Acute Myeloid LeukemiaPhase 2NCT00590187

Efficacy Study of Oral Sapacitabine to Treat Acute Myeloid Leukemia in Elderly Patients

A Phase 2 study testing Sapacitabine, Arm A, Sapacitabine, Arm B and Sapacitabine, Arm C in people with Acute Myeloid Leukemia, run by Cyclacel Pharmaceuticals, Inc. at 15 sites 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

The objective is to treat elderly AML and MDS patients with sapacitabine. Read more about this study

Who is it for?: Ages 60 years and older
Conditions the study is for: Acute Myeloid Leukemia
What is being tested?: Sapacitabine, Arm A, Sapacitabine, Arm B and Sapacitabine, Arm C
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 105 participants
Where: 15 sitesUnited States
Study dates: Dec 2007to 1 Dec 2018
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 60 years and older
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

A histologically or pathologically confirmed diagnosis of AML based on WHO classification which is previously untreated by systemic therapy or is in first relapse after achieving a complete remission to initial induction, consolidation and/or maintenance therapy or MDS with IPSS scores of intermediate -2 or higher risk risk which has been previously treated with hypomethylating agents
Age 70 years or older for AML and 60 years or older for MDS
Eastern Cooperative Oncology Group (ECOG) performance status 0-2
Adequate renal function defined as serum creatinine equal to or less than 1.5 x upper limit of normal (ULN)
Adequate liver function defined as total bilirubin or direct bilirubin equal to or less than 1.5 x ULN; alanine aminotransferase (ALT or SGPT) equal to or less than 2.5 x ULN (5 x ULN if tumor has affected the liver)
Life expectancy reasonably adequate for evaluating the treatment effect

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Patient must be able to swallow capsules
Patients must be at least 2 weeks from prior systemic therapy, radiation therapy, major surgery, or other investigational therapy, and have recovered from clinically significant toxicities of these prior treatments
All men and women of reproductive potential must agree to practice effective contraception for 4 weeks prior to study entry, during the entire study period and for one month after the study unless documentation of infertility exists
Ability to understand and willingness to sign the informed consent form

Who cannot join

AML is of the sub-type of acute promyelocytic leukemia
Having received more than one induction systemic therapy for AML or having received a standard dose or high dose ara-C containing regimen for MDS
Patients with known central nervous system (CNS) involvement by leukemia
Uncontrolled intercurrent illness including, but not limited to ongoing or active infection, active cancer(s) other than AML, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, or psychiatric illness/social situations that would limit compliance with study requirements. Patients receiving intravenous antibiotics for infections that are under control may be included in this study
Known to be HIV-positive

Trial locations and contacts

15 sites in 1 country.

City, postcode or hospital

15 sites in 1 country

United States15 sites

Winship Cancer Institute
Atlanta, Georgia, 30322
University of Alabama at Birmingham
Birmingham, Alabama, 35294
Roswell Park Cancer Institiute
Buffalo, New York, 14263
Northwestern University Feinberg School of Medicine
Chicago, Illinois, 60611
Rush University Medical Center
Chicago, Illinois, 60612
University of Chicago Cancer Research Center
Chicago, Illinois, 60637
The Cancer Center at Hackensack University Medical Center
Hackensack, New Jersey, 07601
New York Medical College
Hawthorne, New York, 10532
Penn State Milton S. Hershey Medical Center
Hershey, Pennsylvania, 17033
The University of Texas MD Anderson Cancer Center
Houston, Texas, 77030-4009
UCLA Division of Hematology-Oncology
Los Angeles, California, 90095
Vanderbilt U Medical Center
Nashville, Tennessee, 37232
University of Nebraska Medical Center
Omaha, Nebraska, 68198
Hospital of the University of Pennsylvania
Philadelphia, Pennsylvania, 19104
Stanford Hospitals and Clinics
Stanford, California, 94305

Other trials in United States

About this study

Official title: A Randomized Phase 2 Study of Oral Sapacitabine in Elderly Patients With Acute Myeloid Leukemia Previously Untreated or in First Relapse, or Previously Treated Myelodysplastic Syndromes

The objective is to treat elderly AML and MDS patients with sapacitabine.

Read the detailed description

The main objective of this study is to learn which sapacitabine treatment is more likely to keep the cancer in check for at least one year in AML patients who are at least 70 years of age or older and in MDS patients who are at least 60 years of age.

Conditions: Acute Myeloid Leukemia
Being tested: Sapacitabine, Arm A, Sapacitabine, Arm B, Sapacitabine, Arm C, Sapacitabine, Arm D, sapacitabine, Arm E
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.

Sapacitabine, Arm ADrug
Also called CYC682
200 mg b.i.d. x 7 days every 3-4 weeks
Sapacitabine, Arm BDrug
Also called CYC682
300 mg b.i.d. x 7 days every 3 - 4 weeks
Sapacitabine, Arm CDrug
Also called CYC682
400 mg b.i.d. x 3 days/week x 2 weeks every 3 - 4 weeks
Sapacitabine, Arm DDrug
Also called CYC682
200 mg b.i.d. x 7 consecutive days every 4 weeks
sapacitabine, Arm EDrug
Also called CYC682
300 mg q.d. x 7 consecutive days every 4 weeks
sapacitabine, Arm FDrug
Also called CYC682
300 mg b.i.d. x 3 consecutive days per week for 2 weeks every 4 weeks
Sapacitabine, Arm GDrug
Also called CYC682
200 mg b.i.d. x 7 consecutive days every 4 weeks
Sapacitabine, Arm HDrug
Also called CYC682
300 mg q.d. x 7 consecutive days every 4 weeks
Sapacitabine, Arm IDrug
Also called CYC682
100 mg q.d. x 5 consecutive days per week for 2 weeks every 4 weeks

Study groups in NCT00590187
Study group	Role	What they receive
A sapacitabine	Experimental	200 mg b.i.d. x 7 days every 3-4 weeks Receives: Drug: Sapacitabine, Arm A
B sapacitabine	Experimental	300 mg b.i.d. x 7 days every 3 - 4 weeks Receives: Drug: Sapacitabine, Arm B
C sapacitabine	Experimental	400 mg b.i.d. x 3 days/week x 2 weeks every 3 - 4 weeks Receives: Drug: Sapacitabine, Arm C
D sapacitabine	Experimental	200 mg b.i.d. x 7 consecutive days every 4 weeks Receives: Drug: Sapacitabine, Arm D
E sapacitabine	Experimental	300 mg q.d. x 7 consecutive days every 4 weeks Receives: Drug: sapacitabine, Arm E
F sapacitabine	Experimental	300 mg b.i.d. x 3 consecutive days per week for 2 weeks every 4 weeks Receives: Drug: sapacitabine, Arm F
G sapacitabine	Experimental	200 mg b.i.d. x 7 consecutive days every 4 weeks Receives: Drug: Sapacitabine, Arm G
H sapacitabine	Experimental	300 mg q.d. x 7 consecutive days every 4 weeks Receives: Drug: Sapacitabine, Arm H
I sapacitabine	Experimental	100 mg q.d. x 5 consecutive days per week for 2 weeks every 4 weeks Receives: Drug: Sapacitabine, Arm I

What is being measured

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

Survival
Percentage of patients alive for one year measured from the date of randomization
Measured: up to 12 months from date of randomization

Secondary outcomes (1)

CR and CRp
Complete remission and complete remission without blood count recovery, transfusion requirements, hospitalized days and safety
Measured: From date of randomization until study withdrawal or death assessed up to 6 months

Timeline

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

Dec 20071 Dec 2018

First posted10 Jan 2008 (estimated)
Study startDec 2007
Primary completion1 Dec 2018
Study completion1 Dec 2018

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.
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 2
Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: None (open label)
Enrolment: 105 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT00590187
Sponsor's protocol ID: CYC682-06
Status last verified: May 2024
First submitted: 23 Dec 2007
Last updated: 4 Jun 2024
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No
Individual data sharing: No

Publications

Kantarjian H, Faderl S, Garcia-Manero G, Luger S, Venugopal P, Maness L, Wetzler M, Coutre S, Stock W, Claxton D, Goldberg SL, Arellano M, Strickland SA, Seiter K, Schiller G, Jabbour E, Chiao J, Plunkett W. Oral sapacitabine for the treatment of acute myeloid leukaemia in elderly patients: a randomised phase 2 study. Lancet Oncol. 2012 Nov;13(11):1096-104. doi: 10.1016/S1470-2045(12)70436-9. Epub 2012 Oct 15.
PubMed 23075701

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

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RecruitingPhase 2
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RecruitingPhase 1/2
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ATRN-119 in Combination With Decitabine in Patients With TP53-Mutated AML or Higher-Risk MDS
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All Acute Myeloid Leukemia trials

Study at a glance

From the registry record, last updated by the sponsor on 4 Jun 2024. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: A Randomized Phase 2 Study of Oral Sapacitabine in Elderly Patients With Acute Myeloid Leukemia Previously Untreated or in First Relapse, or Previously Treated Myelodysplastic Syndromes
ClinicalTrials.gov ID: NCT00590187
Acronym / sponsor ID: CYC682-06
Conditions: Acute Myeloid Leukemia
Phase: Phase 2
Study type: Interventional
Recruitment status: Completed
Enrolment: 105 participants (actual)
Lead sponsor: Cyclacel Pharmaceuticals, Inc.Industry (pharma, biotech, devices)
Study start: Dec 2007 (actual)
Primary completion: 1 Dec 2018 (actual)
Study completion: 1 Dec 2018 (actual)
First posted: 10 Jan 2008 (estimated)
Results: Posted 4 Jun 2024

Clinical summary

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

The objective is to treat elderly AML and MDS patients with sapacitabine.

Detailed description

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: None (open label)
Number of arms: 9

Arm	Type	Receives
A sapacitabine	Experimental	Drug: Sapacitabine, Arm A200 mg b.i.d. x 7 days every 3-4 weeks
B sapacitabine	Experimental	Drug: Sapacitabine, Arm B300 mg b.i.d. x 7 days every 3 - 4 weeks
C sapacitabine	Experimental	Drug: Sapacitabine, Arm C400 mg b.i.d. x 3 days/week x 2 weeks every 3 - 4 weeks
D sapacitabine	Experimental	Drug: Sapacitabine, Arm D200 mg b.i.d. x 7 consecutive days every 4 weeks
E sapacitabine	Experimental	Drug: sapacitabine, Arm E300 mg q.d. x 7 consecutive days every 4 weeks
F sapacitabine	Experimental	Drug: sapacitabine, Arm F300 mg b.i.d. x 3 consecutive days per week for 2 weeks every 4 weeks
G sapacitabine	Experimental	Drug: Sapacitabine, Arm G200 mg b.i.d. x 7 consecutive days every 4 weeks
H sapacitabine	Experimental	Drug: Sapacitabine, Arm H300 mg q.d. x 7 consecutive days every 4 weeks
I sapacitabine	Experimental	Drug: Sapacitabine, Arm I100 mg q.d. x 5 consecutive days per week for 2 weeks every 4 weeks

Who may qualify

Ages: 60 years and older
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (10 listed)

A histologically or pathologically confirmed diagnosis of AML based on WHO classification which is previously untreated by systemic therapy or is in first relapse after achieving a complete remission to initial induction, consolidation and/or maintenance therapy or MDS with IPSS scores of intermediate -2 or higher risk risk which has been previously treated with hypomethylating agents
Age 70 years or older for AML and 60 years or older for MDS
Eastern Cooperative Oncology Group (ECOG) performance status 0-2
Adequate renal function defined as serum creatinine equal to or less than 1.5 x upper limit of normal (ULN)
Adequate liver function defined as total bilirubin or direct bilirubin equal to or less than 1.5 x ULN; alanine aminotransferase (ALT or SGPT) equal to or less than 2.5 x ULN (5 x ULN if tumor has affected the liver)

Key exclusion criteria (5 listed)

AML is of the sub-type of acute promyelocytic leukemia
Having received more than one induction systemic therapy for AML or having received a standard dose or high dose ara-C containing regimen for MDS
Patients with known central nervous system (CNS) involvement by leukemia
Uncontrolled intercurrent illness including, but not limited to ongoing or active infection, active cancer(s) other than AML, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, or psychiatric illness/social situations that would limit compliance with study requirements. Patients receiving intravenous antibiotics for infections that are under control may be included in this study
Known to be HIV-positive

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
Sapacitabine, Arm AAlso: CYC682200 mg b.i.d. x 7 days every 3-4 weeks	Drug	A sapacitabine
Sapacitabine, Arm BAlso: CYC682300 mg b.i.d. x 7 days every 3 - 4 weeks	Drug	B sapacitabine
Sapacitabine, Arm CAlso: CYC682400 mg b.i.d. x 3 days/week x 2 weeks every 3 - 4 weeks	Drug	C sapacitabine
Sapacitabine, Arm DAlso: CYC682200 mg b.i.d. x 7 consecutive days every 4 weeks	Drug	D sapacitabine
sapacitabine, Arm EAlso: CYC682300 mg q.d. x 7 consecutive days every 4 weeks	Drug	E sapacitabine
sapacitabine, Arm FAlso: CYC682300 mg b.i.d. x 3 consecutive days per week for 2 weeks every 4 weeks	Drug	F sapacitabine
Sapacitabine, Arm GAlso: CYC682200 mg b.i.d. x 7 consecutive days every 4 weeks	Drug	G sapacitabine
Sapacitabine, Arm HAlso: CYC682300 mg q.d. x 7 consecutive days every 4 weeks	Drug	H sapacitabine
Sapacitabine, Arm IAlso: CYC682100 mg q.d. x 5 consecutive days per week for 2 weeks every 4 weeks	Drug	I sapacitabine

Primary outcome

Survival
Time frame: up to 12 months from date of randomization
Percentage of patients alive for one year measured from the date of randomization

1 secondary outcome

CR and CRp
Time frame: From date of randomization until study withdrawal or death assessed up to 6 months

Results and safety

Results posted to the registry on 4 Jun 2024, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
A Sapacitabine	40	40
B Sapacitabine	20	20
C Sapacitabine	45	45

Primary outcome: Survival

Time frame: up to 12 months from date of randomization. Number (95% Confidence Interval). Unit: percentage of patients alive for one yea

Measure	A Sapacitabine n = 20	B Sapacitabine n = 20	C Sapacitabine n = 20
Value	35 (16 to 59)	10 (2 to 33)	30 (13 to 54)

Population analysed: Arms D through I were terminated prematurely because of financial restrictions. Accordingly the company made the determination of the dosing schedule which was used in the subsequent Phase 3 study based on the results of Arms A through C.

1 secondary outcome is reported in the full results.

Adverse events

Time frame: Median length of follow-up was 143 weeks.. Other adverse events reported at 5% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
A Sapacitabine	40 of 40 (100%)	40 of 40 (100%)	8 of 40
B Sapacitabine	20 of 20 (100%)	20 of 20 (100%)	6 of 20
C Sapacitabine	45 of 45 (100%)	45 of 45 (100%)	4 of 45

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 4 Jun 2024.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Results publication: PubMed 23075701Kantarjian H, Faderl S, Garcia-Manero G, Luger S, Venugopal P, Maness L, Wetzler M, Coutre S, Stock W, Claxton D, Goldberg SL, Arellano M, Strickland SA, Seiter K, Schiller G, Jabbour E, Chiao J, Plunkett W. Oral sapacitabine for the treatment of acute myeloid leukaemia in elderly patients: a randomised phase 2 study. Lancet Oncol. 2012 Nov;13(11):1096-104. doi: 10.1016/S1470-2045(12)70436-9. Epub 2012 Oct 15.
Oral sapacitabine for the treatment of acute myeloid leukaemia in elderly patients: a randomised phase 2 study.Link provided by the sponsor.
Individual participant dataSharing planned: No

Related trials for Acute Myeloid Leukemia

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
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RecruitingPhase 1/2
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Not yet recruitingPhase 1
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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.

Hagop M Kantarjian, MD study chair

M.D. Anderson Cancer Center

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

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing Sapacitabine, Arm A, Sapacitabine, Arm B and Sapacitabine, Arm C in people with Acute Myeloid Leukemia, run by Cyclacel Pharmaceuticals, Inc. at 15 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 10 inclusion and 5 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 4 Jun 2024. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 15 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 4 Jun 2024). 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?

Survival (time frame: up to 12 months from date of randomization). 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 NCT00590187, 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 4 Jun 2024.