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

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Accession Number
HLB01351620a

Study Type
Clinical Trial

Collection Type
Open BioLINCC Study See bottom of this webpage for request information

Study Period
January 2004 – April 2014

NHLBI Division
DBDR

Dataset(s) Last Updated
December 17, 2020

Study Website
https://bmtctn.net/bmt-ctn-studies

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

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

Consent

Commercial Use Data Restrictions No

Data Restrictions Based On Area Of Research No

Commercial Use Specimen Restrictions No

Non-Genetic Use Specimen Restrictions Based On Area Of Use No

Genetic Use Of Specimens Allowed? Yes

Genetic Use Area Of Research Restrictions No

Specific Consent Restrictions
None.

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.

Participants

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.

Additional Details

Subjects:

551 Subjects

 

Bone Marrow: 278 Subjects

Peripheral Blood Stem Cells: 273 Subjects

 

 

Age:

 

Bone Marrow

Peripheral Blood Stem Cells

Total Subjects

< 18

26

18

44

18 - 24

27

27

54

25 - 29

23

22

45

30 - 34

19

25

44

35 - 39

23

24

47

40 - 44

26

30

56

45 - 49

26

25

51

50 - 54

37

35

72

55 - 59

32

37

69

60 - 64

33

26

59

>= 65

6

4

10

Sex:

 

Bone Marrow

Peripheral Blood Stem Cells

Total Subjects

Male

168

146

314

Female

110

127

237

Race:

 

Bone Marrow

Peripheral Blood Stem Cells

Total Subjects

Black or African American

13

10

23

White

252

248

500

Other, Specify

10

8

18

Unknown

1

5

6

Not Answered

2

2

4

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:

Serum. Plasma

General Freeze/Thaw Status:

Serum - Majority unthawed

Plasma - Majority unthawed

Visits (Vials):

04/18/2024

 

Serum

Plasma

Total Vials

Day 0

1,769

46

1,815

Day 90

88

827

915

Day 180

738

681

1,419

Day 330

414

14

428

Day 365

383

443

826

Day 730

295

419

714

Visits (Subjects):

04/18/2024

 

Serum

Total number of subjects

Average volume (mL) per subject

Day 0

348

2.28

Day 90

14

3.46

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

1.27

Day 180

245

1.57

Day 330

3

3.05

Day 365

163

1.42

Day 730

115

2.16

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Resources Available

Specimens and Study Datasets

Study Catalog

Study Publications (1)

Materials Available

Study Documents

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