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Our Center is currently evaluating a new drug called clofarabine (Clofarex) in young patients with progressive acute ALL in whom the standard treatment drugs have failed. Clofarabine combines two older drugs, fludarabine and cladribine, into a new drug that may be effective in treating leukemia. In a previous dose-finding clinical trial of this drug in patients (including children) with a leukemia that has returned or has not responded to prior treatment, good responses -- including remission -- have been observed. Doctors now have determined what the safe dose of clofarabine is and can begin this new trial to clarify how effective this drug will be in more patients.

We are also conducting a study to test another new two-drug combination for the treatment of recurrent ALL. The two drugs are trimetrexate and leucovorin. Trimetrexate is an investigational drug that is being evaluated as a potential anticancer therapy. Laboratory studies suggest that this drug is effective against leukemias that can't be treated effectively with methotrexate, the standard chemotherapy drug. Leucovorin is an approved drug that protects normal cells from the effects of chemotherapy, but it does not interfere with trimetrexate's action against cancer cells. This study will also evaluate the side effects of this combination therapy.

After patients achieve remission, they will continue to receive consolidation chemotherapy (to kill any lingering cancer cells) or if a matched sibling donor is available, patients will receive a bone marrow (stem cell) transplant.

Our investigators are currently studying the side effects of intensified therapy, which can be substantial. And it is crucial that the essential elements of intensified therapy be selectively administered to children who will benefit from these elements. The aims of this study are to determine whether stronger post-induction therapies in the treatment of children with low-risk and average-risk features will cure more children without adding too many side effects.

A key component of contemporary ALL treatment regimens is risk-adapted therapy. This grouping depends on how quickly the blasts disappear during Induction therapy (rapid vs slow early response); whether or not there were very small amounts of leukemia in the bone marrow (called Minimal Residual Disease or MRD) at the end of induction; and what biologic features their leukemia blasts have. Our investigators are currently creating investigational studies, the data from which will be used to refine subsequent therapy by assignment to a specific treatment protocol for defined risk groups.

Last Updated: Mar. 9, 2006
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