Vincristine PK and PD in the AYA Population Compared to Younger Children

NCT02360930 | Unknown

• 1 other identifier: CHLA CCI-14-00092
• Study Type: observational
• Target: 30
• Locations: 1 country
• Sites: 1

Brief Summary

The trial is to determine if a difference exists in the way that adolescents and young adults metabolize the chemotherapy agent vincristine compared to younger children.

Conditions

Leukemia, Acute Lymphoblastic; Leukemia

Keywords

Acute Lymphoblastic Leukemia; Pharmacokinetics; Vincristine

Outcome Measures

Primary Outcomes (1)

• Vincristine (concentration of vincristine)

  We will evaluate the concentration of vincristine in relations to the production of primary metabolite M1 over time. Vincristine is primary metabolized using CYP3A family of enzymes is responsible.

  4 weeks

Secondary Outcomes (3)

• Calpain level

  4 weeks

• Cytochrome P450 3A5 genotype

  One time

• Development of Vincristine Induced Neuropathy

  4 weeks

Study Arms (2)

Tanner Stage </=2

Patients will be stratified by phase of treatment, and they will be classified into Tanner stage ≤ 2 or ≥ 4, based on physical examination. We plan to have 15 patients in Tanner staging ≤ 2 and 15 patients in Tanner staging ≥ 4.

Tanner Stage >/= 4

Patients will be stratified by phase of treatment, and they will be classified into Tanner stage ≤ 2 or ≥ 4, based on physical examination. We plan to have 15 patients in Tanner staging ≤ 2 and 15 patients in Tanner staging ≥ 4.

Eligibility Criteria

• Age: 1 Year - 24 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)
• Sampling Method: Non-Probability Sample

Study Population

30 patients with ALL. Our study will enroll patients ages 1-24 years with ALL at start of Induction or in Maintenance therapy. Patients will be classified into Tanner stage ≤ 2 or ≥ 4. We plan to have 15 patients in Tanner staging ≤ 2 and 15 patients in Tanner staging ≥ 4. Each patient will receive vincristine weekly x 4 (Induction) or monthly (Maintenance), at a standard dose specified by the treatment protocol. The study will be conducted at Children's Hospital Los Angeles. Tanner staging will take place after the patient is consented to the study using standard Tanner stage diagrams.

You may qualify if:

• Patients ages 1-24 years of age with Acute Lymphoblastic Leukemia
• Patient diagnosed with Acute Lymphoblastic Leukemia (ALL) in Induction phase of therapy
• Patient diagnosed with Acute Lymphoblastic Leukemia (ALL) in first remission in Maintenance phase of therapy Treatment plan for induction therapy includes vincristine given at weekly intervals.
• Treatment plan for Maintenance therapy includes vincristine given at monthly intervals.

You may not qualify if:

• Patients without a central line in induction phase of therapy

Sponsors & Collaborators

• Children's Hospital Los Angeles: lead

Study Sites (1)

Children's Hospital Los Angeles

Los Angeles, California, 90027, United States

Location

MeSH Terms

Conditions

Precursor Cell Lymphoblastic Leukemia-Lymphoma; Leukemia

Condition Hierarchy (Ancestors)

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

Study Officials

• Lakshmi Damerla

  Children's Hospital Los Angeles

  STUDY DIRECTOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Target Duration: 4 Weeks
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Hematology-Oncology Fellow

Study Record Dates

• First Submitted: February 6, 2015
• First Posted: February 11, 2015
• Study Start: September 1, 2014
• Primary Completion: July 1, 2015
• Study Completion: July 1, 2015
• Last Updated: June 22, 2015

Record last verified: 2015-06

Locations

US (1)