Flu,Alemtuzumab,and TBI Followed By Donor Stem Cell Chronic Phase CML
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|ClinicalTrials.gov Identifier: NCT00416884|
Recruitment Status : Terminated (Low enrollment)
First Posted : December 28, 2006
Results First Posted : August 2, 2011
Last Update Posted : September 27, 2017
RATIONALE: Giving low doses of chemotherapy, such as fludarabine, and total-body irradiation (TBI) before a donor stem cell transplant helps stop the growth of cancer cells. It also stops the patient's immune system from rejecting the donor's stem cells. The donated stem cells may replace the patient's immune system and help destroy any remaining cancer cells (graft-versus-tumor effect). Giving an infusion of the donor's T cells (donor lymphocyte infusion) that have been treated in the laboratory after the transplant may help increase this effect. Sometimes the transplanted cells from a donor can also make an immune response against the body's normal cells. Giving cyclosporine and alemtuzumab, and removing the T lymphocyte cells(T cells) from the donor cells before transplant, may stop this from happening.
PURPOSE: This clinical trial is studying how well giving fludarabine, alemtuzumab, and total-body irradiation together with donor stem cell transplant and donor white blood cell (WBC) infusion works in treating patients with chronic phase chronic myelogenous leukemia (CML) that did not respond to previous imatinib mesylate.
|Condition or disease||Intervention/treatment||Phase|
|Leukemia||Drug: Campath Drug: Fludarabine Radiation: Total Body Irradiation (TBI) Other: T-Cell Deplete||Phase 2|
- Determine the treatment-related mortality in patients with imatinib mesylate-resistant chronic phase chronic myelogenous leukemia treated with nonmyeloablative conditioning comprising fludarabine, alemtuzumab, and total-body irradiation followed by T-cell-depleted allogeneic stem cell transplantation and post-transplantation allogeneic T-cell infusion.
- Determine if donor engraftment can be safely established using partial T-cell depletion with additional T-cell infusions in these patients.
OUTLINE: Patients receive alemtuzumab IV over 5-6 hours on day -8 and fludarabine IV on days -4 to -2. Patients undergo total-body irradiation followed by T-cell-depleted (CD34+ selected) allogeneic stem cell transplantation on day 0. Patients receive allogeneic T-cell infusion on days 30 and 60. Patients also receive cyclosporine twice daily beginning on day -3 and continuing until day 100 followed by a taper until day 177.
PROJECTED ACCRUAL: Not specified.
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||1 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||Fludarabine, Campath, TBI T-Cell Deplete NMSCT With Post-Transplant T-Cell Infusions for CML Failing Imatinib Therapy With Imatinib (STI571)|
|Study Start Date :||May 2003|
|Actual Primary Completion Date :||March 2008|
|Actual Study Completion Date :||March 2008|
Experimental: TBI, Campath, Fludarabine T-cell Deplete
(Campath) 30 mg on day -8 over 5-6 hours, Fludarabine 30 mg/m^2 on day -4 through day -2, Total body irradiation single fraction 200 cGy at 7 cGy per minute on day 0., Stem cells will be T cell depleted and given on day 0
30 mg on day -8 over 5-6 hours
Other Names:Drug: Fludarabine
Fludarabine 30 mg/m^2 on day -4 through day -2
Other Names:Radiation: Total Body Irradiation (TBI)
Total body irradiation single fraction 200 cGy at 7 cGy per minute on day 0
Other Names:Other: T-Cell Deplete
Stem cells will be T cell depleted and given on day 0
- Number of Participants With Treatment-related Mortality [ Time Frame: lifetime followup, up to 100 years. ]Treatment related mortality is a consequence of both complications of the preparative regimen and systemic immunological rejection which is manifested as graft versus host disease(GVHD). The preparative regimens which include whole body radiation and/or high dose chemotherapy are complicated by single or multi-organ failure and by prolonged myelosuppression that can lead to infections and bleeding
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00416884
|United States, Oregon|
|OHSU Knight Cancer Institute|
|Portland, Oregon, United States, 97239-3098|
|Study Chair:||Richard Maziarz, MD||OHSU Knight Cancer Institute|