Acute Myeloid LeukemiaPhase 1/2NCT01211457
Study of Sapacitabine in Acute Myeloid Leukemia (AML) or Myelodysplastic Syndromes (MDS)
A Phase 1/2 study testing sapacitabine and decitabine (Part 1 - completed) and sapacitabine and venetoclax (Part 2 - recruiting) in people with Acute Myeloid Leukemia and Myelodysplastic Syndromes, run by Cyclacel Pharmaceuticals, Inc. at 3 sites in United States.
Trial summary
This is a combination study to evaluate sapacitabine administered in alternating cycles with decitabine in previously untreated Acute Myeloid Leukemia (AML) or concomitantly with venetoclax in previously treated AML or MDS Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Acute Myeloid Leukemia, Myelodysplastic Syndromes
- What is being tested?
- sapacitabine and decitabine (Part 1 - completed) and sapacitabine and venetoclax (Part 2 - recruiting)
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 65 participants
- Where
- 3 sitesUnited States
- Study dates
- 17 Jun 2010to 31 Dec 2020
- Phase
- Phase 1/2
- 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Newly diagnosed AML based on WHO classification (Part 1) or previously treated AML or MDS (Part 2)
- Age 70 years or older for whom the treatment of choice is low-intensity therapy by investigator assessment or who has refused intensive induction therapy recommended by investigator (Part 1); age 18 years or older (Part 2)
- ECOG performance status 0-2
- Adequate renal function
- Adequate liver function
- Able to swallow capsules
- Ability to understand and willingness to sign the informed consent form
Who cannot join
- AML is of the sub-type of acute promyelocytic leukemia or extramedullary myeloid tumor without bone marrow involvement
- Known central nervous system (CNS) involvement by leukemia
- Uncontrolled intercurrent illness including
- Known hypersensitivity to decitabine (Part 1) or venetoclax (Part 2)
- Known to be HIV-positive
Trial locations and contacts
3 sites in 1 country.
United States3 sites, 1 recruiting
- Completed
Roswell Park Cancer Institute
Buffalo, New York, 14263
- Completed
Rush University Medical Center
Chicago, Illinois, 60612
- Recruiting
MD Anderson Cancer Center
Houston, Texas, 77030-3387
Debra Bull - Linderman, RN, 713-563-4303, DLBull@mdanderson.org
Tapan M Kadia, MD
About this study
Official title: A Phase I/II Combination Study of Sapacitabine in Acute Myeloid Leukemia or Myelodysplastic Syndromes
This is a combination study to evaluate sapacitabine administered in alternating cycles with decitabine in previously untreated Acute Myeloid Leukemia (AML) or concomitantly with venetoclax in previously treated AML or MDS
Read the detailed description
This is an open-label, single arm, study of sapacitabine administered in alternating cycles with decitabine in elderly patients with previously untreated AML (Part 1) or concomitantly with venetoclax in adult patients with relapsed or refractory AML or MDS (Part 2). Treatment will be administered on an outpatient basis. One treatment cycle is 4 weeks.
- Conditions
- Acute Myeloid Leukemia, Myelodysplastic Syndromes
- Being tested
- sapacitabine and decitabine (Part 1 - completed), sapacitabine and venetoclax (Part 2 - recruiting)
- Keywords
- Sapacitabine, decitabine, venetoclax, elderly, AML, MDS, Refractory, relapsed, untreated
- Medical subject headings
- Leukemia, Myeloid, Acute, Myelodysplastic Syndromes, Recurrence
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
sapacitabine and decitabine (Part 1 - completed)Drug
decitabine will be administered in alternating cycles with sapacitabine
sapacitabine and venetoclax (Part 2 - recruiting)Drug
sapacitabine will be administered concomitantly with venetoclax
| Study group | Role | What they receive |
|---|---|---|
| Sapacitabine/decitabine (Part 1 - completed) | Experimental | decitabine will be administered in alternating cycles with sapacitabine Receives: Drug: sapacitabine and decitabine (Part 1 - completed) |
| sapacitabine/venetoclax (Part 2 - recruiting) | Experimental | sapacitabine will be administered concomitantly with venetoclax Receives: Drug: sapacitabine and venetoclax (Part 2 - recruiting) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of patients who achieve a clinical benefit response including CR, CRp, PR and major HI
Measured: 2 years
Secondary outcomes (4)
response duration
Measured: 2 years
transfusion requirements
Measured: 2 years
hospitalized days
Measured: 2 years
overall survival
Measured: 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Sep 2010 (estimated)
- Study start17 Jun 2010
- Primary completion20 Jun 2020 (estimated)
- Study completion31 Dec 2020 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- 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 1/2
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 65 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Cyclacel Pharmaceuticals, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- M.D. Anderson Cancer Center
- Responsible party
- Sponsor
- Investigators
- Hagop M Kantarjian, MD, Study chair, M.D. Anderson Cancer Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01211457
- Sponsor's protocol ID
- CYC682-11
- Status last verified
- Oct 2018
- First submitted
- 27 Sep 2010
- Last updated
- 16 Jul 2019
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Publications
Pooled Analysis of Elderly Patients with Newly Diagnosed AML Treated with Sapacitabine and Decitabine Administered in Alternating Cycles. Farhad Ravandi, Tapan M. Kadia, Gautam Borthakur, William G. Wierda, Stuart L. Goldberg, Meir Wetzler, Parameswaran Venugopal, Karen Seiter, Judy Chiao and Hagop M. Kantarjian. Blood 2012 120:2630.
Study at a glance
From the registry record, last updated by the sponsor on 16 Jul 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase I/II Combination Study of Sapacitabine in Acute Myeloid Leukemia or Myelodysplastic Syndromes
- ClinicalTrials.gov ID
- NCT01211457
- Acronym / sponsor ID
- CYC682-11
- Conditions
- Acute Myeloid Leukemia, Myelodysplastic Syndromes
- Keywords
- Sapacitabine, decitabine, venetoclax, elderly, AML, MDS, Refractory, relapsed
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 65 participants (estimated)
- Lead sponsor
- Cyclacel Pharmaceuticals, Inc.Industry (pharma, biotech, devices)
- Collaborators
- M.D. Anderson Cancer Center
- Study start
- 17 Jun 2010 (actual)
- Primary completion
- 20 Jun 2020 (estimated)
- Study completion
- 31 Dec 2020 (estimated)
- First posted
- 29 Sep 2010 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This is a combination study to evaluate sapacitabine administered in alternating cycles with decitabine in previously untreated Acute Myeloid Leukemia (AML) or concomitantly with venetoclax in previously treated AML or MDS
Detailed description
This is an open-label, single arm, study of sapacitabine administered in alternating cycles with decitabine in elderly patients with previously untreated AML (Part 1) or concomitantly with venetoclax in adult patients with relapsed or refractory AML or MDS (Part 2). Treatment will be administered on an outpatient basis. One treatment cycle is 4 weeks.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Sapacitabine/decitabine (Part 1 - completed) | Experimental | Drug: sapacitabine and decitabine (Part 1 - completed)decitabine will be administered in alternating cycles with sapacitabine |
| sapacitabine/venetoclax (Part 2 - recruiting) | Experimental | Drug: sapacitabine and venetoclax (Part 2 - recruiting)sapacitabine will be administered concomitantly with venetoclax |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Newly diagnosed AML based on WHO classification (Part 1) or previously treated AML or MDS (Part 2)
- Age 70 years or older for whom the treatment of choice is low-intensity therapy by investigator assessment or who has refused intensive induction therapy recommended by investigator (Part 1); age 18 years or older (Part 2)
- ECOG performance status 0-2
- Adequate renal function
- Adequate liver function
Key exclusion criteria (5 listed)
- AML is of the sub-type of acute promyelocytic leukemia or extramedullary myeloid tumor without bone marrow involvement
- Known central nervous system (CNS) involvement by leukemia
- Uncontrolled intercurrent illness including
- Known hypersensitivity to decitabine (Part 1) or venetoclax (Part 2)
- 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 and decitabine (Part 1 - completed)decitabine will be administered in alternating cycles with sapacitabine | Drug | Sapacitabine/decitabine (Part 1 - completed) |
| sapacitabine and venetoclax (Part 2 - recruiting)sapacitabine will be administered concomitantly with venetoclax | Drug | sapacitabine/venetoclax (Part 2 - recruiting) |
Primary outcome
Number of patients who achieve a clinical benefit response including CR, CRp, PR and major HI
Time frame: 2 years
4 secondary outcomes
response duration
Time frame: 2 years
transfusion requirements
Time frame: 2 years
hospitalized days
Time frame: 2 years
overall survival
Time frame: 2 years
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Jul 2019.
- Results publicationPooled Analysis of Elderly Patients with Newly Diagnosed AML Treated with Sapacitabine and Decitabine Administered in Alternating Cycles. Farhad Ravandi, Tapan M. Kadia, Gautam Borthakur, William G. Wierda, Stuart L. Goldberg, Meir Wetzler, Parameswaran Venugopal, Karen Seiter, Judy Chiao and Hagop M. Kantarjian. Blood 2012 120:2630.
- Individual participant dataSharing planned: No
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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
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1/2 study testing sapacitabine and decitabine (Part 1 - completed) and sapacitabine and venetoclax (Part 2 - recruiting) in people with Acute Myeloid Leukemia and Myelodysplastic Syndromes, run by Cyclacel Pharmaceuticals, Inc. at 3 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 7 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: status not confirmed, as of the sponsor's last update on 16 Jul 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 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 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Judy H Chiao, MD (9085177330, jchiao@cyclacel.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of patients who achieve a clinical benefit response including CR, CRp, PR and major HI (time frame: 2 years). 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 NCT01211457, 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 16 Jul 2019.