CancerNCT00003538
Prevention of Graft-Versus-Host Disease in Patients Undergoing Bone Marrow Transplantation
A study testing graft versus host disease prophylaxis/therapy and allogeneic bone marrow transplantation in people with Cancer, run by Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages Up to 65 years
- Conditions the study is for
- Cancer
- What is being tested?
- graft versus host disease prophylaxis/therapy and allogeneic bone marrow transplantation
- Type of treatment
- Surgery or procedure
- How many people
- Not given
- Where
- 1 siteUnited States
- Study dates
- Mar 1997to May 2004
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Up to 65 years
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
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
Trial locations and contacts
1 site in 1 country.
United States1 site
Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins
Baltimore, Maryland, 21231-2410
About this study
Official title: 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.
Read the 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
- Cancer
- Being tested
- graft versus host disease prophylaxis/therapy, allogeneic bone marrow transplantation
- 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, Waldenstrom macroglobulinemia, stage I multiple myeloma, stage II multiple myeloma
- Medical subject headings
- Neoplasms, Hodgkin Disease, Breast Neoplasms, Precursor Cell Lymphoblastic Leukemia-Lymphoma, Carcinoma, Ovarian Epithelial, Neuroblastoma, Wilms Tumor, Waldenstrom Macroglobulinemia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
graft versus host disease prophylaxis/therapyBiological
allogeneic bone marrow transplantationProcedure or surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Jan 2003 (estimated)
- Study startMar 1997
- Primary completionMay 2004
- Study completionMay 2004
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for CancerStudies of the same condition, open and under way.
- More trials run by Sidney Kimmel Comprehensive Cancer Center at Johns HopkinsThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Collaborators
- National Cancer Institute (NCI)
- Investigators
- Richard J. Jones, MD, Study chair, Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00003538
- Sponsor's protocol ID
- CDR0000066589, J9711
- Other IDs
- P30CA006973, JHOC-97021903, JHOC-J9711, NCI-V98-1460
- Status last verified
- May 2014
- First submitted
- 1 Nov 1999
- Last updated
- 2 May 2014
- Results posted
- No
Publications
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.
PubMed 9849691
Study at a glance
From the registry record, last updated by the sponsor on 2 May 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Stem Cell Augmented, Elutriated Grafts for Allogeneic Bone Marrow Transplantation
- ClinicalTrials.gov ID
- NCT00003538
- Acronym / sponsor ID
- CDR0000066589, J9711
- 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
- Study type
- Interventional
- Recruitment status
- Completed
- Lead sponsor
- Sidney Kimmel Comprehensive Cancer Center at Johns HopkinsUniversity, hospital or other
- Collaborators
- National Cancer Institute (NCI)
- Study start
- Mar 1997
- Primary completion
- May 2004 (actual)
- Study completion
- May 2004 (actual)
- First posted
- 27 Jan 2003 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
Study design
- Primary purpose
- Supportive care
Who may qualify
- Ages
- Up to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| graft versus host disease prophylaxis/therapy | Biological | – |
| allogeneic bone marrow transplantation | Procedure or surgery | – |
Primary outcome
Not reported in the source record.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 May 2014.
- Results publication: PubMed 9849691O'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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Richard J. Jones, MD study chair
Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing graft versus host disease prophylaxis/therapy and allogeneic bone marrow transplantation in people with Cancer, run by Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 2 May 2014. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00003538, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 May 2014.