Evaluation of Allogeneic Marrow Transplants Depleted of T-Cells by CD34+ Selection in Patients Undergoing Transplantation With an Unrelated Matched or 1 Antigen Mismatched Donor or a 1 Antigen Mismatched Related Donor
Phase 4
N/A
50 Years
N/A
50 Years
Not Enrolling
Both
Anemia, Graft Versus Host Disease, Leukemia, Lymphoma, Multiple Myeloma and Plasma Cell Neoplasm, Myelodysplastic Syndromes
Both
Anemia, Graft Versus Host Disease, Leukemia, Lymphoma, Multiple Myeloma and Plasma Cell Neoplasm, Myelodysplastic Syndromes
Trial Information
Evaluation of Allogeneic Marrow Transplants Depleted of T-Cells by CD34+ Selection in Patients Undergoing Transplantation With an Unrelated Matched or 1 Antigen Mismatched Donor or a 1 Antigen Mismatched Related Donor
OBJECTIVES: I. Evaluate the incidence of acute graft versus host disease in patients
undergoing transplantation with an unrelated or related matched or mismatched antigen donor.
II. Evaluate the rapidity of engraftment and CD4 count recovery post-transplantation in this
patient population.
OUTLINE: Patients receive total body irradiation (TBI) three or two times a day on days -8
to -5. Following TBI, patients receive thiotepa IV over 4 hours daily on days -4 and -3 plus
cyclophosphamide IV over 1 hour daily on days -2 and -1. Antithymocyte globulin is
administered by IV over at least 4 hours on days -4 to -1. Patients undergo an allogenic
bone marrow transplantation on day 0. Bone marrow is harvested from patient's donor,
depleted of T-cells, and infused. Patients receive filgrastim (G-CSF) subcutaneously
beginning on day 4.
PROJECTED ACCRUAL: Approximately 26-45 patients will be accrued for this study within 3-4
years.
Inclusion Criteria
DISEASE CHARACTERISTICS: Histologically proven malignancy or condition of the following
types: Acute myelogenous leukemia (not M5 or M6) or lymphocytic leukemia in first or
greater remission or early relapse OR Chronic myelogenous leukemia OR Myelodysplastic
syndrome OR Aggressive or refractory non-Hodgkin's lymphoma OR Aggressive or refractory
Hodgkin's disease OR Multiple myeloma at early relapse or after conventional chemotherapy
to reduce tumor mass OR High risk chronic lymphocytic leukemia OR Aplastic anemia
HLA-matched or 1 antigen mismatched (related or unrelated) available as donor
PATIENT CHARACTERISTICS: Age: 50 and under Performance status: Karnofsky 70-100% Life
expectancy: Greater than 8 weeks Hematopoietic: Not specified Hepatic: Bilirubin less than
2 mg/dL SGOT less than 4 times upper limit of normal (ULN) Renal: Creatinine less than 2
times ULN OR Creatinine clearance greater than 60 mL/min Cardiovascular: LVEF at least 50%
by MUGA Pulmonary: DLCO at least 50% Other: HIV negative No active extramedullary disease
Not pregnant or nursing Negative pregnancy test Fertile patients must use effective
contraception
PRIOR CONCURRENT THERAPY: See Disease Characteristics
Type of Study:
Interventional
Study Design:
Primary Purpose: Treatment
Principal Investigator
Barry R. Meisenberg, MD
Investigator Role:
Study Chair
Investigator Affiliation:
University of Maryland Greenebaum Cancer Center
Authority:
United States: Food and Drug Administration
Study ID:
CDR0000066400
NCT ID:
NCT00003398
Start Date:
September 1998
Completion Date:
May 2000
Related Keywords:
- Anemia
- Graft Versus Host Disease
- Leukemia
- Lymphoma
- Multiple Myeloma and Plasma Cell Neoplasm
- Myelodysplastic Syndromes
- stage III adult Hodgkin lymphoma
- stage IV adult Hodgkin lymphoma
- recurrent childhood acute lymphoblastic leukemia
- recurrent adult Hodgkin lymphoma
- Burkitt lymphoma
- refractory multiple myeloma
- Waldenstrom macroglobulinemia
- stage I multiple myeloma
- stage II multiple myeloma
- stage III multiple myeloma
- stage I childhood lymphoblastic lymphoma
- stage II childhood lymphoblastic lymphoma
- stage III childhood lymphoblastic lymphoma
- stage IV childhood lymphoblastic lymphoma
- recurrent childhood lymphoblastic lymphoma
- stage I chronic lymphocytic leukemia
- stage II chronic lymphocytic leukemia
- stage III chronic lymphocytic leukemia
- stage IV chronic lymphocytic leukemia
- recurrent childhood acute myeloid leukemia
- recurrent adult acute myeloid leukemia
- recurrent adult acute lymphoblastic leukemia
- refractory chronic lymphocytic leukemia
- childhood diffuse large cell lymphoma
- childhood immunoblastic large cell lymphoma
- chronic phase chronic myelogenous leukemia
- accelerated phase chronic myelogenous leukemia
- blastic phase chronic myelogenous leukemia
- meningeal chronic myelogenous leukemia
- adult acute myeloid leukemia in remission
- adult acute lymphoblastic leukemia in remission
- childhood acute myeloid leukemia in remission
- childhood acute lymphoblastic leukemia in remission
- adult acute myeloblastic leukemia without maturation (M1)
- adult acute myeloblastic leukemia with maturation (M2)
- adult acute promyelocytic leukemia (M3)
- adult acute myelomonocytic leukemia (M4)
- adult acute eosinophilic leukemia
- adult acute basophilic leukemia
- adult acute megakaryoblastic leukemia (M7)
- childhood acute myeloblastic leukemia with maturation (M2)
- childhood acute promyelocytic leukemia (M3)
- childhood acute myelomonocytic leukemia (M4)
- childhood acute eosinophilic leukemia
- childhood acute basophilic leukemia
- childhood acute megakaryocytic leukemia (M7)
- stage III childhood Hodgkin lymphoma
- stage IV childhood Hodgkin lymphoma
- recurrent/refractory childhood Hodgkin lymphoma
- stage I grade 1 follicular lymphoma
- stage I grade 2 follicular lymphoma
- stage I grade 3 follicular lymphoma
- stage I adult diffuse small cleaved cell lymphoma
- stage I adult diffuse mixed cell lymphoma
- stage I adult diffuse large cell lymphoma
- stage I adult immunoblastic large cell lymphoma
- stage I adult lymphoblastic lymphoma
- stage I adult Burkitt lymphoma
- stage III grade 1 follicular lymphoma
- stage III grade 2 follicular lymphoma
- stage III grade 3 follicular lymphoma
- stage III adult diffuse small cleaved cell lymphoma
- stage III adult diffuse mixed cell lymphoma
- stage III adult diffuse large cell lymphoma
- stage III adult immunoblastic large cell lymphoma
- stage III adult lymphoblastic lymphoma
- stage III adult Burkitt lymphoma
- stage IV grade 1 follicular lymphoma
- stage IV grade 2 follicular lymphoma
- stage IV grade 3 follicular lymphoma
- stage IV adult diffuse small cleaved cell lymphoma
- stage IV adult diffuse mixed cell lymphoma
- stage IV adult diffuse large cell lymphoma
- stage IV adult immunoblastic large cell lymphoma
- stage IV adult lymphoblastic lymphoma
- stage IV adult Burkitt lymphoma
- recurrent adult diffuse small cleaved cell lymphoma
- recurrent adult diffuse mixed cell lymphoma
- recurrent adult diffuse large cell lymphoma
- recurrent adult immunoblastic large cell lymphoma
- recurrent adult lymphoblastic lymphoma
- recurrent adult Burkitt lymphoma
- de novo myelodysplastic syndromes
- previously treated myelodysplastic syndromes
- secondary myelodysplastic syndromes
- anemia
- graft versus host disease
- adult acute minimally differentiated myeloid leukemia (M0)
- childhood acute minimally differentiated myeloid leukemia (M0)
- stage I childhood small noncleaved cell lymphoma
- stage I childhood large cell lymphoma
- stage II childhood small noncleaved cell lymphoma
- stage II childhood large cell lymphoma
- stage III childhood small noncleaved cell lymphoma
- stage III childhood large cell lymphoma
- stage IV childhood small noncleaved cell lymphoma
- stage IV childhood large cell lymphoma
- recurrent childhood small noncleaved cell lymphoma
- recurrent childhood large cell lymphoma
- stage I mantle cell lymphoma
- contiguous stage II grade 1 follicular lymphoma
- contiguous stage II grade 2 follicular lymphoma
- contiguous stage II grade 3 follicular lymphoma
- contiguous stage II adult diffuse small cleaved cell lymphoma
- contiguous stage II mantle cell lymphoma
- contiguous stage II adult diffuse mixed cell lymphoma
- contiguous stage II adult immunoblastic large cell lymphoma
- contiguous stage II adult diffuse large cell lymphoma
- contiguous stage II adult Burkitt lymphoma
- contiguous 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 adult diffuse small cleaved cell lymphoma
- noncontiguous stage II mantle cell lymphoma
- noncontiguous stage II adult diffuse mixed cell lymphoma
- noncontiguous stage II adult immunoblastic large cell lymphoma
- noncontiguous stage II adult diffuse large cell lymphoma
- noncontiguous stage II adult Burkitt lymphoma
- noncontiguous stage II adult lymphoblastic lymphoma
- stage III mantle cell lymphoma
- stage IV mantle cell lymphoma
- recurrent mantle cell lymphoma
- noncontiguous stage II small lymphocytic lymphoma
- noncontiguous stage II marginal zone lymphoma
- recurrent marginal zone lymphoma
- recurrent small lymphocytic lymphoma
- stage I marginal zone lymphoma
- stage I small lymphocytic lymphoma
- stage III small lymphocytic lymphoma
- stage III marginal zone lymphoma
- stage IV small lymphocytic lymphoma
- stage IV marginal zone lymphoma
- contiguous stage II marginal zone lymphoma
- contiguous stage II small lymphocytic lymphoma
- extranodal marginal zone B-cell lymphoma of mucosa-associated lymphoid tissue
- nodal marginal zone B-cell lymphoma
- splenic marginal zone lymphoma
- childhood myelodysplastic syndromes
- Anemia
- Neoplasms
- Graft vs Host Disease
- Leukemia
- Lymphoma
- Lymphoma, Non-Hodgkin
- Multiple Myeloma
- Neoplasms, Plasma Cell
- Plasmacytoma
- Myelodysplastic Syndromes
- Preleukemia
- Lymphoma, Large-Cell, Immunoblastic
Name | Location |
|---|---|
| Marlene & Stewart Greenebaum Cancer Center, University of Maryland | Baltimore, Maryland 21201 |
