NCT00061581

Experimental Bone Marrow Transplant Protocol

Completed Phase 2 Last updated 26 September 2018

What this trial tests

Phase 2 trial testing Isolex 300i Stem Cell Selection in Acute Lymphocytic Leukemia in 14 participants. Completed in 14 June 2017.

Timeline

19 May 2003

Primary endpoint
28 December 2007

14 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	14
Start date	19 May 2003
Primary completion	28 December 2007
Estimated completion	14 June 2017
Sites	1 location across United States

Drugs / interventions tested

• Isolex 300i Stem Cell Selection

Conditions studied

• Acute Lymphocytic Leukemia — all drugs for Acute Lymphocytic Leukemia →
• Chronic Myeloid Leukemia — all drugs for Chronic Myeloid Leukemia →
• Acute Myelocytic Leukemia — all drugs for Acute Myelocytic Leukemia →
• Myelodysplastic Syndromes — all drugs for Myelodysplastic Syndromes →

Sponsor

National Heart, Lung, and Blood Institute (NHLBI)

Who can join

Adults 10 to 55, any sex, with Acute Lymphocytic Leukemia or Chronic Myeloid Leukemia. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

Bone marrow transplantation (BMT) is a risky procedure. If doctors could reduce the complications, BMT would be safer to use for a wider range of conditions. The purposes of this study are

* to prevent graft rejection by increasing the amount of immunosuppression and by giving some lymphocytes from the donor before transplant;
* to prevent graft-versus-host disease (GVHD) by transplanting T-cell depleted stem cells;
* to improve the immune effect against residual leukemia by the add-back of donor lymphocytes before transplant and six or more weeks after transplant.

Beyond the standard transplant protocol, study participants will undergo additional procedures. First, along with total body irradiation, patients will receive two drugs (a high dose of cyclophosphamide and fludarabine) to suppress immunity and prevent rejection of the transplant. Second, four days before the transplant, patients will be given donor lymphocytes that have been irradiated to make them incapable of causing GVHD. On the day of the transplant, patients will receive an infusion of T-cell depleted bone marrow stem cells. Finally, patients will receive two doses of add-back donor T-cells (45 and 100 days post transplant) and the immunosuppressive drug cyclosporine starting on day 44 until about six months after transplant.

Study participants must be between the ages of 10 and 56 and have a family member who is a suitable stem cell donor match.

Publications & conference data

No peer-reviewed publications indexed yet for this trial. Completed trials usually publish results within 12-18 months.