Philadelphia Chromosome-negative Acute Lymphoblastic Leukemia MedDRA version: 9.1 Level: LLT Classification code 10000845 Term: Acute lymphoblastic leukemia
Conditions
Interventions
Product Name: Marqibo
Pharmaceutical Form: Liposomal dispersion for infusion
INN or Proposed INN: vincristine sulfate
Concentration unit: mg/ml milligram(s)/millilitre
Concentration type: equal
Concen
Sponsors
Talon Therapeutics , Inc.
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Age =18 years. 2. Have Philadelphia chromosome-negative ALL or lymphoblastic lymphoma and be in second relapse or have failed two treatment lines of anti-leukemia chemotherapy. 3. Have histologically or cytologically proven ALL and =10% bone marrow blasts. If =65 years) yes F.1.3.1 Number of subjects for this age range
Exclusion criteria
Exclusion criteria: 1. Burkitt’s lymphoma or Burkitt's leukemia. 2. History of Philadelphia chromosome-positive ALL and/or BCR/ABL rearrangements documented by FISH or PCR. 3. Active CNS disease. History of treated CNS disease is allowable. The CNS disease must have resolved in order for the subject to be eligible. 4. Eligibility for stem cell transplantation. This implies that a suitable donor is readily available, the subject is willing to undergo stem cell transplantation, and the Investigator believes this is a better treatment option than Marqibo. This is at the Investigator’s discretion. 5. Treatment with any investigational agents or chemotherapy agents in the last 21 days before study entry, unless full recovery from side effects has occurred or the patient has rapidly progressing disease judged to be life threatening by the Investigator. 6. Patients receiving any other standard or investigational treatment for their leukemia. a. Intrathecal chemotherapy for CNS prophylaxis is allowable. b. The use of hydroxyurea (Hydrea®) to control leukocytosis is allowable but must be tapered off by Day 14 of Course 1. From Day 15 of Course 1 on through the end of study participation, hydroxyurea (Hydrea®) is not allowed. c. 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. 7. Persistent chronic clinically significant toxicities from prior chemotherapy =Grade 2 (NCI CTCAE v3.0). 8. Persistent =Grade 2 active neuropathy (NCI CTCAE v3.0). 9. History of persistent =Grade 2 active neurologic disorders unrelated to chemotherapy (including demyelinating form of Charcot-Marie-Tooth syndrome, acquired demyelinating disorders, or other demyelinating condition). 10. Patients with a history of allergic reactions or sensitivity attributed to compounds of similar chemical or biologic composition to vincristine or components of Marqibo. 11. Pregnant or breast-feeding women. 12. Active serious infection not controlled by oral or intravenous antibiotics or antifungals. 13. Known human immunodeficiency virus (HIV) status. 14. Any medical condition which in the opinion of the Investigator places the patient at an unacceptably high risk for toxicities. 15. Any condition or circumstance which in the opinion of the Investigator would significantly interfere with the patient’s protocol compliance and put the patient at increased risk.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To evaluate the efficacy of the study treatment as determined by the rate of complete remission (CR) and complete remission with incomplete blood count recovery (CRi) in adult subjects with Philadelphia chromosome-negative acute lymphoblastic leukemia (ALL) in second relapse or adult subjects with Philadelphia chromosome-negative ALL who failed two treatment lines of anti-leukemia chemotherapy. One of these leukemia free intervals must be defined as lasting = 90 days.;Secondary Objective: The secondary objectives of this study are to evaluate: - duration of CR and CRi - overall survival - safety and tolerability;Primary end point(s): The primary efficacy endpoint is complete remission (CR) plus complete remission with incomplete blood count recovery (CRi). | — |
Countries
Germany, United Kingdom
Outcome results
None listed