A Study of Clofarabine in Japanese Paediatric Patients With Relapsed or Refractory Acute Lymphoblastic Leukaemia

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Brief Title

A Study of Clofarabine in Japanese Paediatric Patients With Relapsed or Refractory Acute Lymphoblastic Leukaemia

Official Title

A Phase I, Open-label, Multi-center Study of Clofarabine in Japanese Paediatric Patients With Relapsed or Refractory Acute Lymphoblastic Leukaemia

Brief Summary

      The purpose of this study is primarily to assess the safety, tolerability and
      pharmacokinetics (PK) of clofarabine intravenously administered to pediatric patients with
      relapsed or refractory acute lymphoblastic leukemia (ALL) or for whom no other therapy with
      greater potential clinical benefit exists. The dosing regimen for the intravenous (IV)
      clofarabine is 30 or 52 mg/m2/day for 5 consecutive days. The secondary objectives are to
      document the activity of clofarabine and to explore the impact of deoxycytidine kinase (dCK)
      promoter polymorphism on PK and treatment outcome.
    

Detailed Description

      This is a Phase I Study of Clofarabine in Japanese Paediatric Patients With Relapsed or
      Refractory Acute Lymphoblastic Leukaemia.

      Subjects will receive intravenous administration of clofarabine at 30 or 52 mg/m2/day (2
      hours) for 5 consecutive days and then the administration will be withheld until Day 14. If
      there is no evidence of recovery in neutrophil (≥750/mm3) and/or platelet count
      (≥50,000/mm3), the therapy may be withheld up to Day 42. However, in the absence of
      progression based on the judgment of the investigator after each cycle of treatment and the
      benefit of continued treatment is judged to exceed the risk, subjects may receive up to a
      total of six cycles. If a subject is receiving two or more cycles, a written consent must be
      obtained prior to start of Cycle 2.

      When a subject completes the final dose, the safety will be observed and followed-up for 45
      days after the final study drug administration.

      Cohort 1 will receive 30 mg/m2/day x 5 days at Cycle 1 and will be assessed for tolerability.
      Samples will be drawn to assess pharmacokinetics at this dose. If subjects do not develop
      adverse events indicative of dose limiting toxicity (DLT) at Cycle 1, the dose will be
      increased to 52 mg/m2/day x 5 days from Cycle 2 and the subjects will be assessed for safety
      and activity only.

      Cohort 2 will receive 52 mg/m2/day x 5 days at Cycle 1 and will be assessed for the
      tolerability. Samples will be drawn to assess pharmacokinetics at this dose.

      Whether or not proceeding to Cohort 2 after the Cycle 1 of Cohort 1 is completed will be
      determined by the sponsor based on the assessment of the safety data and the recommendation
      of the Data Safety Monitoring Board (DSMB).
    

Study Phase

Phase 1

Study Type

Interventional


Primary Outcome

Maximum Tolerated Dose (MTD)


Condition

Acute Lymphoblastic Leukemia

Intervention

Clofarabine

Study Arms / Comparison Groups

 Clofarabine
Description:  

Publications

* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information


Recruitment Status

Drug

Estimated Enrollment

7

Start Date

August 2010

Completion Date

May 2011

Primary Completion Date

May 2011

Eligibility Criteria

        Inclusion Criteria:

          -  Signed and written informed consent provided by patients ≥ 20 years old or by the
             parents or guardians of patients less than 20 years old. Investigator should verbally
             obtain informed assent from the patients 7 years old or older and written informed
             assent from patients 12 years old or older.

          -  Greater than or equal to 25 percent blasts present in the bone marrow and/or
             peripheral blood count and diagnosed with ALL .at time of enrollment

          -  Patients with relapsed or refractory ALL. Patients must not be eligible for therapy of
             higher clinical benefit potential and must be in second or subsequent relapse and/or
             refractory, i.e. failed to achieve remission following 2 or more different regimens,
             or for whom no other therapy with greater potential clinical benefit exists.

          -  Have a Karnofsky Performance Status of greater than or equal to 70 for patients 10
             years of age or older or Lansky Performance Status greater than or equal to 70 for
             patients below 10 years of age.

          -  Patients whose hepatic, renal, and pancreatic functional tests are within the ranges
             defined in the protocol.

        Exclusion Criteria:

          -  Received previous treatment with clofarabine.

          -  Have received any other investigational agent within 30 days prior to the first dose
             of the study drug.

          -  Have received any other chemotherapy within 14 days prior to the first dose of
             clofarabine. However, intrathecal drug administration is allowed up to 24 hours prior
             to the first dose of clofarabine. In addition, the patient must have been recovered
             from acute toxicity related to other chemotherapy or investigational agents (baseline
             or less than or equal to Common Terminology Criteria for Adverse Events ver 3.0 Grade
             1)

          -  Have systemic fungal, bacterial, viral, or other infection that cannot be
             controlled(defined as exhibiting ongoing signs/symptoms related to the infection and
             without improvement, despite appropriate antibiotics or other treatment). In addition,
             for patients with a history of fever (≥38.5˚C) within the preceding 3 days at the time
             of enrollment, documentation of negative blood cultures for at least 48 hours
             required.

          -  Have a psychiatric disorder that would interfere with consent, study participation, or
             follow-up.

          -  Patients whose spinal fluid tested immediately before the study registration within 7
             days before dose indicates symptomatic Central Nervous System (CNS) involvement
             (i.e.CNS3).

          -  Have any other severe concurrent disease or a history of serious organ dysfunction or
             disease involving the heart, kidney, liver, or pancreas.

          -  Have received hematopoietic stem cell transplantation (HSCT) within 3 months prior to
             providing the consent or have acute graft-versus-host disease (GVHD) (greater than or
             equal to Grade 2) requiring immunosuppressive therapy or severe (systemic) chronic
             GVHD.

          -  Have a prior positive test for Hepatitis B surface (HBs) antigen or antibody, HBc
             antibody, Hepatitis C virus (HCV) antibody, or human immunodeficiency virus (HIV)
             antibody. (The patients who have had treatment of vaccine and are positive for HBs
             antibody are eligible).

          -  Are pregnant or nursing. Male and female patients of reproductive potential must agree
             to use an effective means of birth control to avoid pregnancy during the study period
             and for 180 days after the last dose of study drug.
      

Gender

All

Ages

1 Year - 21 Years

Accepts Healthy Volunteers

No

Contacts

Medical Monitor, , 

Location Countries

Japan

Location Countries

Japan

Administrative Informations


NCT ID

NCT01196013

Organization ID

CLO05908


Responsible Party

Sponsor

Study Sponsor

Genzyme, a Sanofi Company


Study Sponsor

Medical Monitor, Study Director, Genzyme, a Sanofi Company


Verification Date

March 2014