NCT00001623

Bone Marrow Transplant Studies for Safe and Effective Treatment of Leukemia

Completed NA Last updated 12 December 2019

What this trial tests

NA trial testing Allogeneic Bone Marrow Transplant in Graft vs Host Disease in 41 participants. Completed in 3 August 2017.

Timeline

27 March 1997

Primary endpoint
31 January 2008

3 August 2017

Quick facts

Lead sponsor	National Heart, Lung, and Blood Institute (NHLBI)
Phase	NA
Status	Completed
Study type	INTERVENTIONAL
Allocation	non randomized
Design	single group
Masking	none
Primary purpose	treatment
Enrollment	41
Start date	27 March 1997
Primary completion	31 January 2008
Estimated completion	3 August 2017
Sites	1 location across United States

Drugs / interventions tested

• Allogeneic Bone Marrow Transplant — full drug profile →

Conditions studied

• Graft vs Host Disease — all drugs for Graft vs Host Disease →
• Hematologic Neoplasm — all drugs for Hematologic Neoplasm →
• Leukemia — all drugs for Leukemia →
• Multiple Myeloma — all drugs for Multiple Myeloma →

Sponsor

National Heart, Lung, and Blood Institute (NHLBI)

Who can join

Adults 10 to 55, any sex, with Graft vs Host Disease or Hematologic Neoplasm. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

Bone marrow transplants (BMT) are one of the accepted therapies used to treat leukemia. However, BMT have risks of complications. One potentially life-threatening complication is known as graft-versus-host disease (GVHD).

The GVHD is a reaction caused by an incompatibility between donor cells and recipient cells. Antigens found on the recipient s cells are recognized by the donor s transplanted white blood cell lymphocytes. These lymphocytes begin attacking the recipient s cells and tissues and may lead to death.

One of the most effective ways to prevent this reaction is to remove the lymphocytes from the transplanted marrow. Unfortunately, without lymphocytes the recipient s immune system will be lowered and may result in a relapse of leukemia or an infection.

Researchers have shown they can perform effective BMT by removing the lymphocytes prior to the transplant and then later adding the lymphocytes back. This technique can reduce the potential for GVHD and preserve the graft-versus-leukemia (GVL) effect of the transplant.

In this study researchers plan to use peripheral blood with lymphocytes removed rather than bone marrow. In order to increase the number of progenitor cells, the cells responsible for correcting the leukemia, donors will receive doses of G-CSF prior to the transplant. G-CSF (granulocyte colony stimulating factor) is a growth factor that increases the production of progenitor cells in the donor s blood stream.

The study will be broken into two parts. The first part of the study will attempt to determine if peripheral blood with lymphocytes removed can prevent GVHD while preserving the GVL effect of the transplant.

In the second part of the study, patients that received the transplant will have the lymphocytes added-back on two separate occasions in order reduce the chances of relapse and infection.

The study is designed to treat up to 55 patients ages 10 to 60 years and follow their progress for 5 years.

Publications & conference data

2 peer-reviewed publications reference this trial (live from Europe PMC):

1. Donor lymphocyte count and thymic activity predict lymphocyte recovery and outcomes after matched-sibling hematopoietic stem cell transplant.
   McIver Z, Melenhorst JJ, Wu C, Grim A, et al · · 2013 · cited 18× · PMID 23065508 · DOI 10.3324/haematol.2012.072991
2. Second hematopoietic SCT for leukemia relapsing after myeloablative T cell-depleted transplants does not prolong survival.
   McIver ZA, Yin F, Hughes T, Battiwalla M, et al · · 2013 · cited 10× · PMID 23524640 · DOI 10.1038/bmt.2013.39