined by at least one of the following: Greater than 1 cycle of induction therapy required to achieve remission Preceding myelodysplastic syndrome (MDS) Presence of fms-like tyrosine kinase receptor-3 (Flt3) abnormalities French-American-British (FAB) M6 or M7 leukemia, or Adverse cytogenetics for overall survival such as: Those associated with MDS Complex karyotype (>= 3 abnormalities); or Any of the following: inv(3) or t(3;3), t(6;9), t(6;11), + 8 [alone or with other abnormalities except for t(8;21), t(9;11), inv(16) or t(16;16)], t(11;19)(q23;p13.1)] Other risk factors determined by the patient's attending physician to be high risk features requiring transplantation Acute leukemias in second (2nd) or subsequent remission Biphenotypic/undifferentiated leukemias in first (1st) or subsequent complete remission (CR) High-risk MDS status-post cytotoxic chemotherapy Burkitt's lymphoma: second or subsequent CR Chemotherapy-sensitive (at least stable disease) large cell, mantle cell or Hodgkin's lymphomas that have failed at least 1 prior regimen of multi-agent chemotherapy and are ineligible for an autologous transplant Marginal zone B-cell lymphoma or follicular lymphoma that has progressed after at least two prior therapies (excluding single agent Rituxan) Multiple myeloma (MM) stage II or III patients who have progressed after an initial response to chemotherapy or autologous hematopoietic stem cell transplantation (HSCT) or MM patients with refractory disease who may benefit from tandem autologous-nonmyeloablative allogeneic transplant Left ventricular ejection fraction at rest must be >= 35% Bilirubin =< 2.5 mg/dL Alanine aminotransferase (ALT) < 5 x upper limit of normal (ULN) Aspartate aminotransferase (AST) < 5 x ULN Alkaline phosphatase < 5 x ULN Serum creatinine within normal range for age, or if serum creatinine outside normal range for age, then renal function (creatinine clearance or glomerular filtration rate [GFR]) > 40 mL/min/1.73m^2 Forced expiratory volume in one second (FEV1), forced vital capacity (FVC), diffusion capacity of carbon monoxide (DLCO) (diffusion capacity) >= 40% predicted (corrected for hemoglobin); if unable to perform pulmonary function tests, then oxygen (O2) saturation > 92% on room air Karnofsky/Lansky score >= 60% Patients who have received a prior allogeneic HSCT and who have either rejected their grafts or who have become tolerant of their grafts with no active GVHD requiring immunosuppressive therapy Patients will undergo standard pre-transplant work-up as dictated by standard practice guidelines the results of which may be used for screening for this study DONOR: Donors must be HLA-haploidentical first-degree relatives of the patient; eligible donors include biological parents, siblings, or children, or half-siblings DONOR: Age >= 12 years DONOR: Weight >= 40 kg DONOR: Ability of donors < 18 years of age to undergo apheresis without use of a vascular access device; vein check must be performed and verified by an apheresis nurse prior to arrival at the Seattle Cancer Care Alliance (SCCA) DONOR: Donors must meet the selection criteria as defined by the Foundation for the Accreditation of Cell Therapy (FACT) and will be screened per the American Association of Blood Banks (AABB) guidelines Exclusion Criteria: HLA-matched or single allele-mismatched donor able to donate Pregnancy or breast-feeding Current uncontrolled bacterial, viral or fungal infection (currently taking medication with evidence of progression of clinical symptoms or radiologic findings) Patients with primary idiopathic myelofibrosis DONOR: Positive anti-donor HLA antibody
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Rachel B. Salit
Organizational Affiliation
Fred Hutch/University of Washington Cancer Consortium
Official's Role
Principal Investigator
Facility Information:
Facility Name
Fred Hutch/University of Washington Cancer Consortium
City
Seattle
State/Province
Washington
ZIP/Postal Code
98109
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
No

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Donor Peripheral Blood Stem Cell Transplant in Treating Patients With Hematologic Malignancies

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