Clinical Trial: Standard Maintenance POMP/D Plus Ixazomib Maintenance Therapy in Adult Patients With Acute Lymphoblastic Leukemia, Lymphoblastic Lymphoma or Mixed Phenotype Acute Leukemia in Complete Remission (CR)
Study Status: Not yet recruiting
Recruit Status: Not yet recruiting
Study Type: Interventional
Official Title: Standard Maintenance [POMP/D (Methotrexate, 6 - Mercaptopurine, Vincristine, Prednisone/Dexamethasone)] Plus Ixazomib Maintenance Therapy in Adults With Acute Lymphoblastic Leukemia, Lymphoblastic Lym
Brief Summary: In this phase I study, escalating doses of IXAZOMIB will be combined with the POMP/D regimen.
Detailed Summary:
PRIMARY OBJECTIVE
The primary objective is to determine the maximum-tolerated dose of IXAZOMIB (MLN9708) (maximum of 4 mg, which is the recommended phase II dose for IXAZOMIB (MLN9708) in combination with standard maintenance therapy with POMP/D (methotrexate, 6- mercaptopurine, vincristine, prednisone/dexamethasone) and to assess the tolerability of POMP/D and IXAZOMIB (MLN9708) maintenance in adult patients with acute lymphoblastic leukemia, lymphoblastic lymphoma (LBL) or mixed phenotype acute leukemia (MPAL) in complete remission (CR).
SECONDARY OBJECTIVE
To determine the three-year progression-free survival (PFS) of patients treated with oral IXAZOMIB (MLN9708) and standard maintenance regimen. Progression-free survival will be measured from the start of induction to disease relapse.
STUDY DESIGN
The maximum-tolerated dose of single agent IXAZOMIB was 1.76 to 2.0mg/m2 when given on a twice a week schedule1 and > 2.34 mg/m2 to 2.97 mg/m2 on a weekly schedule in previous studies.
Three patients will be treated per dose level unless dose-limiting toxicity (DLT) is observed. The starting dose of IXAZOMIB will be 3 mg orally on days 1, 8 and 15. If no DLT is seen in the first three patients, the dose will be increased to 4 mg on days 1, 8 and 15 in a classic 3 +3 phase I design. We will not attempt to increase the dose beyond 4 mg orally which, if achieved with acceptable toxicity, would be accepted as the recommended phase 2 dose (RP2D). Zero of three DLTs would allow escalation to the next dose level. One of three DLTs will require expanding to six patients; one of six DLTs will allow escalation again. Two DLTs will requi
Sponsor: Ehab L Atallah
Current Primary Outcome: Maximum tolerated dose of ixazomib with POMP/D maintenance [ Time Frame: Eight (8) weeks ]
Original Primary Outcome: Maximum tolerated dose of ixazomib with POMP/D maintenance [ Time Frame: Eight (8) weeks ]
Current Secondary Outcome: Progression-free survival of patients treated with oral Ixazomib and standard maintenance regimen. [ Time Frame: Three (3) years ]
Original Secondary Outcome: Same as current
Information By: Medical College of Wisconsin
Dates:
Date Received: September 30, 2015
Date Started: June 1, 2017
Date Completion: March 2020
Last Updated: May 2, 2017
Last Verified: May 2017