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Megadose CD34 Selected Progenitor Cells for Transplantation in Patients with Advanced Hematological Malignant Diseases Clinical Trials Info presented on Clinical Trials Search isn't intended to be a substitute for qualified medical advice, visits or professional assistance by using a real mD. We are not docs. Always confer with your physician about Megadose CD34 Selected Progenitor Cells for Transplantation in Patients with Advanced Hematological Malignant Diseases conditions. Clinical Trials Search.org is a website committed to listing clinical research studies in human subjects. Megadose CD34 Selected Progenitor Cells for Transplantation in Patients with Advanced Hematological Malignant Diseases Clinical research trials and Megadose CD34 Selected Progenitor Cells for Transplantation in Patients with Advanced Hematological Malignant Diseases health trials occur in many of cities throughout the US. A clinical trial or clinical study is a research project with human volunteer subjects. Clinical drug trials and pharmaceutical clinical trials generally evaluate the effectivity of new does drugs. The intent of the studies / undertakings is to resolve particular human health questions. Clinical trials are a popular way for physicians, government agencies, and private sector companies to detect remedies for all sorts of conditions, including Megadose CD34 Selected Progenitor Cells for Transplantation in Patients with Advanced Hematological Malignant Diseases. Megadose CD34 Selected Progenitor Cells for Transplantation in Patients with Advanced Hematological Malignant Diseases Clinical Trials and other clinical trials permit volunteers to obtain healthcare treatment alternatives before they are available to the masses. Most times the participants undergo professional assistance for without cost, and occasionally they are compensated for their time. Occasionally there is a cost for a Megadose CD34 Selected Progenitor Cells for Transplantation in Patients with Advanced Hematological Malignant Diseases clinical trial. Test subjects typically receive the most expert healthcare available for their Megadose CD34 Selected Progenitor Cells for Transplantation in Patients with Advanced Hematological Malignant Diseases condition. Dangers are a reality, however, and may include more or frequent mD visits, healthcare dangers (perhaps life-endangering), and/or the treatment being ineffectual. Trials are federally regulated with rigid guidelines to protect clinical trials patients.
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Home > "M" Clinical Trials Conditions > Megadose CD34 Selected Progenitor Cells for Transplantation in Patients with Advanced Hematological Malignant Diseases  Megadose CD34 Selected Progenitor Cells for Transplantation in Patients with Advanced Hematological Malignant Diseases
Megadose CD34 Selected Progenitor Cells for Transplantation in Patients with Advanced Hematological Malignant Diseases
For Condition: Chronic Lymphocytic Leukemia,Acute Myelogenous Leukemia,Myelodysplastic Syndrome,Acute Lymphocytic Leukemia,Non Hodgkin's Lymphoma
Status: Recruiting
Sponsor(s): M.D. Anderson Cancer Center ,
Synopsis: This clinical study will evaluate the feasibility of a purified CD34 peripheral blood progenitor cell (PBPC) transplants in patients with hematological malignancies. The primary objectives of the study are to evaluate donor neutrophil engraftment and the incidence of acute GvHD (Grade III-IV). Secondary objectives include assessments of platelet engraftment, incidence of graft failure and chronic GvHD, overall disease free survival, clinical safety and device performance.
Details: T-cell depletion for control of GvHD has currently been used in allogeneic progenitor cell transplants. Different approaches have been recently reported by several groups where T-cell depletion was accomplished by positive selection of CD34+ cells, using the ClinicMACS device. With a purified CD34 progenitor cell transplant, the patient does not need to receive nephrotoxic post transplant immunosuppression. This will allow patients to receive as prophylaxis foscarnet and ambisome to prevent CMV and fungal infection.
Eligibility:
Study Type: Interventional, Treatment, Non-Randomized, Open Label, Uncontrolled, Single Group Assignment, Safety/Efficacy Study
Minimum Age/Maximum Age: 18 Years/60 Years
Genders: Both
Protocol Entry Criteria: INCLUSION: - Acute leukemia HLA identical sibling in 1st remission; or unrelated or HLA mismatched in acute blast,or 2nd chronic phase. - Or MDS marrow blast greater than/=1-% on differential or Non-Hodgkin's lymphoma for identical or unrelated graft patients, unrelated donor & identical only; or - Refractory CLL, refractory to fludarabine based regimen, unrelated donor & haploidentical only. - Age less than 55 years at registration and receiving haploidentical allograft or less than 60 years if receiving HLA identical sibling graft or unrelated donor graft. - Patient must have HLA identical sibling donor, HLA unrelated donor, match >/=5 of 6 HLA antigens or related donor for HLA, A< BC or Dr loci and mismatched in GvHD for 2-3 HLA AB/DR antigens. - Recovery from prior therapy, chemo or radiotherapy: ECOG status 45%, DLCO >50% corrected for Hgb). - SrCr <1.5mg/dl or Cr clearance >50ml/min for those above serum cr of 1.5; bili <2mg/dL; AST/ALT <2xULN (unless 2nd to disease). - Negative pregnancy test for females of childbearing potential within 3 weeks of registration and use of adequate contraception. - No prior cancer within 5 years except for surgically cured non-melanoma skin cancer or in situ cancer of the cervix. - No prior myeloablative transplant and no prior total body irradiation. - Signed informed consent. EXCLUSION: - Participation in other clinical trials which involve investigational drugs or devices that might influence the endpoints of this study. - Evidence of active hepatitis (B &/or CO or cirrhosis. - HIV positive. - Presence of any other active, uncontrolled bacterial, viral or fungal infection. - Uncontrolled CNS involvement with tumor cells. - Documented allergy to murine proteins or iron dextran. - Patient lactating or unwilling to use adequate birth control. - Medical problem or neurologic/psychiatric dysfunction that would impair ability to comply with regimen & tolerate transplantation or prolong hematologic recovery or put patient at unacceptable risk, according to the Principal Investigator.
Total Enrollment: 61
Location and Contact Information:
MD Anderson Cancer Center *Recruiting*
Houston, Texas, 77030
United States
Recruiting Deborah Geisler 713-745-0039
Additional Information:
Study ID Numbers: ID01-220;
Study Start Date: September 2001
Record last reviewed: January 2004
Additional information available at: clinicaltrials.gov
Clinicaltrials.gov Reference link: NCT00038857
Other Acute Myelogenous Leukemia Studies:
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2. A Phase I Study of DT388GMCSF Fusion Protein in AML and CMML
3. Therapy of Relapsed AML with Chemotherapy and Dendritic Cell Activated Lymphocytes
4. Dosing Study of Ara-C/EL625/Idarubicin in Refractory and Relapsed AML
5. Phase II Study of CLOFARABINE in Adult Patients with Refractory or Relapsed Acute Myelogenous Leukemia
Related Studies:
Other Acute Myelogenous Leukemia Clinical Trials
Other Texas Clinical Trials
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Megadose CD34 Selected Progenitor Cells for Transplantation in Patients with Advanced Hematological Malignant Diseases
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