Four Drug Reinduction With Bortezomib for Relapsed or Refractory ALL or LL in Children and Young Adults
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|ClinicalTrials.gov Identifier: NCT02535806|
Recruitment Status : Terminated (Funding source discontinued)
First Posted : August 31, 2015
Results First Posted : August 13, 2019
Last Update Posted : August 13, 2019
|Condition or disease||Intervention/treatment||Phase|
|Acute Lymphoblastic Leukemia Lymphoblastic Lymphoma||Drug: Velcade Drug: Methotrexate Drug: Methotrexate / Hydrocortisone / Cytarabine Drug: Dexamethasone Drug: Mitoxantrone Drug: Vincristine Drug: Pegaspargase||Phase 2|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||2 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||A Pilot Study of Mitoxantrone-Based Four Drug Reinduction in Combination With Bortezomib for Relapsed or Refractory Acute Lymphoblastic Leukemia or Lymphoblastic Lymphoma in Children and Young Adults|
|Study Start Date :||July 2015|
|Actual Primary Completion Date :||May 25, 2017|
|Actual Study Completion Date :||May 25, 2017|
Experimental: Treatment Arm
Velcade will be given IV push on days 1,4,8 and 11 at a dose of 1.3 mg/m2/dose. At least 72 hours must have relapsed between doses.
IT Methotrexate (CNS Negative patients only) on days 1 and 8; age based dosing IT Methotrexate/Hydrocortisone/AraC (CNS positive patients only) on days 1, 8, 15 and 22; age based dosing.
Dexamethasone: Days 1-5 and 15-19; 10mg/m2/dose PO BID. Mitoxantrone: Days 1 and 2; 10mg/m2/dose Vincristine: days 1, 8, 15, and 22 at 1.5 mg/m2 (Maximum dose 2 mg) PEG-asparaginase: Days 3 and 17, 2500 IU/m2/dose
4 doses of study drug will be given.
Other Name: Bortezomib
Intrathecal dose For CNS negative patients, Day 1 and Day 8
Drug: Methotrexate / Hydrocortisone / Cytarabine
Intrathecal dose for CNS positive patients, Day 1, 8, 15, 22
Days 1-5 and 15-19
Days 1 and 2
Days 1, 8, 15, 22
Days 3 and 17
- Number of Subject With Adverse Events [ Time Frame: 36 days ]Toxicities were assessed and graded according to CTCAE v 4.0.
- Remission Rate Seen With Using Bortezomib in Combination With the ALL R3 Re-induction Regimen in Pediatric Patients With Relapsed or Refractory ALL or LL. [ Time Frame: 36 days ]Number of patients with bone marrow blast percentage <5% after treatment
- Post-induction Level of Minimal Residual Disease Seen With Using Bortezomib in Combination With the ALL R3 Re-induction Regimen in Pediatric Patients With Relapsed or Refractory ALL or LL. [ Time Frame: 36 days ]Percent of Cells Positive for Minimal residual disease measured by multiparameter flow cytometry
- 2-year Overall Survival Seen With Using Bortezomib in Combination With the ALL R3 Re-induction Regimen in Pediatric Patients With Relapsed or Refractory ALL or LL. [ Time Frame: 2 years ]
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): NCT02535806
|United States, Missouri|
|Children's Mercy Hospital|
|Kansas City, Missouri, United States, 64108|
|Principal Investigator:||Keith J August, MD||Children's Mercy Hospital Kansas City|