Blood and Marrow Clinical Trials Network (BMT CTN) Comparing Peripheral Blood Stem Cell Transplantation Versus Bone Marrow Transplantation in Individuals With Hematologic Cancers (0201) - Catalog

Name

Blood and Marrow Clinical Trials Network (BMT CTN) Comparing Peripheral Blood Stem Cell Transplantation Versus Bone Marrow Transplantation in Individuals With Hematologic Cancers (0201)

Accession Number

HLB01351620a

Acronym

BMT CTN-0201

Related studies

BSI Study IDs

PBM

Is public use dataset

False

Keywords

Has Study Datasets

True

Has Specimens

True

Specimen ID Type

Coded

Study Website

https://web.emmes.com/study/bmt2/protocol/0201__protocol/0201_protocol.html

The Framingham Heart Study Group requires that the requestor must obtain full or expedited IRB/Ethics Committee review and approval to obtain these data. Waivers or a determination that the research is exempt from ethical regulations do not suffice.

False

Clinical Trial URLs
https://clinicaltrials.gov/ct2/show/NCT00075816
Study type

Clinical Trial

Collection Type

Open BioLINCC Study

Cohort type

Both

Interventions

Biological: Allogeneic bone marrow transplantationBiological: Peripheral blood stem cell transplantation

Study Open Date (Data)

2015-11-03

Study Open Date (Specimens)

2015-11-03

Date materials available

2010-09-14

Last updated

2015-11-03

Study period

January 2004 – April 2014

Study Contacts
NHLBI Division

DBDR

Classification

Blood Disease

HIV study classification

non-HIV

COVID study classification

non-COVID

Pre-Website # of Specimens Shipped

4042

# of Returned Specimens

0

Primary Publication URLs
https://www.ncbi.nlm.nih.gov/pubmed/23075175
Conditions

Leukemia
Myelodysplastic-Myeloproliferative Diseases
Myeloproliferative Disorders

Objectives

To compare survival rates of patients with hematologic cancers that received transplantation of granulocyte colony stimulating factor (G-CSF) mobilized peripheral blood stem cells (PBSC) versus marrow from HLA-compatible unrelated donors.

Background

Many studies of allogeneic marrow transplantation have shown that a higher dose of marrow cells correlates with a stronger 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 large number of CD34-positive 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. However, some studies have also shown increased risk of acute and chronic graft-versus-host disease (GVHD), as compared to bone marrow.

Subjects

Between March 2004 and September 2009, 551 subjects were enrolled at 48 centers. Eligible subjects were less than 66 years of age and were planning to undergo transplantation for acute leukemia, myelodysplasia, chronic myeloid or myelomonocytic leukemia, or myelofibrosis.

Design

Subjects were randomly assigned in a 1:1 ratio to peripheral-blood stem-cell or bone marrow transplantation, stratified according to transplantation center and disease risk. Donors and recipients were DNA typed to ensure matching for 5 or 6 of the HLA-A, B, and DRB1 antigens. Peripheral-blood stem-cell donors were prescribed filgrastim or lenograstim at a dose of 10 μg per kilogram per day for 5 days and underwent apheresis. Recipients received one of four conditioning regimens and one of two GVHD prophylaxis regimens that were specified prior to randomization. Supportive care and treatment for GVHD were provided according to institutional standards. Subjects were followed in the study for 3 years.


The primary end point was 2-year survival as assessed by means of an intention-to-treat analysis. Secondary end points included post-transplantation incidences of neutrophil and platelet engraftment, graft failure, acute and chronic GVHD, relapse, and infections.

Conclusions

There was no detected significant survival differences between peripheral-blood stem-cell and bone marrow transplantation from unrelated donors. Further analysis indicated that peripheral-blood stem cells may reduce the risk of graft failure, whereas bone marrow may reduce the risk of chronic GVHD.


N Engl J Med. 2012 Oct 18;367(16):1487-96.

Disease classification

Publications

Mat types

Plasma
Serum

The study population available in BioLINCC study data may be lower than total study enrollment due to Informed Consent restrictions and other factors.

  • Subjects

    551 Subjects

     

    Bone Marrow: 278 Subjects

    Peripheral Blood Stem Cells: 273 Subjects

     

     


    Last Modified: Nov. 10, 2015, 3:39 p.m.
  • Age
     

     

    Bone Marrow

    Peripheral Blood Stem Cells

    All

    N

    %

    N

    %

    N

    %

    < 18

    26

    9.35

    18

    6.59

    44

    7.99

    18 - 25

    27

    9.71

    27

    9.89

    54

    9.80

    25 - 30

    23

    8.27

    22

    8.06

    45

    8.17

    30 - 35

    19

    6.83

    25

    9.16

    44

    7.99

    35 - 40

    23

    8.27

    24

    8.79

    47

    8.53

    40 - 45

    26

    9.35

    30

    10.99

    56

    10.16

    45 - 50

    26

    9.35

    25

    9.16

    51

    9.26

    50 - 55

    37

    13.31

    35

    12.82

    72

    13.07

    55 - 60

    32

    11.51

    37

    13.55

    69

    12.52

    60 - 65

    33

    11.87

    26

    9.52

    59

    10.71

    >= 65

    6

    2.16

    4

    1.47

    10

    1.81

     

     


    Last Modified: Nov. 10, 2015, 3:39 p.m.
  • Sex

     

    Bone Marrow

    Peripheral Blood Stem Cells

    All

    N

    %

    N

    %

    N

    %

    Male

    168

    60.43

    146

    53.48

    314

    56.99

    Female

    110

    39.57

    127

    46.52

    237

    43.01

     

     


    Last Modified: Nov. 10, 2015, 3:39 p.m.
  • Race

     

    Bone Marrow

    Peripheral Blood Stem Cells

    All

    N

    %

    N

    %

    N

    %

    Black or African American

    13

    4.68

    10

    3.66

    23

    4.17

    White

    252

    90.65

    248

    90.84

    500

    90.74

    Other, Specify

    10

    3.60

    8

    2.93

    18

    3.27

    Unknown

    1

    0.36

    5

    1.83

    6

    1.09

    Not Answered

    2

    0.72

    2

    0.73

    4

    0.73

     

     


    Last Modified: Nov. 10, 2015, 3:39 p.m.

Please note that biospecimen availability is subject to review by the NHLBI, BioLINCC, and the NHLBI Biorepository. Certain biospecimens may not be made available for your request. Section 3 of the BioLINCC handbook describes the components of the review process

  • Material Types

    Last Modified: Sept. 22, 2016, 3:51 p.m.
  • General Freeze/Thaw Status

    Last Modified: Oct. 26, 2018, 11:41 a.m.
  • Visits (Vials)

    10/26/2018

      Serum Plasma Total
    Day 0 1,769 46 1,815
    Day 90 92 863 955
    Day 180 738 681 1,419
    Day 330 414 14 428
    Day 365 383 443 826
    Day 730 295 419 714

     


    Last Modified: Oct. 26, 2018, 11:41 a.m.
  • Visits (Subjects)

    10/26/2018

      Serum
    Total number of subjects Average volume (ml) per subject
    Day 0 348 2.28
    Day 90 14 3.62
    Day 180 216 1.58
    Day 330 120 1.55
    Day 365 132 1.32
    Day 730 91 1.49
     
      Plasma
    Total number of subjects Average volume (ml) per subject
    Day 0 10 2.29
    Day 90 312 1.53
    Day 180 245 1.57
    Day 330 3 3.05
    Day 365 163 1.42
    Day 730 115 2.16

     


    Last Modified: Oct. 26, 2018, 11:41 a.m.