A Phase 3 Study to Evaluate Marqibo® in the Treatment of Subjects ≥ 60 Years Old With Newly Diagnosed ALL

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
Spectrum Pharmaceuticals, Inc
ClinicalTrials.gov Identifier:
NCT01439347
First received: September 20, 2011
Last updated: March 10, 2015
Last verified: March 2015
  Purpose

A phase 3 study in the treatment of subjects >or= 60 years old with newly diagnosed acute lymphoblastic leukemia (ALL).


Condition Intervention Phase
Acute Lymphoblastic Leukemia (ALL)
Drug: Vincristine Sulfate Liposomes Injection (VSLI)
Drug: Vincristine Sulfate Injection (VSI)
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Phase 3 Study of Study to Evaluate Marqibo® in the Combination Chemotherapy in the Treatment of Subjects >or=60 Years Old With Newly Diagnosed Acute Lymphoblastic Leukemia (ALL)

Resource links provided by NLM:


Further study details as provided by Spectrum Pharmaceuticals, Inc:

Primary Outcome Measures:
  • Primary Efficacy Criterion [ Time Frame: 24 months of Sequential Induction ] [ Designated as safety issue: Yes ]
    Overall Survival will be measured for all subjects from the date of randomization until death from any cause.


Secondary Outcome Measures:
  • Secondary Efficacy Criteria [ Time Frame: Complete Remission ] [ Designated as safety issue: Yes ]
    Complete remission )CR+CRi; best response during study Duration of Response (CR+CRi) Event Free Survival(EFS)will be measured from the date of randomization until the date of the earliest of the following events: Death from any cause, relapse from CR/CRi, Bone marrow and or blood examination documentation failure to achieve CR/CRi following the last course of radiation therapy


Estimated Enrollment: 348
Study Start Date: March 2012
Estimated Study Completion Date: August 2017
Estimated Primary Completion Date: December 2015 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: Vincristine Sulfate Injection (VSI)
This is a phase 3, international, multicenter, open-label randomized, controlled trial with 2 treatment arms that vary only in the administration of standard VSI vs. Marqibo. Eligible subjects will be randomized to combination chemotherapy containing either VSI or Marqibo
Drug: Vincristine Sulfate Injection (VSI)
1.4 mg/m2 with a 2 mg dose cap as an intravenous (IV) infusion over 10 minutes
Other Name: Vincristine
Experimental: Marqibo
administration of standard VSI vs. Marqibo
Drug: Vincristine Sulfate Liposomes Injection (VSLI)
2.25 mg/m2 (without any dose cap) as an IV infusion over 60 minutes
Other Name: Marqibo

Detailed Description:

A phase 3, multicenter, randomized study to evaluate the substitution of Marqibo® (Vincristine Sulfate Liposomes Injection, VSLI) for standard Vincristine Sulfate Injection (VSI) in the induction, intensification, and maintenance phases of combination chemotherapy in the treatment of subjects >or= 60 years old with newly diagnosed acute lymphoblastic leukemia (ALL).

  Eligibility

Ages Eligible for Study:   60 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

Have provided written, signed, and dated informed consent to participate in the study, in accordance with the ICH GCP Guideline E6 and all applicable local regulations.Are age >or=60 years (at the time of providing informed consent).

Have newly diagnosed, histologically proven, untreated Philadelphia chromosome-negative (Ph-) ALL, with >or= 5% bone marrow blasts.

Have an Eastern Cooperative Oncology Group (ECOG) performance status of 0-2. Have a life expectancy >or= 3 months.

Have renal and liver function as defined below within 14 days, inclusive, prior to study enrollment, unless the abnormality is considered attributable to leukemia:

Total bilirubin ≤ 2.0 x the upper limit of normal (ULN), unless the subject has a known diagnosis of Gilbert's disease Aspartate transaminase (AST, SGOT) or alanine transaminase (ALT, SGPT) ≤ 3 x ULN Serum creatinine ≤ 1.5 x ULN. Not have had major surgery within 4 weeks before the planned start of treatment.

If female, are post-menopausal, surgically sterilized, or willing to use acceptable methods of birth control (eg, hormonal contraceptive, intra-uterine device, diaphragm with spermicide, condom with spermicide, or abstinence) from the screening visit through 30 days after the last dose of any protocol defined chemotherapeutic agents.

If male and sexually active with a partner of child-bearing potential, agree to use an acceptable barrier method for contraception from the screening visit through 30 days after the last dose of any protocol defined chemotherapeutic agents.

Have the ability and willingness to fully comply with study procedures and restrictions.

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Exclusion Criteria:

Has had prior systemic chemotherapy (for ALL or other malignancy). Has had prior vincristine for any reason. Is planning to undergo stem cell transplantation (SCT) as any part of first-line therapy for ALL.

Has Burkitt's lymphoma/leukemia. Has Philadelphia chromosome-positive (Ph+) ALL and/or BCR/ABL rearrangements documented by fluorescent in-situ hybridization (FISH), cytogenetics, or polymerase chain reaction (PCR).

Has active central nervous system (CNS) disease. Has ongoing neuropathy of any etiology > Grade 1. Has a history of persistent active neurologic disorders including demyelinating form of Charcot-Marie-Tooth syndrome, acquired demyelinating disorders, and other demyelinating conditions.

Prior hydroxyurea (Hydrea®) for the management of any condition other than leukocytosis or prior hydroxyurea of >7 days duration for the management of leukocytosis (hydroxyurea for the management of leukocytosis must be planned to be tapered off before or on Day 5 of Induction).

Has received prior steroids within 7 days before beginning protocol-specified Induction therapy for reasons other than leukocytosis (steroids for the management of leukocytosis are allowed but must be planned to be tapered off before or on Day 5 of Induction).

Has an active serious infection not controlled by oral or IV antibiotics or antifungals.

Has received any investigational therapy within 28 days before beginning any protocol-defined chemotherapeutic treatment.

-

  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01439347

Locations
United States, California
UC San Diego Moores Cancer Center
La Jolla, California, United States, 92093
UCLA
Los Angeles, California, United States, 90095
United States, Georgia
Emory University, Winship Cancer Institute
Atlanta, Georgia, United States, 30322
United States, Illinois
University of Chicago
Chicago, Illinois, United States, 60637
Northwestern University Fienberg School of Medicine
Chicago, Illinois, United States, 60611
United States, Michigan
Karmanos Cancer Institute
Detroit, Michigan, United States, 48201
United States, Missouri
Washington University School of Medicine
St. Louis, Missouri, United States, 63110-1093
United States, Nebraska
Nebraska Medical Center
Omaha, Nebraska, United States, 68198-7680
United States, New Jersey
Hackensack University Medical Center
Hackensack, New Jersey, United States, 07601
United States, New York
Roswell Park Cancer Institute
Buffalo, New York, United States, 14263
Cornell
New York, New York, United States, 10021
United States, North Carolina
Duke University Medical Center
Durham, North Carolina, United States, 27710
United States, Ohio
Cleveland Clinic
Cleveland, Ohio, United States, 44195
United States, Texas
The University of Texas, M.D. Anderson Cancer Center
Houston, Texas, Texas, United States, 77030-4009
United States, Washington
Seattle Cancer Care Alliance
Seattle, Washington, United States, 98109
Sponsors and Collaborators
Spectrum Pharmaceuticals, Inc
Investigators
Principal Investigator: Susan M O'Brien, MD MD Anderson
  More Information

No publications provided

Responsible Party: Spectrum Pharmaceuticals, Inc
ClinicalTrials.gov Identifier: NCT01439347     History of Changes
Other Study ID Numbers: TTX404
Study First Received: September 20, 2011
Last Updated: March 10, 2015
Health Authority: United States: Food and Drug Administration

Keywords provided by Spectrum Pharmaceuticals, Inc:
Marqibo
HALLMARQ
leukemia
front-line
ALL
acute lymphoblastic leukemia

Additional relevant MeSH terms:
Leukemia
Leukemia, Lymphoid
Precursor Cell Lymphoblastic Leukemia-Lymphoma
Immune System Diseases
Immunoproliferative Disorders
Lymphatic Diseases
Lymphoproliferative Disorders
Neoplasms
Neoplasms by Histologic Type
Vincristine
Antimitotic Agents
Antineoplastic Agents
Antineoplastic Agents, Phytogenic
Mitosis Modulators
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Therapeutic Uses
Tubulin Modulators

ClinicalTrials.gov processed this record on April 23, 2015