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Relapsed Acute Myelogenous LeukemiaPhase 2NCT00939653

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

A Phase 2 study testing Clofarabine, Etoposide and Cyclophosphamide in people with Relapsed Acute Myelogenous Leukemia, run by Therapeutic Advances in Childhood Leukemia Consortium at 4 sites in United States.

Terminated

Stopped early. The study ended before it was planned to and will not resume.

Official record
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Trial summary

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®). Read more about this study

Who is it for?
Ages 1 year to 21 years
Conditions the study is for
Relapsed Acute Myelogenous Leukemia
What is being tested?
Clofarabine, Etoposide and Cyclophosphamide
Type of treatment
Injection or infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
6 participants
Where
4 sitesUnited States
Study dates
10 Jul 2009to 15 Jul 2011
Phase
Phase 2
Are there results?
Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 1 year to 21 years
  • All sexes
  • No healthy volunteers
  • Child, Adult

Who may be able to join

  • 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.
  • 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:
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  • 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.
  • Pediatric Population (age <18): Calculated creatinine clearance ≥ 90 ml/min/1.73m2 as calculated by the Schwartz formula for estimated glomerular filtration rate (GFR) where GFR (ml/min/1.73 m2) = k*Height (cm)/serum creatinine (mg/dl). k is a proportionality constant which varies with age and is a function of urinary creatinine excretion per unit of body size; 0.45 up to 12 months of age; 0.55 children and adolescent girls; and 0.70 adolescent boys.
  • Adult Population (age ≥18): Serum creatinine ≤1.0 mg/dL; if serum creatinine >1.0 mg/dL, then the estimated glomerular filtration rate (GFR) must be >60 mL/min/1.73 m2 as calculated by the Modification of Diet in Renal Disease equation where Predicted GFR (ml/min/1.73 m2) = 186 x (Serum Creatinine)-1.154 x (age in years)-0.023 x (0.742 if patient is female) x (1.212 if patient is black.
  • 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.

Who cannot join

  • 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.
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  • 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.

Trial locations and contacts

4 sites in 1 country.

United States4 sites

  • Children's Memorial

    Chicago, Illinois, 60611

  • Childrens Hospital Los Angeles

    Los Angeles, California, 90027

  • University of Miami Cancer Center

    Miami, Florida, 33136

  • Childrens Hospital & Clinics of Minnesota

    Minneapolis, Minnesota, 55404-4597

Other trials in United States

About this study

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

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®).

Read the detailed description

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.

Being tested
Clofarabine, Etoposide, Cyclophosphamide, Filgrastim, Cytarabine
Keywords
relapsed, relapse, refractory, AML, Acute myelogenous leukemia, Relapsed AML
Medical subject headings
Leukemia, Myeloid, Acute, Recurrence

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • ClofarabineDrug

    Also called Clolar

    40 mg/m2/day IV over 2 hours (given at hours 0 to 2) on days 1 through 5.

  • EtoposideDrug

    Also called VP-16, VePesid, Etopophos

    100 mg/m2/day IV over 2 hours (given at hours 2 to 4) on days 1 through 5.

  • CyclophosphamideDrug

    Also called Cytoxan

    440 mg/m2/day IV as a 30-60 minute infusion (given at hours 4 to 5) on days 1 through 5.

  • FilgrastimDrug

    Also called Neupogen, G-CSF, GCSF, Granulocyte Colony Stimulating Factor

    Administered in Courses 1 and 2 only. 5 micrograms/kg/day IV or SC will begin on Day 6 and end when the ANC is > 1000 x 2 days.

  • CytarabineDrug

    Also called Cytosine Arabinoside, Ara-C, Cytosar, AraC

    Given intrathecally on day 1 at the dose defined by age below:

    30 mg for patients age 1-1.99 50 mg for patients age 2-2.99 70 mg for patients >3 years of age

Study groups in NCT00939653
Study groupRoleWhat they receive
Single Arm - Clofarabine with ChemoExperimentalAll patients receive the same treatment regimen consisting of clofarabine, etoposide, cyclophosphamide, cytarabine, and filgrastim. Up to 4 courses of therapy may be given.
Receives: Drug: Clofarabine; Drug: Etoposide; Drug: Cyclophosphamide; Drug: Filgrastim; Drug: Cytarabine

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Achievement of Complete Remission (CR) at Reinduction

    Disease response assessed after chemotherapy from bone marrow aspirates/biopsies and complete blood count.

    Measured: Between Days 22-36 or on Day 43 and weekly thereafter if peripheral counts haven't recovered

  2. Death

    Number of participants who died.

    Measured: From the first dose of study therapy until 30 days after last therapy dose

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted15 Jul 2009 (estimated)
  2. Study start10 Jul 2009
  3. Primary completion15 Jul 2011
  4. Study completion15 Jul 2011

Why it stopped: Due to insufficient research institution participation and patient enrollment

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 2
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
6 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT00939653
Sponsor's protocol ID
T2007-002
Status last verified
Feb 2020
First submitted
13 Jul 2009
Last updated
19 Feb 2020
Data monitoring committee
Yes
FDA-regulated drug
Yes
FDA-regulated device
No

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing Clofarabine, Etoposide and Cyclophosphamide in people with Relapsed Acute Myelogenous Leukemia, run by Therapeutic Advances in Childhood Leukemia Consortium at 4 sites in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 22 inclusion and 18 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: stopped early, as of the sponsor's last update on 19 Feb 2020. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 4 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 19 Feb 2020). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Achievement of Complete Remission (CR) at Reinduction (time frame: Between Days 22-36 or on Day 43 and weekly thereafter if peripheral counts haven't recovered). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT00939653.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 Feb 2020.

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