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T2007-002 Clofarabine, Etoposide, Cyclophosphamide in Relapsed Acute Myelogenous Leukemia (AML)

Information source: Therapeutic Advances in Childhood Leukemia Consortium
ClinicalTrials.gov processed this data on August 23, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Relapsed Acute Myelogenous Leukemia

Intervention: clofarabine (Drug); etoposide (Drug); cyclophosphamide (Drug); filgrastim (Drug); cytarabine (Drug)

Phase: Phase 2

Status: Terminated

Sponsored by: Therapeutic Advances in Childhood Leukemia Consortium

Official(s) and/or principal investigator(s):
Paul Gaynon, MD, Study Chair, Affiliation: Children's Hospital Los Angeles
Nobuko Hijiya, MD, Study Chair, Affiliation: Ann & Robert H Lurie Children's Hospital of Chicago


Clofarabine is a drug approved by the FDA (Food and Drug Administration) for treating children (age 1-21) with leukemia. This research study will use clofarabine with two other cancer fighting drugs. Clofarabine will be used together with etoposide (VePesid®, VP-16) and cyclophosphamide (Cytoxan®). Clofarabine, etoposide and cyclophosphamide have been used together in a phase I study to find out the highest doses of these drugs that can be safely given to children with relapsed or refractory leukemia. This study is a phase II study which will use the drugs to study how well these drugs work against AML. This study will also examine the safety of this drug combination.

Clinical Details

Official title: T2007-002 A Phase II Study of Clofarabine With Etoposide and Cyclophosphamide in Relapsed/Refractory AML (IND 104,650)

Study design: Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Primary outcome: AML disease status after chemotherapy evaluated by bone marrow aspirates/biopsies and complete blood count.


Minimum age: 1 Year. Maximum age: 21 Years. Gender(s): Both.


Inclusion Criteria:

- Age: patients must be ≥ 1 and ≤ 21 years of age at the of study entry.

- Diagnosis:

- Patients must have a diagnosis of first or second relapse or refractory acute

myelogenous leukemia (AML) according to WHO classification with ≥ 5% blasts in the bone marrow, with or without extramedullary disease. (See Appendix I)

- Patients may have CNS 1 or CNS 2 disease but not CNS 3.

- Performance Level: Karnofsky > 50% for patients > 16 years of age and Lansky > 50%

for patients ≤ 16 years of age.

- Prior Therapy:

- Patients must have fully recovered from the acute toxic effects of all prior

chemotherapy, immunotherapy, or radiotherapy prior to entering this study.

- Patient has not received more than 2 previous induction attempts. (Frontline

therapy is included in this count).

- Patients must have adequate venous access.

- At least 1 year must have elapsed since hematopoietic stem cell transplant

(HSCT) and patients must not have active GVHD.

- Reproductive Function

- Female patients of childbearing potential must have a negative serum pregnancy

test confirmed within 2 weeks prior to enrollment.

- Female patients with infants must agree not to breastfeed their infants while on

this study.

- Male and female patients of child-bearing potential must agree to use an

effective method of contraception approved by the investigator during the study and for a minimum of 6 months after study treatment.

- Renal and Hepatic Function:

Patient must have adequate renal and hepatic functions as indicated by the following laboratory values:

- Patients must have a normal calculated creatinine clearance.

- Total bilirubin <1. 5 x ULN for age and conjugated/direct serum bilirubin ≤ ULN for

age if total bilirubin is elevated.

- Aspartate transaminase (AST)/alanine transaminase (ALT) ≤ 2. 5 × ULN.

- Alkaline phosphatase ≤ 2. 5 × ULN.

- Informed Consent: Patients and/or their parents or legal guardians must be

capable of understanding the investigational nature, potential risks and benefits of the study. All patients and/or their parents or legal guardians must sign a written informed consent.

- Protocol Approval: All institutional, FDA, and OHRP requirements for human

studies must be met. Exclusion Criteria:

- Patients with Down Syndrome.

- Prior treatment with Clofarabine.

- Previous history of veno-occlusive disease (VOD) or findings consistent with a

diagnosis of VOD, defined as: conjugated serum bilirubin > 1. 4 mg/dL AND unexplained weight gain greater than 10% of baseline weight or ascites AND hepatomegaly or right upper quadrant pain without another explanation, OR reversal of portal vein flow on ultrasound, OR pathological confirmation of VOD on liver biopsy.

- Patients who have a history of cirrhosis of the liver or who are positive for

hepatitis B core antibody (anti-HBc) or have a positive test for hepatitis C antibody (anti-HCV).

- Patient has received TBI.

- If it has been less than 1 year since the patient had a HSCT.

- Infection Criteria

- 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).

- Positive blood culture within 48 hours of study registration.

- Patient required supplemental oxygen or vasopressors within 48 hours of study

(Oxygen after anesthesia for procedures is ok).

- Patient is receiving or plans to receive concomitant chemotherapy, radiation therapy,

or immunotherapy other than as specified in the protocol.

- Use of investigational agents within 30 days or any anticancer therapy within 2 weeks

before planned drug initiation with the exception of hydroxyurea or intrathecal therapy given with the diagnostic lumbar puncture.

- 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.

- Pregnant or lactating patients.

- Any significant concurrent disease, illness, psychiatric disorder or social issue

that would compromise patient safety or compliance, interfere with consent, study participation, follow up, or interpretation of study results.

- Have had a diagnosis of another malignancy, unless the patient has been disease-free

for at least 3 years following the completion of curative intent therapy with the following exceptions:

- Patients with treated non-melanoma skin cancer, in situ carcinoma, or cervical

intraepithelial neoplasia, regardless of the disease-free duration, are eligible for this study if definitive treatment for the condition has been completed.

- Patients with organ-confined prostate cancer with no evidence of recurrent or

progressive disease based on prostate-specific antigen (PSA) values are also eligible for this study if hormonal therapy has been initiated or a radical prostatectomy has been performed.

Locations and Contacts

Childrens Hospital Los Angeles, Los Angeles, California 90027, United States

Stanford University Medical Center, Palo Alto, California 94304-1812, United States

UCSF School of Medicine, San Francisco, California 94143-0106, United States

University of Miami Cancer Center, Miami, Florida 33136, United States

Children's Memorial, Chicago, Illinois, United States

C.S. Mott Children's Hospital, Ann Arbor, Michigan 48109-0914, United States

Childrens Hospital & Clinics of Minnesota, Minneapolis, Minnesota 55404-4597, United States

New York University Medical Center, New York, New York 10016, United States

Levine Children's Hospital at Carolinas Medical Center, Charlotte, North Carolina 28203, United States

Vanderbilt Children's Hospital, Nashville, Tennessee, United States

Additional Information

For more information about this and other clinical trials, please visit the TACL website.

Starting date: July 2009
Last updated: March 7, 2012

Page last updated: August 23, 2015

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