Phase III Trial of T Lymphocyte Depletion by Elutriation and CD34 Add-Back for Allogeneic Bone Marrow Transplantation
N/A
65 Years
Both
Graft Versus Host Disease, Leukemia, Lymphoma, Multiple Myeloma and Plasma Cell Neoplasm, Myelodysplastic Syndromes, Myelodysplastic/Myeloproliferative Diseases
Trial Information
Phase III Trial of T Lymphocyte Depletion by Elutriation and CD34 Add-Back for Allogeneic Bone Marrow Transplantation
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.
Inclusion 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
Type of Study:
Interventional
Study Design:
Allocation: Randomized, Masking: Open Label, Primary Purpose: Treatment
Outcome Measure:
Incidence of graft-vs-host disease or graft failure
Safety Issue:
No
Principal Investigator
Richard J. Jones, MD
Investigator Role:
Principal Investigator
Investigator Affiliation:
Sidney Kimmel Comprehensive Cancer Center
Authority:
United States: Food and Drug Administration
Study ID:
CDR0000454926
NCT ID:
NCT00265837
Start Date:
December 2002
Completion Date:
Related Keywords:
- Graft Versus Host Disease
- Leukemia
- Lymphoma
- Multiple Myeloma and Plasma Cell Neoplasm
- Myelodysplastic Syndromes
- Myelodysplastic/Myeloproliferative Diseases
- 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
- accelerated phase chronic myelogenous leukemia
- blastic phase chronic myelogenous leukemia
- childhood chronic myelogenous leukemia
- chronic phase chronic myelogenous leukemia
- relapsing chronic myelogenous leukemia
- secondary acute myeloid leukemia
- de novo myelodysplastic syndromes
- previously treated myelodysplastic syndromes
- secondary myelodysplastic syndromes
- chronic myelomonocytic leukemia
- juvenile myelomonocytic leukemia
- atypical chronic myeloid leukemia
- myelodysplastic/myeloproliferative disease, unclassifiable
- Philadelphia chromosome negative chronic myelogenous leukemia
- stage I multiple myeloma
- stage II multiple myeloma
- stage III multiple myeloma
- refractory multiple myeloma
- stage III adult Hodgkin lymphoma
- stage IV adult Hodgkin lymphoma
- extranodal marginal zone B-cell lymphoma of mucosa-associated lymphoid tissue
- nodal marginal zone B-cell lymphoma
- noncontiguous stage II adult Burkitt lymphoma
- noncontiguous stage II adult diffuse large cell lymphoma
- noncontiguous stage II adult diffuse mixed cell lymphoma
- noncontiguous stage II adult diffuse small cleaved cell lymphoma
- noncontiguous stage II adult immunoblastic large cell lymphoma
- noncontiguous stage II adult lymphoblastic lymphoma
- noncontiguous stage II grade 1 follicular lymphoma
- noncontiguous stage II grade 2 follicular lymphoma
- noncontiguous stage II grade 3 follicular lymphoma
- noncontiguous stage II mantle cell lymphoma
- noncontiguous stage II marginal zone lymphoma
- recurrent adult Hodgkin lymphoma
- recurrent adult Burkitt lymphoma
- recurrent adult diffuse large cell lymphoma
- recurrent adult diffuse mixed cell lymphoma
- recurrent adult diffuse small cleaved cell lymphoma
- recurrent adult immunoblastic large cell lymphoma
- recurrent adult lymphoblastic lymphoma
- recurrent/refractory childhood Hodgkin lymphoma
- recurrent childhood large cell lymphoma
- recurrent childhood lymphoblastic lymphoma
- recurrent childhood small noncleaved cell lymphoma
- recurrent grade 1 follicular lymphoma
- recurrent grade 2 follicular lymphoma
- recurrent grade 3 follicular lymphoma
- recurrent mantle cell lymphoma
- recurrent marginal zone lymphoma
- recurrent small lymphocytic lymphoma
- splenic marginal zone lymphoma
- stage III adult Burkitt lymphoma
- stage III adult diffuse large cell lymphoma
- stage III adult diffuse mixed cell lymphoma
- stage III adult diffuse small cleaved cell lymphoma
- stage IV adult diffuse large cell lymphoma
- stage IV adult diffuse mixed cell lymphoma
- stage IV adult diffuse small cleaved cell lymphoma
- stage III adult lymphoblastic lymphoma
- stage IV adult lymphoblastic lymphoma
- stage III grade 1 follicular lymphoma
- stage III grade 2 follicular lymphoma
- stage III grade 3 follicular lymphoma
- stage IV grade 1 follicular lymphoma
- stage IV grade 2 follicular lymphoma
- stage IV grade 3 follicular lymphoma
- stage III mantle cell lymphoma
- stage III marginal zone lymphoma
- stage IV mantle cell lymphoma
- stage IV marginal zone lymphoma
- stage III small lymphocytic lymphoma
- stage IV small lymphocytic lymphoma
- stage IV adult Burkitt lymphoma
- stage IV adult immunoblastic large cell lymphoma
- childhood myelodysplastic syndromes
- Neoplasms
- Graft vs Host Disease
- Leukemia
- Lymphoma
- Lymphoma, Non-Hodgkin
- Multiple Myeloma
- Neoplasms, Plasma Cell
- Plasmacytoma
- Myelodysplastic Syndromes
- Preleukemia
- Myeloproliferative Disorders
- Lymphoma, Large-Cell, Immunoblastic
- Myelodysplastic-Myeloproliferative Diseases
Name | Location |
|---|---|
| Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins | Baltimore, Maryland 21231-2410 |
