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

• Conditions: Philadelphia Chromosome-negative Acute Lymphoblastic Leukemia; MedDRA version: 9.1Level: LLTClassification code 10000845Term: Acute lymphoblastic leukemia

• Registration Number: EUCTR2006-006978-20-DE
• Lead Sponsor: Talon Therapeutics , Inc.

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2007-08-28
• Last Update Posted: 19 March 2012

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 65

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
<10% bone marrow blasts, subject must have histologically or cytologically proven ALL and evaluable extramedullary disease.
4. Have achieved a complete response to at least one prior anti-leukemia therapy as defined by a leukemia-free interval of = 90 days.
5. For patients with a prior history of stem cell transplantation, =Grade 1 active skin graft-versus-host disease. No active gastrointestinal or liver graft-versus-host disease.
6. ECOG performance status 0–3.
7. Patients must have normal renal and liver function as defined below within 14 days, inclusive, prior to study enrollment, unless the abnormality is considered attributable to leukemia:
a. Total bilirubin =2.0 x institutional upper limit of normal (ULN), unless the patient has a known diagnosis of Gilbert’s disease.
b. Aspartate transaminase (AST, SGOT) or alanine transaminase (ALT, SGPT) =3 x institutional ULN.
c. Serum creatinine =2.0 g/dL or calculated estimated creatinine clearance =50 mL/min/1.73 m2 based on Cockcroft and Gault formula, unless renal dysfunction is considered due to hematologic malignancy.
8. Never received prior Marqibo treatment.
9. Women of childbearing potential must have a negative serum or urine pregnancy test within 14 days prior to enrollment.
10. If female, the patient is post-menopausal, surgically sterilized, or willing to use acceptable methods of birth control (e.g., 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 Marqibo.
11. If male, the patient agrees to use an acceptable barrier method for contraception from the Screening visit through 30 days after the last dose of Marqibo.
12. Before enrollment, the patient is capable of understanding and complying with parameters as outlined in the protocol and able to sign a written informed consent according to ICH/GCP, and national/local regulations.
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range

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.

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified