Stem Cell TransplantationPhase 2NCT00813124
Azacitidine After Allo Blood And Marrow Transplantation (BMT) for Chronic Myelogenous Leukemia (CML)
A Phase 2 study testing Fludarabine, Busulfan and Thymoglobulin in people with Stem Cell Transplantation and Leukemia, 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 Vidaza (azacitidine) when given to patients with CML after an donor stem cell transplant will increase the likelihood of achieving a complete remission of CML. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Stem Cell Transplantation, Leukemia
- What is being tested?
- Fludarabine, Busulfan and Thymoglobulin
- Type of treatment
- Injection or infusion, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 24 participants
- Where
- 1 siteUnited States
- Study dates
- Dec 2008to Sep 2014
- 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 18 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients with age <= 75 years with CML in first chronic phase, which has failed to achieve a cytogenetic or molecular complete remission or has progressed after imatinib treatment. Criteria for failure are the international consensus criteria (Appendix H). Patients intolerant to tyrosine kinase inhibitor therapy are also eligible.
- Patients with age <= 75 with CML in accelerated phase or blast crisis that have <= 15% blasts in the blood and bone marrow at study entry.
- Donor: HLA-compatible related (HLA-A, -B, -DRB1 matched or with one-antigen mismatch) or HLA-compatible unrelated (HLA-A, -B, -C and -DRB1 matched or with one-antigen mismatch).
- Age 18 to 75 years.
- Zubrod performance status <= 2.
- Left ventricular ejection fraction => 40%.
Show all 12Show fewer
- Pulmonary function test within the following parameters: forced expiratory volume at one second (FEV1), forced vital capacity (FVC) and diffusing capacity of lung for carbon monoxide (DLCO) => 50% of expected, corrected for hemoglobin.
- Serum creatinine < 1.5 mg/dL or creatinine clearance greater or equal than 40 cc/min.
- Serum direct bilirubin < 1.5 mg/dL (unless Gilbert's syndrome)
- Serum glutamate pyruvate transaminase (SGPT) <= 200 IU/L unless related to patient's malignancy.
- Patients treated with any tyrosine kinase inhibitor, interferon or any experimental therapy are eligible.
- Patients with age <75 years with CML in second or subsequent chronic phase.
Who cannot join
- Uncontrolled infection, not responding to appropriate antimicrobial agents after seven days of therapy.
- Pleural/pericardial effusion or ascites estimated to be >1L.
- HIV-positive.
- Breast feeding or pregnancy. Pregnancy means a positive beta human chorionic gonadotropin (HCG) test in a woman with child bearing potential defined as not post-menopausal for 12 months or no previous surgical sterilization.
- Known or suspected hypersensitivity to azacitidine or mannitol.
- Patients with advanced malignant hepatic tumors.
Trial locations and contacts
1 site in 1 country.
United States1 site
University of Texas MD Anderson Cancer Center
Houston, Texas, 77030
About this study
Official title: Azacitidine Maintenance Therapy After Allogeneic Stem Cell Transplantation for Chronic Myelogenous Leukemia (CML)
The goal of this clinical research study is to learn if Vidaza (azacitidine) when given to patients with CML after an donor stem cell transplant will increase the likelihood of achieving a complete remission of CML.
Read the detailed description
Study Drug:
Azacitidine is designed to block genes in cancer cells that stop the function of the tumor-fighting genes. By blocking the "bad" genes, the tumor-fighting genes may be able to work better.
Study Drug Administration and Procedures before the Stem Cell Transplant:
If you are found to be eligible to take part in this study, you will be given chemotherapy before the transplant of donor cells. The chemotherapy is designed to kill leukemia cells and will also block your body's ability to reject the donor cells that will be given to you during the transplant. You will receive the chemotherapy on the days before the transplant. You will receive the transplant on Day 0.
This low-level test dose of busulfan is to check how fast busulfan is processed by your body and cleared from your blood. This information will help the doctor decide the dose of busulfan you will receive. You may receive the busulfan test dose as an outpatient during the week before you are admitted to the hospital or as an inpatient on Day -8 (8 days before your stem cell transplant).
About 11 samples of blood (about 1 teaspoon each time) will be drawn for pharmacokinetic (PK) testing. PK testing measures the amount of study drug in the body at different time points. These blood samples will be drawn at various times before you receive busulfan and over the next 11 hours. These blood draws will be repeated again on the first day of high-dose busulfan treatment (Day -5).
A heparin lock line (small IV line) will be placed in your vein to lower the number of needle sticks needed for these draws. If it is not possible for the PK tests to be performed for technical or scheduling reasons, you will receive the standard fixed dose of busulfan.
On Days -5 through -2, you will receive fludarabine by vein over 1 hour, then busulfan by vein over 3 hours.
If you are going to be receiving a transplant from an unrelated donor, or if you have a donor that is mismatched, you will also receive antithymocyte globulin (ATG) by vein over 4 hours on the 3 days before the transplant. This drug is designed to further weaken your immune system to reduce the risk of rejecting of the transplant.
Stem Cell Transplant:
After the blood-forming cells are collected from the donor, they will be given to you by vein. You will be given standard drugs to help decrease the risk of side effects. You may ask the study staff for information about how the drugs are given and their risks.
Drugs to Prevent Infections:
You will receive several drugs to help the stem cell transplant work and to help decrease the risks of infections while your immune system is weak. Tacrolimus and methotrexate will be given to decrease the risk of graft-versus-host disease (GVHD), a problem that may occur if the donor's immune cells fight your body.
- Tacrolimus will be started 2 days before the transplant and will continue for as long as your doctor thinks is necessary. This is usually 3-12 months, but may be longer if you develop GVHD. Tacrolimus is given by vein non-stop until you are able to eat. Once you can eat, it will be given by mouth.
- Methotrexate is given by vein over about 15-30 minutes on Days 1, 3, 6, and 11.
Several drugs will also be given to decrease the risk of other infections. Some of these antibiotics are given by vein, and some are given as pills. The length of time that you will take the antibiotics will vary. Your doctor will describe this to you in more detail.
Study Drug Administration after the Stem Cell Transplant:
You will receive azacitidine as an injection under the skin once a day over 5 days in a row, starting about 5 weeks after the transplant. This may be repeated once a month for up to 4 months after the transplant. You will have about 23 days of "rest" between each cycle of treatment (a cycle is the period of 28 days). If intolerable side effects occur, treatment with azacitidine may be interrupted or stopped altogether.
Study Visits:
You will be in the hospital for about 3-4 weeks after the transplant. You will have check-ups every day until you leave the hospital. After you leave, the number of study visits will vary, depending on your condition.
You will have bone marrow aspirations collected before chemotherapy, around 1, 6, and 12 months after the transplant. To collect a bone marrow aspirate, an area of the hip bone is numbed with anesthetic, and a small amount of bone marrow is withdrawn through a large needle. The bone marrow samples will be used to check the status of the disease and to learn the way azacitidine works.
Blood (about 2 teaspoons each time) will be drawn to learn about patterns of a process called methylation. Methylation is a process by which the body may turn "on and off" certain genes. Blood will be drawn at the following times:
- At baseline.
- Before the stem cell transplant (Day 0).
- Six (6), 9, and 12 months after the transplant.
- Before you receive your first dose of azacitidine (Day 1 of each cycle).
- After you receive the last dose of azacitidine (Day 5 of each cycle).
Blood (about 8 teaspoons each time) will be drawn to learn about the body's immune system recovery, at the following times:
- Cycle 1- Day 1
- Cycle 1 - Day 14
- Cycle 3 - Day 1
Length of Study:
You will remain on study for up to 1 year. You may be taken off study early if the disease gets worse or intolerable side effects occur.
This is an investigational study. Azacitidine is FDA approved and commercially available in patients with myelodysplastic syndrome. Its use in patients with CML is investigational. All other drugs used in this study are FDA approved and commercially available.
Up to 57 patients will take part in this study. All will be enrolled at MD Anderson.
- Conditions
- Stem Cell Transplantation, Leukemia
- Being tested
- Fludarabine, Busulfan, Thymoglobulin, Azacitidine, Stem Cell Transplant
- Keywords
- Chronic Myelogenous Leukemia, CML, Donor stem cell transplant, Allogeneic stem cell transplantation, Stem cell transplant, ATG, Antithymocyte globulin, Vidaza, Azacitidine, 5-Azacitidine, 5-Aza, 5-AZC, Ladakamycin, NSC-102816, allotx, Busulfan, Busulfex, Myleran, Fludarabine, Fludarabine Phosphate
- Medical subject headings
- Leukemia, Leukemia, Myelogenous, Chronic, BCR-ABL Positive, Graft vs Host Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
FludarabineDrug
Also called Fludarabine Phosphate
40 mg/m^2 by vein over 60 minutes on Day -5 through Day -2.
BusulfanDrug
Also called Busulfex, Myleran
Busulfan administered at the dose calculated to achieve an area under curve (AUC) of 4000 µMol-min + 12% based on the pharmacokinetic studies (days -5, -4, -3, and -2).
ThymoglobulinDrug
Also called Antithymocyte globulin, ATG
2.5 mg/kg by vein over about 4-6 hours on Day -3 through Day -1.
AzacitidineDrug
Also called 5-Azacitidine, 5-Aza, 5-AZC, Ladakamycin
Start cycles of 32 mg/m^2 daily as an injection under the skin once a day over 5 days in a row, starting about 5 weeks after the transplant. This may be repeated once a month for up to 4 months after the transplant.
Stem Cell TransplantProcedure or surgery
Also called allotx, allogeneic stem cell transplantation
Stem cell infusion on day 0 administered by vein after collected from donor.
| Study group | Role | What they receive |
|---|---|---|
| Azacytidine Maintenance after allotx | Experimental | Busulfan + Fludarabine + ATG + Azacytidine after allogeneic stem cell transplantation (allotx) Receives: Drug: Fludarabine; Drug: Busulfan; Drug: Thymoglobulin; Drug: Azacitidine; Procedure: Stem Cell Transplant |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of Participants With Molecular Response
Molecular Remission defined as two consecutive bone marrow samples done one month apart with negative PCR( polymerase chain reaction) tor CML.
Measured: 12 month post BMT
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Dec 2008 (estimated)
- Study startDec 2008
- Primary completionSep 2014
- Study completionSep 2014
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 Stem Cell TransplantationStudies 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
- 24 participants (actual)
Sponsor and investigators
- Lead sponsor
- M.D. Anderson Cancer Center
- Sponsor type
- University, hospital or other
- Collaborators
- National Cancer Institute (NCI), Celgene Corporation
- Responsible party
- Sponsor
- Investigators
- Richard E. Champlin, MD, BS, Principal investigator, M.D. Anderson Cancer Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00813124
- Sponsor's protocol ID
- 2008-0087
- Other IDs
- NCI-2012-02122
- Status last verified
- Jan 2021
- First submitted
- 18 Dec 2008
- Last updated
- 11 Feb 2021
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 11 Feb 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Azacitidine Maintenance Therapy After Allogeneic Stem Cell Transplantation for Chronic Myelogenous Leukemia (CML)
- ClinicalTrials.gov ID
- NCT00813124
- Acronym / sponsor ID
- 2008-0087
- Conditions
- Stem Cell Transplantation, Leukemia
- Keywords
- Chronic Myelogenous Leukemia, CML, Donor stem cell transplant, Allogeneic stem cell transplantation, Stem cell transplant, ATG, Antithymocyte globulin, Vidaza
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 24 participants (actual)
- Lead sponsor
- M.D. Anderson Cancer CenterUniversity, hospital or other
- Collaborators
- National Cancer Institute (NCI), Celgene Corporation
- Study start
- Dec 2008
- Primary completion
- Sep 2014 (actual)
- Study completion
- Sep 2014 (actual)
- First posted
- 22 Dec 2008 (estimated)
- Results
- Posted 7 Jan 2021
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 Vidaza (azacitidine) when given to patients with CML after an donor stem cell transplant will increase the likelihood of achieving a complete remission of CML.
Detailed description
Study Drug:
Azacitidine is designed to block genes in cancer cells that stop the function of the tumor-fighting genes. By blocking the "bad" genes, the tumor-fighting genes may be able to work better.
Study Drug Administration and Procedures before the Stem Cell Transplant:
If you are found to be eligible to take part in this study, you will be given chemotherapy before the transplant of donor cells. The chemotherapy is designed to kill leukemia cells and will also block your body's ability to reject the donor cells that will be given to you during the transplant. You will receive the chemotherapy on the days before the transplant. You will receive the transplant on Day 0.
This low-level test dose of busulfan is to check how fast busulfan is processed by your body and cleared from your blood. This information will help the doctor decide the dose of busulfan you will receive. You may receive the busulfan test dose as an outpatient during the week before you are admitted to the hospital or as an inpatient on Day -8 (8 days before your stem cell transplant).
About 11 samples of blood (about 1 teaspoon each time) will be drawn for pharmacokinetic (PK) testing. PK testing measures the amount of study drug in the body at different time points. These blood samples will be drawn at various times before you receive busulfan and over the next 11 hours. These blood draws will be repeated again on the first day of high-dose busulfan treatment (Day -5).
A heparin lock line (small IV line) will be placed in your vein to lower the number of needle sticks needed for these draws. If it is not possible for the PK tests to be performed for technical or scheduling reasons, you will receive the standard fixed dose of busulfan.
On Days -5 through -2, you will receive fludarabine by vein over 1 hour, then busulfan by vein over 3 hours.
If you are going to be receiving a transplant from an unrelated donor, or if you have a donor that is mismatched, you will also receive antithymocyte globulin (ATG) by vein over 4 hours on the 3 days before the transplant. This drug is designed to further weaken your immune system to reduce the risk of rejecting of the transplant.
Stem Cell Transplant:
After the blood-forming cells are collected from the donor, they will be given to you by vein. You will be given standard drugs to help decrease the risk of side effects. You may ask the study staff for information about how the drugs are given and their risks.
Drugs to Prevent Infections:
You will receive several drugs to help the stem cell transplant work and to help decrease the risks of infections while your immune system is weak. Tacrolimus and methotrexate will be given to decrease the risk of graft-versus-host disease (GVHD), a problem that may occur if the donor's immune cells fight your body.
- Tacrolimus will be started 2 days before the transplant and will continue for as long as your doctor thinks is necessary. This is usually 3-12 months, but may be longer if you develop GVHD. Tacrolimus is given by vein non-stop until you are able to eat. Once you can eat, it will be given by mouth.
- Methotrexate is given by vein over about 15-30 minutes on Days 1, 3, 6, and 11.
Several drugs will also be given to decrease the risk of other infections. Some of these antibiotics are given by vein, and some are given as pills. The length of time that you will take the antibiotics will vary. Your doctor will describe this to you in more detail.
Study Drug Administration after the Stem Cell Transplant:
You will receive azacitidine as an injection under the skin once a day over 5 days in a row, starting about 5 weeks after the transplant. This may be repeated once a month for up to 4 months after the transplant. You will have about 23 days of "rest" between each cycle of treatment (a cycle is the period of 28 days). If intolerable side effects occur, treatment with azacitidine may be interrupted or stopped altogether.
Study Visits:
You will be in the hospital for about 3-4 weeks after the transplant. You will have check-ups every day until you leave the hospital. After you leave, the number of study visits will vary, depending on your condition.
You will have bone marrow aspirations collected before chemotherapy, around 1, 6, and 12 months after the transplant. To collect a bone marrow aspirate, an area of the hip bone is numbed with anesthetic, and a small amount of bone marrow is withdrawn through a large needle. The bone marrow samples will be used to check the status of the disease and to learn the way azacitidine works.
Blood (about 2 teaspoons each time) will be drawn to learn about patterns of a process called methylation. Methylation is a process by which the body may turn "on and off" certain genes. Blood will be drawn at the following times:
- At baseline.
- Before the stem cell transplant (Day 0).
- Six (6), 9, and 12 months after the transplant.
- Before you receive your first dose of azacitidine (Day 1 of each cycle).
- After you receive the last dose of azacitidine (Day 5 of each cycle).
Blood (about 8 teaspoons each time) will be drawn to learn about the body's immune system recovery, at the following times:
- Cycle 1- Day 1
- Cycle 1 - Day 14
- Cycle 3 - Day 1
Length of Study:
You will remain on study for up to 1 year. You may be taken off study early if the disease gets worse or intolerable side effects occur.
This is an investigational study. Azacitidine is FDA approved and commercially available in patients with myelodysplastic syndrome. Its use in patients with CML is investigational. All other drugs used in this study are FDA approved and commercially available.
Up to 57 patients will take part in this study. All will be enrolled at MD Anderson.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Azacytidine Maintenance after allotx | Experimental | Drug: Fludarabine, Drug: Busulfan, Drug: Thymoglobulin, Drug: Azacitidine, Procedure: Stem Cell TransplantBusulfan + Fludarabine + ATG + Azacytidine after allogeneic stem cell transplantation (allotx) |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (12 listed)
- Patients with age <= 75 years with CML in first chronic phase, which has failed to achieve a cytogenetic or molecular complete remission or has progressed after imatinib treatment. Criteria for failure are the international consensus criteria (Appendix H). Patients intolerant to tyrosine kinase inhibitor therapy are also eligible.
- Patients with age <= 75 with CML in accelerated phase or blast crisis that have <= 15% blasts in the blood and bone marrow at study entry.
- Donor: HLA-compatible related (HLA-A, -B, -DRB1 matched or with one-antigen mismatch) or HLA-compatible unrelated (HLA-A, -B, -C and -DRB1 matched or with one-antigen mismatch).
- Age 18 to 75 years.
- Zubrod performance status <= 2.
Key exclusion criteria (6 listed)
- Uncontrolled infection, not responding to appropriate antimicrobial agents after seven days of therapy.
- Pleural/pericardial effusion or ascites estimated to be >1L.
- HIV-positive.
- Breast feeding or pregnancy. Pregnancy means a positive beta human chorionic gonadotropin (HCG) test in a woman with child bearing potential defined as not post-menopausal for 12 months or no previous surgical sterilization.
- Known or suspected hypersensitivity to azacitidine or mannitol.
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 |
|---|---|---|
| FludarabineAlso: Fludarabine Phosphate40 mg/m^2 by vein over 60 minutes on Day -5 through Day -2. | Drug | Azacytidine Maintenance after allotx |
| BusulfanAlso: Busulfex, MyleranBusulfan administered at the dose calculated to achieve an area under curve (AUC) of 4000 µMol-min + 12% based on the pharmacokinetic studies (days -5, -4, -3, and -2). | Drug | Azacytidine Maintenance after allotx |
| ThymoglobulinAlso: Antithymocyte globulin, ATG2.5 mg/kg by vein over about 4-6 hours on Day -3 through Day -1. | Drug | Azacytidine Maintenance after allotx |
| AzacitidineAlso: 5-Azacitidine, 5-Aza, 5-AZC, LadakamycinStart cycles of 32 mg/m^2 daily as an injection under the skin once a day over 5 days in a row, starting about 5 weeks after the transplant. This may be repeated once a month for up to 4 months after the transplant. | Drug | Azacytidine Maintenance after allotx |
| Stem Cell TransplantAlso: allotx, allogeneic stem cell transplantationStem cell infusion on day 0 administered by vein after collected from donor. | Procedure or surgery | Azacytidine Maintenance after allotx |
Primary outcome
Number of Participants With Molecular Response
Time frame: 12 month post BMT
Molecular Remission defined as two consecutive bone marrow samples done one month apart with negative PCR( polymerase chain reaction) tor CML.
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Feb 2021.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- University of Texas 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.
Richard E. Champlin, MD, BS principal investigator
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 2 study testing Fludarabine, Busulfan and Thymoglobulin in people with Stem Cell Transplantation and Leukemia, 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 12 inclusion and 6 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 2021. 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 7 Jan 2021). 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?
Number of Participants With Molecular Response (time frame: 12 month post BMT). 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 2021.