Bortezomib, Vorinostat and Dexamethasone for Relapsed/Refractory Acute Lymphoblastic Leukemia (ALL)
|ClinicalTrials.gov Identifier: NCT01312818|
Recruitment Status : Terminated (Slow accrual)
First Posted : March 11, 2011
Results First Posted : May 15, 2015
Last Update Posted : December 28, 2017
|Condition or disease||Intervention/treatment||Phase|
|Acute Lymphoblastic Leukemia||Drug: Bortezomib Drug: Vorinostat Drug: Dexamethasone Drug: Methotrexate Drug: Imatinib mesylate||Phase 2|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||2 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||A Therapeutic Trial of Bortezomib (Velcade), Vorinostat (SAHA) and Dexamethasone for Relapsed/Refractory Acute Lymphoblastic Leukemia (ALL)|
|Study Start Date :||June 2011|
|Primary Completion Date :||January 2013|
|Study Completion Date :||January 2013|
Bortezomib IV Vorinostat PO Dexamethasone PO Intrathecal Methotrexate Imatinib Mesylate PO (for Ph+ ALL patients only)
1.3 mg/m^2 by intravenous pyelogram (IVP) over 3-5 seconds on days 1, 4, 8 and 11.
Other Name: Velcade(R)Drug: Vorinostat
180 mg/m^2 (max dose 400mg) by mouth (PO) divided twice a day (BID) on days 1-14
Other Names:Drug: Dexamethasone
6 mg/m^2 by mouth (PO) divided twice a day (BID) on days 4-15.
Other Name: DecadronDrug: Methotrexate
Intrathecal Methotrexate at age based dose on day 1 (repeat on day 15 or 16 for CNS positive patients only)
Other Names:Drug: Imatinib mesylate
For Ph+ acute lymphoblastic leukemia (ALL) patients only:
Imatinib Mesylate is allowable at 340 mg/m2 PO once a day (rounded to the nearest 100 mg) for age ≤18 years and 400 mg for >18 years on Days 1-16.
Other Name: Gleevec(R)
- Number of Subjects Who Achieved Complete Remission of Their Disease [ Time Frame: Day 30 ]Complete Remission (CR): A CR requires that the following be recorded concurrently: an absolute neutrophil count (segs and bands) > 1000/μL, no circulating blasts, platelets > 100,000/μL; adequate bone marrow cellularity with trilineage hematopoiesis, and < 5% marrow leukemia blast cells. All previous extramedullary manifestations of disease must be absent. If patients continue on with treatment, there can be no evidence of recurrence of ALL for at least 4 weeks.
- Number of Subjects Experiencing Drug Related Adverse Events [ Time Frame: Day 1 of Treatment to 30 Days Post Treatment ]To characterize the toxicities of bortezomib, vorinostat and dexamethasone when used in combination. Toxicity will be graded using the NCI's Common Terminology Criteria for Adverse Events (CTCAE 4.0).
- Number of Subjects With Activated Caspases and Other Regulators of Apoptosis [ Time Frame: From Day 1 to 30 Days After Last Dose ]Activation of caspases and other regulators of apoptosis in treated blast cells will be determined by Western analysis (correlative lab analysis).
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01312818
|United States, Minnesota|
|Masonic Cancer Center, University if Minnesota|
|Minneapolis, Minnesota, United States, 55455|
|Principal Investigator:||Michael Burke, MD||Masonic Cancer Center, University of Minnesota|