Biological Therapy in Treating Patients With Advanced Myelodysplastic Syndrome, Acute or Chronic Myeloid Leukemia, or Acute Lymphoblastic Leukemia Who Are Undergoing Stem Cell Transplantation
NCT00052520 · Status: COMPLETED · Phase: PHASE1/PHASE2 · Type: INTERVENTIONAL · Enrollment: 37
Last updated 2017-03-29
Summary
This phase I/II trial is studying the side effects of biological therapy and to see how well it works in treating patients with advanced myelodysplastic syndrome, chronic myeloid leukemia, acute myeloid leukemia, or acute lymphoblastic leukemia. Biological therapies, including immunotherapy, can potentially be used to stimulate the immune system and stop cancer cells from growing. Immunotherapy given to patients who have undergone donor stem cell transplantation may be a way to eradicate remaining cancer cells
Conditions
- 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)
- B-cell Adult Acute Lymphoblastic Leukemia
- B-cell Childhood Acute Lymphoblastic Leukemia
- Childhood Chronic Myelogenous Leukemia
- Childhood Myelodysplastic Syndromes
- Chronic Myelomonocytic Leukemia
- Essential Thrombocythemia
- Polycythemia Vera
- Previously Treated Myelodysplastic Syndromes
- Recurrent Adult Acute Lymphoblastic Leukemia
- Recurrent Adult Acute Myeloid Leukemia
- Recurrent Childhood Acute Lymphoblastic Leukemia
- Recurrent Childhood Acute Myeloid Leukemia
- Refractory Anemia With Excess Blasts
- Refractory Anemia With Excess Blasts in Transformation
- Relapsing Chronic Myelogenous Leukemia
- Secondary Acute Myeloid Leukemia
- T-cell Adult Acute Lymphoblastic Leukemia
- T-cell Childhood Acute Lymphoblastic Leukemia
Interventions
- BIOLOGICAL
-
therapeutic allogeneic lymphocytes
Given IV
- BIOLOGICAL
-
aldesleukin
Given SC
- PROCEDURE
-
peripheral blood stem cell transplantation
Undergo transplantation
- PROCEDURE
-
allogeneic bone marrow transplantation
Undergo transplantation
- OTHER
-
laboratory biomarker analysis
Correlative studies
- GENETIC
-
gene expression analysis
Correlative studies
- OTHER
-
immunologic technique
Correlative studies
- OTHER
-
flow cytometry
Correlative studies
- GENETIC
-
polymerase chain reaction
Correlative studies
- GENETIC
-
cytogenetic analysis
Correlative studies
- OTHER
-
staining method
Correlative studies
Sponsors & Collaborators
-
National Cancer Institute (NCI)
collaborator NIH -
Fred Hutchinson Cancer Center
lead OTHER
Principal Investigators
-
Merav Bar · Fred Hutchinson Cancer Research Center/University of Washington Cancer Consortium
Study Design
- Allocation
- NA
- Purpose
- TREATMENT
- Masking
- NONE
- Model
- SINGLE_GROUP
Eligibility
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2002-09-30
- Primary Completion
- 2011-04-30
- Completion
- 2013-06-30
Countries
- United States
Study Locations
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