Alisertib, Bortezomib, and Rituximab in Treating Patients With Relapsed or Refractory Mantle Cell Lymphoma or B-cell Low Grade Non-Hodgkin Lymphoma

Part of paid clinical trials in New York, New York.

Sponsor
National Cancer Institute (NCI)
Study ID
NCT01695941
Phase
PHASE1
Status
Active Not Recruiting

Conditions

  • Recurrent B-Cell Non-Hodgkin Lymphoma
  • Recurrent Mantle Cell Lymphoma
  • Refractory B-Cell Non-Hodgkin Lymphoma
  • Refractory Mantle Cell Lymphoma

Eligibility Criteria

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

Interventions

  • Alisertib — DRUG
    Given PO
  • Bortezomib — DRUG
    Given SC
  • Laboratory Biomarker Analysis — OTHER
    Correlative studies
  • Rituximab — BIOLOGICAL
    Given IV

Study Details

This phase I trial studies the side effects and best dose of alisertib and bortezomib when given together with rituximab in treating patients with mantle cell lymphoma or B-cell low grade non-Hodgkin lymphoma that has returned after a period of improvement (relapsed) or does not respond to treatment (refractory). Alisertib and bortezomib may stop the growth of cancer cells by blocking some of the enzymes needed for cell growth. Monoclonal antibodies, such as rituximab, may interfere with the ability of cancer cells to grow and spread. Giving alisertib and bortezomib together with rituximab may be a better treatment for relapsed or refractory mantle cell lymphoma or B-cell low grade non-Hodgkin lymphoma.

Key Dates

Start date
Aug 31, 2012
Status verified
Mar 2026
Primary completion
May 29, 2018
Completion
Mar 3, 2027

Study Design

Enrollment
24 participants (actual)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • Experimental: Treatment (alisertib, bortezomib, and rituximab)
    Patients receive alisertib PO BID on days 1-7; bortezomib SC on days 1, 8, and 15; and rituximab IV on day 1. Treatment repeats every 28 days\* in the absence of disease progression or unacceptable toxicity. Note: \*After 8 courses, treatment with rituximab repeats once every 3 courses (12 weeks) in the absence of disease progression or unacceptable toxicity.

Primary Outcome Measure

Recommended phase II dose of alisertib when combined with bortezomib and rituximab, defined as the highest dose level at which < 33% of the dose cohort experience a dose limiting toxicity (DLT) [ Time Frame: 21 days ]

Locations (4)

FacilityCityStateZIPSite coordinators
Laura and Isaac Perlmutter Cancer Center at NYU LangoneNew YorkNew York10016-
Montefiore Medical Center - Moses CampusThe BronxNew York10467-
Montefiore Medical Center-Einstein CampusThe BronxNew York10461-
Fox Chase Cancer CenterPhiladelphiaPennsylvania19111-

Find similar trials in New York, NY

By research site
Laura and Isaac Perlmutter Cancer Center at NYU Langone· New York, NYMontefiore Medical Center - Moses Campus· The Bronx, NYMontefiore Medical Center-Einstein Campus· The Bronx, NYFox Chase Cancer Center· Philadelphia, PA

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