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Leukemia, Myeloid, AcutePhase 1NCT00727766

Oral Clofarabine for Acute Myeloid Leukemia

A Phase 1 study testing Clofarabine in people with Leukemia, Myeloid, Acute, run by Washington University School of Medicine at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

This is a phase I study designed to test the safety of oral clofarabine when given as consolidation therapy to older patients with AML in remission. Read more about this study

Who is it for?
Ages 60 years and older
Conditions the study is for
Leukemia, Myeloid, Acute
What is being tested?
Clofarabine
Could I receive a placebo?
No, everyone receives an active treatment
How many people
25 participants
Where
1 siteUnited States
Study dates
Jan 2009to Nov 2014
Phase
Phase 1
Are there results?
None posted in the registry

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 60 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Diagnosis of Acute Myeloid Leukemia according to WHO criteria
  • Age ≥ 60 years at enrollment
  • Patients must be in complete remission by bone marrow examination, within 30 days of enrollment, following treatment with a cytotoxic induction chemotherapy regimen (such as 7+3)
  • Complete remission must be confirmed by bone marrow biopsy
  • If one cycle of consolidation was administered, then patient may be within 60 days of the confirmation of complete remission by bone marrow biopsy
  • Minimum platelet count of 100,000
Show all 17Show fewer
  • Patients may have received "low-intensity" therapy (i.e. decitabine, lenalidomide, etc) prior to traditional induction chemotherapy.
  • Patients may have received 1 cycle of cytarabine-based consolidation therapy.
  • Patients must have an ECOG performance status of 0-2 at the beginning of consolidation therapy.
  • Have adequate renal and hepatic functions as indicated by the following laboratory values:
  • 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)
  • Serum total bilirubin ≤ 1.5 mg/dL × upper limit of normal (ULN) except for unconjugated hyperbilirubinemia secondary Gilbert's syndrome
  • Aspartate transaminase (AST)/alanine transaminase (ALT) ≤ 2.5 × ULN
  • Alkaline phosphatase ≤ 2.5 × ULN
  • Capable of understanding the investigational nature, potential risks and benefits of the study, and able to provide signed valid written informed consent or when appropriate, have an appointed legally authorized representative who is capable of understanding the investigational nature, potential risks and benefits of the study, and able to provide signed valid written informed consent for the benefit of the patient.
  • Male and female patients who are of child bearing potential must use an effective contraceptive method during the study and for a minimum of 6 months after study treatment.
  • Patients MAY have received prior therapy with purine analogs (such as fludarabine and cladribine).

Who cannot join

  • Current concomitant chemotherapy, radiation therapy, or immunotherapy other than as specified in the protocol.
  • The diagnosis of AML-M3 (acute promyelocytic leukemia) characterized by translocations involving the retinoic acid receptor-alpha (RAR-alpha) gene.
  • Use of investigational agents within 2 weeks or any anticancer therapy within 2 weeks before study entry. The patient must have recovered from all acute toxicities from any previous therapy.
  • 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.
  • 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).
  • Have currently active gastrointestinal disease, or prior surgery that may affect the ability of the patient to absorb oral clofarabine.

Trial locations and contacts

1 site in 1 country.

United States1 site

  • Washington University

    St Louis, Missouri, 63110

Other trials in United States

About this study

Official title: Phase I Study of Oral Clofarabine Consolidation in Adults Aged 60 and Older With Acute Myeloid Leukemia

This is a phase I study designed to test the safety of oral clofarabine when given as consolidation therapy to older patients with AML in remission.

Read the detailed description

The prognosis of acute myeloid leukemia (AML) in patients 60 and older is dismal with traditional therapy. Several factors contribute to the poor prognosis of older individuals, including the increased incidence of the multidrug resistance efflux pump, comorbidities and unfavorable cytogenetics. The recently reported AML-13 and ALFA trials suggest that less intense consolidation in this population is at least equivalent to more intense, induction style efforts.

Clofarabine is a next generation nucleoside analogue that was designed to optimize the favorable attributes of fludarabine and cladribine, while minimizing toxicity. The intravenous formulation has shown considerable activity in older patients with AML who have been considered either unfit for or unlikely to benefit from conventional therapy. Additionally, clofarabine has an oral formulation that patients may find more acceptable for consolidation therapy rather than multiple courses of intravenous medications, administered over several days.

This study is designed as a traditional 3x3 phase I trial with the intention of defining the maximum tolerated dose of oral clofarabine consolidation for older patients with AML in remission.

Being tested
Clofarabine
Keywords
Clofarabine, Clolar, AML, Consolidation
Medical subject headings
Leukemia, Myeloid, Acute

What participants receive

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

  • ClofarabineDrug

    Also called Clolar

Study groups in NCT00727766
Study groupRoleWhat they receive
Cohort 1ExperimentalClofarabine 1 mg for 14 days followed by 14 days of rest. Each cycle is 28 days long.
Receives: Drug: Clofarabine
Cohort 2ExperimentalClofarabine 2 mg for 21 days followed by 7 days of rest. Each cycle is 28 days long.
Receives: Drug: Clofarabine
Cohort 3ExperimentalClofarabine 3 mg for 21 days followed by 7 days of rest. Each cycle is 28 days long.
Receives: Drug: Clofarabine
Cohort 4ExperimentalClofarabine 4 mg for 21 days followed by 7 days of rest. Each cycle is 28 days long.
Receives: Drug: Clofarabine
Cohort 5ExperimentalClofarabine 5 mg for 21 days followed by 7 days of rest. Each cycle is 28 days long.
Receives: Drug: Clofarabine
Cohort 6ExperimentalClofarabine 6 mg for 21 days followed by 7 days of rest. Each cycle is 28 days long.
Receives: Drug: Clofarabine

What is being measured

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

  1. Maximum tolerated dose (MTD) and dose limiting toxicity (DLT)

    Measured: DLT - 1st cycle (28 days), MTD - completion of 1st cycle by all patients in all cohorts

Secondary outcomes (3)

  1. Adverse events by grade and attribution

    Measured: Start of treatment through 30 days post-last dose

  2. Disease-free survival

    Measured: Every 6 months for 3 years

  3. Overall survival

    Measured: Every 6 months for 3 years

Timeline

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

  1. First posted4 Aug 2008 (estimated)
  2. Study startJan 2009
  3. Primary completionSep 2012
  4. Study completionNov 2014

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 1
Primary purpose
Treatment
Allocation
Non-randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
25 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT00727766
Sponsor's protocol ID
08-0853 / 201108049
Status last verified
Nov 2014
First submitted
30 Jul 2008
Last updated
11 Nov 2014
Results posted
No
Data monitoring committee
Yes

Publications

  • Jacoby MA, Martin MG, Uy GL, Westervelt P, Dipersio JF, Cashen A, Stockerl-Goldstein K, Vij R, Luo J, Reineck T, Bernabe N, Abboud CN. Phase I study of oral clofarabine consolidation in adults aged 60 and older with acute myeloid leukemia. Am J Hematol. 2014 May;89(5):487-92. doi: 10.1002/ajh.23663. Epub 2014 Mar 3.

    PubMed 24415560

Questions about this trial

What is this clinical trial studying?

A Phase 1 study testing Clofarabine in people with Leukemia, Myeloid, Acute, run by Washington University School of Medicine at 1 site 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 17 inclusion and 6 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: finished, as of the sponsor's last update on 11 Nov 2014. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site 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 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.

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

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

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?

Maximum tolerated dose (MTD) and dose limiting toxicity (DLT) (time frame: DLT - 1st cycle (28 days), MTD - completion of 1st cycle by all patients in all cohorts). 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 NCT00727766, which also lists 1 linked publication.

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 11 Nov 2014; AzTrials last refreshed its copy on 6 Nov 2026.

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