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Title   Phase 1 Study of Combotox With Cytarabine in Relapsed/Refractory B-lineage Acute Lymphoblastic Leukemia (ALL)
Description   This study will test different doses of combotox in your disease to find out what dose of this drug can be given safely to patients. Combotox will be given with cytarabine.

You might have been given cytarabine as part of your treatment for ALL before; even if you have received cytarabine before, it usually still works when it is given if the leukemia has not completely disappeared with the first treatment (or is "refractory") or if the leukemia has come back (or has "relapsed").

Another purpose of this study is to find out what effects (good and bad) the experimental drug Combotox has on you and your disease (ALL) when combined with cytarabine.


Eligibility Criteria   To be eligible for this study, patients must meet several criteria, including but not limited to the following:

* Patient must be 18 to 65 years old

* Patient must have histologically confirmed B-lineage ALL at diagnosis and either evidence of relapse / refractory disease based on a Bone Marrow / Peripheral Blood examination or evidence by cytogenetic studies or PCR amplification.

* Patient must have a life expectancy of more than 2 months

Principal Investigator   Stefan Barta, MD
Contact Name   Dale Wyville, PA
Phone   (718) 920-4826
Contact Email   dwyville@montefiore.org
Post Date   07/12/2011
Protocol Number   11-04-146/West
Status   Recruiting
Current Trial Type   Interventional
Montefiore Clinical Trial   No
CHAM Clinical Trial   No