A Phase 1 interventional study of Hum-195/rGel in Acute Myeloid Leukemia, Chronic Myelomonocytic Leukemia and Myeloproliferative Disorders, sponsored by M.D. Anderson Cancer Center. Completed at 1 site in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2013-04-04.
Sponsored by M.D. Anderson Cancer Center · Phase 1, Interventional, and Treatment
The goal of this clinical research study is to find the highest safe dose of the anti-CD33 immunotoxin HuM-195/rGel that can be given to patients with advanced myeloid malignancies. This treatment will be given to patients whose leukemia has not responded to prior chemotherapy.
Before therapy, all patients will be asked about their medical history, and a physical exam (with measurement of vital signs) will be performed. A chest X-ray and an electrocardiogram (ECG - a test to measure the electrical activity of the heart) will be performed. Blood (about 4 teaspoons) will be drawn for routine tests and blood clotting tests. Women who are able to become pregnant will have a urine pregnancy test done. A test will be done to measure the amount of oxygen in your blood by placing a monitoring device on your finger. Blood (about 1 teaspoon) will be taken to measure the amount of a protein that is present on the diseased cells. During the study period, the study staff will draw blood samples for routine tests, pharmacokinetic (PK) tests, and anti-drug antibody tests. Blood (about 1 teaspoon) will be drawn to measure the amount of a protein that is present on the diseased cells. A bone marrow sample will also be obtained before treatment and on Study Day 28.
Patients will receive four injections of the immunotoxin. The immunotoxin is designed to selectively destroy myeloid leukemia cells. The injections will be given through a vein twice weekly for two weeks. Patients will then be evaluated twice weekly for the next two weeks. If there has been improvement in the leukemia, or if the leukemia has remained stable and there have been no serious side effects of treatment, patients will then receive a second course of immunotoxin injections. These will again be given twice weekly for two weeks. Depending on the effectiveness against leukemia and the side effects, patients may receive maintenance treatment. This would also consist of two weekly injections given for two weeks followed by two weeks of observation. Maintenance therapy may continue for up to four months for partial response and up to two months for complete response.
This is an investigational study. Up to 36 patients will take part in this study.
3,035 studies on the registry are indexed under Leukemia, Myeloid, Acute; 746 are open to participants now.
This study's enrollment of 28 is below the median of 40 across 2,561 interventional studies indexed under Leukemia, Myeloid, Acute.
Browse Leukemia, Myeloid, Acute studies →M.D. Anderson Cancer Center is the lead sponsor of 3,044 studies on the registry; 578 are open to participants now.
Of its 608 completed or terminated interventional studies of FDA-regulated products, 407 (67%) have results posted.
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Patients with relapsed or refractory acute myelogenous leukemia (AML), Refractory anemia with excess blasts in transformation (RAEB-t), Refractory Anemia with Excess Blasts (RAEB), or chronic myelomonocytic leukaemia (CMML) who failed at least one previous chemotherapy course. Patients with accelerated CML Ph+ or myeloid blastic crisis are eligible. Patients in accelerated phase of non-Philadelphia chromosome + myeloproliferative disorders are also eligible:
Exclusion Criteria:
Women who are pregnant or lactating
HuM195/rGel starting Dose = 3 mg/m\^2 twice weekly for 2 weeks.
Drug: Hum-195/rGel
Starting Dose = 3 mg/m\^2 twice weekly for 2 weeks.
Maximum Tolerated Dose (MTD)
Dose-limiting toxicity considered to have occurred when (1) \>grade 2 extramedullary toxicity possibly related to HuM195/rGel (except nausea, vomiting or diarrhea unless uncontrolled by optimal management, or electrolyte abnormalities unless clinically significant or not correctable after optimal replacement) is observed or (2) \>42 days from day 1 of therapy elapse before return of neutrophil count to \>500 and platelet count to \>25,000 in absence of leukemia (i.e., with a normal or hypercellular bone marrow with \<5% blasts).
Time frame: Continuous assessment of safety throughout entire study period and determination of dose-limiting toxicities at end of two week evaluation period (4 weeks from start of therapy).
This study is completed, as verified in Apr 2013. You cannot join it, but the record below documents what was studied.
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