To measure how frequently and to what degree a complication of transplant cell acute graft versus host disease (GvHD) occurs.
This study evaluated whether TLI-ATG conditioning followed by allogeneic hematpoietic cell transplant (HCT), which has provided excellent overall survival for patients with relapsed lymphoma after failed autologous HCT, provides a similar benefit in the setting of elderly patients with hematologic malignancies.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
303
Starting day -3 at a dose of 5 mg/kg orally twice daily with a target trough level of 350 to 450 ng/mL
1.5 mg/kg for total dose of 7.5mg/kg, IV starting on day -11 to day -7 before HCT
Begins on day 0 after HCT at a dose of 15 mg/kg. Transplant recipients who received related donor grafts received MMF twice daily and those who received unrelated donor grafts received MMF 3 times daily.
Stanford University School of Medicine
Stanford, California, United States
Acute Graft vs Host Disease (GvHD)
The incidence of acute GvHD after transplantation was assessed per Glucksberg GvHD grade, a compound scale based on the following combinations of disease stages. Skin Stages * 0: No rash * 1: Maculopapular (MP) rash \<25% of body surface area * 2: MP rash on 25-50% of body surface area * 3: Generalized erythroderma (ED) * 4: Generalized ED with bullous formation and desquamation Liver Stages (Bilirubin in mg/dL) * 0: \<2 * 1: 2-3 * 2: 3.01-6 * 3: 6.01-15.0 * 4: \>15 Gastrointestinal (GI) Stages (diarrhea) * 0: None or \< 500 mL/day * 1: 500-999 mL/day * 2: 1000-1499 mL/day * 3: \>1500 mL/day * 4: Severe abdominal pain, with or without ileus Glucksberg Overall grade * Grade 1: Skin 1/2; GI 0; Liver 0; Karnofsky performance scale (KPS) 90-100% * Grade 2: Skin 1-3; GI 1; Liver 1; KPS 70-80 * Grade 2: Skin 2/3; GI 2/3; Liver 2-4; KPS 50-60 * Grade 4: Skin 2-4; GI 2-4; Liver 2-4; KPS 30-40
Time frame: 100 days post-transplant
Acute Graft vs Host Disease (GvHD), All Evaluable
The incidence of acute GvHD after transplantation was assessed per Glucksberg GvHD grade, a compound scale based on the following combinations of disease stages. Skin Stages * 0: No rash * 1: Maculopapular (MP) rash \<25% of body surface area * 2: MP rash on 25-50% of body surface area * 3: Generalized erythroderma (ED) * 4: Generalized ED with bullous formation and desquamation Liver Stages (Bilirubin in mg/dL) * 0: \<2 * 1: 2-3 * 2: 3.01-6 * 3: 6.01-15.0 * 4: \>15 Gastrointestinal (GI) Stages (diarrhea) * 0: None or \< 500 mL/day * 1: 500-999 mL/day * 2: 1000-1499 mL/day * 3: \>1500 mL/day * 4: Severe abdominal pain, with or without ileus Glucksberg Overall grade * Grade 1: Skin 1/2; GI 0; Liver 0; Karnofsky performance scale (KPS) 90-100% * Grade 2: Skin 1-3; GI 1; Liver 1; KPS 70-80 * Grade 2: Skin 2/3; GI 2/3; Liver 2-4; KPS 50-60 * Grade 4: Skin 2-4; GI 2-4; Liver 2-4; KPS 30-40
Time frame: 100 days post-transplant
Incidence of Relapse
Reports the overall rate of disease relapse, occurring any time within 3 years after transplant
Time frame: 3 years
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.
* Donors mobilized with 16 µg/kg/day filgrastim. * As needed, myelosuppression in transplant recipients will be managed with subcutaneous filgrastim 5 µg/kg/day
0.8 Gy/day from day -11 to day -7 (inclusive) from day -4 to day -2 (inclusive) with 2 additional fractions of 0.8 Gy delivered on day -1 for total dose of 8 Gy.
Overall Survival (OS)
Time frame: 3 and 5 years
Event-free Survival (EFS)
Reports the number and proportion of participants who neither died due to any cause nor experienced relapse.
Time frame: 3 and 5 years
Transplant-related Mortality
Reports the proportion of participants who expired within 1 year due to any complication or failure of the transplant.
Time frame: 1 year