Phase I Study Of Vincristine, Doxorubicin, And Dexamethasone (VXD) Plus Ixazomib In Adults With Relapsed Or Refractory Acute Lymphoblastic Leukemia/Lymphoma, Lymphoblastic Lymphoma Or Mixed Phenotype Acute Leukemia
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|ClinicalTrials.gov Identifier: NCT01887587|
Recruitment Status : Terminated (SAE- risk of overall protocol treatment outweighs benefits)
First Posted : June 27, 2013
Last Update Posted : February 12, 2016
|Condition or disease||Intervention/treatment||Phase|
|Relapsed or Refractory Acute Lymphoblastic Leukemia Relapsed or Refractory Lymphoblastic Lymphoma Mixed Phenotype Acute Leukemia||Drug: MLN9708 Drug: Vincristine Drug: Doxorubicin Drug: Dexamethasone||Phase 1|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||18 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||Phase I Study Of Vincristine, Doxorubicin, And Dexamethasone (VXD) Plus Ixazomib In Adults With Relapsed Or Refractory Acute Lymphoblastic Leukemia/Lymphoma, Lymphoblastic Lymphoma Or Mixed Phenotype Acute Leukemia|
|Study Start Date :||October 2013|
|Estimated Primary Completion Date :||December 2017|
|Estimated Study Completion Date :||August 2018|
Experimental: (modified VXLD) plus MLN9708
Vincristine-1.5 mg/m2 to a max dose of 2 mg IV on days 1, 8, 15 and 22
Dexamethasone- 10 mg/m2 orally or IV on days 1-14
Doxorubicin- 60 mg/m2 on day 1 by IV bolus.
For patients without CNS involvement:
For patients with CNS involvement:
-Cytarabine 100 mg will be administered intrathecally on day 1 (+/-1 day) (cytarabine dose should be reduced to 50 mg if given through a central ommaya reservoir) Triple intrathecal chemotherapy with cytarabine 30 mg, methotrexate 15 mg and hydrocortisone 15 mg on (Day 1, 8, 15 and 22 (+/-1 day)).
Other Name: Oncovin
- To determine the number of patients with adverse events. [ Time Frame: At 8 weeks ]Safety, tolerability will be assessed by number of participants with adverse events.
- To determine the optimal dose of MLN9708 [ Time Frame: Baseline and 8 weeks ]Optimal dose will be assessed by number of participants with adverse events.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01887587
|United States, Wisconsin|
|Froedtert Hospital and the Medical College of Wisconsin|
|Milwaukee, Wisconsin, United States, 53226|
|Principal Investigator:||Ehab L Atallah, MD||Medical College of Wisconsin|