Reduced Intensity Total Body Irradiation + Thymoglobulin Followed by Allogeneic PBSCT

Multiple Myeloma Clinical Trial

Official title:

Reduced Intensity Myeloablative Total Body Irradiation and Thymoglobulin Followed by Allogeneic Peripheral Blood Stem Cell Transplantation

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00709592
• Other study ID #: MCC-11561
• Secondary ID: NCI-2011-01698
• Status: Completed
• Phase: Phase 2
• Start date: July 21, 2008
• Est. completion date: June 28, 2017

Study information

• Verified date: November 2018
• Source: Virginia Commonwealth University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 42
• Est. completion date: June 28, 2017
• Est. primary completion date: February 15, 2014
• Accepts healthy volunteers: No
• Gender: All
• Age group: 40 Years to 70 Years

Eligibility

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

Related Conditions & MeSH terms

• Acute Myeloid Leukemia
• Chronic Lymphocytic Leukemia
• Chronic Myelogenous Leukemia
• Hodgkin Disease
• Hodgkin Lymphoma
• Leukemia
• Leukemia, Lymphocytic, Chronic, B-Cell
• Leukemia, Lymphoid
• Leukemia, Myelogenous, Chronic, BCR-ABL Positive
• Leukemia, Myeloid
• Leukemia, Myeloid, Acute
• Lymphoma
• Lymphoma, Non-Hodgkin
• Multiple Myeloma
• Myelodysplastic Syndrome
• Myelodysplastic Syndromes
• Non-Hodgkin's Lymphoma
• Preleukemia

Intervention

Biological:
• Thymoglobulin
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.

Radiation:
• Total-Body Irradiation
Undergo TBI

Procedure:
• Allogeneic PBSCT or BMT
Undergo allogeneic PBSCT or BMT

Drug:
• Tacrolimus
Given PO
• Mycophenolate Mofetil
Given PO

Locations

Country	Name	City	State
United States	Virginia Commonwealth University/Massey Cancer Center	Richmond	Virginia

Sponsors (2)

Lead Sponsor	Collaborator
Virginia Commonwealth University	Genzyme, a Sanofi Company

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	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).	Up to 9 months following transplant
Secondary	Engraftment of Donor Hematopoietic Stem Cells, as Measured by Time in Days to Neutrophil and Platelet Count Recovery Following Allogeneic PBSCT.		Up to 52 weeks post transplant.
Secondary	Survival		2-year survival rate (%)
Secondary	Treatment Related Mortality		Day 100
Secondary	Event-free Survival		2 years
Secondary	Relapse	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.	2 year relapse rate (%)
Secondary	Donor Lymphocyte Infusion		2 year rate of DLI
Secondary	Acute Graft-Versus-Host Disease (GVHD)		2 year rate (%)
Secondary	Chronic Graft-Versus-Host Disease (GVHD)		2 year GVHD rate

External Links

•   VCU Massey Cancer Center