Alemtuzumab and Glucocorticoids in Treating Newly Diagnosed Acute Graft-Versus-Host Disease in Pa… (NCT00410657) | Clinical Trial Compass
CompletedPhase 2
Alemtuzumab and Glucocorticoids in Treating Newly Diagnosed Acute Graft-Versus-Host Disease in Patients Who Have Undergone a Donor Stem Cell Transplant
United States53 participantsStarted 2006-07
Plain-language summary
RATIONALE: Alemtuzumab and glucocorticoids, such as prednisone or methylprednisolone, may be an effective treatment for acute graft-versus-host disease caused by a donor stem cell transplant.
PURPOSE: This phase II trial is studying how well giving alemtuzumab together with glucocorticoids works in treating newly diagnosed acute graft-versus-host disease in patients who have undergone donor stem cell transplant.
Who can participate
SexALL
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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
DISEASE CHARACTERISTICS:
* Newly diagnosed acute graft-versus-host disease (GVHD)
* Grade IIB-IV disease
* Requires glucocorticoids for treatment of GVHD, as indicated by 1 of the following:
* Initial treatment with prednisone or methylprednisolone at 2 mg/kg is indicated (in the judgement of the attending physician) by any of the following:
* Severity of GVHD requires hospitalization
* GVHD manifestations include symptoms other than anorexia, nausea, and vomiting
* GVHD begins within 2-3 weeks after hematopoietic stem cell transplantation (HSCT)
* GVHD manifestations progress rapidly from 1 day to the next before treatment
* Initial treatment with prednisone or methylprednisolone at 1 mg/kg did not produce adequate clinical improvement within the first 4 days (in the judgement of the attending physician)
* Has undergone allogeneic HSCT with myeloablative conditioning
* No nonmyeloablative conditioning or autologous HSCT
* No primary treatment of acute GVHD with methylprednisolone at any of the following doses:
* More than 2 mg/kg/day at any time
* 2 mg/kg/day for \> 72 hours
* 1 mg/kg/day for \> 96 hours
* No presence of distinctive or diagnostic manifestations of chronic GVHD
* No relapsed, refractory, or secondary malignancy
PATIENT CHARACTERISTICS:
* Karnofsky performance status (PS) 20-100% OR Lanksy PS 20-100%
* Life expectancy ≥ 1 month
* Absolute neutrophil count ≥ 500/mm\^3
* Negative pregnancy test
* No Mini Mental State Exam sc…
What they're measuring
1
Proportion of patients with methylprednisolone (MP)-equivalent glucocorticoid doses ≤ 0.75 mg/kg on day 28 after starting therapy for graft-versus-host disease (GVHD)