Prevention of Graft-Versus-Host Disease in Patients Undergoing Bone Marrow Transplantation
Official Title
Stem Cell Augmented, Elutriated Grafts for Allogeneic Bone Marrow Transplantation
Acronym
Not provided
Organization
Sidney Kimmel Comprehensive Cancer Center at Johns HopkinsOTHER
Status Module
Record Verification Date
May 2014
Overall Recruitment Status or Expanded Access Status
Completed
Last Known Status
Not provided
Delayed Posting
Not provided
Why Stopped
Not provided
Expanded Access Info
No
Start Date
Mar 1997
Primary Completion Date
May 2004Actual
Completion Date
May 2004Actual
First Submitted Date
Nov 1, 1999
First Submission Date that Met QC Criteria
Jan 26, 2003
First Posted Date
Jan 27, 2003Estimated
Results Waived
Not provided
Results First Submitted Date
Not provided
Results First Submitted that Met QC Criteria
Not provided
Results First Posted Date
Not provided
Certification/Extension (aka Delayed Results) First Submitted Date
Not provided
Certification/Extension First Submitted that Passed QC Review
Not provided
Certification/Extension First Posted Date
Not provided
Last Update Submitted Date
May 1, 2014
Last Update Posted Date
May 2, 2014Estimated
Sponsor/Collaborators Module
Responsible Party, by Official Title
Not provided
Lead Sponsor
Sidney Kimmel Comprehensive Cancer Center at Johns HopkinsOTHER
Collaborators
Name
Class
National Cancer Institute (NCI)
NIH
Oversight Module
No data available
No data is available for this block.
Description Module
Brief Summary
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.
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
Conditions Module
Conditions
Cancer
Keywords
stage I adult Hodgkin lymphoma
stage II adult Hodgkin lymphoma
stage III adult Hodgkin lymphoma
stage IV adult Hodgkin lymphoma
stage IV breast cancer
stage IIIA breast cancer
stage IIIB breast cancer
recurrent childhood acute lymphoblastic leukemia
recurrent adult Hodgkin lymphoma
recurrent childhood rhabdomyosarcoma
stage II ovarian epithelial cancer
stage III ovarian epithelial cancer
stage IV ovarian epithelial cancer
recurrent ovarian epithelial cancer
disseminated neuroblastoma
recurrent neuroblastoma
recurrent Wilms tumor and other childhood kidney tumors
Design Module
Study Type
Interventional
Number of References to an Expanded Access Study
Not provided
Expanded Access Types
Not provided
Patient Registry
Not provided
Target Follow-Up Duration
Not provided
Phases
Not Applicable
Interventional Study Design
Allocation
Not provided
Intervention Model
Biospecimen
No data available
No data is available for this block.
Enrollment
Not provided
Arms/Interventions Module
Arm Groups
Not provided
Interventions
Name
Type
Description
Arm Group Labels
Other Names
graft versus host disease prophylaxis/therapy
Biological
allogeneic bone marrow transplantation
Procedure
Outcomes Module
No data available
No data is available for this block.
Eligibility Module
Eligibility Criteria
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
O'Donnell PV, Jones RJ, Vogelsang GB, Seber A, Ambinder RF, Flinn I, Miller C, Marcellus DC, Griffin C, Abrams R, Braine HG, Grever M, Hess AD, Piantadosi S, Noga SJ. CD34+ stem cell augmentation of elutriated allogeneic bone marrow grafts: results of a phase II clinical trial of engraftment and graft-versus-host disease prophylaxis in high-risk hematologic malignancies. Bone Marrow Transplant. 1998 Nov;22(10):947-55. doi: 10.1038/sj.bmt.1701476.
See Also Links
Not provided
Available IPD Information
Not provided
IPD Sharing Statement Module
No data available
No data is available for this block.
Jul 10, 2026
Removed Countries
Not provided
Submission Tracking
No data available
No data is available for this block.
Condition Browse Module
MeSH Terms
ID
Term
D009369
Neoplasms
D006689
Hodgkin Disease
D001943
Breast Neoplasms
D054198
Precursor Cell Lymphoblastic Leukemia-Lymphoma
D000077216
Carcinoma, Ovarian Epithelial
D009447
Neuroblastoma
D009396
Wilms Tumor
D008258
Waldenstrom Macroglobulinemia
D009101
Multiple Myeloma
D015470
Leukemia, Myeloid, Acute
D013736
Testicular Neoplasms
D015466
Leukemia, Myeloid, Chronic-Phase
D015465
Leukemia, Myeloid, Accelerated Phase
D001752
Blast Crisis
D009190
Myelodysplastic Syndromes
D015464
Leukemia, Myelogenous, Chronic, BCR-ABL Positive
D007943
Leukemia, Hairy Cell
D012008
Ancestor Terms
ID
Term
D008223
Lymphoma
D009370
Neoplasms by Histologic Type
D008232
Lymphoproliferative Disorders
D008206
Lymphatic Diseases
Browse Leaves
Not provided
Browse Branches
Not provided
Intervention Browse Module
MeSH Terms
ID
Term
D013812
Therapeutics
Ancestor Terms
Not provided
Browse Leaves
Not provided
Browse Branches
Not provided
Waldenstrom macroglobulinemia
stage I multiple myeloma
stage II multiple myeloma
stage III multiple myeloma
stage I childhood lymphoblastic lymphoma
stage III childhood lymphoblastic lymphoma
stage IV childhood lymphoblastic lymphoma
recurrent childhood lymphoblastic lymphoma
recurrent childhood acute myeloid leukemia
recurrent adult acute myeloid leukemia
recurrent adult acute lymphoblastic leukemia
relapsing chronic myelogenous leukemia
stage III malignant testicular germ cell tumor
recurrent malignant testicular germ cell tumor
chronic phase chronic myelogenous leukemia
accelerated phase chronic myelogenous leukemia
blastic phase chronic myelogenous leukemia
meningeal chronic myelogenous leukemia
untreated adult acute lymphoblastic leukemia
untreated adult acute myeloid 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
myelodysplastic syndromes
Philadelphia chromosome positive chronic myelogenous leukemia
Philadelphia chromosome negative chronic myelogenous leukemia