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Comparing ATG or Post-Transplant Cyclophosphamide to Calcineurin Inhibitor-Methotrexate as GVHD Prophylaxis After Myeloablative Unrelated Donor Peripheral Blood Stem Cell Transplantation

Primary Purpose

Acute Lymphoblastic Leukemia in Remission, Acute Myeloid Leukemia Arising From Previous Myelodysplastic Syndrome, Chronic Myelomonocytic Leukemia

Status
Withdrawn
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
Anti-Thymocyte Globulin
Busulfan
Cyclophosphamide
Cyclosporine
Fludarabine Phosphate
Methotrexate
Peripheral Blood Stem Cell Transplantation
Quality-of-Life Assessment
Questionnaire Administration
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 Lymphoblastic Leukemia in Remission

Eligibility Criteria

undefined - 65 Years (Child, Adult, Older Adult)All SexesAccepts Healthy Volunteers

Inclusion Criteria:

  • The following diseases will be permitted, although other diagnoses can be considered if approved by Fred Hutch Patient Care Conference or the participating institution's patient review committees and the principal investigator:

    • Acute lymphocytic leukemia (ALL) in complete remission (CR)1 with high risk features defined as evidence of adverse cytogenetics such as t(9;22), t(1;19), t(4;11), or MLL rearrangements or presence of minimal residual disease
    • Acute myeloid leukemia (AML) in CR1 with high risk features defined as:

      • Intermediate or adverse risk disease as defined by European LeukemiaNet (ELN) 2017
      • Greater than 1 cycle of induction therapy required to achieve remission
      • Preceding myelodysplastic syndrome (MDS) or myelofibrosis
      • Therapy-related AML
      • Presence of FLT3 internal tandem duplications
      • French-American-British (FAB) M6 or M7 classification
    • Acute leukemia (ALL or AML) in second (2nd) or greater CR (CR ≥ 2)
    • Refractory or relapsed AML with =< 5% bone marrow blasts and no circulating blasts by morphology or proven extramedullary disease
    • Myelodysplastic syndrome (MDS) with following high risk features: poor cytogenetics (-7, inv(3)/t(3q)/del(3q), del(7q) or complex cytogenetics defined as >= 3 abnormalities), Revised International Prognostic Scoring System (IPSS-R) risk group intermediate or higher, or treatment-related MDS
    • Any phase of MDS if patient is < 21 years of age
    • Chronic myelogenous leukemia (CML) beyond 1st chronic phase or resistant to tyrosine kinase inhibitors (adults)
    • Chronic myelomonocytic leukemia (CMML)
    • Myeloproliferative disorders/myelofibrosis
    • Hodgkin or non-Hodgkin lymphoma: relapsed chemotherapy-sensitive (complete or partial response)
  • Female patients must have negative standard pregnancy test (all women of child bearing-potential must have test performed)
  • Ability to understand and the willingness to sign a written informed consent document
  • For patients with acute leukemia, CR is defined as =< 5% marrow blasts by morphology. CR with incomplete count recovery is allowed
  • DONOR INCLUSION
  • Unrelated donors matched for human leukocyte antigen (HLA)-A, B, C, DRB1 and DQB1 by high resolution typing
  • Donors are excluded when preexisting immunoreactivity is identified that would jeopardize donor hematopoietic cell engraftment. This determination is based on the standard practice of the individual institution. The recommended procedure for patients with 10 of 10 HLA allele level (phenotypic) match is to obtain a panel reactive antibody (PRA) screens to class I and class II antigens for all patients before hematopoietic cell transplantation (HCT). If the PRA shows > 10% activity, then flow cytometric or B and T cell cytotoxic cross matches should be obtained. The donor should be excluded if any of the cytotoxic cross match assays are positive
  • Only granulocyte colony-stimulating factor (G-CSF) mobilized peripheral blood stem cell (PBSC) will be permitted as a hematopoietic stem cell (HSC) source on this protocol
  • Donors must meet the selection criteria for administration of G-CSF and apheresis defined based on each institution's standard practice protocol for unrelated donors
  • Donors must be capable of giving informed consent

Exclusion Criteria:

  • Prior autologous or allogeneic stem cell transplant
  • Performance status: Karnofsky score <60 or Lansky score <50 for patients <16 years old
  • Uncontrolled infection. The protocol principal investigator (PI) will be final arbiter if there is uncertainty regarding whether a previous infection is under adequate control to allow enrollment in the study
  • Positive serology for human immunodeficiency virus (HIV)-1, 2 or human T-lymphotropic virus (HTLV)-1, 2
  • Left ventricular ejection fraction < 45%. Uncontrolled arrhythmias or symptomatic cardiac disease
  • Symptomatic pulmonary disease. Forced expiratory volume in 1 second (FEV1), forced vital capacity (FVC), diffusion capacity of the lung for carbon monoxide (DLCO) =< 50% of predicted (corrected for hemoglobin). Use of continuous supplemental oxygen
  • Calculated (Cockroft-Gault; or appropriate calculation for pediatric patients) serum creatinine clearance <60 mL/min. If the calculated CrCl is 50-60 mL/min, but a measured CrCl by 24 hour urine collection is > 60 mL/min, this measurement is acceptable
  • Total serum bilirubin more than twice upper normal limit
  • Alanine aminotransferase (ALT) or aspartate aminotransferase (AST) more than 3-fold higher than laboratory upper normal limits
  • History of allergy or anaphylactic reaction to rabbit protein or to any product excipients
  • Subjects may not be enrolled in other investigational trials with acute or chronic GVHD as the primary endpoint
  • DONOR EXCLUSION
  • Donor who will exclusively donate marrow
  • Donors who are HIV-positive
  • Potential donors who for psychological, physiological, or medical reasons cannot tolerate administration of G-CSF or apheresis
  • Donors who are allergic to filgrastim or Escherichia (E.) coli-derived proteins
  • Donor-related risks to recipients
  • Positive anti-donor lymphocytotoxic crossmatch
  • Pregnant or lactating women
  • Prior malignancy within the last 5 years

Sites / Locations

  • Fred Hutch/University of Washington Cancer Consortium

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Experimental

Experimental

Arm Label

Arm 1 (ATG, tacrolimus or cyclosporine, methotrexate)

Arm 2 (cyclophosphamide, tacrolimus or cyclosporine)

Arm 3 (tacrolimus or cyclosporine, methotrexate)

Arm Description

Participants receive conditioning regimen (see detailed description) and then undergo peripheral blood stem cell transplantation on day 0. Participants receive anti-thymocyte globulin IV over 4-6 hours on days -3 to -1. Beginning day -1, participants also receive tacrolimus IV or cyclosporine IV BID tapered at day 50, and methotrexate IV on days 1, 3, 6 and 11 in the absence of disease progression or unacceptable toxicity.

Participants receive conditioning regimen (see detailed description) and then undergo peripheral blood stem cell transplantation on day 0. Participants receive cyclophosphamide IV over 1-2 hours on days 3 and 4. Beginning day 5, participants also receive tacrolimus IV or cyclosporine IV BID tapered at day 50 in the absence of disease progression or unacceptable toxicity.

Participants receive conditioning regimen (see detailed description) and then undergo peripheral blood stem cell transplantation on day 0. Beginning day -1, participants receive tacrolimus IV or cyclosporine IV BID tapered at day 50, and methotrexate IV on days 1, 3, 6 and 11.

Outcomes

Primary Outcome Measures

Moderate to severe chronic graft versus host disease (GVHD) based on National Institute of Health 2014 consensus criteria
Probabilities of chronic GVHD at one year will be compared using a chi-square test.

Secondary Outcome Measures

Survival
GVHD-free relapse-free survival (GRFS)
Chronic GVHD-free relapse-free survival (CRFS)
Grade II-IV acute GVHD
Grade III-IV acute GVHD
Relapse
Non-relapse mortality

Full Information

First Posted
July 13, 2018
Last Updated
June 25, 2021
Sponsor
Fred Hutchinson Cancer Center
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1. Study Identification

Unique Protocol Identification Number
NCT03602898
Brief Title
Comparing ATG or Post-Transplant Cyclophosphamide to Calcineurin Inhibitor-Methotrexate as GVHD Prophylaxis After Myeloablative Unrelated Donor Peripheral Blood Stem Cell Transplantation
Official Title
A Randomized Phase II Study to Compare ATG or Post-Transplant Cyclophosphamide to Calcineurin Inhibitor-Methotrexate as GVHD Prophylaxis After Myeloablative Unrelated Donor Peripheral Blood Stem Cell Transplantation
Study Type
Interventional

2. Study Status

Record Verification Date
June 2021
Overall Recruitment Status
Withdrawn
Why Stopped
Insufficient funding
Study Start Date
June 1, 2021 (Anticipated)
Primary Completion Date
September 17, 2023 (Anticipated)
Study Completion Date
September 17, 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
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 3 different drug combinations prevent graft versus host disease (GVHD) after donor stem cell transplant. Calcineurin inhibitors, such as cyclosporine and tacrolimus, may stop the activity of donor cells that can cause GVHD. Chemotherapy drugs, such as cyclophosphamide and methotrexate, may also stop the donor cells that can lead to GVHD while not affecting the cancer-fighting donor cells. Immunosuppressive therapy, such as anti-thymocyte globulin (ATG), is used to decrease the body's immune response and reduces the risk of GVHD. It is not yet known which combination of drugs: 1) ATG, methotrexate, and calcineurin inhibitor 2) cyclophosphamide and calcineurin inhibitor, or 3) methotrexate and calcineurin inhibitor may work best to prevent graft versus host disease and result in best overall outcome after donor stem cell transplant.
Detailed Description
OUTLINE: CONDITIONING REGIMENS: Participants receive 1 of 3 regimens and are randomized to 1 of 3 arms for GVHD prophylaxis. REGIMEN A: Participants undergo total body irradiation (TBI) twice daily (BID) on days -6 to -4 (-7 to -4 for those < 18 years), then receive cyclophosphamide IV over 1-2 hours on days -3 and -2. Participants randomized to Arm 2 only receive TBI on days -3 to -1 (-4 to -1 for those < 18 years). REGIMEN B: Participants receive fludarabine phosphate IV and busulfan IV every 6 hours on days -5 to -2. REGIMEN C: Participants receive busulfan orally (PO) or IV every 6 hours on days -7 to -4 and cyclophosphamide IV over 1-2 hours on days -3 and -2. Myelofibrosis or other myeloproliferative neoplasms: Participants >= 18 years receive cyclophosphamide IV over 1-2 hours on days -7 and -6 and busulfan IV on days -5 to -2. Participants < 17 years receive busulfan IV every 6 hours on days -7 to -4 and cyclophosphamide IV on days -3 and -2. All participants undergo peripheral blood stem cell transplantation on day 0. ARM 1: Participants receive anti-thymocyte globulin IV over 4-6 hours on days -3 to -1. Beginning day -1, participants also receive tacrolimus IV or cyclosporine IV twice daily (BID) tapered at day 50, and methotrexate IV on days 1, 3, 6 and 11 in the absence of disease progression or unacceptable toxicity. ARM 2: Participants receive cyclophosphamide IV over 1-2 hours on days 3 and 4. Beginning day 5, participants also receive tacrolimus IV or cyclosporine IV BID tapered at day 50 in the absence of disease progression or unacceptable toxicity. ARM 3: Beginning day -1, participants receive tacrolimus IV or cyclosporine IV BID tapered at day 50, and methotrexate IV on days 1, 3, 6 and 11 in the absence of disease progression or unacceptable toxicity. After completion of study treatment, participants are followed up at 6 months, then annually up to 5 years.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Acute Lymphoblastic Leukemia in Remission, Acute Myeloid Leukemia Arising From Previous Myelodysplastic Syndrome, Chronic Myelomonocytic Leukemia, Chronic Phase Chronic Myelogenous Leukemia, BCR-ABL1 Positive, Hematopoietic and Lymphoid System Neoplasm, Myelodysplastic Syndrome, Myelofibrosis, Myeloproliferative Neoplasm, Recurrent Acute Myeloid Leukemia, Recurrent Hodgkin Lymphoma, Recurrent Non-Hodgkin Lymphoma, Refractory Acute Myeloid Leukemia, Therapy-Related Acute Myeloid Leukemia

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
0 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Arm 1 (ATG, tacrolimus or cyclosporine, methotrexate)
Arm Type
Experimental
Arm Description
Participants receive conditioning regimen (see detailed description) and then undergo peripheral blood stem cell transplantation on day 0. Participants receive anti-thymocyte globulin IV over 4-6 hours on days -3 to -1. Beginning day -1, participants also receive tacrolimus IV or cyclosporine IV BID tapered at day 50, and methotrexate IV on days 1, 3, 6 and 11 in the absence of disease progression or unacceptable toxicity.
Arm Title
Arm 2 (cyclophosphamide, tacrolimus or cyclosporine)
Arm Type
Experimental
Arm Description
Participants receive conditioning regimen (see detailed description) and then undergo peripheral blood stem cell transplantation on day 0. Participants receive cyclophosphamide IV over 1-2 hours on days 3 and 4. Beginning day 5, participants also receive tacrolimus IV or cyclosporine IV BID tapered at day 50 in the absence of disease progression or unacceptable toxicity.
Arm Title
Arm 3 (tacrolimus or cyclosporine, methotrexate)
Arm Type
Experimental
Arm Description
Participants receive conditioning regimen (see detailed description) and then undergo peripheral blood stem cell transplantation on day 0. Beginning day -1, participants receive tacrolimus IV or cyclosporine IV BID tapered at day 50, and methotrexate IV on days 1, 3, 6 and 11.
Intervention Type
Biological
Intervention Name(s)
Anti-Thymocyte Globulin
Other Intervention Name(s)
Antithymocyte Globulin, Antithymocyte Serum, ATG, ATS
Intervention Description
Given IV
Intervention Type
Drug
Intervention Name(s)
Busulfan
Other Intervention Name(s)
1, 4-Bis[methanesulfonoxy]butane, BUS, Bussulfam, Busulfanum, Busulfex, Busulphan, CB 2041, CB-2041, Glyzophrol, GT 41, GT-41, Joacamine, Methanesulfonic Acid Tetramethylene Ester, Methanesulfonic acid, tetramethylene ester, Mielucin, Misulban, Misulfan, Mitosan, Myeleukon, Myeloleukon, Myelosan, Mylecytan, Myleran, Sulfabutin, Tetramethylene Bis(methanesulfonate), Tetramethylene bis[methanesulfonate], WR-19508
Intervention Description
Given IV or PO
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
Drug
Intervention Name(s)
Cyclosporine
Other Intervention Name(s)
27-400, Ciclosporin, CsA, Cyclosporin, Cyclosporin A, Gengraf, Neoral, OL 27-400, Sandimmune, SangCya
Intervention Description
Given IV or PO
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)
Methotrexate
Other Intervention Name(s)
Abitrexate, Alpha-Methopterin, Amethopterin, Brimexate, CL 14377, CL-14377, Emtexate, Emthexat, Emthexate, Farmitrexat, Fauldexato, Folex, Folex PFS, Lantarel, Ledertrexate, Lumexon, Maxtrex, Medsatrexate, Metex, Methoblastin, Methotrexate LPF, Methotrexate Methylaminopterin, Methotrexatum, Metotrexato, Metrotex, Mexate, Mexate-AQ, MTX, Novatrex, Rheumatrex, Texate, Tremetex, Trexeron, Trixilem, WR-19039
Intervention Description
Given IV
Intervention Type
Procedure
Intervention Name(s)
Peripheral Blood Stem Cell Transplantation
Other Intervention Name(s)
PBPC transplantation, PBSCT, Peripheral Blood Progenitor Cell Transplantation, Peripheral Stem Cell Support, Peripheral Stem Cell Transplant, Peripheral Stem Cell Transplantation
Intervention Description
Undergo peripheral blood stem cell transplantation
Intervention Type
Other
Intervention Name(s)
Quality-of-Life Assessment
Other Intervention Name(s)
Quality of Life Assessment
Intervention Description
Ancillary studies
Intervention Type
Other
Intervention Name(s)
Questionnaire Administration
Intervention Description
Ancillary studies
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, Whole-Body Irradiation, TBI
Intervention Description
Undergo TBI
Primary Outcome Measure Information:
Title
Moderate to severe chronic graft versus host disease (GVHD) based on National Institute of Health 2014 consensus criteria
Description
Probabilities of chronic GVHD at one year will be compared using a chi-square test.
Time Frame
At 1 year
Secondary Outcome Measure Information:
Title
Survival
Time Frame
At 1 year post transplant
Title
GVHD-free relapse-free survival (GRFS)
Time Frame
At 1 year post transplant
Title
Chronic GVHD-free relapse-free survival (CRFS)
Time Frame
At 1 year post transplant
Title
Grade II-IV acute GVHD
Time Frame
At 100 days
Title
Grade III-IV acute GVHD
Time Frame
At 100 days
Title
Relapse
Time Frame
At 1 year post transplant
Title
Non-relapse mortality
Time Frame
At 1 year post transplant

10. Eligibility

Sex
All
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: The following diseases will be permitted, although other diagnoses can be considered if approved by Fred Hutch Patient Care Conference or the participating institution's patient review committees and the principal investigator: Acute lymphocytic leukemia (ALL) in complete remission (CR)1 with high risk features defined as evidence of adverse cytogenetics such as t(9;22), t(1;19), t(4;11), or MLL rearrangements or presence of minimal residual disease Acute myeloid leukemia (AML) in CR1 with high risk features defined as: Intermediate or adverse risk disease as defined by European LeukemiaNet (ELN) 2017 Greater than 1 cycle of induction therapy required to achieve remission Preceding myelodysplastic syndrome (MDS) or myelofibrosis Therapy-related AML Presence of FLT3 internal tandem duplications French-American-British (FAB) M6 or M7 classification Acute leukemia (ALL or AML) in second (2nd) or greater CR (CR ≥ 2) Refractory or relapsed AML with =< 5% bone marrow blasts and no circulating blasts by morphology or proven extramedullary disease Myelodysplastic syndrome (MDS) with following high risk features: poor cytogenetics (-7, inv(3)/t(3q)/del(3q), del(7q) or complex cytogenetics defined as >= 3 abnormalities), Revised International Prognostic Scoring System (IPSS-R) risk group intermediate or higher, or treatment-related MDS Any phase of MDS if patient is < 21 years of age Chronic myelogenous leukemia (CML) beyond 1st chronic phase or resistant to tyrosine kinase inhibitors (adults) Chronic myelomonocytic leukemia (CMML) Myeloproliferative disorders/myelofibrosis Hodgkin or non-Hodgkin lymphoma: relapsed chemotherapy-sensitive (complete or partial response) Female patients must have negative standard pregnancy test (all women of child bearing-potential must have test performed) Ability to understand and the willingness to sign a written informed consent document For patients with acute leukemia, CR is defined as =< 5% marrow blasts by morphology. CR with incomplete count recovery is allowed DONOR INCLUSION Unrelated donors matched for human leukocyte antigen (HLA)-A, B, C, DRB1 and DQB1 by high resolution typing Donors are excluded when preexisting immunoreactivity is identified that would jeopardize donor hematopoietic cell engraftment. This determination is based on the standard practice of the individual institution. The recommended procedure for patients with 10 of 10 HLA allele level (phenotypic) match is to obtain a panel reactive antibody (PRA) screens to class I and class II antigens for all patients before hematopoietic cell transplantation (HCT). If the PRA shows > 10% activity, then flow cytometric or B and T cell cytotoxic cross matches should be obtained. The donor should be excluded if any of the cytotoxic cross match assays are positive Only granulocyte colony-stimulating factor (G-CSF) mobilized peripheral blood stem cell (PBSC) will be permitted as a hematopoietic stem cell (HSC) source on this protocol Donors must meet the selection criteria for administration of G-CSF and apheresis defined based on each institution's standard practice protocol for unrelated donors Donors must be capable of giving informed consent Exclusion Criteria: Prior autologous or allogeneic stem cell transplant Performance status: Karnofsky score <60 or Lansky score <50 for patients <16 years old Uncontrolled infection. The protocol principal investigator (PI) will be final arbiter if there is uncertainty regarding whether a previous infection is under adequate control to allow enrollment in the study Positive serology for human immunodeficiency virus (HIV)-1, 2 or human T-lymphotropic virus (HTLV)-1, 2 Left ventricular ejection fraction < 45%. Uncontrolled arrhythmias or symptomatic cardiac disease Symptomatic pulmonary disease. Forced expiratory volume in 1 second (FEV1), forced vital capacity (FVC), diffusion capacity of the lung for carbon monoxide (DLCO) =< 50% of predicted (corrected for hemoglobin). Use of continuous supplemental oxygen Calculated (Cockroft-Gault; or appropriate calculation for pediatric patients) serum creatinine clearance <60 mL/min. If the calculated CrCl is 50-60 mL/min, but a measured CrCl by 24 hour urine collection is > 60 mL/min, this measurement is acceptable Total serum bilirubin more than twice upper normal limit Alanine aminotransferase (ALT) or aspartate aminotransferase (AST) more than 3-fold higher than laboratory upper normal limits History of allergy or anaphylactic reaction to rabbit protein or to any product excipients Subjects may not be enrolled in other investigational trials with acute or chronic GVHD as the primary endpoint DONOR EXCLUSION Donor who will exclusively donate marrow Donors who are HIV-positive Potential donors who for psychological, physiological, or medical reasons cannot tolerate administration of G-CSF or apheresis Donors who are allergic to filgrastim or Escherichia (E.) coli-derived proteins Donor-related risks to recipients Positive anti-donor lymphocytotoxic crossmatch Pregnant or lactating women Prior malignancy within the last 5 years
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Masumi Ueda Oshima
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

Learn more about this trial

Comparing ATG or Post-Transplant Cyclophosphamide to Calcineurin Inhibitor-Methotrexate as GVHD Prophylaxis After Myeloablative Unrelated Donor Peripheral Blood Stem Cell Transplantation

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