Chemoimmunotherapy With Epratuzumab in Relapsed Acute Lymphoblastic Leukemia (ALL)
This Phase II trial is studying how well giving epratuzumab together with an established chemotherapy platform works in treating young patients with relapsed acute lymphoblastic leukemia. Monoclonal antibodies, such as epratuzumab, can block cancer growth in different ways. Some block the ability of cancer cells to grow and spread. Others find cancer cells and help kill them or carry cancer-killing substances to them. Chemotherapy drugs work in different ways to stop the growth of cancer cells, either by killing them or by stopping them from dividing. Giving monoclonal antibody therapy in combination chemotherapy may kill cancer cells more effectively.
Recurrent Childhood Acute Lymphoblastic Leukemia
Drug: doxorubicin hydrochloride
Drug: therapeutic hydrocortisone
Drug: liposomal vincristine sulfate
Drug: dexrazoxane hydrochloride
Drug: leucovorin calcium
|Study Design:||Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
|Official Title:||A Feasibility Pilot and Phase 2 Study Of Chemoimmunotherapy With Epratuzumab (IND #12034) for Children With Relapsed CD22-Positive Acute Lymphoblastic Leukemia (ALL)|
- Feasibility of an intensive chemoimmunotherapy approach for the treatment of relapsed CD-22 positive B-precursor acute lymphoblastic leukemia [ Time Frame: 14 days ] [ Designated as safety issue: No ]
- Toxicity graded using the NCI CTCAE version 4.0 [ Time Frame: Up to 30 days after completion of study treatment ] [ Designated as safety issue: Yes ]
- Response rate determined by bone marrow aspiration and peripheral blood blast counts [ Time Frame: Up to day 36 ] [ Designated as safety issue: No ]Quantified by the observed response rate and associated 95% confidence interval.
- Event-free survival [ Time Frame: 4 months ] [ Designated as safety issue: No ]Estimated using the Kaplan-Meier method.
- Minimal residual disease [ Time Frame: Up to day 36 ] [ Designated as safety issue: No ]Tested using a one-sample Z-test.
- Pharmacokinetics [ Time Frame: Up to day 36 ] [ Designated as safety issue: No ]Determined along with the mean, median, standard deviation and range of the parameters of interest. Statistical analysis will be purely descriptive.
|Study Start Date:||February 2005|
|Primary Completion Date:||April 2011 (Final data collection date for primary outcome measure)|
Experimental: Reinduction Chemoimmunotherapy with Epratuzumab
Drugs considered in the two phases of re-induction therapy are as follows:
Other Names:Drug: doxorubicin hydrochloride
Other Names:Drug: therapeutic hydrocortisone
Other Names:Drug: liposomal vincristine sulfate
Other Names:Biological: epratuzumab
Other Names:Drug: cytarabine
Other Names:Drug: prednisone
Other Names:Drug: pegaspargase
Other Names:Drug: dexrazoxane hydrochloride
Other Names:Drug: methotrexate
Other Names:Drug: etoposide
Other Names:Drug: cyclophosphamide
Other Names:Drug: leucovorin calcium
Other Names:Biological: filgrastim
Show Detailed Description