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Acute Lymphoid Leukemia RelapsePhase 1VandevolNCT01279096

Safety of Clofarabine With Multiagent Chemotherapy in Childhood Acute Lymphoblastic Leukemia

A Phase 1 study testing Clofarabine in people with Acute Lymphoid Leukemia Relapse and Acute Lymphoid Leukemia Relapse After Bone Marrow Transplant, run by University Hospital, Lille at 2 sites in France.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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… Read more about this study

Who is it for?
Ages 1 year to 23 years
What is being tested?
Clofarabine
How many people
20 participants
Where
2 sitesFrance
Study dates
Jan 2010to Jun 2013
Phase
Phase 1
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 1 year to 23 years
  • All sexes
  • No healthy volunteers
  • Child, Adult

Who may be able to join

  • 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
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  • 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.

Who cannot join

  • 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.
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  • 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.

Trial locations and contacts

2 sites in 1 country.

France2 sites

  • Besançon University Hospital

    Besançon, 25000

  • Lille University Hospital

    Lille, 59037

Other trials in France

About this study

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 -

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).

Read the 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).
Being tested
Clofarabine
Keywords
Acute lymphoblastic leukemia, relapse, childhood, clofarabine
Medical subject headings
Precursor Cell Lymphoblastic Leukemia-Lymphoma, Recurrence

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • ClofarabineDrug

    Also called etoposide,, asparaginase,, mitoxantrone, dexamethasone

    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

What is being measured

The primary outcome is the main question the study is designed to answer.

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

    Measured: within the 40 days after the chemotherapy

Secondary outcomes (2)

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

    Complete remission rate and minimal residual disease level

    Measured: 40 days after the chemotherapy

  2. Event free survival

    Measured: 4 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted19 Jan 2011 (estimated)
  2. Study startJan 2010
  3. Primary completionJun 2012
  4. Study completionJun 2013

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 1
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
20 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT01279096
Sponsor's protocol ID
2009-010826-20
Other IDs
2008_40/0905, 2009
Acronym
Vandevol
Status last verified
Dec 2014
First submitted
17 Jan 2011
Last updated
22 Apr 2026
Results posted
No
Data monitoring committee
Yes

Publications

  • 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.

    PubMed 26376115

Questions about this trial

What is this clinical trial studying?

A Phase 1 study testing Clofarabine in people with Acute Lymphoid Leukemia Relapse and Acute Lymphoid Leukemia Relapse After Bone Marrow Transplant, run by University Hospital, Lille at 2 sites in France.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 9 inclusion and 11 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 22 Apr 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 2 sites in France. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

maximum tolerated dose of clofarabine in combination with etoposide, asparaginase, mitoxantrone and dexamethasone (time frame: within the 40 days after the chemotherapy). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT01279096, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 Apr 2026.

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