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A Phase 3, Randomized, Two-Arm, Open-Label, Multicenter, International Trial of Alisertib (MLN8237) or Investigator's Choice (Selected Single Agent) in Patients With Relapsed or Refractory Peripheral T-Cell Lymphoma


Phase 3
18 Years
N/A
Open (Enrolling)
Both
Relapsed Peripheral T-Cell Lymphoma, Refractory Peripheral T-Cell Lymphoma

Thank you

Trial Information

A Phase 3, Randomized, Two-Arm, Open-Label, Multicenter, International Trial of Alisertib (MLN8237) or Investigator's Choice (Selected Single Agent) in Patients With Relapsed or Refractory Peripheral T-Cell Lymphoma


Inclusion Criteria:



- Male or female patients age 18 or older

- Patients with PTCL according to World Health Organization (WHO) criteria and have
relapsed or are refractory to at least 1 prior systemic, cytoxic therapy for PTCL.
Patients must have received conventional therapy as a prior therapy. Cutaneous-only
disease is no permitted. Patients must have documented evidence of progressive
disease.

- Tumor biopsy available for central hematopathologic review

- Measurable disease according to the IWG criteria

- Eastern Cooperative Oncology Group (ECOG) performance status of 0-2

- Female patients who are post menopausal for at least 1 year, surgically sterile, or
agree to practice 2 effective methods of contraception through 30 days after the last
dose of study drug or agree to abstain from heterosexual intercourse.

- Male patients who agree to practice effective barrier contraception through 6 months
after the last dose of alisertib or agree to abstain from heterosexual intercourse

- Suitable venous access

- Voluntary written consent

Exclusion Criteria

- Known central nervous system lymphoma

- Systemic antineoplastic therapy, immunotherapy, investigational agent or radiation
therapy within 4 weeks of first dose of study treatment or concomitant use during
study

- Prior administration of an Aurora A kinase-targeted agent, including alisertib; or
all of the 3 comparator drugs (pralatrexate, or romidepsin or gemcitabine; or known
hypersensitivity)

- History of uncontrolled sleep apnea syndrome or other conditions that could result in
excessive daytime sleepiness

- Cardiac condition as specified in study protocol, including left ventricular ejection
fraction (LVEF) <40%

- Concomitant use of other medicines as specified in study protocol

- Patients with abnormal gastric or bowel function who require continuous treatment
with H2-receptor antagonists or proton pump inhibitors

- Known active infection with human immunodeficiency virus (HIV), hepatitis B virus, or
hepatitis C

- Autologous stem cell transplant less than 3 months prior to enrollment

- Patients who have undergone allogeneic stem cell or organ transplantation any time

- Inadequate blood levels, bone marrow or other organ function as specified in study
protocol

- The patient must have recovered to National Cancer Institute Common Terminology
Criteria for Adverse Events (NCI CTCAE) Grade ≤ 1 toxicity, to patients's baseline
status (except alopecia), or deemed irreversible from the effects of prior cancer
therapy

- Major surgery, serious infection, or infection requiring systemic antibiotic therapy
within 14 days prior to the first dose of study treatment

- Female patients who are breastfeeding or pregnant

- Coexistent second malignancy or history of prior solid organ malignancy within
previous 3 years

- Serious medical or psychiatric illness or laboratory abnormality that could, in the
investigator's opinion, potentially interfere with the completion of treatment
according to the protocol

Type of Study:

Interventional

Study Design:

Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

Number of patients with overall response

Outcome Description:

Overall response rate (ORR) by central review + progression free survival (PFS)

Outcome Time Frame:

Change from screening period in response assessed at the end of every 8 weeks from date of first dose treatment; every 12 weeks after 40 week assessment; at end of treatment visit until progressive disease. Duration is approximately 3 years

Safety Issue:

No

Principal Investigator

Medical Monitor

Investigator Role:

Study Director

Investigator Affiliation:

Millennium Pharmaceuticals, Inc.

Authority:

United States: Food and Drug Administration

Study ID:

C14012

NCT ID:

NCT01482962

Start Date:

April 2012

Completion Date:

April 2017

Related Keywords:

  • Relapsed Peripheral T-Cell Lymphoma
  • Refractory Peripheral T-Cell Lymphoma
  • Lymphoma
  • Lymphoma, T-Cell
  • Lymphoma, T-Cell, Peripheral

Name

Location

Medical University of South Carolina Charleston, South Carolina  29425-0721
MD Anderson Cancer Center Orlando Orlando, Florida  32806
Fletcher Allen Health Care Burlington, Vermont  05401
University of Kansas Medical Center Kansas City, Kansas  66160-7353
Hackensack University Medical Center Hackensack, New Jersey  07601
Mayo Clinic Jacksonville Jacksonville, Florida  32224
Columbia Comprehensive Cancer Care Clinic Columbia, Missouri  65201
Vanderbilt University Medical Center Nashville, Tennessee  37232-2516
Methodist Hospital Houston, Texas  77030
University of Virginia Charlottesville, Virginia  22908
Duke University Medical Center Durham, North Carolina  27710
Henry Ford Health System Detroit, Michigan  48202
H. Lee Moffitt Cancer Center & Research Institute Tampa, Florida  33612
Dana Farber Cancer Institute Boston, Massachusetts  02115
Mary Babb Randolph Cancer Center Morgantown, West Virginia  26506
UCLA Los Angeles, California  90095
Karmanos Cancer Institute Detroit, Michigan  48201
Providence Saint Joseph Medical Center Burbank, California  91505-4866
Columbia University Medical Center New York, New York  10032
Mayo Clinic Rochester Rochester, Minnesota  55905
Weill Cornell Medical College New York, New York  10021
University of Iowa Hospitals & Clinics Iowa City, Iowa  52242
SUNY Upstate Medical Center Syracuse, New York  13210
Mercy St. Vincent Medical Center Toledo, Ohio  43608
ProMedica Health System, Inc. Toledo, Ohio  43606
AMPM Research Clinic Miami, Florida  33145
Dartmouth Lebanon, New Hampshire  03755
Seattle Cancer Care Seattle, Washington  98109