LeukemiaPhase 2NCT01019317
Fludarabine and Cytarabine in Acute Myelogenous Leukemia (AML) and High-Risk Myelodysplastic Syndrome (MDS)
A Phase 2 study testing Cytarabine and Fludarabine in people with Leukemia and AML, run by M.D. Anderson Cancer Center at 1 site in United States.
Trial summary
The goal of this clinical research study is to learn if the combination of fludarabine and cytarabine can help to control Acute Myelogenous Leukemia (AML), High-Risk Myelodysplastic Syndrome (MDS) or Chronic Myeloid Leukemia (CML) in myeloid blast crisis. The safety of this drug combination will also be studied. Read more about this study
- Who is it for?
- Ages 12 years and older
- What is being tested?
- Cytarabine and Fludarabine
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 151 participants
- Where
- 1 siteUnited States
- Study dates
- Nov 2009to Sep 2012
- 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 12 years and older
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Sign an Internal Review Board (IRB)-approved informed consent document.
- Age >/= 12 years.
- Diagnosis of AML [other than acute promyelocytic leukemia (APL)] with refractory/relapsed disease. Patients with newly diagnosed AML will be eligible if not a candidate for intensive chemotherapy. Patients with high-risk (intermediate-2 or high by IPSS or >/=10% blasts) MDS will also be eligible. Patients with chronic myeloid leukemia (CML) in blast crisis will be eligible as well.
- Eastern Cooperative Oncology Group (ECOG) performance status of </= 3 at study entry.
- Organ function as defined below (unless due to leukemia):
- Serum creatinine </= 3 mg/dL; ii. Total bilirubin </= 3 mg/dL; iii. Alanine aminotransferase (ALT)(Serum Glutamic Pyruvate Transaminase (SGPT)) </= 5 times upper limit of normal (ULN) or </= 10 times ULN if related to disease.
- Women of childbearing potential (WCBP) must have a negative serum or urine pregnancy test within 7 days . Men must agree not to father a child and agree to use a condom if his partner is of child bearing potential.
Who cannot join
- Pregnant or breastfeeding females.
- Diagnosis of acute promyelocytic leukemia (M3).
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Phase II Study of Twice Daily Cytarabine and Fludarabine in Acute Myelogenous Leukemia and High-Risk Myelodysplastic Syndrome
The goal of this clinical research study is to learn if the combination of fludarabine and cytarabine can help to control Acute Myelogenous Leukemia (AML), High-Risk Myelodysplastic Syndrome (MDS) or Chronic Myeloid Leukemia (CML) in myeloid blast crisis. The safety of this drug combination will also be studied.
Read the detailed description
The Study Drugs Fludarabine is designed to make cancer cells less able to repair damaged DNA (the genetic material of cells). This may increase the likelihood of the cells dying.
Cytarabine is designed to insert itself into DNA and stop the DNA from repairing itself.
Study Drug Administration:
If you are found to be eligible to take part in this study, you will receive fludarabine and cytarabine.
During each cycle (about 4-6 weeks), you will receive the study drugs for up to 5 days and you will be watched by the study staff for about 1 month.
Induction (Cycle 1):
For 3, 4, or 5 days during Days 1-5 of Cycle 1, you will receive fludarabine by vein over 15-30 minutes 2 times a day (about every 12 hours).
For 3, 4, or 5 days during Days 1-5 of Cycle 1, you will receive cytarabine by vein over about 2 hours 2 times a day (about every 12 hours).
If the cancer does not completely respond after Cycle 1, you may repeat induction (Cycle 1).
If the cancer completely responds, you will begin the consolidation cycles.
Consolidation (Cycles 2-7):
For 3 or 4 days during Days 1-4 of Cycles 2-7, you will receive fludarabine by vein over 15-30 minutes 2 times a day (about every 12 hours).
For 3 or 4 days during Days 1-4 of Cycles 2-7, you will receive cytarabine by vein over about 2 hours 2 times a day (about every 12 hours).
Study Visits:
At each study visit, you will be asked about any side effects you may be having and about any other drugs you may be taking.
During Induction Therapy (Cycle 1):
- Blood (about 2 tablespoons) will be drawn for routine tests every 3-7 days.
- About Day 28, you may have a bone marrow aspirate to check the status of the disease.
During Consolidation Therapy (Cycles 2-7):
- Blood (about 2 tablespoons) will be drawn for routine tests every 1-2 weeks.
- You will have a bone marrow aspirate every 2-3 cycles to check the status of the disease.
Length of Study:
You will be able to receive the study drugs for up to about 8 months. You will be taken off study treatment if you have intolerable side effects, if the disease gets worse, or if the study doctor thinks it is in your best interest.
Long-Term Follow-Up:
Every 3 months for 2 years after you are off study treatment, you will be called and asked how you are feeling, about any side effects you may be having, and about another other drugs you may be taking.
Supportive Care:
Please talk with your doctor about drugs that you can or cannot take while you are on study.
This is an investigational study. Cytarabine is FDA approved and commercially available as a frontline (first) treatment for AML. Fludarabine is FDA approved and commercially available for the treatment of CLL.
The combination of these 2 drugs to treat AML, MDS, or CML in myeloid blast crisis is investigational.
Up to 150 patients will take part in this study. All will be enrolled at M. D. Anderson.
- Being tested
- Cytarabine, Fludarabine
- Keywords
- Acute Myelogenous Leukemia, High-Risk Myelodysplastic Syndrome, Chronic myeloid leukemia, CML, Blast crisis, Cytarabine, Ara-C, Cytosar, DepoCyt, Cytosine arabinosine hydrochloride, Arabinosine Hydrochloride, Fludarabine, Fludarabine Phosphate, Fludara, Gemtuzumab Ozogamicin, Mylotarg
- Medical subject headings
- Leukemia, Leukemia, Myeloid, Acute, Leukemia, Myelogenous, Chronic, BCR-ABL Positive, Blast Crisis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CytarabineDrug
Also called Ara-C, Cytosar, DepCyt, Cytosine arabinosine hydrochloride
0.5 grams/m^2 over 2 hours(+/- 15 minutes) IV every 12 (+/-2) hours for 5 days (4 days in patients > 65 years and 3 days in patients with Eastern Cooperative Oncology Group (ECOG) performance status (PS) > 3).
FludarabineDrug
Also called Fludara, Fludarabine Phosphate
15 mg/m^2 to be given IV over 15-30 minutes every 12 (+/- 2) hours for 5 days. (4 days in patients > 65 years and 3 days in patients with PS > 3).
| Study group | Role | What they receive |
|---|---|---|
| Cytarabine + Fludarabine | Experimental | Fludarabine 15 mg/m^2 intravenous (IV) every 12 hours for 5 days; Cytarabine 0.5 grams/m^2 IV over 2 hours every 12 hours for 5 days. Receives: Drug: Cytarabine; Drug: Fludarabine |
What is being measured
The primary outcome is the main question the study is designed to answer.
Participants With a Complete Response
Complete Response (CR) was defined as: Neutrophil count ≥ 1.0 ×109/L, Platelet count ≥ 100 ×109/L, Bone marrow aspirate ≤5% blasts and No extramedullary leukemia. Response evaluation following Induction Therapy (Cycle 1) and every 2-3 cycles during Consolidation Therapy (Cycles 2 - 7) where Cycle is 4-6 weeks.
Measured: Minimally 6 weeks (Cycle 1) up to 1 year (7 cycles)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Nov 2009 (estimated)
- Study startNov 2009
- Primary completionSep 2012
- Study completionSep 2012
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 LeukemiaStudies of the same condition, open and under way.
- More trials run by M.D. Anderson Cancer CenterThe 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
- 151 participants (actual)
Sponsor and investigators
- Lead sponsor
- M.D. Anderson Cancer Center
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Elias Jabbour, MD, Study chair, UT MD Anderson Cancer Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01019317
- Sponsor's protocol ID
- 2009-0781
- Status last verified
- Oct 2013
- First submitted
- 23 Nov 2009
- Last updated
- 15 Mar 2016
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 15 Mar 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase II Study of Twice Daily Cytarabine and Fludarabine in Acute Myelogenous Leukemia and High-Risk Myelodysplastic Syndrome
- ClinicalTrials.gov ID
- NCT01019317
- Acronym / sponsor ID
- 2009-0781
- Keywords
- Acute Myelogenous Leukemia, High-Risk Myelodysplastic Syndrome, Chronic myeloid leukemia, CML, Blast crisis, Cytarabine, Ara-C, Cytosar
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 151 participants (actual)
- Lead sponsor
- M.D. Anderson Cancer CenterUniversity, hospital or other
- Study start
- Nov 2009
- Primary completion
- Sep 2012 (actual)
- Study completion
- Sep 2012 (actual)
- First posted
- 25 Nov 2009 (estimated)
- Results
- Posted 3 Dec 2013
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The goal of this clinical research study is to learn if the combination of fludarabine and cytarabine can help to control Acute Myelogenous Leukemia (AML), High-Risk Myelodysplastic Syndrome (MDS) or Chronic Myeloid Leukemia (CML) in myeloid blast crisis. The safety of this drug combination will also be studied.
Detailed description
The Study Drugs Fludarabine is designed to make cancer cells less able to repair damaged DNA (the genetic material of cells). This may increase the likelihood of the cells dying.
Cytarabine is designed to insert itself into DNA and stop the DNA from repairing itself.
Study Drug Administration:
If you are found to be eligible to take part in this study, you will receive fludarabine and cytarabine.
During each cycle (about 4-6 weeks), you will receive the study drugs for up to 5 days and you will be watched by the study staff for about 1 month.
Induction (Cycle 1):
For 3, 4, or 5 days during Days 1-5 of Cycle 1, you will receive fludarabine by vein over 15-30 minutes 2 times a day (about every 12 hours).
For 3, 4, or 5 days during Days 1-5 of Cycle 1, you will receive cytarabine by vein over about 2 hours 2 times a day (about every 12 hours).
If the cancer does not completely respond after Cycle 1, you may repeat induction (Cycle 1).
If the cancer completely responds, you will begin the consolidation cycles.
Consolidation (Cycles 2-7):
For 3 or 4 days during Days 1-4 of Cycles 2-7, you will receive fludarabine by vein over 15-30 minutes 2 times a day (about every 12 hours).
For 3 or 4 days during Days 1-4 of Cycles 2-7, you will receive cytarabine by vein over about 2 hours 2 times a day (about every 12 hours).
Study Visits:
At each study visit, you will be asked about any side effects you may be having and about any other drugs you may be taking.
During Induction Therapy (Cycle 1):
- Blood (about 2 tablespoons) will be drawn for routine tests every 3-7 days.
- About Day 28, you may have a bone marrow aspirate to check the status of the disease.
During Consolidation Therapy (Cycles 2-7):
- Blood (about 2 tablespoons) will be drawn for routine tests every 1-2 weeks.
- You will have a bone marrow aspirate every 2-3 cycles to check the status of the disease.
Length of Study:
You will be able to receive the study drugs for up to about 8 months. You will be taken off study treatment if you have intolerable side effects, if the disease gets worse, or if the study doctor thinks it is in your best interest.
Long-Term Follow-Up:
Every 3 months for 2 years after you are off study treatment, you will be called and asked how you are feeling, about any side effects you may be having, and about another other drugs you may be taking.
Supportive Care:
Please talk with your doctor about drugs that you can or cannot take while you are on study.
This is an investigational study. Cytarabine is FDA approved and commercially available as a frontline (first) treatment for AML. Fludarabine is FDA approved and commercially available for the treatment of CLL.
The combination of these 2 drugs to treat AML, MDS, or CML in myeloid blast crisis is investigational.
Up to 150 patients will take part in this study. All will be enrolled at M. D. Anderson.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Cytarabine + Fludarabine | Experimental | Drug: Cytarabine, Drug: FludarabineFludarabine 15 mg/m^2 intravenous (IV) every 12 hours for 5 days; Cytarabine 0.5 grams/m^2 IV over 2 hours every 12 hours for 5 days. |
Who may qualify
- Ages
- 12 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (7 listed)
- Sign an Internal Review Board (IRB)-approved informed consent document.
- Age >/= 12 years.
- Diagnosis of AML [other than acute promyelocytic leukemia (APL)] with refractory/relapsed disease. Patients with newly diagnosed AML will be eligible if not a candidate for intensive chemotherapy. Patients with high-risk (intermediate-2 or high by IPSS or >/=10% blasts) MDS will also be eligible. Patients with chronic myeloid leukemia (CML) in blast crisis will be eligible as well.
- Eastern Cooperative Oncology Group (ECOG) performance status of </= 3 at study entry.
- Organ function as defined below (unless due to leukemia):
Key exclusion criteria (2 listed)
- Pregnant or breastfeeding females.
- Diagnosis of acute promyelocytic leukemia (M3).
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 |
|---|---|---|
| CytarabineAlso: Ara-C, Cytosar, DepCyt, Cytosine arabinosine hydrochloride0.5 grams/m^2 over 2 hours(+/- 15 minutes) IV every 12 (+/-2) hours for 5 days (4 days in patients > 65 years and 3 days in patients with Eastern Cooperative Oncology Group (ECOG) performance status (PS) > 3). | Drug | Cytarabine + Fludarabine |
| FludarabineAlso: Fludara, Fludarabine Phosphate15 mg/m^2 to be given IV over 15-30 minutes every 12 (+/- 2) hours for 5 days. (4 days in patients > 65 years and 3 days in patients with PS > 3). | Drug | Cytarabine + Fludarabine |
Primary outcome
Participants With a Complete Response
Time frame: Minimally 6 weeks (Cycle 1) up to 1 year (7 cycles)
Complete Response (CR) was defined as: Neutrophil count ≥ 1.0 ×109/L, Platelet count ≥ 100 ×109/L, Bone marrow aspirate ≤5% blasts and No extramedullary leukemia. Response evaluation following Induction Therapy (Cycle 1) and every 2-3 cycles during Consolidation Therapy (Cycles 2 - 7) where Cycle is 4-6 weeks.
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Mar 2016.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- UT MD Anderson Cancer Center websiteLink provided by the sponsor.
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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.
Elias Jabbour, MD study chair
UT MD Anderson Cancer Center
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 Cytarabine and Fludarabine in people with Leukemia and AML, run by M.D. Anderson Cancer Center 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 7 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 15 Mar 2016. 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 3 Dec 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?
Participants With a Complete Response (time frame: Minimally 6 weeks (Cycle 1) up to 1 year (7 cycles)). 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 15 Mar 2016.