Acute Lymphocytic Leukemia Clinical Trial
Official title:
A Phase II Study of Punctual, Cyclic, and Intensive Chemotherapy With Liposomal Cytarabine (Depocyt®) CNS Prophylaxis for Adults With Acute Lymphoblastic Leukemia and Lymphoblastic Lymphoma
NCT number | NCT02043587 |
Other study ID # | 130934 |
Secondary ID | |
Status | Terminated |
Phase | Phase 2 |
First received | |
Last updated | |
Start date | January 2014 |
Est. completion date | April 14, 2022 |
Verified date | April 2022 |
Source | University of California, San Diego |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
The objective of this protocol is to improve survival for adults with acute lymphoblastic leukemia or acute lymphoblastic lymphoma by reducing systemic and central nervous system (CNS) relapse with acceptable toxicity using intensive chemotherapy with liposomal cytarabine (Depocyt®) CNS prophylaxis.
Status | Terminated |
Enrollment | 31 |
Est. completion date | April 14, 2022 |
Est. primary completion date | April 14, 2022 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years to 60 Years |
Eligibility | Inclusion Criteria: - Ability to understand and the willingness to sign a written informed consent. - Diagnosis of acute lymphoblastic leukemia or lymphoblastic lymphoma as defined by the World Health Organization [94] - Untreated disease EXCEPT for corticosteroids, hydroxyurea, leukapheresis, and/or tyrosine kinase inhibitors for up to 2 weeks prior to initiation of study therapy. - Age 18 through 60 years - ECOG performance status 0,1, or 2 (see Appendix A) - Adequate organ function defined as: - Total bilirubin < 2 mg/dL (unless due to ALL) - AST(SGOT)/ALT(SGPT) < 3 times institutional upper limit of normal (unless due to ALL) - Serum creatinine < 2 mg/dL (unless elevated creatinine felt by investigator to be acute and reversible) OR creatinine clearance >60 mL/min/1.73 m2 for patients with creatinine levels above institutional normal - Left ventricular ejection fraction =50% - Women of child-bearing potential and men with partners of child- bearing potential must agree to use adequate contraception (hormonal or barrier method of birth control; abstinence) prior to study entry, for the duration of study participation, and for 90 days following completion of therapy. Should a woman become pregnant or suspect she is pregnant while participating in this study, she should inform her treating physician immediately. - A woman of child-bearing potential is any female (regardless of sexual orientation, having undergone a tubal ligation, or remaining celibate by choice) who meets the following criteria: - Has not undergone a hysterectomy or bilateral oophorectomy; or - Has not been naturally postmenopausal for at least 12 consecutive months (i.e., has had menses at any time in the preceding 12 consecutive months) Exclusion Criteria: - Current or anticipated use of other investigational agents during the study - Known central nervous system mass lesion - History of allergic reactions attributed to compounds of similar chemical or biologic composition to liposomal cytarabine or other agents used in study inclusive of known allergy to polyethylene glycol. - History of unprovoked venous thrombosis/thromboembolism - Recurrent or chronic pancreatitis - Uncontrolled diabetes mellitus - Uncontrolled intercurrent illness that would limit compliance with study requirements including, but not limited to, ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, or psychiatric illness/social situations that would limit compliance with study requirements. - Pregnant or nursing. - Any condition, in the opinion of the investigator, that compromises compliance with study requirements - Known HIV positivity |
Country | Name | City | State |
---|---|---|---|
United States | UCSD, Division of Blood and Marrow Transplantation, Moores Cancer Center | La Jolla | California |
United States | Hematological Malignancies/Stem Cell Transplantation Unit, David Geffen School of Medicine at UCLA | Los Angeles | California |
United States | University of California Davis Comprehensive Cancer Center | Sacramento | California |
United States | UCSF Comprehensive Cancer Center | San Francisco | California |
Lead Sponsor | Collaborator |
---|---|
University of California, San Diego | Leadiant Biosciences, Inc. |
United States,
Linker C, Damon L, Ries C, Navarro W. Intensified and shortened cyclical chemotherapy for adult acute lymphoblastic leukemia. J Clin Oncol. 2002 May 15;20(10):2464-71. — View Citation
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Other | Minimal residual disease and outcomes | 3 years | ||
Other | Asparaginase antibodies and asparaginase activity | 3 years | ||
Primary | Event-free survival | 3-year | ||
Secondary | Liposomal cytarabine toxicity | 3 years | ||
Secondary | CNS relapse rate | 3-year | ||
Secondary | Overall survival | 3-year | ||
Secondary | Leukemia-free survival | 3-year | ||
Secondary | Efficacy of hydrocortisone premedication for reduced PEG-asparaginase allergic reactions | 3 years | ||
Secondary | PEG-asparaginase toxicities | 3 years | ||
Secondary | Complete and overall response rates | 3 years | ||
Secondary | Non-relapse mortality | 3-year |
Status | Clinical Trial | Phase | |
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