A Phase 2 interventional study of Gleevec and Ara-C in Leukemia, Myeloid and Myelodysplastic Syndromes, sponsored by M.D. Anderson Cancer Center. Completed at 1 site in United States. Open to participants aged 60 Years and older. Per ClinicalTrials.gov, last updated 2012-08-01.
Sponsored by M.D. Anderson Cancer Center · Phase 2, Interventional, and Treatment
The goal of this clinical research study is to learn if the combination of Gleevec (imatinib mesylate) and low doses of Cytarabine (ara-C) may help to control leukemia while causing fewer side effects than standard high dose chemotherapy.
Imatinib mesylate is a drug that blocks a certain protein. This protein is thought to be important in the growth of leukemia cells. Ara-C is a chemotherapy drug that has been used for many years to treat AML and MDS.
Imatinib mesylate (Gleevec) is a protein-tyrosine kinase inhibitor that inhibits the Bcr-Abl tyrosine kinase, as well as the receptor tyrosine kinases for platelet- derived growth factor (PDGF) and stem cell factor (SCF), c-Kit, and inhibits PDGF- and SCF-mediated cellular events. c-Kit is expressed in over 90% of patients with AML.
The treatment of AML for patients age 65 or older with AML or high-risk MDS (age ³ 60 if high-risk cytogenetics) have a poor prognosis with induction chemotherapy. Response rate is no more than 45% with an induction mortality of at least 25%, and 1-year survival no better than 20%. Indeed, most patients in these age groups are not even offered therapy and are managed with supportive care only. Thus, new therapies that are better tolerated are needed.
Imatinib alone can induce response in nearly 20% of patients, and there is synergy with low concentrations of ara-C. In this study we plan to investigate the combination of imatinib and low-dose ara-C.
5,441 studies on the registry are indexed under Leukemia; 636 are open to participants now.
This study's enrollment of 10 is below the median of 38 across 4,247 interventional studies indexed under Leukemia.
Browse Leukemia studies →M.D. Anderson Cancer Center is the lead sponsor of 2,999 studies on the registry; 581 are open to participants now.
Of its 599 completed or terminated interventional studies of FDA-regulated products, 402 (67%) have results posted.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
Drug: Gleevec · Drug: Ara-C
600 mg (capsules) by mouth once daily
Also known as: Imatinib Mesylate, STI-571, Imatinib, NSC-716051
10 mg as an injection under the skin daily for 21 days of every 28 day cycle
Also known as: Cytarabine, Cytosar-U®, DepoCyt, Cytosine arabinosine hydrochloride, Arabinosylcytosine
Efficacy of a combination of imatinib and low dose ara-C in elderly or high-risk patients with AML and MDS, as measured by the rate of early mortality or progression.
Time frame: April 2007
Rate of overall response, including CRp and PR.
Time frame: April 2007
To determine the safety profile of this combination.
Time frame: April 2007
To determine the impact on long-term survival of this therapy.
Time frame: April 2007
To determine the duration of responses obtained with this therapy.
Time frame: April 2007
To determine the impact of this therapy in cognitive function.
Time frame: April 2007
To determine the effect of this approach in quality of life of this patient population.
Time frame: April 2007
To determine the overall costs (health economic analysis) associated with this combination therapy.
Time frame: April 2007
This study is completed, as verified in Jul 2012. You cannot join it, but the record below documents what was studied.
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M.D. Anderson Cancer Center