- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00003538
Prevention of Graft-Versus-Host Disease in Patients Undergoing Bone Marrow Transplantation
Stem Cell Augmented, Elutriated Grafts for Allogeneic Bone Marrow Transplantation
RATIONALE: Bone marrow transplantation may be able to replace immune cells that were destroyed by chemotherapy or radiation therapy used to kill tumor cells. Sometimes the transplanted cells can make an immune response against the body's normal tissues. Stem cells that have been treated in the laboratory to remove lymphocytes may prevent this from happening.
PURPOSE: Clinical trial to prevent graft-versus-host disease in patients undergoing bone marrow transplantation.
Study Overview
Status
Conditions
Detailed Description
OBJECTIVES:
- Determine whether stem cell augmented, elutriated grafts prevent graft versus host disease in patients undergoing allogeneic bone marrow transplantation.
OUTLINE: Patients receive elutriated CD34+ augmented donor bone marrow on day 0.
Bone marrow samples are obtained before day 100, around 6 months, and 1 year after transplant.
PROJECTED ACCRUAL: Not specified
Study Type
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
Maryland
-
Baltimore, Maryland, United States, 21231-2410
- Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
DISEASE CHARACTERISTICS:
Histologically confirmed diagnosis of one the following:
- Acute myelogenous leukemia in CR1, ER1, CR2, ER2, CR3
- Acute lymphocytic leukemia in CR1, ER1, CR2, ER2, CR3
- Non-Hodgkin's lymphoma
- Hodgkin's lymphoma
- Multiple myeloma with no more than 12 months of prior alkylator based chemotherapy
- Myelodysplastic syndrome (MDS)
- Acute leukemia arising out of MDS
- Primary resistant acute leukemia
- Chronic myelomonocytic leukemia
- Aplastic anemia (40 years of age and over)
- Solid tumor malignancy (germ cell, sarcoma, breast, etc.)
- Genetic disorders or inborn errors of metabolism as defined by preparative regimen protocol
- Chronic myelogenous leukemia
- Must meet all inclusion criteria specified by the respective preparative regimen protocol
- No aplastic anemia under 40 years of age or myelofibrosis
PATIENT CHARACTERISTICS:
Age:
- 0.5 to 65
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 transfusions from a sibling donor
Chemotherapy:
- Not specified
Endocrine therapy:
- Not specified
Radiotherapy:
- Not specified
Surgery:
- Not specified
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Supportive Care
Collaborators and Investigators
Collaborators
Investigators
- Study Chair: Richard J. Jones, MD, Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins
Publications and helpful links
Study record dates
Study Major Dates
Study Start
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Estimate)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
- stage III malignant testicular germ cell tumor
- stage IV breast cancer
- stage IIIA breast cancer
- stage IIIB breast cancer
- anemia
- stage III ovarian epithelial cancer
- stage IV ovarian epithelial cancer
- recurrent ovarian epithelial cancer
- stage III adult diffuse large cell lymphoma
- stage III adult immunoblastic large cell lymphoma
- stage III adult Burkitt lymphoma
- stage IV grade 3 follicular lymphoma
- stage IV adult diffuse large cell lymphoma
- stage IV adult immunoblastic large cell lymphoma
- stage IV adult Burkitt lymphoma
- recurrent grade 3 follicular lymphoma
- recurrent adult diffuse large cell lymphoma
- recurrent adult immunoblastic large cell lymphoma
- recurrent adult Burkitt 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
- chronic myelomonocytic leukemia
- de novo myelodysplastic syndromes
- previously treated myelodysplastic syndromes
- secondary myelodysplastic syndromes
- secondary acute myeloid leukemia
- childhood acute lymphoblastic leukemia in remission
- childhood acute myeloid leukemia in remission
- chronic phase chronic myelogenous leukemia
- childhood chronic myelogenous leukemia
- childhood myelodysplastic syndromes
- recurrent adult acute myeloid leukemia
- untreated adult acute myeloid leukemia
- adult acute myeloid leukemia in remission
- AIDS-related peripheral/systemic lymphoma
- recurrent adult Hodgkin lymphoma
- recurrent/refractory childhood Hodgkin lymphoma
- recurrent adult diffuse small cleaved cell lymphoma
- recurrent adult diffuse mixed cell lymphoma
- blastic phase chronic myelogenous leukemia
- relapsing chronic myelogenous leukemia
- Philadelphia chromosome negative chronic myelogenous leukemia
- Waldenstrom macroglobulinemia
- 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 IV grade 1 follicular lymphoma
- stage IV grade 2 follicular lymphoma
- stage IV adult diffuse small cleaved cell lymphoma
- stage IV adult diffuse mixed cell lymphoma
- stage III mantle cell lymphoma
- stage IV mantle cell lymphoma
- stage II multiple myeloma
- stage III multiple myeloma
- stage I grade 1 follicular lymphoma
- stage I grade 2 follicular lymphoma
- stage I adult diffuse small cleaved cell lymphoma
- recurrent grade 1 follicular lymphoma
- recurrent grade 2 follicular lymphoma
- contiguous stage II grade 1 follicular lymphoma
- contiguous stage II grade 2 follicular lymphoma
- contiguous stage II adult diffuse small cleaved cell lymphoma
- noncontiguous stage II grade 1 follicular lymphoma
- noncontiguous stage II grade 2 follicular lymphoma
- noncontiguous stage II adult diffuse small cleaved 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
- stage I multiple myeloma
- recurrent adult lymphoblastic lymphoma
- recurrent mantle cell lymphoma
- recurrent childhood rhabdomyosarcoma
- stage III adult Hodgkin lymphoma
- stage IV adult Hodgkin lymphoma
- stage III adult lymphoblastic lymphoma
- stage IV adult lymphoblastic lymphoma
- stage III adult T-cell leukemia/lymphoma
- stage IV adult T-cell leukemia/lymphoma
- recurrent adult T-cell leukemia/lymphoma
- angioimmunoblastic T-cell lymphoma
- anaplastic large cell lymphoma
- disseminated neuroblastoma
- recurrent neuroblastoma
- Philadelphia chromosome positive chronic myelogenous leukemia
- recurrent adult acute lymphoblastic leukemia
- refractory hairy cell leukemia
- prolymphocytic leukemia
- recurrent childhood acute lymphoblastic leukemia
- stage I childhood large cell lymphoma
- stage III childhood large cell lymphoma
- stage I childhood lymphoblastic lymphoma
- stage III childhood lymphoblastic lymphoma
- stage IV childhood lymphoblastic lymphoma
- stage II ovarian epithelial cancer
- contiguous stage II mantle cell lymphoma
- noncontiguous stage II mantle cell lymphoma
- noncontiguous stage II adult diffuse large cell lymphoma
- noncontiguous stage II adult diffuse mixed cell lymphoma
- noncontiguous stage II adult lymphoblastic lymphoma
- noncontiguous stage II grade 3 follicular lymphoma
- accelerated phase chronic myelogenous leukemia
- adult acute lymphoblastic leukemia in remission
- recurrent ovarian germ cell tumor
- stage IV childhood Hodgkin lymphoma
- recurrent childhood acute myeloid leukemia
- noncontiguous stage II adult Burkitt lymphoma
- noncontiguous stage II adult immunoblastic large cell lymphoma
- recurrent childhood lymphoblastic lymphoma
- stage III childhood Hodgkin lymphoma
- recurrent malignant testicular germ cell tumor
- stage I mantle cell lymphoma
- acute undifferentiated leukemia
- stage I adult Hodgkin lymphoma
- stage II adult Hodgkin lymphoma
- stage I adult Burkitt lymphoma
- contiguous stage II adult Burkitt lymphoma
- contiguous stage II adult immunoblastic large cell lymphoma
- stage I adult immunoblastic large cell lymphoma
- stage I childhood Hodgkin lymphoma
- stage II childhood Hodgkin lymphoma
- untreated adult acute lymphoblastic leukemia
- recurrent Wilms tumor and other childhood kidney tumors
- meningeal chronic myelogenous leukemia
- poor prognosis metastatic gestational trophoblastic tumor
- contiguous stage II grade 3 follicular lymphoma
- stage I grade 3 follicular lymphoma
- contiguous stage II adult diffuse large cell lymphoma
- contiguous stage II adult diffuse mixed cell lymphoma
- stage I adult diffuse large cell lymphoma
- stage I adult diffuse mixed cell lymphoma
- myelodysplastic syndromes
- progressive hairy cell leukemia, initial treatment
- untreated hairy cell leukemia
- AIDS-related primary CNS lymphoma
- contiguous stage II adult lymphoblastic lymphoma
- stage I adult lymphoblastic lymphoma
- non-Hodgkin lymphoma during pregnancy
- graft versus host disease
Additional Relevant MeSH Terms
Other Study ID Numbers
- CDR0000066589, J9711
- P30CA006973 (U.S. NIH Grant/Contract)
- JHOC-97021903
- JHOC-J9711
- NCI-V98-1460
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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