A Phase 2/3 interventional study of Mylotarg in Leukemia, sponsored by M.D. Anderson Cancer Center. Terminated at 1 site in United States. Open to participants aged 55 Years to 75 Years. Per ClinicalTrials.gov, last updated 2018-10-31.
Sponsored by M.D. Anderson Cancer Center · Phase 2/3, Interventional, and Treatment
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:
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 Graft vs. Leukemia (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.
5,441 studies on the registry are indexed under Leukemia; 636 are open to participants now.
This study's enrollment of 3 is below the median of 38 across 4,247 interventional studies indexed under Leukemia.
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Exclusion Criteria:
Drug: Mylotarg
Also known as: CMA-676
Maximum Tolerated Dose (MTD) of CMA-676
Time frame: Continual Reassessment Method (CRM); each cycle
This study is terminated, as verified in Oct 2018. You cannot join it, but the record below documents what was studied.
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M.D. Anderson Cancer Center