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Safety of Clofarabine With Multiagent Chemotherapy in Childhood Acute Lymphoblastic Leukemia (Vandevol)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT01279096
Recruitment Status : Completed
First Posted : January 19, 2011
Last Update Posted : December 9, 2014
Sponsor:
Collaborators:
Information provided by (Responsible Party):

January 17, 2011
January 19, 2011
December 9, 2014
January 2010
June 2012   (Final data collection date for 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 ]
safety of clofarabine in combination with etoposide, asparaginase, mitoxantrone and dexamethasone [ Time Frame: within the 40 days after the chemotherapy ]
Complete list of historical versions of study NCT01279096 on ClinicalTrials.gov Archive Site
  • efficacy of clofarabine used in combination with etoposide, asparaginase, mitoxantrone and dexamethasone [ Time Frame: 40 days after the chemotherapy ]
    Complete remission rate and minimal residual disease level
  • Event free survival [ Time Frame: 4 months ]
Same as current
Not Provided
Not Provided
 
Safety of Clofarabine With Multiagent Chemotherapy in Childhood Acute Lymphoblastic Leukemia
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).

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).
Interventional
Phase 1
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
  • Acute Lymphoid Leukemia Relapse
  • Acute Lymphoid Leukemia Relapse After Bone Marrow Transplant
Drug: Clofarabine
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
Other Names:
  • etoposide,
  • asparaginase,
  • mitoxantrone
  • dexamethasone
Not Provided
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
20
June 2013
June 2012   (Final data collection date for primary outcome measure)

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.
Sexes Eligible for Study: All
1 Year to 23 Years   (Child, Adult)
No
Contact information is only displayed when the study is recruiting subjects
France
 
 
NCT01279096
2009-010826-20
2008_40/0905 ( Other Identifier: Sponsor )
Yes
Not Provided
Not Provided
University Hospital, Lille
University Hospital, Lille
  • Centre Hospitalier Universitaire de Besancon
  • Saint-Louis Hospital, Paris, France
  • Assistance Publique - Hôpitaux de Paris
  • Hospices Civils de Lyon
  • University Hospital, Toulouse
  • Central Hospital, Nancy, France
  • University Hospital, Marseille
  • University Hospital, Bordeaux
  • Nantes University Hospital
  • Rennes University Hospital
Principal Investigator: Brigitte Nelken, MD PhD Lille Unıversity Hospital, Lille, France
Study Chair: Pıerre S Rohrlich, MD, PhD Besancon University Hospital
University Hospital, Lille
December 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP