Acute Myeloid LeukemiaPhase 1/2NCT00602225

Clofarabine, Cytarabine, and G-CSF in Treating Patients With Relapsed or Refractory Acute Myeloid Leukemia

A Phase 1/2 study testing clofarabine, cytarabine and filgrastim in people with Acute Myeloid Leukemia and Adult Acute Myeloid Leukemia With 11q23 (MLL) Abnormalities, run by University of Washington 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

Search all trials

Trial summary

Who is it for?: Ages 18 to 70 years
Conditions the study is for: Acute Myeloid Leukemia, Adult Acute Myeloid Leukemia With 11q23 (MLL) Abnormalities, Adult Acute Myeloid Leukemia With Inv(16)(p13;q22)
What is being tested?: clofarabine, cytarabine and filgrastim
Type of treatment: Injection or infusion
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 50 participants
Where: 1 siteUnited States
Study dates: Dec 2007to Apr 2015
Phase: Phase 1/2
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 18 to 70 years
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

ECOG performance status 0-2
Capable of understanding the investigational nature, potential risks and benefits of the study, and able to provide valid informed consent
Female patients of childbearing potential must have a negative serum pregnancy test within 2 weeks prior to enrollment
Male and female patients must be willing to use an effective contraceptive method during the study and for a minimum of 6 months after study treatment
Serum Total or Direct bilirubin =< 1.5 times upper limit of normal (ULN)
Aspartate transaminase (AST)/alanine transaminase (ALT) =< 2.5 times ULN

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Diagnosis of acute myeloid leukemia by WHO criteria, either relapsed or refractory; acute promyelocytic leukemia [acute promyelocytic leukemia with t(15;17)(q22;q12) and variants] would be eligible only after failure of a regimen containing arsenic trioxide
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 m^2
Alkaline phosphatase =< 2.5 times ULN

Who cannot join

Use of investigational agents within 30 days or initiation of any other anticancer therapy within 2 weeks before study entry with the exception of hydroxyurea, and intrathecal therapy for leukemic meningitis
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)
Pregnant or lactating patients
Any significant concurrent disease, illness, or psychiatric disorder that would compromise patient safety or compliance, interfere with consent, study participation, follow up, or interpretation of study results
Have any other severe concurrent disease, history of serious organ dysfunction, or disease involving the heart, kidney, liver (including symptomatic hepatitis, veno-occlusive disease, or hepatic graft-versus-host disease [for acute >= grade 2]), or other organ system dysfunction
No concomitant cytotoxic therapy or investigational therapy is allowed during the study with the exception of intrathecal therapy for leukemic meningitis; intrathecal therapy must not be given during or within 24 hours of any 5 day Clofarabine/Cytarabine treatment period

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To the extent possible, use of nephrotoxic (e.g., vancomycin, amphotericin B, etc) and hepatotoxic (e.g., voriconazole, cyclosporine, etc) agents is to be avoided during clofarabine; use of alternative medications (e.g., herbal or botanical for anticancer purposes) is not permitted during the entire study period
Current concomitant chemotherapy, radiation therapy, or immunotherapy other than as specified in the protocol
More than two failed induction attempts for initial diagnosis or current relapse; for patients enrolled under part III of the protocol, patients must be at first salvage after relapse less than one year from complete remission, or salvage after initial induction chemotherapy
Allogeneic transplant recipients on immunosuppression or on treatment for GVHD

Trial locations and contacts

1 site in 1 country.

United States1 site

Fred Hutchinson Cancer Research Center/University of Washington Cancer Consortium
Seattle, Washington, 98109

Other trials in United States

About this study

Official title: Dose Escalation Study of Clofarabine in Combination With Cytarabine (Ara-C) and G-CSF Priming for Relapsed or Refractory Acute Myeloid Leukemia (AML) Patients

RATIONALE: Drugs used in chemotherapy, such as clofarabine and cytarabine, work in different ways to stop the growth of cancer cells, either by killing the cells or stopping them from dividing. Colony stimulating factors, such as G-CSF, may increase the number of immune cells found in bone marrow or peripheral blood and may help the immune system recover from the side effects of chemotherapy.

PURPOSE: This phase I trial is studying the side effects and best dose of clofarabine to see how well it works when given together with cytarabine and G-CSF in treating patients with relapsed or refractory acute myeloid leukemia

Read the detailed description

PRIMARY OBJECTIVES:

To determine the maximum tolerated dose of clofarabine, and the dose-limiting toxicities of the combination of clofarabine and cytarabine with G-CSF priming, in the treatment of patients with relapsed or refractory AML.

SECONDARY OBJECTIVES:

To determine the hematological and non-hematological side effect profile of the combination of clofarabine, cytarabine, and G-CSF.

II. To determine the efficacy of clofarabine in combination with cytarabine and G-CSF priming in the treatment of patients with relapsed or refractory AML.

III. To determine the disease-free and overall survival after therapy with clofarabine, cytarabine, and G-CSF for relapsed or refractory AML.

OUTLINE: This is a dose escalation study of clofarabine.

PART I:

INDUCTION THERAPY: Patients receive clofarabine IV over 1 hour and cytarabine IV over 2 hours on days 1-5, and filgrastim (G-CSF) subcutaneously once daily beginning 24 hours prior to chemotherapy and continuing until blood count recover. Patients with residual leukemia (>= 5% blasts by morphology) at day 14 and if blast remain > 5% by day 21 receive a second course of induction therapy.

CONSOLIDATION THERAPY: Patients receive clofarabine, cytarabine, and G-CSF as in induction therapy. Patients may receive a second course of consolidation therapy depending on response and whether additional therapy (e.g., stem cell transplant or donor lymphocyte infusion) is planned.

PARTS II and III:

Patients receive induction therapy and consolidation therapy as in part 1.

After completion of study treatment, patients are followed every 3 months for 2 years and then annually for 3 years.

Conditions: Acute Myeloid Leukemia, 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)
Being tested: clofarabine, cytarabine, filgrastim
Medical subject headings: Leukemia, Myeloid, Acute, Congenital Abnormalities, Leukemia, Promyelocytic, Acute

What participants receive

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

clofarabineDrug
Also called CAFdA, Clofarex, Clolar
Given IV
cytarabineDrug
Also called ARA-C, arabinofuranosylcytosine, arabinosylcytosine, Cytosar-U
Given IV
filgrastimBiological
Also called G-CSF, Neupogen
Given subcutaneously

Study groups in NCT00602225
Study group	Role	What they receive
Arm I	Experimental	See Detailed Description Receives: Drug: clofarabine; Drug: cytarabine; Biological: filgrastim

What is being measured

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

Maximum Tolerated Dose of Clofarabine
Measured: 45 days after the last dose of clofarabine
Dose-limiting Toxicity as Assessed by NCI CTCAE v3.0
Measured: 45 days after the last dose of clofarabine
Response Rates by Cytogenetic Risk Category
Number of participants who achieved Complete Remission (less than 5% blasts in the marrow and count recovery of Absolute Neutrophil Count to 1,000/microL and Platelet Count to 100,000/microL) under each cytogenetic risk category.
Measured: 45 days after the last dose of clofarabine
Response Rates by Cytogenetic Risk Category and Clofarabine Dose
Number of participants under each Cytogenetic Risk Category and Clofarabine dose who achieve CR (Complete Remission = less than 5% blasts in the marrow and count recovery of Absolute Neutrophil Count to 1,000/microL and Platelet Count to 100,000/microL) or CRp (Complete Remission, but with a platelet count of less than 100,000/microL).
Measured: 45 days after the last dose of clofarabine
Response Rates by Duration First Complete Remission (CR1)
Number of participants whose first Complete Remission lasted 0, 1-6, 6-12, or greater than 12 months. Only those participant who had a first CR are included in this data.
Measured: 45 days after the last dose of clofarabine
Response Rates by Salvage Number
Number of participants in each Salvage number category who achieved a Complete Remission. Salvage number refers to whether treatment with GCLAC on this study was the pariticipant's first salvage regimen (1), second salvage regimen (2), or third or greater salvage regimen (3 or greater).
Measured: 45 days after the last dose of clofarabine

Secondary outcomes (4)

Hematologic and Non-hematologic Side Effect Profile
Measured: 45 days after the last dose of clofarabine
Efficacy
Number of Patients Surviving at Five Years
Measured: At five years after the last dose of clofarabine
Disease-free Survival
Number of participants who survived and were disease-free at 5 years
Measured: At five years after the last dose of clofarabine
Overall Survival
Measured: At five years after the last dose of clofarabine

Timeline

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

Dec 2007Apr 2015

First posted28 Jan 2008 (estimated)
Study startDec 2007
Primary completionMar 2010
Study completionApr 2015

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Publications (1)Papers the sponsor has linked to this study.
Other trials for Acute Myeloid LeukemiaStudies of the same condition, open and under way.
More trials run by University of WashingtonThe sponsor's other registered studies.
What the trial phases meanHow a treatment moves from first tests in people to approval.

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 1/2
Primary purpose: Treatment
Allocation: Not applicable
Intervention model: Single group
Masking: None (open label)
Enrolment: 50 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT00602225
Sponsor's protocol ID: 6562
Other IDs: NCI-2009-01464
Status last verified: Feb 2018
First submitted: 23 Jan 2008
Last updated: 9 Mar 2018
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No

Publications

Becker PS, Kantarjian HM, Appelbaum FR, Storer B, Pierce S, Shan J, Faderl S, Estey EH. Retrospective comparison of clofarabine versus fludarabine in combination with high-dose cytarabine with or without granulocyte colony-stimulating factor as salvage therapies for acute myeloid leukemia. Haematologica. 2013 Jan;98(1):114-8. doi: 10.3324/haematol.2012.063438. Epub 2012 Jul 16.
PubMed 22801963

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

RecruitingPhase 1
A Study of CHM-029 in Participants With NPM1 Mutated, KMT2A or NUP98 Rearranged AML
AML (Acute Myeloid Leukemia)
RecruitingPhase 2
Testing New Therapies for Patients With Acute Myeloid Leukemia Who Are Newly Diagnosed and Have Not Yet Started Treatment (A MyeloMATCH Treatment Trial)
Acute Myeloid Leukemia, Acute Myeloid Leukemia Arising From Previous Myelodysplastic/Myeloproliferative Neoplasm
Active, not recruitingPhase 2
Clofarabine and Melphalan Before Donor Stem Cell Transplant in Treating Patients With Myelodysplasia, Acute Leukemia in Remission, or Chronic Myelomonocytic Leukemia
Adult Acute Lymphoblastic Leukemia in Remission, Acute Myeloid Leukemia Arising From Previous Myelodysplastic Syndrome
RecruitingPhase 1/2
Venetoclax and CLAG-M for the Treatment of Acute Myeloid Leukemia and High-Grade Myeloid Neoplasms
Acute Biphenotypic Leukemia, Acute Myeloid Leukemia
Not yet recruitingPhase 1
ATRN-119 in Combination With Decitabine in Patients With TP53-Mutated AML or Higher-Risk MDS
Acute Myeloid Leukemia, High-risk Myelodysplastic Syndrome

All Acute Myeloid Leukemia trials

Study at a glance

From the registry record, last updated by the sponsor on 9 Mar 2018. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Dose Escalation Study of Clofarabine in Combination With Cytarabine (Ara-C) and G-CSF Priming for Relapsed or Refractory Acute Myeloid Leukemia (AML) Patients
ClinicalTrials.gov ID: NCT00602225
Acronym / sponsor ID: 6562
Conditions: Acute Myeloid Leukemia, 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)
Phase: Phase 1/2
Study type: Interventional
Recruitment status: Completed
Enrolment: 50 participants (actual)
Lead sponsor: University of WashingtonUniversity, hospital or other
Collaborators: National Cancer Institute (NCI)
Study start: Dec 2007
Primary completion: Mar 2010 (actual)
Study completion: Apr 2015 (actual)
First posted: 28 Jan 2008 (estimated)
Results: Posted 8 Sep 2017

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Detailed description

PRIMARY OBJECTIVES:

To determine the maximum tolerated dose of clofarabine, and the dose-limiting toxicities of the combination of clofarabine and cytarabine with G-CSF priming, in the treatment of patients with relapsed or refractory AML.

SECONDARY OBJECTIVES:

To determine the hematological and non-hematological side effect profile of the combination of clofarabine, cytarabine, and G-CSF.

II. To determine the efficacy of clofarabine in combination with cytarabine and G-CSF priming in the treatment of patients with relapsed or refractory AML.

III. To determine the disease-free and overall survival after therapy with clofarabine, cytarabine, and G-CSF for relapsed or refractory AML.

OUTLINE: This is a dose escalation study of clofarabine.

PART I:

PARTS II and III:

Patients receive induction therapy and consolidation therapy as in part 1.

After completion of study treatment, patients are followed every 3 months for 2 years and then annually for 3 years.

Study design

Primary purpose: Treatment
Allocation: Not applicable
Intervention model: Single group
Masking: None (open label)
Number of arms: 1

Arm	Type	Receives
Arm I	Experimental	Drug: clofarabine, Drug: cytarabine, Biological: filgrastimSee Detailed Description

Who may qualify

Ages: 18 to 70 years
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (9 listed)

ECOG performance status 0-2
Capable of understanding the investigational nature, potential risks and benefits of the study, and able to provide valid informed consent
Female patients of childbearing potential must have a negative serum pregnancy test within 2 weeks prior to enrollment
Male and female patients must be willing to use an effective contraceptive method during the study and for a minimum of 6 months after study treatment
Serum Total or Direct bilirubin =< 1.5 times upper limit of normal (ULN)

Key exclusion criteria (10 listed)

Use of investigational agents within 30 days or initiation of any other anticancer therapy within 2 weeks before study entry with the exception of hydroxyurea, and intrathecal therapy for leukemic meningitis
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)
Pregnant or lactating patients
Any significant concurrent disease, illness, or psychiatric disorder that would compromise patient safety or compliance, interfere with consent, study participation, follow up, or interpretation of study results
Have any other severe concurrent disease, history of serious organ dysfunction, or disease involving the heart, kidney, liver (including symptomatic hepatitis, veno-occlusive disease, or hepatic graft-versus-host disease [for acute >= grade 2]), or other organ system dysfunction

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
clofarabineAlso: CAFdA, Clofarex, ClolarGiven IV	Drug	Arm I
cytarabineAlso: ARA-C, arabinofuranosylcytosine, arabinosylcytosine, Cytosar-UGiven IV	Drug	Arm I
filgrastimAlso: G-CSF, NeupogenGiven subcutaneously	Biological	Arm I

Primary outcome

Maximum Tolerated Dose of Clofarabine
Time frame: 45 days after the last dose of clofarabine
Dose-limiting Toxicity as Assessed by NCI CTCAE v3.0
Time frame: 45 days after the last dose of clofarabine
Response Rates by Cytogenetic Risk Category
Time frame: 45 days after the last dose of clofarabine
Number of participants who achieved Complete Remission (less than 5% blasts in the marrow and count recovery of Absolute Neutrophil Count to 1,000/microL and Platelet Count to 100,000/microL) under each cytogenetic risk category.
Response Rates by Cytogenetic Risk Category and Clofarabine Dose
Time frame: 45 days after the last dose of clofarabine
Number of participants under each Cytogenetic Risk Category and Clofarabine dose who achieve CR (Complete Remission = less than 5% blasts in the marrow and count recovery of Absolute Neutrophil Count to 1,000/microL and Platelet Count to 100,000/microL) or CRp (Complete Remission, but with a platelet count of less than 100,000/microL).
Response Rates by Duration First Complete Remission (CR1)
Time frame: 45 days after the last dose of clofarabine
Number of participants whose first Complete Remission lasted 0, 1-6, 6-12, or greater than 12 months. Only those participant who had a first CR are included in this data.
Response Rates by Salvage Number
Time frame: 45 days after the last dose of clofarabine
Number of participants in each Salvage number category who achieved a Complete Remission. Salvage number refers to whether treatment with GCLAC on this study was the pariticipant's first salvage regimen (1), second salvage regimen (2), or third or greater salvage regimen (3 or greater).

4 secondary outcomes

Hematologic and Non-hematologic Side Effect Profile
Time frame: 45 days after the last dose of clofarabine
Efficacy
Time frame: At five years after the last dose of clofarabine
Disease-free Survival
Time frame: At five years after the last dose of clofarabine
Overall Survival
Time frame: At five years after the last dose of clofarabine

Results and safety

Results posted to the registry on 8 Sep 2017, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Arm I: Filgrastim + Clofarabine + Cytarabine (GCLAC)	50	50

Primary outcome: Maximum Tolerated Dose of Clofarabine

Time frame: 45 days after the last dose of clofarabine. Number. Unit: mg/m^2 of clofarabine

Measure	Arm I: Filgrastim + Clofarabine + Cytarabine (GCLAC) n = 50
Value	25

Primary outcome: Dose-limiting Toxicity as Assessed by NCI CTCAE v3.0

Time frame: 45 days after the last dose of clofarabine. Count of participants. Unit: Participants

Measure	Arm I: Filgrastim + Clofarabine + Cytarabine (GCLAC) n = 50
Value	2

Primary outcome: Response Rates by Cytogenetic Risk Category

Time frame: 45 days after the last dose of clofarabine. Count of participants. Unit: Participants

Measure	Arm I n = 46
Favorable risk Complete Remission	3
Intermediate risk Complete remission	10
Unfavorable risk Complete remission	9

Population analysed: Of the 50 patients, 4 were excluded from analysis of response: 2 patients with GVHD, 1 patient who received only 1 g/m2 ara-C, and 1 patient who did not have a marrow confirming remission status prior to beginning a preparative regimen for allogeneic HCT.

Primary outcome: Response Rates by Cytogenetic Risk Category and Clofarabine Dose

Time frame: 45 days after the last dose of clofarabine. Count of participants. Unit: Participants

Measure	Arm I n = 46
Favorable Risk + 25 mg/m^2 achieve CR	2
Intermediate Risk + 15 mg/m^2 achieve CR	2
Intermediate Risk + 20 mg/m^2 achieve CR	3
Intermediate Risk + 25 mg/m^2 achieve CR	5
Intermediate Risk + 25 mg/m^2 achieve CRp	4
Unfavorable Risk + 15 mg/m^2 achieve CR	2
Unfavorable Risk + 20 mg/m^2 achieve CR	1
Unfavorable Risk + 25 mg/m^2 achieve CR	6

4 secondary outcomes are reported in the full results.

Adverse events

Other adverse events reported at 0% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Arm I	23 of 50 (46%)	0 of 0	Not reported

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 9 Mar 2018.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Derived from this study: PubMed 22801963Becker PS, Kantarjian HM, Appelbaum FR, Storer B, Pierce S, Shan J, Faderl S, Estey EH. Retrospective comparison of clofarabine versus fludarabine in combination with high-dose cytarabine with or without granulocyte colony-stimulating factor as salvage therapies for acute myeloid leukemia. Haematologica. 2013 Jan;98(1):114-8. doi: 10.3324/haematol.2012.063438. Epub 2012 Jul 16.

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Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

Pamela Becker principal investigator

Fred Hutchinson Cancer Research Center/University of Washington Cancer Consortium

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

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 9 inclusion and 10 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 9 Mar 2018. 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 combined 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.

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 8 Sep 2017). 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?

Maximum Tolerated Dose of Clofarabine (time frame: 45 days after the last dose of clofarabine). The study lists 6 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 NCT00602225, 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 9 Mar 2018.