Safety and Efficacy of Marqibo in Relapsed Acute Lymphoblastic Leukemia

• Register: ClinicalTrials.gov
• Last refreshed on: 17 October 2012
• Main ID: NCT00495079
• Date of registration: 28/06/2007
• Primary sponsor: Talon Therapeutics, Inc
• Public title: Safety and Efficacy of Marqibo in Relapsed Acute Lymphoblastic Leukemia
• Scientific title: A Phase 2 Study to Evaluate the Safety and Efficacy of Weekly Doses of Marqibo® (Vincristine Sulfate Liposomes Injection) in Adult Patients With Philadelphia Chromosome-negative Acute Lymphoblastic Leukemia (ALL) in Second Relapse or Adult Patients With Philadelphia Chromosome-negative ALL Who Failed Two Treatment Lines of Anti-leukemia Chemotherapy
• Date of first enrolment: May 2007
• Target sample size: 65
• Recruitment status: Completed
• URL: http://clinicaltrials.gov/show/NCT00495079
• Study type: Interventional
• Study design: Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Countries of recruitment

Canada, Germany, Israel, United Kingdom, United States

Contacts

• Name: Susan O'Brien, MD
• Affiliation: M.D. Anderson Cancer Center

Key inclusion & exclusion criteria

Main Eligibility Criteria:

- Age =18 years.

- Patients with Philadelphia chromosome-negative ALL in second relapse, or patients
with Philadelphia-chromosome-negative ALL who failed two treatment lines of
anti-leukemia chemotherapy.

- Burkitt's lymphoma is excluded.

- Histologically proven ALL and =10% bone marrow blasts. Diagnostic material of the
screening bone marrow aspirate and biopsy must be submitted to the central
hematopathologist.

- Responsive to a prior anti-leukemia therapy as defined by a leukemia-free interval of
=3 months.

- ECOG performance status 0-3.

- No active CNS disease. History of treated CNS disease is allowable.

- Systemic corticosteroids must have been tapered off, preferably before the start of
study treatment, but no later than by Day 5 of Course 1. From Day 6 of Course 1 on
through the end of study participation, systemic corticosteroids are not allowed,
unless the patient shows disease progression or disease relapse, is discontinued from
the study treatment, and requires subsequent anti-leukemia therapy.



Age minimum: 18 Years
Age maximum: N/A
Gender: Both

Health Condition(s) or Problem(s) studied

Acute Lymphoblastic Leukemia

Intervention(s)

Drug: Marqibo® (vincristine sulfate liposomes injection)

Primary Outcome(s)

Complete remission plus complete remission without full platelet recovery [Time Frame: Every 28 days]

Secondary ID(s)

HBS407

Source(s) of Monetary Support

Please refer to primary and secondary sponsors

Secondary Sponsor(s)

Parexel