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

This study is currently recruiting participants. (see Contacts and Locations)
Verified July 2014 by Spectrum Pharmaceuticals, Inc
Sponsor:
Information provided by (Responsible Party):
Spectrum Pharmaceuticals, Inc
ClinicalTrials.gov Identifier:
NCT01439347
First received: September 20, 2011
Last updated: July 17, 2014
Last verified: July 2014

September 20, 2011
July 17, 2014
March 2012
December 2015   (final data collection date for primary outcome measure)
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.
Overall Survival (OS) [ Time Frame: Dec 2012 ] [ Designated as safety issue: Yes ]
Complete list of historical versions of study NCT01439347 on ClinicalTrials.gov Archive Site
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
Not Provided
Not Provided
Not Provided
 
A Phase 3 Study to Evaluate Marqibo® in the Treatment of Subjects ≥ 60 Years Old With Newly Diagnosed ALL
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)

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

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).

Interventional
Phase 3
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Acute Lymphoblastic Leukemia (ALL)
  • Drug: Vincristine Sulfate Liposomes Injection (VSLI)
    2.25 mg/m2 (without any dose cap) as an IV infusion over 60 minutes
    Other Name: 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
  • 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
    Intervention: Drug: Vincristine Sulfate Injection (VSI)
  • Experimental: Marqibo
    administration of standard VSI vs. Marqibo
    Intervention: Drug: Vincristine Sulfate Liposomes Injection (VSLI)
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
348
August 2017
December 2015   (final data collection date for primary outcome measure)

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.

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Both
60 Years and older
No
Contact: Dennis Kim, MD 949-743-9229 Dennis.Kim@sppirx.com
United States
 
NCT01439347
TTX404
No
Spectrum Pharmaceuticals, Inc
Spectrum Pharmaceuticals, Inc
Not Provided
Principal Investigator: Susan M O'Brien, MD MD Anderson
Spectrum Pharmaceuticals, Inc
July 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP