| Label |
NCT00003196
|
| Slug |
nct00003196
|
| Trialid |
NCT00003196
|
| Lookup name |
NCT00003196
|
| Provenance |
http://clinicaltrials.gov/show/NCT00003196?displayxml=true
|
| Lastchanged date |
September 6, 2011
|
| Firstreceived results date |
|
| Firstreceived date |
November 1, 1999
|
| Id info nct id |
NCT00003196
|
| Overall status |
Active, not recruiting
|
| Id info secondary id |
FHCRC-1225.00
|
| Biospec retention |
|
| Required header link text |
Link to the current ClinicalTrials.gov record.
|
| Enrollment |
30
|
| Number of arms |
|
| Is section 801 |
No
|
| Is fda regulated |
Yes
|
| Brief title |
Peripheral Stem Cell Transplantation With Donor White Blood Cells in Treating Older Patients With Hematologic Cancers
|
| Acronym |
|
| Official title |
Induction of Mixed Hematopoietic Chimerism In Older Patients With B-Cell Malignancies and in Selected Other Patients, Using Low Dose TBI, PBSC Infusion and Post-Transplant Immunosuppression With Cyclosporine and Mycophenolate Mofetil to be Followed by Donor Lymphocyte Infusion: A Pilot Study.
|
| Study type |
Interventional
|
| Id info nct alias |
|
| Completion date |
|
| Verification date |
September 2011
|
| Why stopped |
|
| Id info org study id |
1225.00
|
| Required header url |
http://clinicaltrials.gov/show/NCT00003196
|
| Study design |
Primary Purpose: Treatment
|
| Source |
Fred Hutchinson Cancer Research Center
|
| Primary completion date |
April 2002
|
| Brief summary |
|
| Number of groups |
|
| Required header download date |
Information obtained from ClinicalTrials.gov on February 02, 2012
|
| Phase |
Phase 1
|
| Start date |
September 1997
|
| Has expanded access |
No
|
| Biospec descr |
|
| Detailed description |
OBJECTIVES: I. Determine whether mixed hematopoietic chimerism can be safely established
using a nonmyeloablative conditioning regimen in patients with non-Hodgkin's lymphoma,
chronic lymphocytic leukemia, or multiple myeloma. II. Determine whether mixed chimerism can
be safely converted to full donor hematopoietic chimerism by infusions of donor lymphocytes.
OUTLINE: Patients with advanced malignancies receive cytoreduction per FHCRC-506 to reduce
tumor bulk. Patients may also receive radiation to high risk bulky disease or skeleton
lesions before transplantation. Donors receive subcutaneous filgrastim (G-CSF) on days -4 to
0. Peripheral blood stem cells (PBSC) are collected on days -1 and 0. Patients receive
cyclosporine IV on days -1 and 0, then orally on days 1-35. On day 0, patients undergo total
body irradiation, then receive unmodified G-CSF mobilized PBSC by infusion. Mycophenolate
mofetil is administered beginning after the PBSC infusion and continuing until day 27.
Patients are evaluated for lymphoid and myeloid chimerism on days 28 and 56. Patients with
mixed chimerism on day 56, and with no evidence of graft-versus-host disease (GVHD) receive
the first infusion of donor lymphocytes (DLI) on day 65. Up to 3 more infusions may be
administered, if there is evidence of increasing or persistent cancer, provided no active
GVHD or low blood counts are present. Donors undergo leukopheresis and collection of
nonmobilized peripheral bone marrow cells (PBMC) on the day of the first DLI. The
unirradiated donor PBMC are administered to the patient by IV infusion over 30 minutes.
Patients are followed weekly until day 90 after the last DLI, then at 4 and 6 months, then
every 6 months for 2 years, and then annually for 3 years.
PROJECTED ACCRUAL: A total of 20 patients with non-Hodgkin's lymphoma, chronic lymphocytic
leukemia, or multiple myeloma will be accrued for this study in 2 years. A maximum of 10
patients with other hematologic malignancies will also be accrued.
|
| Condition browse |
d0ac14be2029db2dc108fb7cfae54a7c
|
| Intervention browse |
6faf250cc9e52d26445920476af280b0
|
| Responsible party |
35984d8ca27a161e62ebf54f647bc1c4
|
| Overall contact |
None
|
| Overall contact backup |
None
|
| Sponsor group |
f740aa1da4e0bea9987a3e911973e253
|
| Oversight info |
United States: Federal Government (Oversight_info)
|
| Eligibility |
439375ef42cecd8367ae26538eddc91c
|
| Keywords |
adult acute lymphoblastic leukemia in remission,
adult acute myeloid leukemia in remission,
B-cell chronic lymphocytic leukemia
More →
|
| Conditions |
Chronic Myeloproliferative Disorders,
Leukemia,
Lymphoma,
Multiple Myeloma and Plasma Cell Neoplasm,
Myelodysplastic Syndromes
|
| Locations |
31dfd9fd7c5ace212e8a9e5e78c6d9e0
|
| Links |
http://cancer.gov/clinicaltrials/FHCRC-1225.00
|
| Results references |
None
|
| Arm groups |
None
|
| Location countries |
United States
|
| Interventions |
cyclosporine (Intervention),
mycophenolate mofetil (Intervention),
radiation therapy (Intervention),
peripheral blood stem cell transplantation (Intervention),
filgrastim (Intervention),
allogeneic bone marrow transplantation (Intervention)
|
| Secondary outcomes |
None
|
| References |
None
|
| Primary outcomes |
None
|
| Removed countries |
None
|
| Overall officials |
3eddcb0e477efca41392e48305fd69ab
|
