Acute Myelogenous LeukemiaPhase 3NCT00656448
A Randomized Trial of Procrit vs. No Procrit in AML and High Risk MDS
A Phase 3 study testing Procrit in people with Acute Myelogenous Leukemia and Myelodysplastic Syndrome, run by M.D. Anderson Cancer Center at 1 site in United States.
Trial summary
The goal of this clinical research study is to find out if Procrit (epoetin alfa) will help decrease the need for blood transfusions in patients who have Acute Myelogenous Leukemia (AML) or High-risk Myelodysplastic Syndrome (MDS) and are receiving chemotherapy. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Acute Myelogenous Leukemia, Myelodysplastic Syndrome, Leukemia
- What is being tested?
- Procrit
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 51 participants
- Where
- 1 siteUnited States
- Study dates
- Mar 2008to Jun 2013
- Phase
- Phase 3
- 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 Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Patients with a diagnosis of AML or high-risk MDS (based on International Prognostic Scoring System (IPSS): refractory anemia with excess of blasts (RAEB) or RAEB in transformation [RAEB-t]) receiving frontline induction chemotherapy with any high dose or conventional dose cytarabine-containing regimen or clofarabine-containing regimen at MD Anderson Cancer Center.
- Patients must be enrolled on the study within two weeks of the start of induction chemotherapy.
- Patients with documented iron, vitamin B12, or folate deficiency are eligible, but should receive replacement therapy while on study.
- Understand and voluntarily sign an informed consent form.
Who cannot join
- Patients with prior treatment with any form of erythropoietin within the previous month.
- Patients with uncontrolled hypertension (> or =140/90), uncontrolled, clinically significant cardiac arrhythmias, or history of pulmonary embolism or thrombosis within the last 5 years.
- New onset (within 3 months prior to randomization) or poorly controlled seizures.
- Patients with known hypersensitivity to the active substance or any of the excipients.
- Pregnant or lactating women.
- Acute Erythroleukemia (M6 French-American-British (FAB) classification)
Show all 11Show fewer
- Hemoglobin greater than or equal to 10g/dl
- Patients with head and neck cancer receiving radiation therapy when erythropoiesis-stimulating agents (ESAs) were given to maintain hemoglobin levels of more than 12 g/dL.
- Patients with metastatic breast cancer receiving chemotherapy when ESAs were given to maintain hemoglobin levels of more than 12 g/dL.
- Patients with chronic kidney failure when ESAs were given to maintain hemoglobin levels of more than 12 g/dL.
- Patients requiring major surgery would be taken off study due to a higher chance of blood clots being reported while taking ESAs.
Trial locations and contacts
1 site in 1 country.
United States1 site
The University of Texas M.D. Anderson Cancer Center
Houston, Texas, 77030
About this study
Official title: Randomized Study of Procrit vs no Procrit in Patients With Newly Diagnosed Acute Myelogenous Leukemia (AML) or High-risk Myelodysplastic Syndrome (MDS) Undergoing Frontline Myelosuppressive Induction/Consolidation Chemotherapy
The goal of this clinical research study is to find out if Procrit (epoetin alfa) will help decrease the need for blood transfusions in patients who have Acute Myelogenous Leukemia (AML) or High-risk Myelodysplastic Syndrome (MDS) and are receiving chemotherapy. Researchers also want to learn about the remission rates (rates of recovery) in patients with cancer who have received treatment with epoetin alfa. The safety and effectiveness of this therapy will also be studied.
Read the detailed description
Epoetin alfa is a medication that helps the body make more red blood cells. Researchers want to find out if it will be effective in reducing the need for blood transfusions in patients who have AML or high-risk MDS and are receiving chemotherapy.
If you are found to be eligible to take part in this study, you will be randomly assigned (as in the toss of a coin) to one of 2 treatment groups. Participants in one group will be given epoetin alfa along with blood transfusions, if the doctor thinks it is necessary. Participants in the other group will not receive epoetin alfa. Instead they will only have blood transfusions, which is the standard of care.
No matter what group you are in, you will receive transfusions if your hemoglobin (an element of red blood cells that carries oxygen) drops below a certain level or if the doctor thinks it is necessary. You will be asked to keep a diary listing the dates of all transfusions you receive.
The study doctor will monitor your hemoglobin levels by checking your standard blood tests done by your treating doctor. If your hemoglobin rises above a certain level, treatment with epoetin alfa may be temporarily stopped until your hemoglobin level decreases.
If you are assigned to receive epoetin alfa, you will receive it once a week by subcutaneous (just under the skin) injection during your regularly scheduled chemotherapy. You will receive treatment with epoetin alfa for up to 12 weeks.
If you experience any intolerable side effects or the disease gets worse, you will be taken off this study.
Participants in both groups will continue to receive chemotherapy during this study as regularly scheduled. During chemotherapy (as part of your standard of care), you will have around 1 tablespoon of blood drawn every 1-2 weeks for routine blood tests.
This is an investigational study. Epoetin alfa is FDA approved and commercially available. Up to 54 patients will take part in this study. All will be enrolled at the University of Texas (UT) MD Anderson Cancer Center.
- Being tested
- Procrit
- Keywords
- Acute Myelogenous Leukemia, AML, Myelodysplastic Syndrome, MDS, Leukemia, Procrit, Epoetin Alfa, Epogen
- Medical subject headings
- Leukemia, Myeloid, Acute, Myelodysplastic Syndromes, Leukemia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ProcritDrug
Also called Epoetin Alfa, Epogen
40,000 units sq every week starting within two weeks (before or after) from the start of induction chemotherapy.
| Study group | Role | What they receive |
|---|---|---|
| Procrit Arm | Experimental | Participants receive Procrit along with blood transfusions. Procrit 40,000 units subcutaneously every week starting within two weeks (before or after) from the start of induction chemotherapy. Receives: Drug: Procrit |
| No Procrit: Standard Arm | No intervention | Participants do not receive Procrit before receiving blood transfusions. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Median Number of Participant Transfusions Required During 12 Weeks of Treatment
The number and frequency of packed red blood cells (PRBC) transfusions assessed and compared between two groups, treatment group ("Procrit") and standard care group ("No Procrit"). Participants log all PRBC transfusions. Reported are the number of transfusions in the treatment arm during induction and consolidation chemotherapy with the concomitant use of epoetin alfa during therapy, and in the standard arm those that occured during same 12 week period.
Measured: 12 weeks
Secondary outcomes (1)
Number of Participants With Complete Remission
International Working Group (IWG) criteria for responses defined as: Complete Remission (CR) - Disappearance of all clinical and/or radiologic evidence of disease. Neutrophil count > 1.0 x 10^9/L and platelet count > 100 x 10^9/L, and normal bone marrow differential (< 5% blasts); Partial remission (PR): as CR except for presence of 5-25% marrow blasts and with a decrease of marrow blast at least 50%.
Measured: After 1 course of therapy, one course is 4 weeks.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Apr 2008 (estimated)
- Study startMar 2008
- Primary completionJun 2013
- Study completionJun 2013
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 Acute Myelogenous 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 3
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 51 participants (actual)
Sponsor and investigators
- Lead sponsor
- M.D. Anderson Cancer Center
- Sponsor type
- University, hospital or other
- Collaborators
- Centocor, Inc.
- Responsible party
- Sponsor
- Investigators
- Jorge E. Cortes, M.D., Study chair, M.D. Anderson Cancer Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00656448
- Sponsor's protocol ID
- 2005-0890
- Status last verified
- May 2018
- First submitted
- 7 Apr 2008
- Last updated
- 30 May 2018
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 30 May 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Randomized Study of Procrit vs no Procrit in Patients With Newly Diagnosed Acute Myelogenous Leukemia (AML) or High-risk Myelodysplastic Syndrome (MDS) Undergoing Frontline Myelosuppressive Induction/Consolidation Chemotherapy
- ClinicalTrials.gov ID
- NCT00656448
- Acronym / sponsor ID
- 2005-0890
- Keywords
- Acute Myelogenous Leukemia, AML, Myelodysplastic Syndrome, MDS, Leukemia, Procrit, Epoetin Alfa, Epogen
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 51 participants (actual)
- Lead sponsor
- M.D. Anderson Cancer CenterUniversity, hospital or other
- Collaborators
- Centocor, Inc.
- Study start
- Mar 2008
- Primary completion
- Jun 2013 (actual)
- Study completion
- Jun 2013 (actual)
- First posted
- 11 Apr 2008 (estimated)
- Results
- Posted 23 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 find out if Procrit (epoetin alfa) will help decrease the need for blood transfusions in patients who have Acute Myelogenous Leukemia (AML) or High-risk Myelodysplastic Syndrome (MDS) and are receiving chemotherapy. Researchers also want to learn about the remission rates (rates of recovery) in patients with cancer who have received treatment with epoetin alfa. The safety and effectiveness of this therapy will also be studied.
Detailed description
Epoetin alfa is a medication that helps the body make more red blood cells. Researchers want to find out if it will be effective in reducing the need for blood transfusions in patients who have AML or high-risk MDS and are receiving chemotherapy.
If you are found to be eligible to take part in this study, you will be randomly assigned (as in the toss of a coin) to one of 2 treatment groups. Participants in one group will be given epoetin alfa along with blood transfusions, if the doctor thinks it is necessary. Participants in the other group will not receive epoetin alfa. Instead they will only have blood transfusions, which is the standard of care.
No matter what group you are in, you will receive transfusions if your hemoglobin (an element of red blood cells that carries oxygen) drops below a certain level or if the doctor thinks it is necessary. You will be asked to keep a diary listing the dates of all transfusions you receive.
The study doctor will monitor your hemoglobin levels by checking your standard blood tests done by your treating doctor. If your hemoglobin rises above a certain level, treatment with epoetin alfa may be temporarily stopped until your hemoglobin level decreases.
If you are assigned to receive epoetin alfa, you will receive it once a week by subcutaneous (just under the skin) injection during your regularly scheduled chemotherapy. You will receive treatment with epoetin alfa for up to 12 weeks.
If you experience any intolerable side effects or the disease gets worse, you will be taken off this study.
Participants in both groups will continue to receive chemotherapy during this study as regularly scheduled. During chemotherapy (as part of your standard of care), you will have around 1 tablespoon of blood drawn every 1-2 weeks for routine blood tests.
This is an investigational study. Epoetin alfa is FDA approved and commercially available. Up to 54 patients will take part in this study. All will be enrolled at the University of Texas (UT) MD Anderson Cancer Center.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Procrit Arm | Experimental | Drug: ProcritParticipants receive Procrit along with blood transfusions. Procrit 40,000 units subcutaneously every week starting within two weeks (before or after) from the start of induction chemotherapy. |
| No Procrit: Standard Arm | No intervention | –Participants do not receive Procrit before receiving blood transfusions. |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (4 listed)
- Patients with a diagnosis of AML or high-risk MDS (based on International Prognostic Scoring System (IPSS): refractory anemia with excess of blasts (RAEB) or RAEB in transformation [RAEB-t]) receiving frontline induction chemotherapy with any high dose or conventional dose cytarabine-containing regimen or clofarabine-containing regimen at MD Anderson Cancer Center.
- Patients must be enrolled on the study within two weeks of the start of induction chemotherapy.
- Patients with documented iron, vitamin B12, or folate deficiency are eligible, but should receive replacement therapy while on study.
- Understand and voluntarily sign an informed consent form.
Key exclusion criteria (11 listed)
- Patients with prior treatment with any form of erythropoietin within the previous month.
- Patients with uncontrolled hypertension (> or =140/90), uncontrolled, clinically significant cardiac arrhythmias, or history of pulmonary embolism or thrombosis within the last 5 years.
- New onset (within 3 months prior to randomization) or poorly controlled seizures.
- Patients with known hypersensitivity to the active substance or any of the excipients.
- Pregnant or lactating women.
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 |
|---|---|---|
| ProcritAlso: Epoetin Alfa, Epogen40,000 units sq every week starting within two weeks (before or after) from the start of induction chemotherapy. | Drug | Procrit Arm |
Primary outcome
Median Number of Participant Transfusions Required During 12 Weeks of Treatment
Time frame: 12 weeks
The number and frequency of packed red blood cells (PRBC) transfusions assessed and compared between two groups, treatment group ("Procrit") and standard care group ("No Procrit"). Participants log all PRBC transfusions. Reported are the number of transfusions in the treatment arm during induction and consolidation chemotherapy with the concomitant use of epoetin alfa during therapy, and in the standard arm those that occured during same 12 week period.
1 secondary outcome
Number of Participants With Complete Remission
Time frame: After 1 course of therapy, one course is 4 weeks.
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 May 2018.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- The University of Texas MD Anderson Cancer Center's Official 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.
Jorge E. Cortes, M.D. study chair
M.D. 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 3 study testing Procrit in people with Acute Myelogenous Leukemia and Myelodysplastic Syndrome, 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 4 inclusion and 11 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 30 May 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 phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
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 23 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?
Median Number of Participant Transfusions Required During 12 Weeks of Treatment (time frame: 12 weeks). 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 30 May 2018.