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Safety of Clofarabine With Multiagent Chemotherapy in Childhood Acute Lymphoblastic Leukemia

Information source: University Hospital, Lille
ClinicalTrials.gov processed this data on August 23, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Acute Lymphoid Leukemia Relapse; Acute Lymphoid Leukemia Relapse After Bone Marrow Transplant

Intervention: Clofarabine (Drug)

Phase: Phase 1

Status: Completed

Sponsored by: University Hospital, Lille

Official(s) and/or principal investigator(s):
Brigitte Nelken, MD PhD, Principal Investigator, Affiliation: Lille Unıversity Hospital, Lille, France
Pıerre S Rohrlich, MD, PhD, Study Chair, Affiliation: Besancon University Hospital

Summary

The purpose of this study is to determine Maximum Tolerated Dosage (MTD), Dosage Limited Toxicities (DLT), and the Rate Phase 2 Dosage of clofarabine when used in combination with etoposide, asparaginase, mitoxantrone and dexamethasone and to assess the feasibility and safety of this combination regimen to treat children with high risk relapsed or refractory acute lymphoblastic leukemia (ALL).

Clinical Details

Official title: A Phase I Dose Escalation Study of Clofarabine Given in Combination With Multi-agent Therapy for Remission Induction in Pediatric Patients With Acute Lymphoblastic Leukemia in First Relapse or Refractory to First Line Therapy -

Study design: Endpoint Classification: Safety Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Primary outcome: maximum tolerated dose of clofarabine in combination with etoposide, asparaginase, mitoxantrone and dexamethasone

Secondary outcome:

efficacy of clofarabine used in combination with etoposide, asparaginase, mitoxantrone and dexamethasone

Event free survival

Detailed description: I. 3 Primary Objectives : To determine the MTD of escalating doses of clofarabine starting from 20 mg/m2/day to 40 mg/m2/day from day 1 to day 5, as a replacement of cytarabine as part of a combination of etoposide, asparaginase, mitoxantrone and dexamethasone (VANDA regimen). I. 4 Secondary Objectives : 1. To determine the safety and tolerability of clofarabine when used in combination with etoposide, asparaginase, mitoxantrone and dexamethasone (VANDA regimen) and determine the duration, seriousness, and relationship of adverse events that occur during the treatment and follow-up periods ; we search DLT 2. To determine the Overall Response rate (OR) (Complete Remission + Complete Remission without platelet's normalization) of clofarabine plus etoposide ,asparaginase, mitoxantrone and dexamethasone (VANDA regimen) in pediatric patients with refractory or relapsed ALL at the established clofarabine RP2D. 3. To document the rate of Partial Response[s] in the study population 4. To document time-to-event parameters, including duration of remission, Event Free Survival (EFS), 4-month EFS, and overall survival (OS).

Eligibility

Minimum age: 1 Year. Maximum age: 23 Years. Gender(s): Both.

Criteria:

Inclusion Criteria:

- 1 to 21 years old at the date of acute lymphoblastic leukemia initial diagnosis

- Very early medullary first relapse occurring during the first 18th months after

complete remission OR patients with second relapse OR a relapse occurring 6 months or more after myeloablative stem cell transplantation will be eligible.

- Have a Karnofsky Performance Status (KPS) of ≥70 for patients >10 years of age or a

Lansky Performance Status (LPS) of ≥60 for patients ≤10 years of age.

- No concomitant malignant disease.

- No active uncontrolled infection.

- Have adequate renal and hepatic functions

- absence of concomitant severe cardiovascular disease, i. e. congestive heart failure

- Female patients of childbearing potential must have a negative serum pregnancy test

within 2 weeks prior to enrollment.

- Male and female patients must use an effective contraceptive method during the study

and for a minimum of 6 months after study treatment. Exclusion Criteria:

- Current concomitant chemotherapy, radiation therapy, or immunotherapy other than as

specified in the protocol.

- Use of any investigational agent within 30 days.

- Known hypersensitivity to clofarabine or excipients.

- Known hypersensitivity to mitoxantrone, etoposide or excipients.

- Allergy to both E Coli-Asparaginase and Erwinia Asparaginase

- Prior transplant less than 6 months ago.

- Trisomy 21

- Have any other severe concurrent disease, or have a history of serious organ

dysfunction or disease involving the heart, kidney, liver, or other organ system that may place the patient at undue risk to undergo treatment.

- Patients with a systemic fungal, bacterial, viral, or other infection not controlled

(defined as exhibiting ongoing signs/symptoms related to the infection and without improvement, despite appropriate antibiotics or other treatment).

- Pregnant or lactating patients.

- Any significant concurrent disease, illness, or psychiatric disorder that would

compromise patient safety or compliance, interfere with consent, study participation, follow up, or interpretation of study results.

Locations and Contacts

Besançon University Hospital, Besançon 25000, France

Lille University Hospital, Lille 59037, France

Additional Information

Starting date: January 2010
Last updated: December 8, 2014

Page last updated: August 23, 2015

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