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Peripheral Blood Stem Cell Transplant vs Bone Marrow Transplant in Individuals With Hematologic Cancers (BMT CTN 0201)

Primary Purpose

Leukemia, Myeloproliferative Disorders, Myelodysplastic-Myeloproliferative Diseases

Status
Completed
Phase
Phase 3
Locations
International
Study Type
Interventional
Intervention
Allogeneic bone marrow transplantation
Peripheral blood stem cell transplantation
Sponsored by
Medical College of Wisconsin
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Leukemia

Eligibility Criteria

undefined - 66 Years (Child, Adult, Older Adult)All SexesDoes not accept healthy volunteers

Patient Inclusion Criteria: One of the following diagnoses: Acute myelogenous leukemia at the following stages: first remission, second remission, third or subsequent remission, or not in remission Acute lymphoblastic leukemia at the following stages: first remission, second remission, third or subsequent remission, or not in remission Chronic myelogenous leukemia at the following stages: chronic phase, accelerated phase, or blast phase Myelodysplastic syndromes (MDS) at the following stages: refractory anemia; refractory anemia with ringed sideroblasts; refractory cytopenia with multilineage dysplasia; refractory cytopenia with multilineage dysplasia and ringed sideroblasts; refractory anemia with excess blasts-1 (5-10% blasts); refractory anemia with excess blasts-2 (10-20% blasts); myelodysplastic syndrome, unclassified; or MDS associated with isolated del (5q) Myeloproliferative diseases: chronic myelomonocytic leukemia; agnogenic myeloid metaplasia with myelofibrosis (idiopathic myelofibrosis); juvenile myelomonocytic leukemia Therapy-related acute myelogenous leukemia (AML) or MDS with prior malignancy that has been in remission for at least 12 months. If the remission is less than 12 months, Medical Monitor or Protocol Chair approval is required for eligibility Patient Exclusion Criteria: Prior allogeneic or autologous transplants using any hematopoietic stem cell source; patients with secondary malignancies who have had a prior autologous transplant will be eligible; the prior autologous transplant must have been performed for the primary malignancy (such as lymphoma) and must have occurred 12 or more months prior to enrollment Lymphoma (11% of 2001 NMDP transplants), other malignant disorders (6%), and non-malignant disorders (9%) Donor Inclusion Criteria: Matched for HLA-A, B, and DRB1 antigens One antigen mismatch at HLA-A, B, or DRB1 is acceptable with or without mismatch at HLA-C Typing is by DNA techniques: intermediate resolution for A, B, and C, and high resolution for DRB1. HLA-C typing is mandatory but will not count in the match. Willing to undergo both bone marrow harvest and G-CSF administration with apheresis Willing to be randomly assigned to either marrow or PBSC collection Adequate peripheral venous access for leukapheresis or willing to undergo placement of a central catheter Donor center affiliation with NMDP Additional donor inclusion criteria can be found in the Donor Companion Manual Donor Exclusion Criteria: Pregnant (positive serum β-HCG) or uninterruptible breastfeeding Known allergy to G-CSF or to E. Coli-derived recombinant protein products History of autoimmune disorders History of deep vein thrombosis or venous thromboembolism History of iritis or episcleritis History of serious adverse reaction to anesthesia Thrombocytopenia (platelets less than 150,000 per mcL) at baseline evaluation Current treatment with lithium Presence of sickle hemoglobin as demonstrated by appropriate testing such as hemoglobin electrophoresis Receiving experimental therapy or investigational agents

Sites / Locations

  • University of Alabama at Birmingham
  • City of Hope National Medical Center
  • UCSD Cancer Center
  • University of California, San Francisco
  • Stanford Hospital and Clinics
  • University of Florida College of Medicine (Shands)
  • Emory University
  • Loyola University
  • IBMT (Indiana Blood and Marrow Transplant) at St Francis Franciscan Health
  • University of Iowa Hospitals and Clinics
  • University of Kansas Hospital
  • University of Maryland
  • DFCI/Brigham & Women's
  • University of Michigan Medical Center
  • University of Minnesota
  • Mayo Clinic Cancer Center
  • Washington University/Barnes Jewish Hospital
  • Washington University/St. Louis Children's Hospital
  • University of Nebraska Medical Center
  • Hackensack University Medical Center Cancer Center
  • Roswell Park Cancer Institute
  • Cohen Children's Hospital
  • Duke University Medical Center
  • Wake Forest University Health Sciences
  • Ohio State/Arthur G. James Cancer Hospital
  • University of Oklahoma Medical Center
  • Oregon Health & Science University (Peds)
  • Oregon Health Sciences University
  • University of Pennsylvania Cancer Center
  • University of Pittsburgh Cancer Institute
  • Vanderbilt University
  • Baylor University Medical Center
  • Baylor College of Medicine/The Methodist Hospital
  • University of Texas/MD Anderson CRC
  • Texas Transplant Institute
  • Utah BMT/Primary Children's Medical Center
  • Utah BMT/University of Utah Medical School
  • Virginia Commonwealth University MCV Hospitals
  • Fred Hutchinson Cancer Research Center
  • Tom Baker Cancer Centre, Calgary
  • Vancouver General Hospital
  • Hamilton Health Sciences - McMaster Site
  • Ottawa Hospital
  • University of Toronto, Princess Margaret Hospital
  • Queen Elizabeth II Health Sciences Centre - Halifax

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Active Comparator

Arm Label

Bone Marrow Transplant

Blood Stem Cell Transplant

Arm Description

Allogeneic bone marrow transplantation

Peripheral blood stem cell transplantation

Outcomes

Primary Outcome Measures

Two-year Overall Survival
Overall survival rate at 2 years according to an intention-to-treat analysis.

Secondary Outcome Measures

Neutrophil Engraftment
Platelet Engraftment
Graft Failure
Extensive Chronic Graft-versus-host Disease (GVHD)
Chronic GVHD
Relapse
Analysis restricted to patients who received the transplant.
Infections
Number of infection reports per patient.
Grades III-V Unexpected Adverse Events
Acute GVHD Grade II-IV
Acute GVHD Grade III-IV
Current Immunosuppressive (IS) Free Survival
This outcome measure takes into account subsequent immunosuppressive therapy that may occur following discontinuation of initial immunosuppressive therapy.
Immune Reconstitution
Donor Recovery of Baseline Complete Blood Count (CBC) and White Blood Cell Count (WBC) Differential
Donor Recovery to Baseline Toxicity Scores
Donor Quality of Life
Patient Quality of Life

Full Information

First Posted
January 9, 2004
Last Updated
December 7, 2022
Sponsor
Medical College of Wisconsin
Collaborators
National Heart, Lung, and Blood Institute (NHLBI), Blood and Marrow Transplant Clinical Trials Network, National Cancer Institute (NCI), National Marrow Donor Program
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1. Study Identification

Unique Protocol Identification Number
NCT00075816
Brief Title
Peripheral Blood Stem Cell Transplant vs Bone Marrow Transplant in Individuals With Hematologic Cancers (BMT CTN 0201)
Official Title
A Phase III Randomized, Multicenter Trial Comparing G-CSF Mobilized Peripheral Blood Stem Cell With Marrow Transplantation From Human Leukocyte Antigen (HLA) Compatible Unrelated Donors (BMT CTN #0201)
Study Type
Interventional

2. Study Status

Record Verification Date
December 2022
Overall Recruitment Status
Completed
Study Start Date
January 2004 (undefined)
Primary Completion Date
April 2013 (Actual)
Study Completion Date
April 2014 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Medical College of Wisconsin
Collaborators
National Heart, Lung, and Blood Institute (NHLBI), Blood and Marrow Transplant Clinical Trials Network, National Cancer Institute (NCI), National Marrow Donor Program

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

Brief Summary
The study is designed as a Phase III, randomized, open label, multicenter, prospective, comparative trial of granulocyte colony stimulating factor (G-CSF)-mobilized peripheral blood stem cells (PBSC) versus marrow from unrelated donors for transplantation in patients with hematologic malignancies. Recipients will be stratified by transplant center and disease risk and will be randomized to either the PBSC or marrow arm in a 1:1 ratio.
Detailed Description
BACKGROUND: Many studies of allogeneic marrow transplantation have shown that a higher dose of marrow cells correlates with more robust hematopoietic engraftment and lower mortality from infectious complications. Peripheral blood stem cells (PBSC) collected after mobilization with granulocyte colony stimulating factor (G-CSF) contain a larger number of CD34-positive (CD34) progenitors and total cells than bone marrow. These observations led to the hypothesis that transplantation of PBSC would lead to lower mortality compared to transplantation of marrow. In addition, PBSC grafts have a higher T cell content, predicting a possibly more powerful anti-leukemia effect. However, the higher T cell content of PBSC may also lead to increased incidence and severity of acute and chronic graft-versus-host disease (GVHD). This concern is especially serious when the donor is unrelated to the recipient. This prospective, randomized, multicenter clinical trial of unrelated donor transplantation will test the hypothesis that transplantation of PBSC leads to similar patient survival compared to transplantation of marrow. DESIGN NARRATIVE: This is a Phase III randomized, open label, multicenter clinical trial sponsored by the National Marrow Donor Program (NMDP) and the National Institutes of Health (NIH). The objective of the trial is to test the null hypothesis that there is no difference in overall survival after PBSC versus marrow transplants from HLA compatible unrelated donors. The study will compare G-CSF-mobilized PBSC transplantation with bone marrow transplantation from HLA-compatible unrelated donors for patients with leukemia, myelodysplastic or myeloproliferative syndromes. Conditioning and GVHD prophylaxis regimens will vary by center and within centers, however, the center must declare before randomization what regimens will be used for each patient. The primary endpoint of this trial is 2-year survival following randomization. Secondary analyses will consider neutrophil and platelet recovery, acute and chronic GVHD, time off all immunosuppressive therapy, relapse, infections, adverse events and immune reconstitution. The trial will include evaluation of patient and donor quality of life, composition of the graft, and immune reconstitution. Accrual is anticipated for 3 years with a follow-up period of 3 years.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Leukemia, Myeloproliferative Disorders, Myelodysplastic-Myeloproliferative Diseases

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
551 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Bone Marrow Transplant
Arm Type
Active Comparator
Arm Description
Allogeneic bone marrow transplantation
Arm Title
Blood Stem Cell Transplant
Arm Type
Active Comparator
Arm Description
Peripheral blood stem cell transplantation
Intervention Type
Biological
Intervention Name(s)
Allogeneic bone marrow transplantation
Intervention Description
Bone marrow transplant from HLA compatible unrelated donors.
Intervention Type
Biological
Intervention Name(s)
Peripheral blood stem cell transplantation
Intervention Description
Peripheral blood transplant from HLA compatible unrelated donors.
Primary Outcome Measure Information:
Title
Two-year Overall Survival
Description
Overall survival rate at 2 years according to an intention-to-treat analysis.
Time Frame
Measured at 2 years
Secondary Outcome Measure Information:
Title
Neutrophil Engraftment
Time Frame
Measured at Day 28
Title
Platelet Engraftment
Time Frame
Measured at Day 180
Title
Graft Failure
Time Frame
Measured at 28 and 100 days
Title
Extensive Chronic Graft-versus-host Disease (GVHD)
Time Frame
Measured at 730 days
Title
Chronic GVHD
Time Frame
Measured at 2 years
Title
Relapse
Description
Analysis restricted to patients who received the transplant.
Time Frame
Measured at 2 years
Title
Infections
Description
Number of infection reports per patient.
Time Frame
Measured at 1 and 2 years
Title
Grades III-V Unexpected Adverse Events
Time Frame
Measured by 2 years
Title
Acute GVHD Grade II-IV
Time Frame
100 days, 180 days
Title
Acute GVHD Grade III-IV
Time Frame
100 days, 180 days
Title
Current Immunosuppressive (IS) Free Survival
Description
This outcome measure takes into account subsequent immunosuppressive therapy that may occur following discontinuation of initial immunosuppressive therapy.
Time Frame
Measured at 2 years
Title
Immune Reconstitution
Time Frame
Measured at 100 days, 6 months, and 1 and 2 years
Title
Donor Recovery of Baseline Complete Blood Count (CBC) and White Blood Cell Count (WBC) Differential
Time Frame
Measured at 1, 6, and 12 months
Title
Donor Recovery to Baseline Toxicity Scores
Time Frame
Measured at 1, 6, and 12 months
Title
Donor Quality of Life
Time Frame
Measured at 1, 6, and 12 months
Title
Patient Quality of Life
Time Frame
Measured at baseline, 6 months, and 1, 2, and 5 years

10. Eligibility

Sex
All
Maximum Age & Unit of Time
66 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Patient Inclusion Criteria: One of the following diagnoses: Acute myelogenous leukemia at the following stages: first remission, second remission, third or subsequent remission, or not in remission Acute lymphoblastic leukemia at the following stages: first remission, second remission, third or subsequent remission, or not in remission Chronic myelogenous leukemia at the following stages: chronic phase, accelerated phase, or blast phase Myelodysplastic syndromes (MDS) at the following stages: refractory anemia; refractory anemia with ringed sideroblasts; refractory cytopenia with multilineage dysplasia; refractory cytopenia with multilineage dysplasia and ringed sideroblasts; refractory anemia with excess blasts-1 (5-10% blasts); refractory anemia with excess blasts-2 (10-20% blasts); myelodysplastic syndrome, unclassified; or MDS associated with isolated del (5q) Myeloproliferative diseases: chronic myelomonocytic leukemia; agnogenic myeloid metaplasia with myelofibrosis (idiopathic myelofibrosis); juvenile myelomonocytic leukemia Therapy-related acute myelogenous leukemia (AML) or MDS with prior malignancy that has been in remission for at least 12 months. If the remission is less than 12 months, Medical Monitor or Protocol Chair approval is required for eligibility Patient Exclusion Criteria: Prior allogeneic or autologous transplants using any hematopoietic stem cell source; patients with secondary malignancies who have had a prior autologous transplant will be eligible; the prior autologous transplant must have been performed for the primary malignancy (such as lymphoma) and must have occurred 12 or more months prior to enrollment Lymphoma (11% of 2001 NMDP transplants), other malignant disorders (6%), and non-malignant disorders (9%) Donor Inclusion Criteria: Matched for HLA-A, B, and DRB1 antigens One antigen mismatch at HLA-A, B, or DRB1 is acceptable with or without mismatch at HLA-C Typing is by DNA techniques: intermediate resolution for A, B, and C, and high resolution for DRB1. HLA-C typing is mandatory but will not count in the match. Willing to undergo both bone marrow harvest and G-CSF administration with apheresis Willing to be randomly assigned to either marrow or PBSC collection Adequate peripheral venous access for leukapheresis or willing to undergo placement of a central catheter Donor center affiliation with NMDP Additional donor inclusion criteria can be found in the Donor Companion Manual Donor Exclusion Criteria: Pregnant (positive serum β-HCG) or uninterruptible breastfeeding Known allergy to G-CSF or to E. Coli-derived recombinant protein products History of autoimmune disorders History of deep vein thrombosis or venous thromboembolism History of iritis or episcleritis History of serious adverse reaction to anesthesia Thrombocytopenia (platelets less than 150,000 per mcL) at baseline evaluation Current treatment with lithium Presence of sickle hemoglobin as demonstrated by appropriate testing such as hemoglobin electrophoresis Receiving experimental therapy or investigational agents
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Mary Horowitz, MD
Organizational Affiliation
Center for International Blood and Marrow Transplant Research
Official's Role
Study Director
Facility Information:
Facility Name
University of Alabama at Birmingham
City
Birmingham
State/Province
Alabama
ZIP/Postal Code
35294
Country
United States
Facility Name
City of Hope National Medical Center
City
Duarte
State/Province
California
ZIP/Postal Code
91010
Country
United States
Facility Name
UCSD Cancer Center
City
La Jolla
State/Province
California
ZIP/Postal Code
92093-0960
Country
United States
Facility Name
University of California, San Francisco
City
San Francisco
State/Province
California
ZIP/Postal Code
94143
Country
United States
Facility Name
Stanford Hospital and Clinics
City
Stanford
State/Province
California
ZIP/Postal Code
94305
Country
United States
Facility Name
University of Florida College of Medicine (Shands)
City
Gainesville
State/Province
Florida
ZIP/Postal Code
32610-100277
Country
United States
Facility Name
Emory University
City
Atlanta
State/Province
Georgia
ZIP/Postal Code
30322
Country
United States
Facility Name
Loyola University
City
Maywood
State/Province
Illinois
ZIP/Postal Code
60153
Country
United States
Facility Name
IBMT (Indiana Blood and Marrow Transplant) at St Francis Franciscan Health
City
Indianapolis
State/Province
Indiana
ZIP/Postal Code
46237
Country
United States
Facility Name
University of Iowa Hospitals and Clinics
City
Iowa City
State/Province
Iowa
ZIP/Postal Code
52242
Country
United States
Facility Name
University of Kansas Hospital
City
Kansas City
State/Province
Kansas
ZIP/Postal Code
66160
Country
United States
Facility Name
University of Maryland
City
Baltimore
State/Province
Maryland
ZIP/Postal Code
21228
Country
United States
Facility Name
DFCI/Brigham & Women's
City
Boston
State/Province
Massachusetts
ZIP/Postal Code
02114
Country
United States
Facility Name
University of Michigan Medical Center
City
Ann Arbor
State/Province
Michigan
ZIP/Postal Code
48109-0942
Country
United States
Facility Name
University of Minnesota
City
Minneapolis
State/Province
Minnesota
ZIP/Postal Code
55455
Country
United States
Facility Name
Mayo Clinic Cancer Center
City
Rochester
State/Province
Minnesota
ZIP/Postal Code
55905
Country
United States
Facility Name
Washington University/Barnes Jewish Hospital
City
Saint Louis
State/Province
Missouri
ZIP/Postal Code
63110
Country
United States
Facility Name
Washington University/St. Louis Children's Hospital
City
Saint Louis
State/Province
Missouri
ZIP/Postal Code
63110
Country
United States
Facility Name
University of Nebraska Medical Center
City
Omaha
State/Province
Nebraska
ZIP/Postal Code
68198-3330
Country
United States
Facility Name
Hackensack University Medical Center Cancer Center
City
Hackensack
State/Province
New Jersey
ZIP/Postal Code
07601
Country
United States
Facility Name
Roswell Park Cancer Institute
City
Buffalo
State/Province
New York
ZIP/Postal Code
14263-0001
Country
United States
Facility Name
Cohen Children's Hospital
City
New Hyde Park
State/Province
New York
ZIP/Postal Code
11040
Country
United States
Facility Name
Duke University Medical Center
City
Durham
State/Province
North Carolina
ZIP/Postal Code
27705
Country
United States
Facility Name
Wake Forest University Health Sciences
City
Winston-Salem
State/Province
North Carolina
ZIP/Postal Code
27157-1082
Country
United States
Facility Name
Ohio State/Arthur G. James Cancer Hospital
City
Columbus
State/Province
Ohio
ZIP/Postal Code
43210
Country
United States
Facility Name
University of Oklahoma Medical Center
City
Oklahoma City
State/Province
Oklahoma
ZIP/Postal Code
73104
Country
United States
Facility Name
Oregon Health & Science University (Peds)
City
Portland
State/Province
Oregon
ZIP/Postal Code
97239-3098
Country
United States
Facility Name
Oregon Health Sciences University
City
Portland
State/Province
Oregon
ZIP/Postal Code
97239
Country
United States
Facility Name
University of Pennsylvania Cancer Center
City
Philadelphia
State/Province
Pennsylvania
ZIP/Postal Code
19104
Country
United States
Facility Name
University of Pittsburgh Cancer Institute
City
Pittsburgh
State/Province
Pennsylvania
ZIP/Postal Code
15232
Country
United States
Facility Name
Vanderbilt University
City
Nashville
State/Province
Tennessee
ZIP/Postal Code
37232-6838
Country
United States
Facility Name
Baylor University Medical Center
City
Dallas
State/Province
Texas
ZIP/Postal Code
77030
Country
United States
Facility Name
Baylor College of Medicine/The Methodist Hospital
City
Houston
State/Province
Texas
ZIP/Postal Code
77030-2399
Country
United States
Facility Name
University of Texas/MD Anderson CRC
City
Houston
State/Province
Texas
ZIP/Postal Code
77030-4009
Country
United States
Facility Name
Texas Transplant Institute
City
San Antonio
State/Province
Texas
ZIP/Postal Code
78229
Country
United States
Facility Name
Utah BMT/Primary Children's Medical Center
City
Salt Lake City
State/Province
Utah
ZIP/Postal Code
84112
Country
United States
Facility Name
Utah BMT/University of Utah Medical School
City
Salt Lake City
State/Province
Utah
ZIP/Postal Code
84132
Country
United States
Facility Name
Virginia Commonwealth University MCV Hospitals
City
Richmond
State/Province
Virginia
ZIP/Postal Code
23298-0037
Country
United States
Facility Name
Fred Hutchinson Cancer Research Center
City
Seattle
State/Province
Washington
ZIP/Postal Code
98104
Country
United States
Facility Name
Tom Baker Cancer Centre, Calgary
City
Calgary
State/Province
Alberta
ZIP/Postal Code
T2N 4N2
Country
Canada
Facility Name
Vancouver General Hospital
City
Vancouver
State/Province
British Columbia
ZIP/Postal Code
V5Z1M9
Country
Canada
Facility Name
Hamilton Health Sciences - McMaster Site
City
Hamilton
State/Province
Ontario
Country
Canada
Facility Name
Ottawa Hospital
City
Ottawa
State/Province
Ontario
Country
Canada
Facility Name
University of Toronto, Princess Margaret Hospital
City
Toronto
State/Province
Ontario
ZIP/Postal Code
M5G 2M9
Country
Canada
Facility Name
Queen Elizabeth II Health Sciences Centre - Halifax
City
Halifax
Country
Canada

12. IPD Sharing Statement

Plan to Share IPD
Yes
IPD Sharing Plan Description
Results will be published in a manuscript
IPD Sharing Time Frame
Within 6 months of official study closure at participating sites.
IPD Sharing Access Criteria
Available to the public
IPD Sharing URL
https://biolincc.nhlbi.nih.gov/home/
Citations:
PubMed Identifier
23075175
Citation
Anasetti C, Logan BR, Lee SJ, Waller EK, Weisdorf DJ, Wingard JR, Cutler CS, Westervelt P, Woolfrey A, Couban S, Ehninger G, Johnston L, Maziarz RT, Pulsipher MA, Porter DL, Mineishi S, McCarty JM, Khan SP, Anderlini P, Bensinger WI, Leitman SF, Rowley SD, Bredeson C, Carter SL, Horowitz MM, Confer DL; Blood and Marrow Transplant Clinical Trials Network. Peripheral-blood stem cells versus bone marrow from unrelated donors. N Engl J Med. 2012 Oct 18;367(16):1487-96. doi: 10.1056/NEJMoa1203517.
Results Reference
result
PubMed Identifier
23077239
Citation
Foley B, Cooley S, Verneris MR, Curtsinger J, Luo X, Waller EK, Anasetti C, Weisdorf D, Miller JS. Human cytomegalovirus (CMV)-induced memory-like NKG2C(+) NK cells are transplantable and expand in vivo in response to recipient CMV antigen. J Immunol. 2012 Nov 15;189(10):5082-8. doi: 10.4049/jimmunol.1201964. Epub 2012 Oct 17.
Results Reference
result
PubMed Identifier
24184336
Citation
Switzer GE, Bruce JG, Harrington D, Haagenson M, Drexler R, Foley A, Confer D, Bishop M, Anderlini P, Rowley S, Leitman SF, Anasetti C, Wingard JR. Health-related quality of life of bone marrow versus peripheral blood stem cell donors: a prespecified subgroup analysis from a phase III RCT-BMTCTN protocol 0201. Biol Blood Marrow Transplant. 2014 Jan;20(1):118-27. doi: 10.1016/j.bbmt.2013.10.024. Epub 2013 Nov 1.
Results Reference
result
PubMed Identifier
24982459
Citation
Waller EK, Logan BR, Harris WA, Devine SM, Porter DL, Mineishi S, McCarty JM, Gonzalez CE, Spitzer TR, Krijanovski OI, Linenberger ML, Woolfrey A, Howard A, Wu J, Confer DL, Anasetti C. Improved survival after transplantation of more donor plasmacytoid dendritic or naive T cells from unrelated-donor marrow grafts: results from BMTCTN 0201. J Clin Oncol. 2014 Aug 1;32(22):2365-72. doi: 10.1200/JCO.2013.54.4577. Epub 2014 Jun 30.
Results Reference
result
PubMed Identifier
26071866
Citation
Khera N, Majhail NS, Brazauskas R, Wang Z, He N, Aljurf MD, Akpek G, Atsuta Y, Beattie S, Bredeson CN, Burns LJ, Dalal JD, Freytes CO, Gupta V, Inamoto Y, Lazarus HM, LeMaistre CF, Steinberg A, Szwajcer D, Wingard JR, Wirk B, Wood WA, Joffe S, Hahn TE, Loberiza FR, Anasetti C, Horowitz MM, Lee SJ. Comparison of Characteristics and Outcomes of Trial Participants and Nonparticipants: Example of Blood and Marrow Transplant Clinical Trials Network 0201 Trial. Biol Blood Marrow Transplant. 2015 Oct;21(10):1815-22. doi: 10.1016/j.bbmt.2015.06.004. Epub 2015 Jun 11.
Results Reference
result
PubMed Identifier
26409243
Citation
Young JH, Logan BR, Wu J, Wingard JR, Weisdorf DJ, Mudrick C, Knust K, Horowitz MM, Confer DL, Dubberke ER, Pergam SA, Marty FM, Strasfeld LM, Brown JWM, Langston AA, Schuster MG, Kaul DR, Martin SI, Anasetti C; Blood and Marrow Transplant Clinical Trials Network Trial 0201. Infections after Transplantation of Bone Marrow or Peripheral Blood Stem Cells from Unrelated Donors. Biol Blood Marrow Transplant. 2016 Feb;22(2):359-370. doi: 10.1016/j.bbmt.2015.09.013. Epub 2015 Sep 25.
Results Reference
result
PubMed Identifier
27013014
Citation
Burns LJ, Logan BR, Chitphakdithai P, Miller JP, Drexler R, Spellman S, Switzer GE, Wingard JR, Anasetti C, Confer DL; Blood and Marrow Transplant Clinical Trials Network. Recovery of Unrelated Donors of Peripheral Blood Stem Cells versus Recovery of Unrelated Donors of Bone Marrow: A Prespecified Analysis from the Phase III Blood and Marrow Transplant Clinical Trials Network Protocol 0201. Biol Blood Marrow Transplant. 2016 Jun;22(6):1108-1116. doi: 10.1016/j.bbmt.2016.02.018. Epub 2016 Mar 21.
Results Reference
result
PubMed Identifier
27532508
Citation
Lee SJ, Logan B, Westervelt P, Cutler C, Woolfrey A, Khan SP, Waller EK, Maziarz RT, Wu J, Shaw BE, Confer D, Horowitz MM, Anasetti C. Comparison of Patient-Reported Outcomes in 5-Year Survivors Who Received Bone Marrow vs Peripheral Blood Unrelated Donor Transplantation: Long-term Follow-up of a Randomized Clinical Trial. JAMA Oncol. 2016 Dec 1;2(12):1583-1589. doi: 10.1001/jamaoncol.2016.2520.
Results Reference
derived
Links:
URL
https://bethematch.org/
Description
National Marrow Donor Program

Learn more about this trial

Peripheral Blood Stem Cell Transplant vs Bone Marrow Transplant in Individuals With Hematologic Cancers (BMT CTN 0201)

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