Trial Information

Pilot Trial of Two Dose Levels of Thymoglobulin® as Part of a Myeloablative-Conditioning for a HLA Identical Matched Related Donor (MRD) Stem Cell Transplant With Cyclosporine (CsA) as Posttransplant Graft vs Host Disease (GvHD) Prophylaxis

OBJECTIVES:

Primary

- Compare the incidence of acute graft-vs-host disease (GVHD) within the first 100 days
after transplantation in patients with acute lymphoblastic leukemia or acute myeloid
leukemia treated with a myeloablative conditioning regimen comprising cyclophosphamide
(with or without radiotherapy) and low- vs high-dose anti-thymocyte globulin followed
by allogeneic HLA-matched related stem cell transplantation and cyclosporine.

- Compare the incidence of serious adverse events within the first 100 days after
transplantation in patients treated with these regimens.

Secondary

- Compare 100-day and 6-month survival in patients treated with these regimens.

- Compare the severity of acute GVHD in patients treated with these regimens.

- Compare the incidence of culture-proven infections at 100 days and 6 months after
transplantation in patients treated with these regimens.

- Compare the incidence of mucositis, in terms of presence, severity, and duration, in
patients treated with these regimens.

- Compare the number of days on opiate drugs within the first 30 days after
transplantation in patients treated with these regimens.

- Compare the time to engraftment in patients treated with these regimens.

- Compare the incidence of hospitalization within the first 6 months after
transplantation, in terms of length of initial stay, cumulative total days, and number
of hospitalizations, in patients treated with these regimens.

- Compare the relapse rate and time to relapse in patients treated with these regimens.

- Compare the incidence and severity of chronic GVHD between 100 days and 6 months after
transplantation in patients treated with these regimens.

OUTLINE: This is a pilot, randomized, open-label, multicenter study.

- Conditioning: All patients receive a standard myeloablative-conditioning regimen that
contains cyclophosphamide IV over 2 hours per center regimen, typically on days -6 to
-3. Patients also undergo total body irradiation OR receive busulfan.

- Graft-versus-host disease (GVHD) prophylaxis (as part of conditioning): Patients are
randomized to 1 of 2 treatment arms.

- Arm I: Patients receive low-dose anti-thymocyte globulin IV over 4-8 hours on days
-3 to -1.

- Arm II: Patients receive high-dose anti-thymocyte globulin IV over 4-8 hours on
days -5 to -1.

- Allogeneic hematopoietic stem cell transplantation: Patients in both arms undergo
allogeneic peripheral blood stem cell or bone marrow transplantation on day 0.

- Post-transplantation GVHD prophylaxis: Patients in both arms receive cyclosporine IV
over 1-4 hours or orally twice daily beginning on day -1 and continuing until
approximately day 60 followed by tapering doses until day 180 in the absence of GVHD.

Patients are followed at 7, 14, 21, 30, 100, and 180 days.

PROJECTED ACCRUAL: A total of 30-60 patients (15-30 per treatment arm) will be accrued for
this study.