NCT00709592 · REGISTRY CONDITION SEARCH

Reduced Intensity Total Body Irradiation + Thymoglobulin Followed by Allogeneic PBSCT

Found through the registry condition index, not selected as a treatment recommendation. This discovery collection was restricted to studies with posted results.

Phase: PHASE2
Status at capture: COMPLETED
Registry last update: 2018-11-09

One of two different doses of thymoglobulin will allow bone marrow engraftment with minimal Graft-versus-Host Disease and allow adequate immune response to allow the transplanted stem cells to replace the tumor cells.

Open the original ClinicalTrials.gov record → · Download preserved record

What did the study report?

Outcomes, safety and baseline populations are separate source sections. Quality-of-life measures appear under their original outcome titles.

flow

Participant flow

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baseline

Baseline characteristics

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outcome · POSTED

The Comparison of Functional Immune Reconstitution at 6-9 Months Following Transplant as Measured by Antibody Response to Vaccination With Inactivated Hepatitis A or B Vaccine.

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outcome · POSTED

Engraftment of Donor Hematopoietic Stem Cells, as Measured by Time in Days to Neutrophil and Platelet Count Recovery Following Allogeneic PBSCT.

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outcome · POSTED

Survival

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outcome · POSTED

Treatment Related Mortality

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outcome · POSTED

Event-free Survival

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outcome · POSTED

Relapse

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outcome · POSTED

Donor Lymphocyte Infusion

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outcome · POSTED

Acute Graft-Versus-Host Disease (GVHD)

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outcome · POSTED

Chronic Graft-Versus-Host Disease (GVHD)

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adverse events

Adverse events

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more info

Limitations, agreements, and source contact

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Who could take part

eligibility Criteria: Inclusion Criteria: * Patients with hematological malignancies for which allogeneic stem cell transplantation indicated including non-Hodgkin lymphoma (NHL), multiple myeloma (MM), acute myeloid leukemia (AML), Hodgkin lymphoma (HD), chronic lymphocytic leukemia (CLL), chronic myelogenous leukemia (CML), and myelodysplastic syndrome (MDS) * Patients with HLA compatible related or unrelated stem cell donor, willing and able to serve as an allogenic HSC donor. Unrelated donors have to be matched at HLA-A, B, C and DRB1 loci. A single locus mismatch will be tolerated in the event a more closely matched donor is not available. * Patients age \>/=40 to \</=70 with an ECOG performance status \< 2 * Patients between 18 and 40 years of age will be eligible only if they have co-morbidities precluding conventional allogeneic transplantation with full intensity myeloablative conditioning * Adequate cardiac, pulmonary, renal and hepatic function for transplant * Negative serology for HIV * Negative serum pregnancy test * Patients who have received therapeutic radiation to a localized field will be eligible, provided critical structure tolerance doses have not been exceeded * Patients who have had prior myeloablative autologous transplant will be eligible Exclusion Criteria: * Evidence of uncontrolled viral, fungal, bacterial infection * Evidence of active meningeal or CNS disease * Prior therapy with rabbit ATG, prior treatment with equine ATG is allowed if more than 3 months ago * Breast feeding mothers are excluded
healthy Volunteers: false
maximum Age: 70 Years
minimum Age: 40 Years
sex: ALL
std Ages: ADULT
OLDER_ADULT

Treatment arms and interventions

arm Groups

description
(Rabbit-ATG;Thymoglobulin,Genzyme) ATG 5.1 mg/kg in three divided doses (1.7 mg/kg/d) given over three days (day -9 to -7) followed by 450 cGy TBI and tacrolimus plus MMF GVHD prophylaxis. Patients receive lower dose anti-thymocyte globulin IV on days -9 to -7. Patients undergo total-body radiation (TBI) twice daily (BID) on day -1 and once daily (QD) on day 0. Patients then undergo peripheral blood stem cells or bone marrow transplant on day 0. GRAFT-VERSUS-HOST DISEASE PROPHYLAXIS: patients receive tacrolimus orally (PO) on days -2 to 90-120 with taper for 2 months, and mycophenolate mofetil (MMF) PO BID on days 0-30.
intervention Names
Biological: Thymoglobulin
Radiation: Total-Body Irradiation
Procedure: Allogeneic PBSCT or BMT
Drug: Tacrolimus
Drug: Mycophenolate Mofetil
label
ATG 1.7 mg/kg, TBI, transplant
type
EXPERIMENTAL
description
(Rabbit-ATG;Thymoglobulin,Genzyme) ATG 7.5 mg/kg in three divided doses (2.5 mg/kg/d) given over three days (day -9 to -7) followed by 450 cGy TBI and tacrolimus plus MMF GVHD prophylaxis. Patients receive higher dose anti-thymocyte globulin intravenously (IV) on days -9 to -7. Patients undergo total-body radiation (TBI) twice daily (BID) on day -1 and once daily (QD) on day 0. Patients then undergo peripheral blood stem cells or bone marrow transplant on day 0. GRAFT-VERSUS-HOST DISEASE PROPHYLAXIS: patients receive tacrolimus orally (PO) on days -2 to 90-120 with taper for 2 months, and mycophenolate mofetil (MMF) PO BID on days 0-30.
intervention Names
Biological: Thymoglobulin
Radiation: Total-Body Irradiation
Procedure: Allogeneic PBSCT or BMT
Drug: Tacrolimus
Drug: Mycophenolate Mofetil
label
ATG 2.5 mg/kg/d, TBI, transplant
type
EXPERIMENTAL

interventions

arm Group Labels
ATG 1.7 mg/kg, TBI, transplant
ATG 2.5 mg/kg/d, TBI, transplant
description
Patients eligible for participation in this study will be randomized between receiving rabbit ATG for 3 days. Thymoglobulin will be administered according to VCU BMT standard of care starting day -9 and continued daily through day -7.
name
Thymoglobulin
other Names
anti-thymocyte globulin (rabbit)
ATG
Genzyme
anti-thymocyte globulin
Rabbit
Rabbit-ATG
type
BIOLOGICAL
arm Group Labels
ATG 1.7 mg/kg, TBI, transplant
ATG 2.5 mg/kg/d, TBI, transplant
description
Undergo TBI
name
Total-Body Irradiation
other Names
Whole-Body Irradiation
Total Body Irradiation [TBI]
type
RADIATION
arm Group Labels
ATG 1.7 mg/kg, TBI, transplant
ATG 2.5 mg/kg/d, TBI, transplant
description
Undergo allogeneic PBSCT or BMT
name
Allogeneic PBSCT or BMT
other Names
PBPC transplantation
Peripheral Blood Progenitor Cell Transplantation
Peripheral Blood Stem Cell Transplantation [Allogenic PBSCT]
Allogeneic Bone Marrow Transplantation [BMT]
Allogeneic BMT
Allogeneic Hematopoietic Stem Cell Transplantation
HSCT
type
PROCEDURE
arm Group Labels
ATG 1.7 mg/kg, TBI, transplant
ATG 2.5 mg/kg/d, TBI, transplant
description
Given PO
name
Tacrolimus
other Names
Fujimycin
Hecoria
Prograf
Protopic
type
DRUG
arm Group Labels
ATG 1.7 mg/kg, TBI, transplant
ATG 2.5 mg/kg/d, TBI, transplant
description
Given PO
name
Mycophenolate Mofetil
other Names
CellCept
MMF
type
DRUG

Study design

allocation

RANDOMIZED

intervention Model

PARALLEL

masking Info

masking: NONE

primary Purpose

TREATMENT

Enrollment

count: 42
type: ACTUAL

Registered outcome plans (not posted results)

primary Outcomes

description
A positive test result will indicate immune reconstitution, while a negative test results will indicate lack of immune reconstitution. Participants not done (ND) will be counted with the negative (Neg).
measure
The Comparison of Functional Immune Reconstitution at 6-9 Months Following Transplant as Measured by Antibody Response to Vaccination With Inactivated Hepatitis A or B Vaccine.
time Frame
Up to 9 months following transplant

secondary Outcomes

measure
Engraftment of Donor Hematopoietic Stem Cells, as Measured by Time in Days to Neutrophil and Platelet Count Recovery Following Allogeneic PBSCT.
time Frame
Up to 52 weeks post transplant.
measure
Survival
time Frame
2-year survival rate (%)
measure
Treatment Related Mortality
time Frame
Day 100
measure
Event-free Survival
time Frame
2 years
description
Patients with different disease relapses was determined according to current clinical standards based on the disease. For example, AML or MDS relapse is determined by a bone marrow biopsy. Multiple myeloma relapse requires a number of labs and/or biopsy to diagnose such as SPEP, UPEP, immunofixation, serum and urine light chains. In lymphoma disease is followed using CT and/or PET scans.
measure
Relapse
time Frame
2 year relapse rate (%)
measure
Donor Lymphocyte Infusion
time Frame
2 year rate of DLI
measure
Acute Graft-Versus-Host Disease (GVHD)
time Frame
2 year rate (%)
measure
Chronic Graft-Versus-Host Disease (GVHD)
time Frame
2 year GVHD rate

Full study description

brief Summary: One of two different doses of thymoglobulin will allow bone marrow engraftment with minimal Graft-versus-Host Disease and allow adequate immune response to allow the transplanted stem cells to replace the tumor cells.
detailed Description: This randomized phase II trial studies how well giving low dose total-body irradiation (TBI) with anti-thymocyte globulin followed by donor peripheral blood stem cell transplant (PBSCT) works in treating patients with hematologic malignancies. Giving reduced intensity total-body irradiation and anti-thymocyte globulin before a donor peripheral blood stem cell transplant helps stop the growth of cancer cells. It may also stop the patient's immune system from rejecting the donor's stem cells. When the healthy stem cells from a donor are infused into the patient they may help the patient's bone marrow make stem cells, red blood cells, white blood cells, and platelets. Sometimes the transplanted cells from a donor can make an immune response against the body's normal cells. Giving total-body irradiation together with antithymocyte globulin before transplant may stop this from happening.

Source references