A Safety and Tolerability Study of Clofarabine, Etoposide, Cyclophosphamide, PEG-asparaginase, and Vincristine in Pediatric Acute Lymphoblastic Leukemia (ALL) - NCT00991133-02115(Clinical Trial 443079)
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Boston |
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State:
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MA |
| Zip Code: |
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02115 |
| Conditions: |
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Lymphoblastic Leukemia, Acute, Childhood |
| Purpose: |
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This is an open-label study of Clofarabine, Etoposide, Cyclophosphamide, PEG-asparaginase,
and Vincristine to assess this 5-drug treatment's safety and tolerability in pediatric
patients with first relapse Acute Lymphoblastic Leukemia (ALL).
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| Study summary: |
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The trial is a Phase I, open-label study to assess the safety and tolerability of
incorporating clofarabine into an intensive chemotherapy regimen of etoposide,
cyclophosphamide, pegylated E.coli asparaginase (PEG-asparaginase), and vincristine.
Patients enrolled in this study will receive a maximum of 2 cycles of the 5-drug regimen,
then will be treated according to investigator discretion. After the study treatment period,
all patients will be followed for a maximum of 2 years beyond the final study visit. Types
and timing of assessments may differ based on the patient's response status. This study will
include a maximum of 12 evaluable patients. |
| Criteria: |
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Inclusion Criteria:
- Be in first relapse with >25% blasts in the bone marrow with a duration of first
remission of ≥6 months and no longer in the intensive phase(s) of initial ALL therapy
(e.g., patients who are in the maintenance or continuation phases of therapy [or
beyond] and who have completed the induction or intensification phases).
- Have received no more than 2 prior induction regimens prior to the date of first
relapse.
- Be ≥1 and ≤30 years old and have a body weight of >10 kg at study entry. (Note: no
more than 3 patients aged >21 ≤30 are to be enrolled.)
- Be able to receive all study drugs with no known contra-indications.
- Be able to provide adequate venous access.
- Have a Karnofsky Performance Status (KPS) of ≥50 for patients >10 years of age or a
Lansky Performance Status (LPS) of ≥50 for patients ≤10 years of age.
- Patients (≥18 years of age) or the parent or legal guardian(s) (for patients <18
years of age) must provide signed, written informed consent according to local
institutional review board (IRB) and institutional requirements. For patients <18
years of age, signed assent should be obtained according to local IRB and
institutional requirements.
- Be able to comply with study procedures and follow-up examinations.
- Have adequate liver, renal, pancreatic, and cardiac function considered acceptable by
laboratory values and cardiac assessments
- Have no active central nervous system (CNS) leukemia (i.e., should be CNS1 or CNS2),
as evidenced by negative cytology on lumbar puncture and absence of clinical central
neurologic symptoms. Diagnostic lumbar puncture should be performed only after all
other eligibility assessments have been completed and reviewed, except for bone
marrow aspirate and/or biopsy.
- Have recovered to baseline from all toxicities from prior chemotherapy regimens prior
to enrollment in the study.
Exclusion Criteria:
- Have received previous treatment with clofarabine.
- Have a history of clinical allergy (Grade 3 or 4) to PEG-asparaginase.
- Have a history of severe pancreatitis (Grade 3 or 4) attributed to asparaginase
therapy.
- Have Burkitt's leukemia.
- Have overt testicular relapse.
- Adequate time has not elapsed since patient's last therapy. Patients who relapse
while receiving standard ALL maintenance chemotherapy will not be required to have a
washout period before entry onto this study. Note that patients may receive
intrathecal (IT) ara-C, methotrexate, or hydrocortisone immediately prior to the
administration of study drugs. Patients may also receive hydroxyurea up to 24 hours
prior to the start of study therapy. Patients who relapse when they are not receiving
standard ALL maintenance therapy must have fully recovered from the acute toxic
effects of all prior therapy (excluding hematologic toxicity), immunotherapy or
radiotherapy.
- Have an uncontrolled systemic fungal, bacterial, viral, or other infection. For
patients with a history of fever within the preceding 3 days at the time of
enrollment, documentation of negative blood cultures for at least 48 hours is
required.
- Are pregnant or lactating.
- Male and female patients who are fertile must agree to use an effective means of
birth control (i.e., latex condom, diaphragm, cervical cap, etc.) while on study
therapy, and for a minimum of1 month following final study visit.
- Have psychiatric disorders that would interfere with consent, study participation, or
follow-up.
- Have any other severe concurrent disease, or have a history of serious organ
dysfunction or disease involving the heart, kidney, liver, or pancreas.
- Have received any stem cell transplantation or high-dose chemotherapy with stem cell
rescue regimen.
- Have a history of cirrhosis or known human immunodeficiency virus (HIV)/acquired
immunodeficiency syndrome (AIDS).
- Have tested positive for hepatitis B (+ hepatitis B surface antigen) or hepatitis C
(+ hepatitis C antibody) infection.
- Have Down syndrome.
- Are currently participating in another concurrent investigational treatment protocol. |
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If you are interested in this clinical trial please use the contact information above. If you would like to get additional information about this clinical trial please visit ClinicalTrials.gov.
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| Data Source: |
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ClinicalTrials.gov |
| Date Processed: |
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February 17, 2011 |
Modifications to
this listing: |
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Only selected fields are shown, please use the link
above to view all information about this clinical trial. |
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