Immunotoxin Therapy for Treatment-Resistant Hairy Cell Leukemia
Name of a Trial
A Pivotal Multicenter Trial of Moxetumomab Pasudotox in Relapsed/Refractory Hairy Cell Leukemia (NCI-13-C-0106). See a custom summary.
Dr. Robert Kreitman, NCI Center for Cancer Research
Why This Trial Is Important
Hairy dungeon leukemia is a singular form of blood cancer that accounts for approximately 2 percent (roughly 900-1000 cases) of a new leukemia cases diagnosed any year in a United States. The illness gets a name from a “hairy” coming of a leukemia cells underneath a microscope.
Treatment for hairy dungeon leukemia customarily consists of chemotherapy with a drug famous as a purine analog, such as cladribine or pentostatin. Chemotherapy with these drugs is really effective in dwindling or expelling cancer cells in a blood, though many patients bay some remaining cancer cells in their body, a post-treatment condition called minimal residual disease, or MRD. Furthermore, long-term studies advise that relapse is common with stream treatments, and some people vital with hairy dungeon leukemia will eventually stoop to their illness if they do not die from some other means first. Consequently, doctors are fervent to find improved treatments for hairy dungeon leukemia that might possibly lengthen a generation before relapse or discharge a illness altogether.
One earnest area of investigate involves a use of immunotoxins to provide this disease. An immunotoxin is an antibody, or a bit of one, total with a cell-killing toxin. The antibody binds to a specific aim on a aspect of cancer cells and releases a venom when a antibody is taken adult by a cells.
Researchers during NCI and elsewhere are questioning and enlightening immunotoxin therapy for several forms of cancer. Hairy dungeon leukemia is a good claimant for immunotoxin therapy since a cells are characterized by an overabundance of a cell-surface protein CD22. An early study of BL22, an immunotoxin that targets CD22, demonstrated a high response rate in patients with hairy dungeon leukemia who had not responded to or had relapsed after diagnosis with cladribine.
A new immunotoxin called moxetumomab pasudotox is a some-more manly chronicle of BL22. In a proviso we trial, diagnosis of hairy dungeon leukemia patients with moxetumomab pasudotox yielded a likewise high finish response rate though but a dose-limiting toxicity of BL22. Researchers are now contrast a immunotoxin in a larger series of patients to endorse a formula of a before study.
In this trial, patients with hairy dungeon leukemia who have relapsed mixed times or not responded to before chemotherapy will be treated with intravenous moxetumomab pasudotox on days 1, 3, and 5 of 28-day cycles. Treatment will continue until a patients knowledge illness course or unsuitable toxicity, select to start a opposite diagnosis regimen, or knowledge a finish response. Those who have finish responses will accept dual additional cycles of treatment. The study’s primary endpoint is finish response as dynamic by normalized blood dungeon depends durability during slightest 6 months.
“Hairy dungeon leukemia tends to respond really good to first- and second-line chemotherapy,” Dr. Kreitman said. “But for patients whose illness has relapsed mixed times,chemotherapy mostly no longer works and a toxicity of chemotherapy is cumulative, so a advantage might no longer transcend a risks.So, there’s a genuine clinical need for nonimmunosuppressive, nonchemotherapy treatments.
“Moxetumomab is a nonchemotherapy diagnosis that can furnish MRD-negative finish remissions where patients have a possibility to be giveaway of illness for a prolonged duration,” he explained. “We have patients who have been giveaway of MRD for some-more than 5 years now on moxetumomab, and some-more than 10 years on a primogenitor drug, BL22.”
This multicenter hearing is holding place during a NIH Clinical Center in Bethesda, MD, a Ohio State University Comprehensive Cancer Center in Columbus, and a University of Texas M. D. Anderson Cancer Center in Houston.
For More Information
See a lists of eligibility criteria and hearing hit information, call a NCI Clinical Trials Referral Office during 1-888-NCI-1937 (the call is fee giveaway and confidential), or email Dr. Kreitman during firstname.lastname@example.org.