- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01196013
A Study of Clofarabine in Japanese Paediatric Patients With Relapsed or Refractory Acute Lymphoblastic Leukaemia
A Phase I, Open-label, Multi-center Study of Clofarabine in Japanese Paediatric Patients With Relapsed or Refractory Acute Lymphoblastic Leukaemia
Study Overview
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 Type
Enrollment (Actual)
Phase
- Phase 1
Contacts and Locations
Study Locations
-
-
-
Fukuoka, Japan
- National Kyusyu Cancer Center
-
Fukushima, Japan
- Fukushima Medical University Hospital
-
Kagoshima, Japan
- Kagoshima University Medical and Dental Hospital
-
Kanagawa, Japan
- Tokai University Hospital
-
Niigata, Japan
- Niigata Cancer Center Hospital
-
Osaka, Japan
- Osaka City General Hospital
-
Saitama, Japan
- Saitama Chilidren's Medical Center
-
Shizuoka, Japan
- Shizuoka Children's Hospital
-
Tokyo, Japan
- St. Luke's International Hospital
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
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.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Non-Randomized
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Clofarabine
|
Intravenous, 30 mg/m2, 52 mg/m2
Other Names:
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Maximum Tolerated Dose (MTD)
Time Frame: 14 days (1st cycle)
|
14 days (1st cycle)
|
Safety as evaluated by adverse events (incidence, severity, duration, causality, seriousness, type)
Time Frame: 45 days after final study drug administration
|
45 days after final study drug administration
|
Pharmacokinetics as measured by maximum drug serum concentration (Cmax)
Time Frame: Day 1 to Day 5
|
Day 1 to Day 5
|
Pharmacokinetics as measured by Time to maximum serum concentration (Tmax)
Time Frame: Day 1 to Day 5
|
Day 1 to Day 5
|
Pharmacokinetics as measured by Area Under the drug-concentration curve (AUC)
Time Frame: Day 1 to Day 5
|
Day 1 to Day 5
|
Pharmacokinetics as measured by half life (t1/2)
Time Frame: Day 1 to Day 5
|
Day 1 to Day 5
|
Pharmacokinetics as measured by renal clearance (CLr)
Time Frame: Day 1 to Day 5
|
Day 1 to Day 5
|
Collaborators and Investigators
Sponsor
Study record dates
Study Major Dates
Study Start
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Estimate)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
- Immune System Diseases
- Neoplasms by Histologic Type
- Neoplasms
- Lymphoproliferative Disorders
- Lymphatic Diseases
- Immunoproliferative Disorders
- Leukemia
- Precursor Cell Lymphoblastic Leukemia-Lymphoma
- Leukemia, Lymphoid
- Molecular Mechanisms of Pharmacological Action
- Antimetabolites, Antineoplastic
- Antimetabolites
- Antineoplastic Agents
- Clofarabine
Other Study ID Numbers
- CLO05908
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Acute Lymphoblastic Leukemia
-
National Cancer Institute (NCI)CompletedB-cell Adult Acute Lymphoblastic Leukemia | Acute Undifferentiated Leukemia | Philadelphia Chromosome Positive Adult Precursor Acute Lymphoblastic Leukemia | B-cell Childhood Acute Lymphoblastic Leukemia | L1 Childhood Acute Lymphoblastic Leukemia | L2 Childhood Acute Lymphoblastic Leukemia | T-cell... and other conditionsUnited States
-
National Cancer Institute (NCI)Active, not recruitingAcute Lymphoblastic Leukemia | Recurrent Adult Acute Lymphoblastic Leukemia | Adult B Acute Lymphoblastic Leukemia | Adult T Acute Lymphoblastic Leukemia | Adult B Acute Lymphoblastic Leukemia With t(9;22)(q34.1;q11.2); BCR-ABL1 | Adult L1 Acute Lymphoblastic Leukemia | Adult L2 Acute Lymphoblastic...United States
-
Autolus LimitedCompletedCD19 /22 CAR T Cells (AUTO3) for the Treatment of B Cell Acute Lymphoblastic Leukemia (ALL) (AMELIA)Recurrent Childhood Acute Lymphoblastic Leukemia | B Acute Lymphoblastic Leukemia | B-cell Acute Lymphoblastic Leukemia | Refractory Childhood Acute Lymphoblastic LeukemiaUnited Kingdom
-
Children's Oncology GroupNational Cancer Institute (NCI); ImmunoGen, Inc.WithdrawnRecurrent Acute Myeloid Leukemia | Refractory Acute Myeloid Leukemia | Recurrent B Acute Lymphoblastic Leukemia | Refractory B Acute Lymphoblastic Leukemia | Recurrent Mixed Phenotype Acute Leukemia | Refractory Mixed Phenotype Acute Leukemia | Refractory T Acute Lymphoblastic Leukemia | Recurrent...
-
National Cancer Institute (NCI)CompletedRecurrent Childhood Acute Lymphoblastic Leukemia | L1 Childhood Acute Lymphoblastic Leukemia | L2 Childhood Acute Lymphoblastic Leukemia | T-cell Childhood Acute Lymphoblastic Leukemia | Non-T, Non-B Childhood Acute Lymphoblastic LeukemiaUnited States
-
University of BirminghamAstraZeneca; Cancer Research UKTerminatedAcute Lymphoblastic Leukemia | Acute Lymphoblastic Leukemia, Pediatric | Acute Lymphoblastic Leukemia, in Relapse | Acute Lymphoblastic Leukemia, Adult | Acute Lymphoblastic Leukemia RecurrentUnited Kingdom, Denmark, Netherlands
-
University College, LondonNot yet recruitingAcute Lymphoblastic Leukemia, Pediatric | Acute Lymphoblastic Leukemia, in Relapse | Acute Lymphoblastic Leukemia, Adult | Acute Lymphoblastic Leukemia With Failed Remission | Acute Lymphoblastic Leukemia Not Having Achieved Remission
-
Children's Oncology GroupNational Cancer Institute (NCI)CompletedChildhood Acute Lymphoblastic Leukemia in Remission | Graft Versus Host Disease | B-cell Childhood Acute Lymphoblastic Leukemia | L1 Childhood Acute Lymphoblastic Leukemia | L2 Childhood Acute Lymphoblastic Leukemia | T-cell Childhood Acute Lymphoblastic LeukemiaUnited States, Canada, Australia
-
Medical College of WisconsinChildren's Hospital and Health System Foundation, WisconsinRecruitingAcute Lymphoblastic Leukemia | Acute Lymphoblastic Leukemia, Pediatric | Acute Lymphoblastic Leukemia, in Relapse | Acute Lymphoblastic Leukemia Recurrent | Acute Lymphoblastic Leukemia With Failed Remission | Acute Lymphoblastic Leukemia Not Having Achieved RemissionUnited States
-
Therapeutic Advances in Childhood Leukemia ConsortiumEnzon Pharmaceuticals, Inc.TerminatedLymphoblastic Leukemia, Acute, Childhood | Leukemia, Lymphoblastic, Acute | Lymphoblastic Leukemia, Acute | Leukemia, Lymphoblastic, Acute, T CellUnited States, Australia
Clinical Trials on Clofarabine
-
University of TexasCompletedAcute Lymphocytic Leukemia | Acute Myelogenous Leukemia | Chronic Myelogenous Leukemia
-
Genzyme, a Sanofi CompanyTerminatedMyelodysplastic SyndromesUnited States
-
Indiana University School of MedicineGenzyme, a Sanofi CompanyCompletedHematologic MalignanciesUnited States
-
Memorial Sloan Kettering Cancer CenterNational Cancer Institute (NCI); The Cleveland Clinic; University of RochesterCompletedLymphoma | Leukemia | Small Intestine CancerUnited States
-
Genzyme, a Sanofi CompanyCompletedAcute Myelogenous LeukemiaUnited States
-
Genzyme, a Sanofi CompanyCompletedAcute Myeloid Leukemia | Acute Myelogenous LeukemiaUnited States
-
Omar MianRecruitingAdenocarcinoma | Carcinoma | Metastatic CancerUnited States
-
Genzyme, a Sanofi CompanyCompletedLeukemia, Lymphoblastic, Acute, PediatricUnited States
-
Indiana University School of MedicineGenzyme, a Sanofi CompanyCompletedNon Hodgkin's LymphomaUnited States
-
Genzyme, a Sanofi CompanyCompletedSolid Tumors | Leukemia, Myelocytic, Acute, Pediatric | Leukemia, Lymphocytic, Acute, Pediatric | Leukemia, Lymphocytic, Acute, Adult | Leukemia, Myelocytic, Acute, Adult | Myelodysplastic Syndromes, AdultUnited States