Safety of Clofarabine With Multiagent Chemotherapy in Childhood Acute Lymphoblastic Leukemia

NCT01279096 | Completed Phase 1 DMC

• 2 other identifiers: 2009-010826-202008_40/0905
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 2

Brief 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).

Conditions

Acute Lymphoid Leukemia Relapse; Acute Lymphoid Leukemia Relapse After Bone Marrow Transplant

Keywords

Acute lymphoblastic leukemia; relapse; childhood; clofarabine

Outcome Measures

Primary Outcomes (1)

• maximum tolerated dose of clofarabine in combination with etoposide, asparaginase, mitoxantrone and dexamethasone

  within the 40 days after the chemotherapy

Secondary Outcomes (2)

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

  40 days after the chemotherapy

• Event free survival

  4 months

Interventions

Clofarabine DRUG

escalating doses of clofarabine starting from 20 mg/m2/day to 40 mg/m2/day from day 1 to day 5 used in association with etoposide, asparaginase, mitoxantrone and dexamethasone

Also known as: etoposide,, asparaginase,, mitoxantrone, dexamethasone

Eligibility Criteria

• Age: 1 Year - 23 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• University Hospital, Lille: lead
• Centre Hospitalier Universitaire de Besancon: collaborator
• Saint-Louis Hospital, Paris, France: collaborator
• Hospices Civils de Lyon: collaborator
• Assistance Publique - Hôpitaux de Paris: collaborator
• University Hospital, Toulouse: collaborator
• Central Hospital, Nancy, France: collaborator
• University Hospital, Marseille: collaborator
• University Hospital, Bordeaux: collaborator
• Nantes University Hospital: collaborator
• Rennes University Hospital: collaborator

Study Sites (2)

Besançon University Hospital

Besançon, 25000, France

Location

Lille University Hospital

Lille, 59037, France

Location

Related Publications (1)

• Nelken B, Cave H, Leverger G, Galambrun C, Plat G, Schmitt C, Thomas C, Verite C, Brethon B, Gandemer V, Bertrand Y, Baruchel A, Rohrlich P. A Phase I Study of Clofarabine With Multiagent Chemotherapy in Childhood High Risk Relapse of Acute Lymphoblastic Leukemia (VANDEVOL Study of the French SFCE Acute Leukemia Committee). Pediatr Blood Cancer. 2016 Feb;63(2):270-5. doi: 10.1002/pbc.25751. Epub 2015 Sep 16.

  PMID: 26376115 RESULT

MeSH Terms

Conditions

Precursor Cell Lymphoblastic Leukemia-Lymphoma; Recurrence

Interventions

Clofarabine; Etoposide; Asparaginase; Mitoxantrone; Dexamethasone

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; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Adenine Nucleotides; Purine Nucleotides; Purines; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds; Arabinonucleosides; Nucleosides; Nucleic Acids, Nucleotides, and Nucleosides; Nucleotides; Ribonucleotides; Podophyllotoxin; Tetrahydronaphthalenes; Naphthalenes; Polycyclic Aromatic Hydrocarbons; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons; Organic Chemicals; Polycyclic Compounds; Glucosides; Glycosides; Carbohydrates; Amidohydrolases; Hydrolases; Enzymes; Enzymes and Coenzymes; Anthraquinones; Anthrones; Anthracenes; Quinones; Pregnadienetriols; Pregnadienes; Pregnanes; Steroids; Fused-Ring Compounds; Steroids, Fluorinated

Study Officials

• Brigitte Nelken, MD PhD

  Lille Unıversity Hospital, Lille, France

  PRINCIPAL INVESTIGATOR

• Pıerre S Rohrlich, MD, PhD

  Besancon University Hospital

  STUDY CHAIR

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 17, 2011
• First Posted: January 19, 2011
• Study Start: January 1, 2010
• Primary Completion: June 1, 2012
• Study Completion: June 1, 2013
• Last Updated: April 22, 2026

Record last verified: 2014-12

Locations

FR (2)