Myelodysplastic SyndromePhase 2NCT00774046
High-dose Cytarabine/Mitoxantrone Followed by Autotransplantation for t-MDS/t-AML
A Phase 2 study testing Ara-C, Mitoxantrone and Etoposide in people with Myelodysplastic Syndrome and Acute Myeloid Leukemia, run by University of Chicago at 1 site in United States.
Trial summary
The purpose of this study is to determine the effectiveness of a particular combination of drugs used to treat cancer. Read more about this study
- Who is it for?
- Ages 10 years and older
- Conditions the study is for
- Myelodysplastic Syndrome, Acute Myeloid Leukemia
- What is being tested?
- Ara-C, Mitoxantrone and Etoposide
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 32 participants
- Where
- 1 siteUnited States
- Study dates
- Dec 2002to Mar 2011
- 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 10 years and older
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Patients must have received cytotoxic chemotherapy,radiation,or a drug known to affect the properties of DNA or cell growth for some condition other than acute myeloid leukemia prior to diagnosis.
- Patients must have t-MDS/t-AML
- To be eligible for allogeneic transplantation, patients must have a suitable donor who is HLA compatible.
- Patients must be over the age of 10.
- Patients must be reviewed and discussed at the Leukemia and Transplant Conferences of the Section of Hematology/Oncology.
Who cannot join
- Patients must not have any other serious medical condition(e.g.uncontrolled or severe cardiovascular disease, diabetes, pulmonary disease, or infection)
- Psychiatric condition which would prevent compliance or possibly be worsened by treatment
Trial locations and contacts
1 site in 1 country.
About this study
Official title: High-dose Cytarabine/Mitoxantrone Followed by Autotransplantation for Therapy-Related Myelodysplastic Syndrome/Therapy -Related Acute Myeloid Leukemia
The purpose of this study is to determine the effectiveness of a particular combination of drugs used to treat cancer.
- Conditions
- Myelodysplastic Syndrome, Acute Myeloid Leukemia
- Being tested
- Ara-C, Mitoxantrone, Etoposide
- Keywords
- Therapy-related myelodysplastic syndrome/ Therapy -related Acute myeloid leukemia, Myelodysplastic syndrome, Acute myeloid leukemia
- Medical subject headings
- Myelodysplastic Syndromes, Leukemia, Myeloid, Acute
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Ara-CDrug
Also called Cytarabine, HiDAC
Induction: 3000mg/m2 IV infusion for day 1 and day 5
Mobilization: within 2 weeks of end of induction therapy - 2000mg/m2 as 2 hour IV infusion once every 12 hours for 3 days (6 doses total)
MitoxantroneDrug
Induction: 30mg/m2 after the end of HiDAC day 1 and day 5
EtoposideDrug
Also called VP-16
Mobilization: 30mg/kg over 6 doses given once every 12 hours for 3 days
| Study group | Role | What they receive |
|---|---|---|
| Induction chemotherapy followed by stem cell transplant | Experimental | Ara-C Mitoxantrone Etoposide Stem cell mobilization Autologous transplant Receives: Drug: Ara-C; Drug: Mitoxantrone; Drug: Etoposide |
What is being measured
The primary outcome is the main question the study is designed to answer.
Response to Induction Chemotherapy (CR or PR)
Complete remission (CR): <5% bone marrow blasts with recovery of peripheral blood counts; complete cytogenetic remission, the disappearance of any pre-existing cytogenetic abnormality Partial remission (PR): >5% bone marrow blasts, but less than the pre-treatment blast percentage within the bone marrow Resistant disease (RD): no significant cytoreduction in bone marrow leukemic cells from pre-treatment levels Not evaluable (NE): patients who died during induction chemotherapy or who withdrew from follow-up before assessment could be made
Measured: Day 28-40
Overall Survival
Measured: Up to 2000 days
Relapse-free Survival
Relapse is defined as bone marrow blasts >5% if the patient had achieved a complete remission, or the recurrence of any clonal cytogenetic abnormality.
Measured: Up to 2000 days
Secondary outcomes (4)
Feasibility of Stem Cell Collection
Feasibility is the ability to cryopreserve >=2.0 x 10^6 CD34+ cells/kg
Measured: 1-5 days from initiation of stem cell collection
Numbers of Stem Cells Collected
Measured: 1-5 days from initiation of stem cell collection
Overall Survival in Patients Undergoing Autologous Stem Cell Transplant
Measured: Up to 817 days
Disease-free Survival in Patients Undergoing Autologous Stem Cell Transplant
Measured: Up to 883 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Oct 2008 (estimated)
- Study startDec 2002
- Primary completionMar 2011
- Study completionMar 2011
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.
- Other trials for Myelodysplastic SyndromeStudies of the same condition, open and under way.
- More trials run by University of ChicagoThe 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 2
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 32 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Chicago
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Lucy Godley, M.D., Principal investigator, University of Chicago
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00774046
- Sponsor's protocol ID
- 11884A
- Status last verified
- Jan 2014
- First submitted
- 15 Oct 2008
- Last updated
- 11 Feb 2014
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 11 Feb 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- High-dose Cytarabine/Mitoxantrone Followed by Autotransplantation for Therapy-Related Myelodysplastic Syndrome/Therapy -Related Acute Myeloid Leukemia
- ClinicalTrials.gov ID
- NCT00774046
- Acronym / sponsor ID
- 11884A
- Conditions
- Myelodysplastic Syndrome, Acute Myeloid Leukemia
- Keywords
- Therapy-related myelodysplastic syndrome/ Therapy -related Acute myeloid leukemia, Myelodysplastic syndrome, Acute myeloid leukemia
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 32 participants (actual)
- Lead sponsor
- University of ChicagoUniversity, hospital or other
- Study start
- Dec 2002
- Primary completion
- Mar 2011 (actual)
- Study completion
- Mar 2011 (actual)
- First posted
- 16 Oct 2008 (estimated)
- Results
- Posted 24 Jun 2013
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of this study is to determine the effectiveness of a particular combination of drugs used to treat cancer.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Induction chemotherapy followed by stem cell transplant | Experimental | Drug: Ara-C, Drug: Mitoxantrone, Drug: EtoposideAra-C Mitoxantrone Etoposide Stem cell mobilization Autologous transplant |
Who may qualify
- Ages
- 10 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (5 listed)
- Patients must have received cytotoxic chemotherapy,radiation,or a drug known to affect the properties of DNA or cell growth for some condition other than acute myeloid leukemia prior to diagnosis.
- Patients must have t-MDS/t-AML
- To be eligible for allogeneic transplantation, patients must have a suitable donor who is HLA compatible.
- Patients must be over the age of 10.
- Patients must be reviewed and discussed at the Leukemia and Transplant Conferences of the Section of Hematology/Oncology.
Key exclusion criteria (2 listed)
- Patients must not have any other serious medical condition(e.g.uncontrolled or severe cardiovascular disease, diabetes, pulmonary disease, or infection)
- Psychiatric condition which would prevent compliance or possibly be worsened by treatment
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 |
|---|---|---|
| Ara-CAlso: Cytarabine, HiDACInduction: 3000mg/m2 IV infusion for day 1 and day 5 Mobilization: within 2 weeks of end of induction therapy - 2000mg/m2 as 2 hour IV infusion once every 12 hours for 3 days (6 doses total) | Drug | Induction chemotherapy followed by stem cell transplant |
| MitoxantroneInduction: 30mg/m2 after the end of HiDAC day 1 and day 5 | Drug | Induction chemotherapy followed by stem cell transplant |
| EtoposideAlso: VP-16Mobilization: 30mg/kg over 6 doses given once every 12 hours for 3 days | Drug | Induction chemotherapy followed by stem cell transplant |
Primary outcome
Response to Induction Chemotherapy (CR or PR)
Time frame: Day 28-40
Complete remission (CR): <5% bone marrow blasts with recovery of peripheral blood counts; complete cytogenetic remission, the disappearance of any pre-existing cytogenetic abnormality Partial remission (PR): >5% bone marrow blasts, but less than the pre-treatment blast percentage within the bone marrow Resistant disease (RD): no significant cytoreduction in bone marrow leukemic cells from pre-treatment levels Not evaluable (NE): patients who died during induction chemotherapy or who withdrew from follow-up before assessment could be made
Overall Survival
Time frame: Up to 2000 days
Relapse-free Survival
Time frame: Up to 2000 days
Relapse is defined as bone marrow blasts >5% if the patient had achieved a complete remission, or the recurrence of any clonal cytogenetic abnormality.
4 secondary outcomes
Feasibility of Stem Cell Collection
Time frame: 1-5 days from initiation of stem cell collection
Numbers of Stem Cells Collected
Time frame: 1-5 days from initiation of stem cell collection
Overall Survival in Patients Undergoing Autologous Stem Cell Transplant
Time frame: Up to 817 days
Disease-free Survival in Patients Undergoing Autologous Stem Cell Transplant
Time frame: Up to 883 days
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Feb 2014.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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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.
Lucy Godley, M.D. principal investigator
University of Chicago
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Ara-C, Mitoxantrone and Etoposide in people with Myelodysplastic Syndrome and Acute Myeloid Leukemia, run by University of Chicago 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 5 inclusion and 2 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 Feb 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 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 24 Jun 2013). 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?
Response to Induction Chemotherapy (CR or PR) (time frame: Day 28-40). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 Feb 2014.