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Nonmyeloablative preparative regimen using Mylotarg for patients with high risk AML, ALL, CML and MDS Clinical Trials Information presented on Clinical Trials Search isn't intended to be a substitute for proven healthcare advice, trips or treatment using a real physician. We are not docs. Always confer with your mD on Nonmyeloablative preparative regimen using Mylotarg for patients with high risk AML, ALL, CML and MDS conditions. Clinical Trials Search.org is a site dedicated to listing clinical research studies in human subjects. Nonmyeloablative preparative regimen using Mylotarg for patients with high risk AML, ALL, CML and MDS Clinical research trials and Nonmyeloablative preparative regimen using Mylotarg for patients with high risk AML, ALL, CML and MDS medical trials take place in hundreds of localities across the U.S.. A clinical trial or clinical study is a research project with human volunteer subjects. Clinical drug trials and pharmaceutical clinical trials usually measure the effectiveness of new drugs. The intention of the studies / projects is to resolve certain human health questions. Clinical trials are a popular means for physicians, government agencies, and private sector corporations to detect remedies for all forms of circumstances, like Nonmyeloablative preparative regimen using Mylotarg for patients with high risk AML, ALL, CML and MDS. Nonmyeloablative preparative regimen using Mylotarg for patients with high risk AML, ALL, CML and MDS Clinical Trials and other clinical trials allow for volunteers to undergo healthcare treatment options before they are available to the masses. Most times the participants receive treatment for free, and every now and again they are paid for their time. Occasionally there is a cost for a Nonmyeloablative preparative regimen using Mylotarg for patients with high risk AML, ALL, CML and MDS clinical trial. Subjects typically recieve the finest healthcare available for their Nonmyeloablative preparative regimen using Mylotarg for patients with high risk AML, ALL, CML and MDS condition. Hazards are a reality, nonetheless, and might include more or frequent mD trips, health risks (potentially life-endangering), and/or the treatment being ineffective. Trials are federally regulated with stern guidelines to protect clinical trials subjects.
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Home > "N" Clinical Trials Conditions > Nonmyeloablative preparative regimen using Mylotarg for patients with high risk AML, ALL, CML and MDS  Nonmyeloablative preparative regimen using Mylotarg for patients with high risk AML, ALL, CML and MDS
Nonmyeloablative preparative regimen using Mylotarg for patients with high risk AML, ALL, CML and MDS
For Condition: Leukemia
Status: Suspended
Sponsor(s): M.D. Anderson Cancer Center ,
Synopsis: Primary Objective: To determine the safety and maximum tolerated dose of CMA-676 as part of an intensive but nonmyeloablative preparative regimen in older or medically infirm patients undergoing mini-allogeneic peripheral blood stem cell transplantation Secondary Objectives: 1. To evaluate response rates, engraftment kinetics and degree of chimerism achievable with this strategy. 2. To evaluate disease-free and overall survival and relapse rates. 3. To evaluate the need and ability to give multiple cycles of Mylotarg plus FA and mobilized DLI in patients not achieving complete remission.
Details: Mylotarg is a novel immunoconjugate directed against the CD33 antigen found on most leukemia cells. This humanized murine IgG4 monoclonal antibody is tagged with the toxin, calicheamicin. In equal molar concentrations, calicheamicin is about 3200 times more potent than adriamycin. In a Phase I study involving adult patients with relapse AML, Mylotarg has been shown to have significant anti-leukemia activity with little toxicity. The most concerning side effects of Mylotarg were prolonged neutropenia and thrombocytopenia. Phase II studies have also demonstrated good efficacy with little toxicity. The goal of this proposal is to include Mylotarg in a nonmyeloablative preparative regimen similar to FAI used at MD Anderson Cancer Center. The hypothesis is that Mylotarg will provide potent anti-leukemic effects without adding toxicity to the mini-allogeneic bone marrow transplant regimen. A more potent anti-leukemic response may increase the complete remission rates and induce a state of minimal residual disease (MRD). Therefore, the GVL effect of allogeneic transplantation will have a better chance for success. In addition, the administration of donor cells after Mylotarg should ameliorate the cytopenias previously associated with Mylotarg. This medication likely will be well-tolerated. Patients with high-risk hematopoietic malignancies that express CD33 (i.e. AML, ALL, CML and MDS) will be included. We will enroll older patients (>55 years old) or medically infirm patients who are unable to tolerate standard allogeneic bone marrow transplant. Patients will be evaluated at 28 days post-transplant for evidence of response. Those with residual disease may be eligible for additional Mylotarg given together with donor lymphocyte infusions. Additional courses of Mylotarg may improve overall survival in this poor prognosis group.
Eligibility:
Study Type: Interventional, Treatment, Non-Randomized, Open Label, Uncontrolled, Single Group Assignment, Safety/Efficacy Study
Minimum Age/Maximum Age: 55 Years/75 Years
Genders: Both
Protocol Entry Criteria: Inclusion Criteria - Patients 12-75 years of age - Patients are eligible if deemed ineligible for conventional high dose chemotherapy programs because of concurrent medical conditions. Patients with refractory AML are eligible provided ejection fraction35%,FEV1,FVC,or DLCO  40%, GPT< 3 x normal,direct bilirubin < 2. - Patients must have recovered form previous Grade III-IV toxicity due to prior antineoplastic therapy (except alopecia). - Patients with AML with induction failure, relapse or 2nd remission - Patients with MDS with IPI INT-2 or High-risk disease (Appendix 4) or CMML. - Patients with CML in accelerated phase or blast crisis - Patients with ALL with induction failure, relapse or 2nd remission - Patients receiving prior BMT are eligible. If myeloablative chemoradiotherapy was used in the prior transplant patients must be >90 days from transplant. If non-myeloablative therapy was used patients must be >30 days post-transplant. - Leukemia cells must express cell surface CD33 evaluated by flow cytometry in > 20% of leukemia cells. - Patients must have an HLA identical related donor capable of donating G-CSF stimulated peripheral blood stem cells using apheresis techniques. If patient has a contraindication to PBSC collection bone marrow can be used. - Patients must have a Zubrod PS<2 (Appendix 6), Cr<2.0, direct bilirubin <2, and transaminases SGPT <3x normal - Patients must have an estimated life expectancy > 3 months - Patient and donor must sign informed consent Exclusion Criteria: - no uncontrolled active infection - no HIV disease - no pregnancy and no nursing - no active, uncontrolled CNS leukemia
Total Enrollment: 45
Location and Contact Information:
MDAnderson Cancer Center
Houston, Texas, 77030
United States
Additional Information:
Study ID Numbers: ID00-153;
Study Start Date: May 2001
Record last reviewed: February 2004
Additional information available at: clinicaltrials.gov
Clinicaltrials.gov Reference link: NCT00038805
Other Leukemia Studies:
1. 506U78 in Treating Patients With Hematologic Cancer and Kidney or Liver Impairment
2. Selective T-Cell Depletion to Reduce Graft-Versus-Host-Disease in Patients Receiving Stem Cell Transplantation to Treat Leukemia, Lymphoma or Myelodysplastic Syndromes
3. VNP40101M in Treating Patients With Advanced or Metastatic Cancer
4. Beclomethasone in Treating Patients With Graft-Versus-Host Disease of the Esophagus, Stomach, Small Intestine, or Colon
5. Stem Cell Transplant for Patients with Blood Malignancy Using Donors and Less Toxic Chemotherapy with CAMPATH 1H
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Nonmyeloablative preparative regimen using Mylotarg for patients with high risk AML, ALL, CML and MDS
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