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Chronic Myeloproliferative DisordersPhase 1NCT00293410

Clofarabine and Cyclophosphamide in Treating Patients With Relapsed or Refractory Acute Leukemia, Chronic Myelogenous Leukemia, or Myeloproliferative Disorders

A Phase 1 study testing clofarabine and cyclophosphamide in people with Chronic Myeloproliferative Disorders and Leukemia, run by Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins 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

RATIONALE: Drugs used in chemotherapy, such as clofarabine and cyclophosphamide, work in different ways to stop the growth of cancer cells, either by killing the cells or by stopping them from dividing. Giving more than one drug (combination chemotherapy) may kill more cancer cells. Read more about this study

Who is it for?
Ages 2 years and older
What is being tested?
clofarabine and cyclophosphamide
How many people
70 participants
Where
1 siteUnited States
Study dates
Nov 2005to Apr 2010
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 2 years and older
  • All sexes
  • No healthy volunteers
  • Child, Adult, Older adult

DISEASE CHARACTERISTICS:

  • Histologically confirmed leukemia or myeloproliferative disorders, including 1 of the following:
  • Acute myeloid leukemia (AML) of any subtype
  • Treatment-related AML OR AML evolving from myeloproliferative disorders (MPD) or transformed from myelodysplastic syndrome
  • Acute lymphocytic leukemia
  • Acute progranulocytic leukemia
  • Must not be eligible for arsenic or retinoic acid therapy
  • Chronic myelogenous leukemia in accelerated phase or blast crisis
  • High-risk MPD, including any of the following:
  • Myelofibrosis
  • Chronic myelomonocytic leukemia with 5%-19% blasts
  • Relapsed or refractory juvenile myelomonocytic leukemia
  • Relapsed and/or refractory disease with progressive disease since last therapy
  • No more than 3 prior induction regimens with cytotoxic agents for adults
  • Must be in second relapse for patients < 21 years of age

PATIENT CHARACTERISTICS:

  • ECOG performance status 0-2 (for adults) OR Lansky 50-100% (for pediatric patients)
  • Bilirubin ≤ 1.5 mg/dL (may be elevated due to hemolysis in adult patients)
  • AST and ALT ≤ 5 times upper limit of normal
  • Creatinine ≤ 2.0 mg/dL (for adults)
  • Normal renal function (for pediatric patients)
  • Cardiac function normal as measured by MUGA scan or echocardiogram
  • Not pregnant or nursing
  • Negative pregnancy test
  • Fertile patients must use effective barrier contraception during and for at least 6 months after completion of study treatment
  • HIV negative
  • No active graft-versus-host disease ≥ grade 2
  • No active, uncontrolled infection
  • No fever
  • No unstable CT scans of the lungs, sinuses, or abdomen within the past 4 weeks
  • No arrhythmias (other than atrial flutter or fibrillation) requiring medication
  • No dyspnea at rest or with minimal exertion
  • No uncontrolled congestive heart failure
  • No myocardial infarction within the past 3 months
  • No history of severe coronary artery disease
  • No other significant concurrent disease, illness, or psychiatric disorder that would compromise patient safety or compliance or interfere with consent, study participation, follow up, or interpretation of study results

PRIOR CONCURRENT THERAPY:

  • Must have recovered from all acute toxic effects from prior treatment
  • More than 30 days since prior investigational cytotoxic agents
  • At least 3 days since prior azacitidine, thalidomide, hydroxyurea, imatinib mesylate, or interferon
  • At least 1 week since prior growth factors except epoetin alfa
  • More than 3 weeks since any other prior anticancer therapy
  • No concurrent chemotherapy, radiotherapy, or immunotherapy
  • No other concurrent anticancer investigational or commercial agents
  • No routine prophylactic use of a colony-stimulating factor (filgrastim [G-CSF] or sargramostim [GM-CSF])
  • Therapeutic use of colony-stimulating factors may be considered at the discretion of the investigator
  • No prolonged use of corticosteroids to prevent or treat emesis or as a chemotherapeutic agent

Trial locations and contacts

1 site in 1 country.

United States1 site

  • Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins

    Baltimore, Maryland, 21231-2410

Other trials in United States

About this study

Official title: Phase I Dose-Escalation Trial of Clofarabine Followed by Escalating Doses of Fractionated Cyclophosphamide in Adults and Children With Relapsed or Refractory Acute Leukemias

RATIONALE: Drugs used in chemotherapy, such as clofarabine and cyclophosphamide, work in different ways to stop the growth of cancer cells, either by killing the cells or by stopping them from dividing. Giving more than one drug (combination chemotherapy) may kill more cancer cells.

PURPOSE: This phase I trial is studying the side effects and best dose of clofarabine and cyclophosphamide in treating patients with relapsed or refractory acute leukemia, chronic myelogenous leukemia, or myeloproliferative disorders.

Read the detailed description

OBJECTIVES:

Primary

  • Determine the feasibility and tolerability of administering clofarabine and fractionated cyclophosphamide in patients with relapsed or refractory acute leukemia, chronic myelogenous leukemia, or high-risk myeloproliferative disorders
  • Determine the maximum tolerated dose of clofarabine and fractionated cyclophosphamide in these patients.
  • Determine the toxic effects of these drugs in these patients.

Secondary

  • Obtain preliminary data of biologic and pharmacodynamic effects of this regimen on marrow and circulating leukemic blasts in these patients.

OUTLINE: This is a dose-escalation study. Patients are stratified according to age (adult vs child).

Patients receive cyclophosphamide IV over 2 hours on day 0. Patients then receive clofarabine IV over 2 hours and cyclophosphamide IV over 2 hours on days 1-3 and 8-10. Treatment with clofarabine and cyclophosphamide repeats every 28 days for at least 2 courses in the absence of disease progression or unacceptable toxicity.

Cohorts of 3-6 patients receive escalating doses of clofarabine and cyclophosphamide until the maximum tolerated dose (MTD) is determined. The MTD is defined as the dose preceding that at which 2 of 3 or 2 of 6 patients experience dose-limiting toxicity. At least 10 patients are treated at the MTD.

After completion of study treatment, patients are followed periodically for 1 year.

PROJECTED ACCRUAL: A total of 70 patients will be accrued for this study.

Being tested
clofarabine, cyclophosphamide
Keywords
adult acute myeloid leukemia with 11q23 (MLL) abnormalities, adult acute myeloid leukemia with inv(16)(p13;q22), adult acute myeloid leukemia with t(15;17)(q22;q12), adult acute myeloid leukemia with t(16;16)(p13;q22), adult acute myeloid leukemia with t(8;21)(q22;q22), recurrent adult acute myeloid leukemia, recurrent childhood acute myeloid leukemia, secondary acute myeloid leukemia, myelodysplastic/myeloproliferative disease, unclassifiable, accelerated phase chronic myelogenous leukemia, chronic idiopathic myelofibrosis, chronic myelomonocytic leukemia, juvenile myelomonocytic leukemia, recurrent adult acute lymphoblastic leukemia, recurrent childhood acute lymphoblastic leukemia, acute undifferentiated leukemia, blastic phase chronic myelogenous leukemia, childhood chronic myelogenous leukemia, adult acute basophilic leukemia, adult acute eosinophilic leukemia
Medical subject headings
Myeloproliferative Disorders, Leukemia, Myelodysplastic-Myeloproliferative Diseases, Congenital Abnormalities, Leukemia, Myeloid, Acute, Leukemia, Myeloid, Accelerated Phase, Primary Myelofibrosis, Leukemia, Myelomonocytic, Chronic

What participants receive

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

Timeline

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

  1. First posted17 Feb 2006 (estimated)
  2. Study startNov 2005
  3. Primary completionApr 2010

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
Enrolment
70 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT00293410
Sponsor's protocol ID
J0561 CDR0000456431
Other IDs
P30CA006973, JHOC-J0561, JHOC-00000845
Status last verified
May 2010
First submitted
16 Feb 2006
Last updated
6 May 2010
Results posted
No

Publications

  • Karp JE, Ricklis RM, Balakrishnan K, Briel J, Greer J, Gore SD, Smith BD, McDevitt MA, Carraway H, Levis MJ, Gandhi V. A phase 1 clinical-laboratory study of clofarabine followed by cyclophosphamide for adults with refractory acute leukemias. Blood. 2007 Sep 15;110(6):1762-9. doi: 10.1182/blood-2007-03-081364. Epub 2007 Jun 11.

    PubMed 17562873

Questions about this trial

What is this clinical trial studying?

A Phase 1 study testing clofarabine and cyclophosphamide in people with Chronic Myeloproliferative Disorders and Leukemia, run by Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins 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?

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 6 May 2010. 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.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT00293410, 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 6 May 2010.

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