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Phase III Trial of T Lymphocyte Depletion by Elutriation and CD34 Add-Back for Allogeneic Bone Marrow Transplantation


Phase 3
N/A
65 Years
Not Enrolling
Both
Graft Versus Host Disease, Leukemia, Lymphoma, Multiple Myeloma and Plasma Cell Neoplasm, Myelodysplastic Syndromes, Myelodysplastic/Myeloproliferative Diseases

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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 HopkinsBaltimore, Maryland  21231-2410