MLN8237 in Patients With Relapsed or Refractory Aggressive B-Cell Lymphoma Treated With Rituximab +/- Vincristine

Part of paid clinical trials in Tucson, Arizona.

Sponsor
Millennium Pharmaceuticals, Inc.
Study ID
NCT01397825
Phase
PHASE1/PHASE2
Status
Completed

Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Alisertib (MLN8237) — DRUG
    Alisertib (MLN8237) enteric coated tablet (ECT).
  • Rituximab — DRUG
    Rituximab IV infusion.
  • Vincristine — DRUG
    Vincristine IV Infusion.

Study Details

This is a single-arm, open-label, multicenter, dose escalation, phase 1-2 study of alisertib (MLN8237) administered in patients with relapsed or refractory diffuse large B-cell lymphoma (DLBCL)/transformed follicular lymphoma (TFL) treated with rituximab and vincristine. The study has three parts as follows: Phase 1, Part 1: Safety lead-in cohort to evaluate alisertib (MLN8237) and rituximab. Phase 1, Part 2: Dose escalation cohort to evaluate alisertib (MLN8237) + Rituximab + Vincristine and determine Phase 2 dose. Patients with other types of B-cell lymphoma (including mantle cell or Burkitt's lymphoma may enroll in Parts 1 and 2. Phase 2: Alisertib (MLN8237) + Rituximab + Vincristine in patients with relapsed or refractory DLBCL or TFL at recommended Phase 2 dose. Note that in 2013 Sponsor decision was taken to not initiate the phase 2 portion of the trial, which would have investigated the triplet at the recommended phase 2 dose identified in part 2. This decision was based on reprioritization within the company and not on any clinical or safety outcomes observed.

Key Dates

Start date
Aug 9, 2011
Status verified
Feb 2018
Primary completion
Feb 5, 2015
Completion
Oct 5, 2016

Study Design

Enrollment
45 participants (actual)
Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: Safety Lead-in
    Alisertib 50 mg, enteric coated tablets (ECT), orally, twice daily (BID), on Days 1 to 7 followed by a 14-day rest period in 21-day cycles plus rituximab 375 mg/m\^2, intravenous (IV), infusion on Day 1 of each 21-day cycle for up to 8 cycles. Following 8 cycles of treatment (or early discontinuation of rituximab) all participants with documented disease response or stabilization may continue with alisertib single-agent therapy for up to 2 years.
  • Experimental: Dose Escalation, Alisertib 30 mg
    Alisertib 30 mg, ECT, orally, BID, on Days 1 to 7 followed by a 14-day rest period plus rituximab 375 mg/m\^2, IV, infusion on Day 1, plus vincristine 1.4 mg/m\^2 (max 2 mg), IV, on Days 1 and 8 in a 21-day cycle for up to 8 cycles. Following 8 cycles of treatment (or early discontinuation of rituximab and/ or vincristine) all participants with documented disease response or stabilization may continue with alisertib single-agent therapy for up to 2 years.
  • Experimental: Dose Escalation, Alisertib 40 mg
    Alisertib 40 mg, ECT, orally, BID, on Days 1 to 7 followed by a 14-day rest period plus rituximab 375 mg/m\^2, IV, infusion on Day 1 plus vincristine 1.4 mg/m\^2, IV (max 2mg), on Days 1 and 8 in a 21-day cycle for up to 8 cycles. Following 8 cycles of treatment (or early discontinuation of rituximab and/ or vincristine) all participants with documented disease response or stabilization may continue with alisertib single-agent therapy for up to 2 years.
  • Experimental: Dose Escalation, Alisertib 50 mg
    Alisertib 50 mg, ECT, orally, BID, on Days 1 to 7 followed by a 14-day rest period plus rituximab 375 mg/m\^2, IV, infusion on Day 1 plus vincristine 1.4 mg/m\^2, IV (max 2mg), on Days 1 and 8 in a 21-day cycle for up to 8 cycles. Following 8 cycles of treatment (or early discontinuation of rituximab and/ or vincristine) all participants with documented disease response or stabilization may continue with alisertib single-agent therapy for up to 2 years.
  • Experimental: Phase 2: Alisertib
    Phase 2: Alisertib (MLN8237) at the Recommended Phase 2 Dose, ECT orally twice/day on Days 1-7 \& rituximab as an IV infusion on Day 1 \& vincristine IV on Days 1 \& 8 in a 21 Day cycle for up to 8 cycles was planned but not conducted.

Primary Outcome Measure

Number of Participants With Clinically Significant Vital Signs Findings (Treatment Related and Unrelated) [Phase 1] [ Time Frame: First dose of alisertib through 30 days after the last dose of alisertib (Up to 5.2 Years) ]

Locations (15)

FacilityCityStateZIPSite coordinators
-TucsonArizona--
-Beverly HillsCalifornia--
-BurbankCalifornia--
-MiamiFlorida--
-LexingtonKentucky--
-WorcesterMassachusetts--
-New YorkNew York--
-RochesterNew York--
-Chapel HillNorth Carolina--
-PhiladelphiaPennsylvania--
-GermantownTennessee--
-MemphisTennessee--
-HoustonTexas--
-San AntonioTexas--
-BurlingtonVermont--

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