LeukemiaPhase 2NCT01572662
Allogeneic Transplantation Using Timed Sequential Busulfan and Fludarabine Conditioning
A Phase 2 study testing Fludarabine monophosphate, Busulfan and Stem Cell Infusion in people with Leukemia and Acute Myeloid 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 giving busulfan and fludarabine before a stem cell transplant can help control the disease better than the standard method in patients with leukemia, lymphoma, multiple myeloma, MDS, or MPD. Read more about this study
- Who is it for?
- Ages 5 to 75 years
- Conditions the study is for
- Leukemia, Acute Myeloid Leukemia, Acute Lymphocytic Leukemia
- What is being tested?
- Fludarabine monophosphate, Busulfan and Stem Cell Infusion
- Type of treatment
- Pill or oral medicine, Injection or infusion, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 201 participants
- Where
- 1 siteUnited States
- Study dates
- 11 Apr 2012to 11 Aug 2022
- 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 5 to 75 years
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Patients with high-risk hematologic malignancies with anticipated poor prognosis with non transplant therapy, including those in remission or with induction failure and after treated or untreated relapse. Diagnoses to be included a) Acute myeloid leukemia; b) Acute lymphocytic leukemia; c) Chronic myeloid leukemia; d) Chronic lymphocytic leukemia; e) Myelodysplastic syndrome; f) Myeloproliferative syndromes; g) Non-Hodgkins lymphoma; h) Hodgkins Lymphoma; i) Multiple myeloma.
- Patients must have a histocompatible stem cell donor. An HLA-identical related donor or a 8/8 matched unrelated donor.
- Age 5 to 75 years old.
- Performance score of >/= 70 by Karnofsky/Lansky or PS 0 to 1 (ECOG </=1).
- Left ventricular ejection fraction at least 40%.
- Adequate pulmonary function with FEV1, FVC and DLCO >/=50% of expected corrected for hemoglobin and/or volume. Children unable to perform pulmonary function tests (e.g., less than 7 years old) pulse oximetry of >/= 92% on room air
Show all 10Show fewer
- Creatinine clearance (calculated creatinine clearance is permitted) should be >40 ml/min.
- Bilirubin </= 2 x the upper limit of normal (except Gilbert's Syndrome). SGPT (ALT) < 200.
- Negative Beta HCG test in a woman with child bearing potential, defined as not post-menopausal for 12 months or no previous surgical sterilization. Women of child bearing potential must be willing to use an effective contraceptive measure while on study.
- Patient or patient's legal representative, parent(s) or guardian able to sign informed consent.
Who cannot join
- HIV seropositivity.
- Uncontrolled infections.
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: Phase II Study of Timed Sequential Busulfan in Combination With Fludarabine in Allogeneic Stem Cell Transplantation
The goal of this clinical research study is to learn if giving busulfan and fludarabine before a stem cell transplant can help control the disease better than the standard method in patients with leukemia, lymphoma, multiple myeloma, MDS, or MPD. In this study, 2 doses of busulfan will be given 2 weeks before a stem cell transplant followed by 4 doses of busulfan and fludarabine during the week before the stem cell transplant, rather than the standard method of giving 4 doses of busulfan and fludarabine only during the week before the stem cell transplant.
The safety of this combination therapy will also be studied.
Read more
Busulfan is designed to kill cancer cells by binding to DNA (the genetic material of cells), which may cause cancer cells to die. Busulfan is commonly used in stem cell transplants.
Fludarabine is designed to interfere with the DNA of cancer cells, which may cause the cancer cells to die.
Read the detailed description
Central Venous Catheter:
If you choose to take part in this study, the chemotherapy, some of the other drugs in this study, and the stem cell transplant will be given by vein through your central venous catheter (CVC). A CVC is a sterile flexible tube and needle that will be placed into a large vein while you are under local anesthesia. Blood samples will also be drawn through your CVC. The CVC will remain in your body during treatment. Your doctor will explain this procedure to you in more detail, and you will be required to sign a separate consent form.
Study Drug Administration and Procedures:
For a stem cell transplant, the days before you receive your stem cells are called minus days. The day you receive the stem cells is called Day 0. The days after you receive the stem cells are called plus days.
You will receive a dose of busulfan by vein over about 3 hours on Day -13 and Day -12. With the Day -13 busulfan infusion, about 11 samples of blood (about 1-2 teaspoons each time) will be drawn for pharmacokinetic (PK) testing at various time points before and after you receive your first dose of busulfan. The study staff will tell you the blood testing schedule. PK testing measures the amount of study drug in the body at different time points. The PK testing will help the doctor decide your dose of busulfan for Days -6 through -3. If needed, PK blood testing may also be done on Day -6 during your dose of Busulfan. You may receive the Day -13 and Day -12 busulfan dose either as an outpatient in the clinic or as an inpatient in the hospital.
A heparin lock 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 reasons, you will be taken off study and receive the standard fixed dose of busulfan.
On Days -13 and -12, you will receive busulfan by vein over 3 hours.
On Days -11 through -7, you will rest.
On Days -6 through -3, you will receive fludarabine by vein over 1 hour, then busulfan by vein over 3 hours.
On Days -2 and -1, you will rest.
On Day 0, you will receive the stem cell transplant by vein.
After the transplant, you will receive tacrolimus, methotrexate, or other drugs to weaken the immune system in the standard manner to lower the risk of graft-vs-host disease (GVHD), a reaction of the donor's immune cells against the recipient's body.
You will receive tacrolimus by vein as a nonstop infusion until you are able to take it by mouth to help lower the risk of GVHD. You will then take tacrolimus by mouth 2 times a day for about 3 months. After that, your tacrolimus dose may be lowered if you do not have GVHD. Your doctor will discuss this with you. On Days 1, 3, and 6, if your stem cells are from a related or matched unrelated donor, you will receive methotrexate over 30 minutes each day by vein to help lower the risk of GVHD. Participants receiving a matched unrelated donor will also receive methotrexate on Day 11 after the transplant.
You will receive filgrastim as an injection under the skin 1 time a day, starting 1 week after the transplant, until your blood cell levels return to normal. Filgrastim is designed to help with the growth of white blood cells.
Study Testing:
While you are in the hospital, you will be checked for any side effects as part of your standard of care. Blood (about 2 teaspoons) will be drawn every day to check for side effects, for routine tests, to check your blood counts, kidney and liver function, and to check for infections.
As part of standard care, you will remain in the hospital for about 3-4 weeks after the transplant. After you are sent home from the hospital, you must remain in the Houston area to be checked for infections and other transplant side effects until about 3 months after transplant. During this time, you will return to the clinic at least 1 time each week. The following tests and procedures will be performed:
- You will be asked about how you are feeling and about any side effects you may be having.
- Blood (about 2 teaspoons) will be drawn for routine tests.
About 1, 3, 6, and 12 months after the transplant:
- You will have a physical exam, including measurement of your vital signs (blood pressure, heart rate, temperature, and breathing rate).
- You will be asked about how you are feeling and about any side effects you may be having.
- Blood (about 5 teaspoons) will be drawn to see how well the transplant has "taken."
- You will have a bone marrow aspiration to check the status of the disease, if your doctor thinks it is needed. To collect a bone marrow aspiration, an area of the hip or other site is numbed with anesthetic, and a small amount of bone marrow is withdrawn through a large needle.
Length of Study:
You will be taken off study 3 years after the end of treatment. You may be taken off study early if the disease gets worse, if you have any intolerable side effects, of if you are unable to follow study directions.
You should talk to the study doctor if you want to leave the study early. If you are taken off study early, you still may need to return for routine follow-up visits after the transplant, if your transplant doctor decides it is needed.
It may be life-threatening to leave the study after you have begun to receive the study drugs but before you receive the stem cells.
This is an investigational study. Busulfan and fludarabine are both FDA approved and commercially available. The investigational part of this study is the addition of 2 more doses of busulfan.
Up to 200 patients will take part in this study. All will be enrolled at MD Anderson.
- Conditions
- Leukemia, Acute Myeloid Leukemia, Acute Lymphocytic Leukemia, Chronic Myeloid Leukemia, Chronic Lymphocytic Leukemia, Myeloproliferative Diseases
- Being tested
- Fludarabine monophosphate, Busulfan, Stem Cell Infusion, Tacrolimus, Methotrexate
- Keywords
- Leukemia, Acute myeloid leukemia, Acute lymphocytic leukemia, Chronic myeloid leukemia, Chronic lymphocytic leukemia, Myeloproliferative Diseases, Non-Hodgkins Lymphoma, Hodgkins lymphoma, Multiple myeloma, Myelodysplastic syndrome, MDS, Fludarabine monophosphate, Fludarabine phosphate, Fludara, Busulfan, Busulfex, Myleran, Tacrolimus, Prograf, Methotrexate
- Medical subject headings
- Leukemia, Leukemia, Myeloid, Acute, Precursor Cell Lymphoblastic Leukemia-Lymphoma, Leukemia, Myelogenous, Chronic, BCR-ABL Positive, Leukemia, Lymphocytic, Chronic, B-Cell, Lymphoma, Non-Hodgkin, Hodgkin Disease, Multiple Myeloma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Fludarabine monophosphateDrug
Also called Fludarabine Phosphate, Fludara
40 mg/m2 by vein on Days -6 through -3.
BusulfanDrug
Also called Busulfex, Myleran
First two doses of Busulfan, 80 mg/m2 administered as an outpatient or as an inpatient to facilitate for this pharmacokinetically directed therapy. Busulfan is administered at the dose calculated to achieve a total (including first two doses delivered on day -13 and -12) systemic exposure of 20,000 ± 12% µMol-min based on the pharmacokinetic studies.
Stem Cell InfusionProcedure or surgery
Fresh or cryopreserved bone marrow or peripheral blood progenitor cells infused on Day 0.
TacrolimusDrug
Also called Prograf
Starting dose of 0.015 mg/kg (ideal body weight) as 24 hour continuous infusion daily adjusted to achieve therapeutic level of 5-15 ng/ml. Tacrolimus changed to oral dosing when tolerated and can be tapered off after day +90 if no graft versus host disease (GVHD) present.
MethotrexateDrug
5 mg/m2 by vein on Days 1, 3, 6 and 11 post transplant.
G-CSFDrug
Also called Filgrastim, Neupogen
5 mcg/kg/day subcutaneously beginning on Day +7, and continuing until absolute neutrophil count (ANC) is > 500 * 10/L for 3 consecutive days.
| Study group | Role | What they receive |
|---|---|---|
| Fludarabine + Busulfan | Experimental | Fludarabine administered by vein at dose of 40 mg/m2 in 100 ml of normal saline (NS) on Days -6 through -3.
First two doses of Busulfan, 80 mg/m2 administered as an outpatient or as an inpatient to facilitate for this pharmacokinetically directed therapy. Busulfan is administered at the dose calculated to achieve a total (including first two doses delivered on day -13 and -12) systemic exposure of 20,000 ± 12% µMol-min based on the pharmacokinetic studies. Receives: Drug: Fludarabine monophosphate; Drug: Busulfan; Procedure: Stem Cell Infusion; Drug: Tacrolimus; Drug: Methotrexate; Drug: G-CSF |
What is being measured
The primary outcome is the main question the study is designed to answer.
Non-Relapse Mortality Rate (NRM)
Number of participants expired within the first 100 days after transplant not due to relapsed disease.
Measured: 100 days
Secondary outcomes (2)
Overall Survival
Number of participants that are disease free and alive one year post transplant.
Measured: Up to 1 year post-transplant
Overall Survival
Number of participants that were diseased free and alive 3 years post-transplant.
Measured: Up to 3 years post-transplant
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Apr 2012 (estimated)
- Study start11 Apr 2012
- Primary completion11 Aug 2022
- Study completion11 Aug 2022
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.
- Publications (1)Papers the sponsor has linked to this study.
- 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
- 201 participants (actual)
Sponsor and investigators
- Lead sponsor
- M.D. Anderson Cancer Center
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Uday Popat, MD, Principal investigator, M.D. Anderson Cancer Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01572662
- Sponsor's protocol ID
- 2011-0958
- Other IDs
- NCI-2012-00573
- Status last verified
- Jun 2023
- First submitted
- 4 Apr 2012
- Last updated
- 29 Jun 2023
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
Publications
Popat UR, Mehta RS, Bassett R, Chen J, Valdez BC, Kawedia J, Ahmed S, Alousi AM, Anderlini P, Al-Atrash G, Bashir Q, Ciurea SO, Hosing CM, Im JS, Jones R, Kebriaei P, Khouri I, Marin D, Nieto Y, Olson A, Oran B, Parmar S, Rezvani K, Qazilbash MH, Shah N, Srour SA, Shpall EJ, Champlin RE, Andersson BS. Fludarabine with a higher versus lower dose of myeloablative timed-sequential busulfan in older patients and patients with comorbidities: an open-label, non-stratified, randomised phase 2 trial. Lancet Haematol. 2018 Nov;5(11):e532-e542. doi: 10.1016/S2352-3026(18)30156-X.
PubMed 30389035
Study at a glance
From the registry record, last updated by the sponsor on 29 Jun 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Phase II Study of Timed Sequential Busulfan in Combination With Fludarabine in Allogeneic Stem Cell Transplantation
- ClinicalTrials.gov ID
- NCT01572662
- Acronym / sponsor ID
- 2011-0958
- Conditions
- Leukemia, Acute Myeloid Leukemia, Acute Lymphocytic Leukemia, Chronic Myeloid Leukemia, Chronic Lymphocytic Leukemia, Myeloproliferative Diseases
- Keywords
- Leukemia, Acute myeloid leukemia, Acute lymphocytic leukemia, Chronic myeloid leukemia, Chronic lymphocytic leukemia, Myeloproliferative Diseases, Non-Hodgkins Lymphoma, Hodgkins lymphoma
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 201 participants (actual)
- Lead sponsor
- M.D. Anderson Cancer CenterUniversity, hospital or other
- Study start
- 11 Apr 2012 (actual)
- Primary completion
- 11 Aug 2022 (actual)
- Study completion
- 11 Aug 2022 (actual)
- First posted
- 6 Apr 2012 (estimated)
- Results
- Posted 29 Jun 2023
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 giving busulfan and fludarabine before a stem cell transplant can help control the disease better than the standard method in patients with leukemia, lymphoma, multiple myeloma, MDS, or MPD. In this study, 2 doses of busulfan will be given 2 weeks before a stem cell transplant followed by 4 doses of busulfan and fludarabine during the week before the stem cell transplant, rather than the standard method of giving 4 doses of busulfan and fludarabine only during the week before the stem cell transplant.
The safety of this combination therapy will also be studied.
Busulfan is designed to kill cancer cells by binding to DNA (the genetic material of cells), which may cause cancer cells to die. Busulfan is commonly used in stem cell transplants.
Fludarabine is designed to interfere with the DNA of cancer cells, which may cause the cancer cells to die.
Detailed description
Central Venous Catheter:
If you choose to take part in this study, the chemotherapy, some of the other drugs in this study, and the stem cell transplant will be given by vein through your central venous catheter (CVC). A CVC is a sterile flexible tube and needle that will be placed into a large vein while you are under local anesthesia. Blood samples will also be drawn through your CVC. The CVC will remain in your body during treatment. Your doctor will explain this procedure to you in more detail, and you will be required to sign a separate consent form.
Study Drug Administration and Procedures:
For a stem cell transplant, the days before you receive your stem cells are called minus days. The day you receive the stem cells is called Day 0. The days after you receive the stem cells are called plus days.
You will receive a dose of busulfan by vein over about 3 hours on Day -13 and Day -12. With the Day -13 busulfan infusion, about 11 samples of blood (about 1-2 teaspoons each time) will be drawn for pharmacokinetic (PK) testing at various time points before and after you receive your first dose of busulfan. The study staff will tell you the blood testing schedule. PK testing measures the amount of study drug in the body at different time points. The PK testing will help the doctor decide your dose of busulfan for Days -6 through -3. If needed, PK blood testing may also be done on Day -6 during your dose of Busulfan. You may receive the Day -13 and Day -12 busulfan dose either as an outpatient in the clinic or as an inpatient in the hospital.
A heparin lock 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 reasons, you will be taken off study and receive the standard fixed dose of busulfan.
On Days -13 and -12, you will receive busulfan by vein over 3 hours.
On Days -11 through -7, you will rest.
On Days -6 through -3, you will receive fludarabine by vein over 1 hour, then busulfan by vein over 3 hours.
On Days -2 and -1, you will rest.
On Day 0, you will receive the stem cell transplant by vein.
After the transplant, you will receive tacrolimus, methotrexate, or other drugs to weaken the immune system in the standard manner to lower the risk of graft-vs-host disease (GVHD), a reaction of the donor's immune cells against the recipient's body.
You will receive tacrolimus by vein as a nonstop infusion until you are able to take it by mouth to help lower the risk of GVHD. You will then take tacrolimus by mouth 2 times a day for about 3 months. After that, your tacrolimus dose may be lowered if you do not have GVHD. Your doctor will discuss this with you. On Days 1, 3, and 6, if your stem cells are from a related or matched unrelated donor, you will receive methotrexate over 30 minutes each day by vein to help lower the risk of GVHD. Participants receiving a matched unrelated donor will also receive methotrexate on Day 11 after the transplant.
You will receive filgrastim as an injection under the skin 1 time a day, starting 1 week after the transplant, until your blood cell levels return to normal. Filgrastim is designed to help with the growth of white blood cells.
Study Testing:
While you are in the hospital, you will be checked for any side effects as part of your standard of care. Blood (about 2 teaspoons) will be drawn every day to check for side effects, for routine tests, to check your blood counts, kidney and liver function, and to check for infections.
As part of standard care, you will remain in the hospital for about 3-4 weeks after the transplant. After you are sent home from the hospital, you must remain in the Houston area to be checked for infections and other transplant side effects until about 3 months after transplant. During this time, you will return to the clinic at least 1 time each week. The following tests and procedures will be performed:
- You will be asked about how you are feeling and about any side effects you may be having.
- Blood (about 2 teaspoons) will be drawn for routine tests.
About 1, 3, 6, and 12 months after the transplant:
- You will have a physical exam, including measurement of your vital signs (blood pressure, heart rate, temperature, and breathing rate).
- You will be asked about how you are feeling and about any side effects you may be having.
- Blood (about 5 teaspoons) will be drawn to see how well the transplant has "taken."
- You will have a bone marrow aspiration to check the status of the disease, if your doctor thinks it is needed. To collect a bone marrow aspiration, an area of the hip or other site is numbed with anesthetic, and a small amount of bone marrow is withdrawn through a large needle.
Length of Study:
You will be taken off study 3 years after the end of treatment. You may be taken off study early if the disease gets worse, if you have any intolerable side effects, of if you are unable to follow study directions.
You should talk to the study doctor if you want to leave the study early. If you are taken off study early, you still may need to return for routine follow-up visits after the transplant, if your transplant doctor decides it is needed.
It may be life-threatening to leave the study after you have begun to receive the study drugs but before you receive the stem cells.
This is an investigational study. Busulfan and fludarabine are both FDA approved and commercially available. The investigational part of this study is the addition of 2 more doses of busulfan.
Up to 200 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 |
|---|---|---|
| Fludarabine + Busulfan | Experimental | Drug: Fludarabine monophosphate, Drug: Busulfan, Procedure: Stem Cell Infusion, Drug: Tacrolimus, Drug: Methotrexate, Drug: G-CSFFludarabine administered by vein at dose of 40 mg/m2 in 100 ml of normal saline (NS) on Days -6 through -3. First two doses of Busulfan, 80 mg/m2 administered as an outpatient or as an inpatient to facilitate for this pharmacokinetically directed therapy. Busulfan is administered at the dose calculated to achieve a total (including first two doses delivered on day -13 and -12) systemic exposure of 20,000 ± 12% µMol-min based on the pharmacokinetic studies. |
Who may qualify
- Ages
- 5 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (10 listed)
- Patients with high-risk hematologic malignancies with anticipated poor prognosis with non transplant therapy, including those in remission or with induction failure and after treated or untreated relapse. Diagnoses to be included a) Acute myeloid leukemia; b) Acute lymphocytic leukemia; c) Chronic myeloid leukemia; d) Chronic lymphocytic leukemia; e) Myelodysplastic syndrome; f) Myeloproliferative syndromes; g) Non-Hodgkins lymphoma; h) Hodgkins Lymphoma; i) Multiple myeloma.
- Patients must have a histocompatible stem cell donor. An HLA-identical related donor or a 8/8 matched unrelated donor.
- Age 5 to 75 years old.
- Performance score of >/= 70 by Karnofsky/Lansky or PS 0 to 1 (ECOG </=1).
- Left ventricular ejection fraction at least 40%.
Key exclusion criteria (2 listed)
- HIV seropositivity.
- Uncontrolled infections.
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 |
|---|---|---|
| Fludarabine monophosphateAlso: Fludarabine Phosphate, Fludara40 mg/m2 by vein on Days -6 through -3. | Drug | Fludarabine + Busulfan |
| BusulfanAlso: Busulfex, MyleranFirst two doses of Busulfan, 80 mg/m2 administered as an outpatient or as an inpatient to facilitate for this pharmacokinetically directed therapy. Busulfan is administered at the dose calculated to achieve a total (including first two doses delivered on day -13 and -12) systemic exposure of 20,000 ± 12% µMol-min based on the pharmacokinetic studies. | Drug | Fludarabine + Busulfan |
| Stem Cell InfusionFresh or cryopreserved bone marrow or peripheral blood progenitor cells infused on Day 0. | Procedure or surgery | Fludarabine + Busulfan |
| TacrolimusAlso: PrografStarting dose of 0.015 mg/kg (ideal body weight) as 24 hour continuous infusion daily adjusted to achieve therapeutic level of 5-15 ng/ml. Tacrolimus changed to oral dosing when tolerated and can be tapered off after day +90 if no graft versus host disease (GVHD) present. | Drug | Fludarabine + Busulfan |
| Methotrexate5 mg/m2 by vein on Days 1, 3, 6 and 11 post transplant. | Drug | Fludarabine + Busulfan |
| G-CSFAlso: Filgrastim, Neupogen5 mcg/kg/day subcutaneously beginning on Day +7, and continuing until absolute neutrophil count (ANC) is > 500 * 10/L for 3 consecutive days. | Drug | Fludarabine + Busulfan |
Primary outcome
Non-Relapse Mortality Rate (NRM)
Time frame: 100 days
Number of participants expired within the first 100 days after transplant not due to relapsed disease.
2 secondary outcomes
Overall Survival
Time frame: Up to 1 year post-transplant
Overall Survival
Time frame: Up to 3 years post-transplant
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Jun 2023.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 30389035Popat UR, Mehta RS, Bassett R, Chen J, Valdez BC, Kawedia J, Ahmed S, Alousi AM, Anderlini P, Al-Atrash G, Bashir Q, Ciurea SO, Hosing CM, Im JS, Jones R, Kebriaei P, Khouri I, Marin D, Nieto Y, Olson A, Oran B, Parmar S, Rezvani K, Qazilbash MH, Shah N, Srour SA, Shpall EJ, Champlin RE, Andersson BS. Fludarabine with a higher versus lower dose of myeloablative timed-sequential busulfan in older patients and patients with comorbidities: an open-label, non-stratified, randomised phase 2 trial. Lancet Haematol. 2018 Nov;5(11):e532-e542. doi: 10.1016/S2352-3026(18)30156-X.
- MD Anderson Cancer CenterLink 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.
Uday Popat, MD 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 monophosphate, Busulfan and Stem Cell Infusion in people with Leukemia and Acute Myeloid 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 10 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 29 Jun 2023. 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 29 Jun 2023). 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?
Non-Relapse Mortality Rate (NRM) (time frame: 100 days). 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 NCT01572662, 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 29 Jun 2023.