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

Phase 2

Completed

• Conditions: Blood Cancer; Leukemia
• Interventions: Drug: Cyclosporine; Drug: Anti-thymocyte globulin (ATG); Drug: Mycophenolate mofetil (MMF); Drug: Filgrastim; Radiation: Total Lymphoid Irradiation (TLI)

• Registration Number: NCT00185640
• Lead Sponsor: Stanford University

Brief Summary

To measure how frequently and to what degree a complication of transplant cell acute graft versus host disease (GvHD) occurs.

Detailed Description

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 Timeline

• Study Start: 2003-03
• Study First Submitted: 2005-09-12
• Study First Submitted QC: 2005-09-12
• Study First Posted: 2005-09-16
• Primary Completion: 2014-04
• Study Completion: 2016-01
• Results First Submitted: 2016-12-01
• Results First Submitted QC: 2017-09-04
• Results First Posted: 2017-10-03
• Status Verified: 2021-06
• Last Update Submitted: 2021-06-24
• Last Update Posted: 2021-06-29

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 303

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Non-myeloablative transplantation	Anti-thymocyte globulin (ATG)	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.
Non-myeloablative transplantation	Total Lymphoid Irradiation (TLI)	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.
Non-myeloablative transplantation	Mycophenolate mofetil (MMF)	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.
Non-myeloablative transplantation	Cyclosporine	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.
Non-myeloablative transplantation	Filgrastim	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.

Primary Outcome Measures

Name	Time	Method
Acute Graft vs Host Disease (GvHD)	100 days post-transplant	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

Secondary Outcome Measures

Name	Time	Method
Overall Survival (OS)	3 and 5 years
Event-free Survival (EFS)	3 and 5 years	Reports the number and proportion of participants who neither died due to any cause nor experienced relapse.
Transplant-related Mortality	1 year	Reports the proportion of participants who expired within 1 year due to any complication or failure of the transplant.
Acute Graft vs Host Disease (GvHD), All Evaluable	100 days post-transplant	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
Incidence of Relapse	3 years	Reports the overall rate of disease relapse, occurring any time within 3 years after transplant

Trial Locations

Locations (1)

Stanford University School of Medicine; 🇺🇸 Stanford, California, United States