Intravenous Erwinia Chrysanthemi Asparaginase in Patients With Newly Diagnosed Philadelphia Chromosome Negative Acute Lymphoblastic Leukemia Aged 60 Years or Older

NCT02647190 | Withdrawn Phase 1

• 1 other identifier: 15-107
• Study Type: interventional
• Target: N/A
• Locations: 1 country
• Sites: 1

Brief Summary

The purpose of this study is to test the safety of Erwinia Chrysanthemi asparaginase when used alone and together with chemotherapy and find out what effects, if any, it has on people.

Conditions

Acute Lymphoblastic Leukemia (ALL); Newly Diagnosed Philadelphia Chromosome Negative; Aged 60 Years or Older

Keywords

Erwinia Chrysanthemi Asparaginase; 15-107

Outcome Measures

Primary Outcomes (1)

• proportion of patients who have a dose limiting toxicity (DLT)

  DLTs are defined as any of the following: grade 4 pancreatitis, grade 4 hemorrhage, grade 4 thromboembolism, grade 4 hyperbilirubinemia and any grade 5 toxicity attributable (definitely, probably or possible) to Erwinia asparaginase.

  with in 6 weeks of starting the study drug

Study Arms (1)

Erwinia Chrysanthemi asparaginase

EXPERIMENTAL

This is a phase I trial designed to assess the safety of IV Erwinia Chrysanthemi asparaginase during initial induction in patients aged 60 years or older with newly diagnosed Ph-negative ALL. A total of 12 patients will be accrued to the study.

Drug: Erwinia Chrysanthemi asparaginase

Interventions

Erwinia Chrysanthemi asparaginase DRUG

Erwinia Chrysanthemi asparaginase

Eligibility Criteria

• Age: 60 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Ages 60 years or older
• Previously untreated Philadelphia chromosome negative acute lymphoblastic leukemia
• No prior treatment for ALL, except steroids or hydroxyurea (stopped within 24 hour before start of protocol treatment)
• Serum creatinine ≤ 2 x upper limit of normal (ULN)
• Adequate liver function, including total bilirubin ≤ 1.5 x ULN unless the patient has documented Gilbert syndrome, and aspartate and alanine aminotransferase (AST and ALT) ≤ 5 x ULN. If organ function abnormalities are considered due to leukemic infiltration, total bilirubin must be ≤ 2 x ULN.
• ECOG performance status ≤3
• Male and female patients of childbearing potential must agree to use a highly effective method of contraception throughout the study and for a minimum of 90 days after the last dose of treatment on protocol. A patient is of childbearing potential if, in the opinion of the investigator, he/she is biologically capable of having children and is sexually active. Female patients who are not of childbearing potential should meet at least one of the following criteria:
• Have undergone hysterectomy or bilateral oophorectomy; or
• Have medically confirmed ovarian failure; or
• Are medically confirmed to be post-menopausal (cessation of regular menses for at least 12 consecutive months with no alternative pathological or physiological cause

You may not qualify if:

• Lymphoblastic crisis of CML
• Mature B cell (Burkitt's) ALL
• Pregnant women or women who are breast-feeding
• Concurrent active malignancy requiring immediate therapy
• Patients with human immunodeficiency virus (HIV)

Sponsors & Collaborators

• Memorial Sloan Kettering Cancer Center: lead
• Jazz Pharmaceuticals: collaborator

Study Sites (1)

Memorial Sloan Kettering Cancer Center

New York, New York, 10065, United States

Location

Related Links

• Memorial Sloan Kettering Cancer Center

MeSH Terms

Conditions

Precursor Cell Lymphoblastic Leukemia-Lymphoma

Interventions

asparaginase erwinia chrysanthemi recombinant

Condition Hierarchy (Ancestors)

Leukemia, Lymphoid; Leukemia; Neoplasms by Histologic Type; Neoplasms; Hematologic Diseases; Hemic and Lymphatic Diseases; Lymphoproliferative Disorders; Lymphatic Diseases; Immunoproliferative Disorders; Immune System Diseases

Study Officials

• Jae Park, MD

  Memorial Sloan Kettering Cancer Center

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 5, 2016
• First Posted: January 6, 2016
• Study Start: January 1, 2016
• Primary Completion: June 1, 2017
• Study Completion: June 1, 2017
• Last Updated: June 2, 2017

Record last verified: 2017-06

Locations

US (1)