Laboratory-Treated Donor Bone Marrow in Treating Patients Who Are Undergoing a Donor Bone Marrow Transplant for Hematologic Cancer
Official Title
Phase III Trial of T Lymphocyte Depletion by Elutriation and CD34 Add-Back for Allogeneic Bone Marrow Transplantation
Acronym
Not provided
Organization
Sidney Kimmel Comprehensive Cancer Center at Johns HopkinsOTHER
Status Module
Record Verification Date
Apr 2014
Overall Recruitment Status or Expanded Access Status
Completed
Last Known Status
Not provided
Delayed Posting
Not provided
Why Stopped
Not provided
Expanded Access Info
Not provided
Start Date
Dec 2002
Primary Completion Date
Aug 2007Actual
Completion Date
Aug 2007Actual
First Submitted Date
Dec 14, 2005
First Submission Date that Met QC Criteria
Dec 14, 2005
First Posted Date
Dec 15, 2005Estimated
Results Waived
Not provided
Results First Submitted Date
Not provided
Results First Submitted that Met QC Criteria
Not provided
Results First Posted Date
Not provided
Certification/Extension (aka Delayed Results) First Submitted Date
Not provided
Certification/Extension First Submitted that Passed QC Review
Not provided
Certification/Extension First Posted Date
Not provided
Last Update Submitted Date
Apr 16, 2014
Last Update Posted Date
Apr 17, 2014Estimated
Sponsor/Collaborators Module
Responsible Party, by Official Title
Not provided
Lead Sponsor
Sidney Kimmel Comprehensive Cancer Center at Johns HopkinsOTHER
Collaborators
Name
Class
National Cancer Institute (NCI)
NIH
Oversight Module
No data available
No data is available for this block.
Description Module
Brief Summary
RATIONALE: Giving chemotherapy and total-body irradiation before a donor bone marrow transplant or peripheral blood stem cell transplant helps stop the growth of cancer and abnormal cells and helps stop the patient's immune system from rejecting the donor's stem cells. When certain 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. Removing the T cells from the donor cells before transplant may stop this from happening.
PURPOSE: This randomized phase III trial is studying donor bone marrow that is treated in the laboratory using two different devices to compare how well they work in treating patients who are undergoing a donor bone marrow transplant for hematologic cancer.
Detailed Description
OBJECTIVES:
Compare the effectiveness, in terms of incidence of graft failure and incidence of greater than grade 1 acute graft-vs-host disease, of ex vivo manipulation of bone marrow cells comprising counterflow centrifugal elutriation for T-lymphocyte depletion followed by CD34-positive stem cell selection using CliniMACS vs Isolex 300i in patients with a hematologic malignancy undergoing allogeneic bone marrow transplantation from an HLA-identical sibling donor.
OUTLINE: This is a randomized study. Patients are stratified by age (< 40 vs 40-65) and disease status (low-risk [i.e., chronic phase chronic myelogenous leukemia, acute myeloid leukemia in first complete remission (CR), acute lymphocytic leukemia in first CR, Hodgkin's or non-Hodgkin's lymphoma in sensitive relapse, or multiple myeloma in CR or partial remission) vs high-risk [i.e., all others]). Patients are randomized to 1 of 2 treatment arms.
Arm I: Allogeneic bone marrow cells are subjected to counterflow centrifugal elutriation (CCE) for T-lymphocyte depletion. The elutriation fractions are then processed over 2-2.5 hours using CliniMACS to select for CD34-positive stem cells.
Arm II: Allogeneic bone marrow cells are subjected to CCE for T-lymphocyte depletion. The elutriation fractions are then processed over 4-4.5 hours using Isolex 300i to select for CD34-positive stem cells.
Patients in both arms then undergo ex vivo manipulated, T-lymphocyte-depleted, CD34-positive stem cell-selected, allogeneic bone marrow transplantation on day 0.
After the transplantation, patients are followed periodically for 1 year.
PROJECTED ACCRUAL: A total of 206 patients will be accrued for this study.](streamdown:incomplete-link)
Conditions Module
Conditions
Graft Versus Host Disease
Leukemia
Lymphoma
Multiple Myeloma and Plasma Cell Neoplasm
Myelodysplastic Syndromes
Myelodysplastic/Myeloproliferative Diseases
Keywords
graft versus host disease
adult acute myeloid leukemia in remission
adult acute myeloid leukemia with 11q23 (MLL) abnormalities
adult acute myeloid leukemia with inv(16)(p13;q22)
adult acute myeloid leukemia with t(15;17)(q22;q12)
adult acute myeloid leukemia with t(16;16)(p13;q22)
adult acute myeloid leukemia with t(8;21)(q22;q22)
recurrent adult acute myeloid leukemia
recurrent childhood acute myeloid leukemia
childhood acute myeloid leukemia in remission
adult acute lymphoblastic leukemia in remission
recurrent adult acute lymphoblastic leukemia
childhood acute lymphoblastic leukemia in remission
recurrent childhood acute lymphoblastic leukemia
Design Module
Study Type
Interventional
Number of References to an Expanded Access Study
Not provided
Expanded Access Types
Not provided
Patient Registry
Not provided
Target Follow-Up Duration
Not provided
Phases
Phase 3
Interventional Study Design
Allocation
Biospecimen
No data available
No data is available for this block.
Enrollment
72Actual
Arms/Interventions Module
Arm Groups
Not provided
Interventions
Name
Type
Description
Arm Group Labels
Other Names
graft versus host disease prophylaxis/therapy
Biological
allogeneic bone marrow transplantation
Procedure
in vitro-treated bone marrow transplantation
Procedure
Outcomes Module
Primary Outcomes
Measure
Description
Time Frame
Incidence of graft-vs-host disease or graft failure
Secondary Outcomes
Not provided
Other Outcomes
Not provided
Eligibility Module
Eligibility Criteria
DISEASE CHARACTERISTICS:
Diagnosis of 1 of the following hematologic malignancies or genetic disorders:
Acute myeloid leukemia (AML), meeting 1 of the following criteria
Primary resistant disease
Disease in complete remission (CR)
Disease in first early relapse
Secondary AML arising out of myelodysplastic syndrome
Acute lymphocytic leukemia (ALL), meeting 1 of the following criteria:
Primary resistant disease
Disease in CR
Disease in first early relapse
Chronic myelogenous leukemia
Myelodysplastic syndrome (MDS)
Chronic myelomonocytic leukemia
Philadelphia chromosome-negative myeloproliferative disorder
Multiple myeloma
Hodgkin's lymphoma
Non-Hodgkin's lymphoma
Genetic disorders or inborn errors of metabolism
Planning allogeneic bone marrow transplantation at the Sidney Kimmel Comprehensive Cancer Center at the Johns Hopkins Medical Center
Must have an HLA-identical sibling donor by serologic or molecular typing of HLA class I antigens and molecular typing of HLA class II antigens
PATIENT CHARACTERISTICS:
Performance status
Not specified
Life expectancy
Not specified
Hematopoietic
Not specified
Hepatic
Not specified
Renal
Not specified
PRIOR CONCURRENT THERAPY:
Biologic therapy
No prior red blood cell or platelet transfusion from the same donor
Other
Concurrent participation in another clinical trial allowed
Accepts Healthy Volunteers
No
Sex
All
Sex/Gender Based
Not provided
Sex/Gender Description
Not provided
Minimum Age
Not provided
Maximum Age
65 Years
Standard Ages
ChildAdultOlder Adult
Study Population
Not provided
Sampling Method
Not provided
Contacts/Locations Module
Central Contacts
Not provided
Overall Officials
Name
Affiliation
Role
Richard J. Jones, MD
Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins
Principal Investigator
Locations
Facility
Status
City
State
ZIP
Country
Contacts
Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins