NCT00001873

The Role of Cyclosporine in Blood Cell Transplants With T-Cell Add-Back for Blood Cancers

Completed Phase 2 Last updated 26 September 2018

What this trial tests

Phase 2 trial testing Isolex 300i plus MoAbs in Chronic Lymphocytic Leukemia in 102 participants. Completed in 13 June 2017.

Timeline

22 February 1999

Primary endpoint
28 December 2007

13 June 2017

Quick facts

Lead sponsor	National Heart, Lung, and Blood Institute (NHLBI)
Phase	Phase 2
Status	Completed
Study type	INTERVENTIONAL
Allocation	non randomized
Design	single group
Masking	none
Primary purpose	treatment
Enrollment	102
Start date	22 February 1999
Primary completion	28 December 2007
Estimated completion	13 June 2017
Sites	1 location across United States

Drugs / interventions tested

• Isolex 300i plus MoAbs

Conditions studied

• Chronic Lymphocytic Leukemia — all drugs for Chronic Lymphocytic Leukemia →
• Graft vs Host Disease — all drugs for Graft vs Host Disease →
• Hematologic Neoplasm — all drugs for Hematologic Neoplasm →
• 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 Chronic Lymphocytic Leukemia or Graft vs Host Disease. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

Cancers of the blood, sometimes referred to as hematologic malignancies, are disorders of bone marrow cells that lead to the failure of the normal function of bone marrow and the uncontrolled growth of cancerous cells in the bone marrow. These cancerous cells can spill over into the bloodstream and affect other organs causing widespread symptoms. The disease is life threatening because it blocks the normal function of the marrow, which is to produce red cells (preventing anemia), white cells (preventing infection), and platelets (preventing progression).

Bone marrow transplants are a potential form of therapy for patients with hematologic malignancies. However, BMT is a complicated procedure and can be associated with dangerous side effects.

In this study researchers are attempting to find ways to reduce the complications of BMT, so that it would be possible to use it more safely and can be offered more patients. In order to do this, researchers are developing new techniques to make BMT safer. It requires making small changes to the standard procedure, which may improve the outcome.

The experimental procedures researchers are evaluating are:

1. \<TAB\>T-cell depleted peripheral blood progenitor cell (PBPC) transplantation
2. \<TAB\> Cyclosporine given immediately after the transplant
3. \<TAB\>Add-back of donor lymphocytes

Patients undergoing these experimental techniques must be monitored closely to see if any benefit or harmful effects will occur. Information gathered from this study can be used to develop further research studies and potential new therapies for hematologic malignancies.

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