Neoplasms

Blood and Lymph Conditions

All Conditions

Leukemia

Hematologic Neoplasms

Hematologic Diseases

Anti-Infective Agents

Antirheumatic Agents

Dermatologic Agents

All Drugs and Chemicals

Antineoplastic Agents

Cyclosporine

Cyclosporins

Lenograstim

Mycophenolic Acid

Thymoglobulin

Antilymphocyte Serum

Adjuvants, Immunologic

Immunologic Factors

Enzyme Inhibitors

Immunosuppressive Agents

Clotrimazole

Miconazole

Antifungal Agents

Calcineurin Inhibitors

Anti-Bacterial Agents

Antibiotics, Antitubercular

Antitubercular Agents

Pre-transplant total lymphoid irradiation (TLI) and anti-thymocyte globulin (ATG) infusion with Day 0 allogeneic hematopoietic cell transplant (HCT), followed by post-transplant immunosuppression by cyclosporine and mycophenolate mofetil.

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

Anti-thymocyte globulin (ATG)

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.

Mycophenolate mofetil (MMF)

* Donors mobilized with 16 µg/kg/day filgrastim.
* As needed, myelosuppression in transplant recipients will be managed with subcutaneous filgrastim 5 µg/kg/day

Filgrastim

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.

Total Lymphoid Irradiation (TLI)

Robert Lowsky

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.

Allogeneic Transplantation Using Total Lymphoid Irradiation (TLI) and Anti-Thymocyte Globulin (ATG) for Older Patients With Hematologic Malignancies

Allogeneic Hematopoietic Cell Transplantation Using a Non-Myeloablative Preparative Regimen of Total Lymphoid Irradiation and Anti-Thymocyte Globulin for Older Patients With Hematologic Malignancies

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

Reports the overall rate of disease relapse, occurring any time within 3 years after transplant

Reports the number and proportion of participants who neither died due to any cause nor experienced relapse.

Reports the proportion of participants who expired within 1 year due to any complication or failure of the transplant.

Stanford University

Professor of Medicine

Adverse events other than death, secondary malignancy, or relapse were not collected.

Non-myeloablative Transplantation

Pre-transplant total lymphoid irradiation (TLI) and anti-thymocyte globulin (ATG) infusion with Day 0 allogeneic hematopoietic cell transplant (HCT), followed by post-transplant immunosuppression by cyclosporine and mycophenolate mofetil

Age, Categorical

Sex: Female, Male

Ethnicity (NIH/OMB)

Race (NIH/OMB)

Acute Biphenotypic Leukemia

Acute Leukemia, Nos

Acute Monocytic Leukemia

Acute Myeloid Leukemia

Acute Promyelocytic Leukemia

Angioimmunoblastic T-Cell Lymphoma

B lymphoblastic leukemia/lymphoma, NOS

B-Cell Chr. Lymph. Leuk./Small Lymph. Lymphoma

Chronic Myelogenous Leukemia, Bcr/Abl Positive

Chronic Myeloid Leukemia, Nos

Chronic Myeloproliferative Disease, Nos

Cutaneous T-Cell Lymphoma, Nos

Follicular Lymphoma, Grade 1-3

Hodgkin Lymphoma, Nodular Sclerosis, Nos

Hodgkin Lymphoma, Nos

Malignant Lymphoma, Non-Hodgkin

Mantle Cell Lymphoma

Marginal Zone B-Cell Lymphoma, Nos

Mature T-Cell Lymphoma, Nos

Ml, Large B-Cell, Diffuse

Ml, Small B Lymphocytic, Nos

Myelodysplastic Syndrome, Nos

Precursor Cell Lymphoblastic Leukemia, Nos

Prolymphocytic Leukemia, Nos

Prolymphocytic Leukemia, T-Cell Type

Subcutaneous Panniculitis-Like T-Cell Lymphoma

Unknown

Histology

Reports the incidence of Grades 2 to 4 acute GvHD, as observed for the initial 37 participants treated on this study, who constitute the Primary Analysis for the study. See linked citation Lowsky, et al. NEJM. 29Sep2005;353(13)1321-1331.

Spots Global Cancer Trial Database for Allogeneic Transplantation Using Total Lymphoid Irradiation (TLI) and Anti-Thymocyte Globulin (ATG) for Older Patients With Hematologic Malignancies

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