Hematologic DiseasesPhase 2NCT00800839
Busulfan and Fludarabine Followed by Post-transplant Cyclophosphamide
A Phase 2 study testing Busulfan, Fludarabine and Cyclophosphamide in people with Hematologic Diseases 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 cyclophosphamide given after busulfan and fludarabine can help to prevent graft versus host disease (GVHD - a condition in which transplanted tissue attacks the body into which it is transplanted) in patients receiving a stem cell transplant. Read more about this study
- Who is it for?
- Ages 6 months to 75 years
- Conditions the study is for
- Hematologic Diseases, Leukemia, Lymphoma
- What is being tested?
- Busulfan, Fludarabine and Cyclophosphamide
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 56 participants
- Where
- 1 siteUnited States
- Study dates
- Sep 2008to Jul 2015
- 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 6 months to 75 years
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Patients with high risk hematological malignancies, including those with induction failure and after treated or untreated relapse.
- HLA-identical sibling or matched unrelated donor transplants not eligible for protocols of higher priority.
- Age 6 months to 75 years.
- Bilirubin </= 1.5 mg/dl, serum glutamate pyruvate transaminase (SGPT) </= 200 IU/ml (unless Gilbert's syndrome).
- Calculated creatinine clearance of >50mL/min using the Cockcroft-Gault equation for adult patients 18 to 70 years old, and the Schwartz equation for pediatric patients 6 months to 17 years old.
- Diffusing capacity for carbon monoxide (DLCO) >45% predicted corrected for hemoglobin (as reported by the Pulmonary Function Laboratory at MDACC). For most children </= 6 years of age who are unable to perform pulmonary function test (PFT), pulse oximetry >/= 92% on room air.
- left ventricular ejection fraction (LVEF) >/= 35%.
Who cannot join
- HIV seropositivity
- Uncontrolled infections.
- 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
- Inability to sign consent
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: Busulfan (IV) and Fludarabine Followed by Post-allogeneic Transplantation Cyclophosphamide for Graft-versus-Host Disease Prophylaxis in Patients With Hematologic Malignancies.
The goal of this clinical research study is to learn if cyclophosphamide given after busulfan and fludarabine can help to prevent graft versus host disease (GVHD - a condition in which transplanted tissue attacks the body into which it is transplanted) in patients receiving a stem cell transplant. The safety of this drug combination will also be studied.
Read the detailed description
The Study Drugs:
Busulfan is designed to bind to DNA (the genetic material of cells), which may cause cancer cells to die.
Fludarabine is designed to make cancer cells less able to repair damaged DNA. This may increase the likelihood of the cells dying.
Cyclophosphamide is designed to interfere with the multiplication of cancer cells, which may slow or stop their growth and spread throughout the body. This may cause the cancer cells to die. It is also designed to suppress the immune system and help prevent GVHD.
Study Drug Administration and Transplant:
If you are an inpatient, on Day -8 (8 days before the date of transplant), you will receive a low-level test dose of busulfan through a needle in your vein over 1 hour.
If you are an outpatient, on Day -30 through Day -8, you will receive a low-level test dose of busulfan through a needle in your vein over 1 hour each day.
You will be given an anti-seizure drug to help prevent seizures each time you receive busulfan. Your doctor will explain how the drug will be given and the drug's risks. Seizures are a rare but serious side effect of busulfan.
On Days -8, -6, and -4, blood (about 1 teaspoon each time) will then be drawn a total of 11 times for pharmacokinetic (PK) testing. PK testing measures the amount of study drug in the body at different time points. This PK testing will be done to find the dose of busulfan needed for your body size on the other days that you receive busulfan.
On Day -6 through Day -3, you will receive your body-specific dose of busulfan by vein over 3 hours each day. If you cannot have the blood level tests performed for any reason, you will receive the standard busulfan dose. You will receive fludarabine through a needle in your vein over 1 hour on each of these days before you receive busulfan.
On Day 0, you will receive the donor bone marrow or blood stem cells by vein over about 1 hour.
On Day +3 and Day +4, you will receive cyclophosphamide by vein over 3 hours.
On Days +3 thru +5 just before the first dose of cyclophosphamide and then every 4 hours, you will receive mesna by vein over 30 minutes for a total of 10 doses. Mesna is a drug that protects bladder cells from damage by chemotherapy drugs. It is used to decrease the risk of bleeding in the bladder.
Once a day starting on Day +7, you will receive filgrastim (G-CSF -- a drug that helps with the growth of white blood cells) through a needle under your skin until your blood cell levels reach "recovered" levels for 3 days in a row.
Study Visits:
Every day you are in the hospital and at each outpatient visit, you will have a physical exam to check for symptoms of GVHD.
Blood (about 3 teaspoons) will be drawn at least 2 times a week for the first 100 days after the transplant for routine tests.
About 1 month after your transplant, then once every 3 months up to a year, the following tests and procedures will be performed:
- Blood (about 5 tablespoons) will be drawn for routine tests and to check for CMV. Blood draws may be repeated more often, if you doctor thinks it is needed.
- Urine will be collected for routine tests.
- You will have a bone marrow aspirate and biopsy to check the status of the disease.
At Months 1, 2, 3, 6, and 12 after your transplant, blood (about 4 tablespoons) will be drawn to check the status of your immune system.
Tests and procedures may be repeated more often during the study, if your doctor thinks it is needed.
Length of Study:
You will be on study in the hospital for about 4 weeks. You will be taken off study if the disease gets worse or if the study doctor thinks it is in your best interest.
Long-Term Follow-Up:
After the first 24 months, you will receive either a phone call or a letter from the study doctor or your regular doctor 1 time each year to check the status of the disease. If you are contacted by mail, you will be given a self-addressed stamped envelope with which you can return your responses to the doctor.
This is an investigational study. Busulfan is FDA approved and commercially available for the treatment of chronic myelogenous leukemia (CML). Fludarabine is FDA approved and commercially available for the treatment of chronic lymphocytic leukemia (CLL). Cyclophosphamide is FDA approved and commercially available for the treatment of lymphoma. The use of these drugs together for the possible prevention of GVHD is investigational.
Up to 40 participants will take part in this study. All will be enrolled at M. D. Anderson.
- Conditions
- Hematologic Diseases, Leukemia, Lymphoma, Myeloma
- Being tested
- Busulfan, Fludarabine, Cyclophosphamide
- Keywords
- Post-allogeneic transplantation, Graft-versus-Host Disease Prophylaxis, Graft-versus-Host Disease, GVHD, Hematologic malignancies, Leukemia, Lymphoma, Myeloma, Human Leukocyte Antigen, HLA, Busulfan, Cyclophosphamide, Fludarabine, Mesna, Cytoxan®, Neosar®, Busulfex, Myleran®, Fludarabine Phosphate
- Medical subject headings
- Hematologic Diseases, Leukemia, Lymphoma, Neoplasms, Plasma Cell, Graft vs Host Disease, Hematologic Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
BusulfanDrug
Also called Bulsulfex™, Myleran®
Starting dose of 32 mg/m^2 by vein over 3 hours each day. Test dose day -8 (inpatient) or test dose day -30 to day -8 (outpatient) and then, days -6,-5,-4, and -3.
FludarabineDrug
Also called Fludarabine Phosphate, Fludara
Dose of 40 mg/m^2 by vein over 1 hour each day on Day -6 through Day -3 before receiving Busulfan.
CyclophosphamideDrug
Also called Cytoxan®, Neosar®
Dose of 50 mg/kg by vein over 3 hours on Days 3 and 4.
| Study group | Role | What they receive |
|---|---|---|
| Busulfan + Fludarabine + Cyclophosphamide | Experimental | Busulfan starting dose of 32 mg/m^2 by vein over 3 hours each day. Test dose day -8 (inpatient) or test dose day -30 to day -8 (outpatient) and then, days -6,-5,-4, and -3. Fludarabine dose of 40 mg/m^2 by vein over 1 hour each day on Day -6 through Day -3 before receiving Busulfan. Cyclophosphamide dose of 50 mg/kg by vein over 3 hours on Days 3 and 4. Receives: Drug: Busulfan; Drug: Fludarabine; Drug: Cyclophosphamide |
What is being measured
The primary outcome is the main question the study is designed to answer.
Cumulative Incidence of Grade II to IV Acute GVHD
Graft Versus Host Disease (GVHD) defined as grade 2 to 4 GVHD within first 100 days post transplant. Death or disease progression before diagnosis of GVHD were considered competing risks in the estimation of the incidence of acute GVHD.
Measured: 100 days post transplant
Cumulative Incidence of Grade III to IV Acute GVHD
Graft Versus Host Disease (GVHD) defined as grade 3 to 4 GVHD within first 100 days post transplant. Death or disease progression before diagnosis of GVHD were considered competing risks in the estimation of the incidence of acute GVHD.
Measured: 100 days post transplant
Day-100 Treatment-Related Mortality
Treatment-Related Mortality (TRM) was estimated from the date of transplant using the cumulative incidence method to account for competing risks. Disease progression or relapse death were considered competing risk for TRM.
Measured: 100 days post transplant
Secondary outcomes (3)
Rate of Engraftment
Engraftment defined as the evidence of donor derived cells (more than 5%) by bone marrow chimerism studies in the presence of neutrophil recovery by day 28 post stem cell (SC) infusion. Engraftment date is the first day of three (3) consecutive days that the ANC exceeds 0.5 x109/L. Delayed engraftment is defined as the evidence of engraftment beyond day 28 post SC infusion achieved after the administration of therapeutic (high dose) hematopoietic growth factors.
Measured: From engraftment to 60 days post transplant
2-year Progression-Free Survival
Progression-free survival (PFS) is defined as the interval between day of transplant and day of death or disease progression.
Measured: First 25-35 days post transplant and then every 3 months for a maximum of 2 years
2-year Overall Survival
Overall Survival (OS) is defined as the interval between day of transplant and day of death.
Measured: First 25-35 days post transplant and then every 3 months for a maximum of 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Dec 2008 (estimated)
- Study startSep 2008
- Primary completionJul 2015
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 Hematologic DiseasesStudies 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
- 56 participants (actual)
Sponsor and investigators
- Lead sponsor
- M.D. Anderson Cancer Center
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Amin Alousi, MD, Principal investigator, M.D. Anderson Cancer Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00800839
- Sponsor's protocol ID
- 2008-0261
- Other IDs
- NCI-2012-01660
- Status last verified
- Jul 2016
- First submitted
- 1 Dec 2008
- Last updated
- 19 Sep 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 19 Sep 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Busulfan (IV) and Fludarabine Followed by Post-allogeneic Transplantation Cyclophosphamide for Graft-versus-Host Disease Prophylaxis in Patients With Hematologic Malignancies.
- ClinicalTrials.gov ID
- NCT00800839
- Acronym / sponsor ID
- 2008-0261
- Conditions
- Hematologic Diseases, Leukemia, Lymphoma, Myeloma
- Keywords
- Post-allogeneic transplantation, Graft-versus-Host Disease Prophylaxis, Graft-versus-Host Disease, GVHD, Hematologic malignancies, Leukemia, Lymphoma, Myeloma
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 56 participants (actual)
- Lead sponsor
- M.D. Anderson Cancer CenterUniversity, hospital or other
- Study start
- Sep 2008
- Primary completion
- Jul 2015 (actual)
- First posted
- 2 Dec 2008 (estimated)
- Results
- Posted 19 Sep 2016
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 cyclophosphamide given after busulfan and fludarabine can help to prevent graft versus host disease (GVHD - a condition in which transplanted tissue attacks the body into which it is transplanted) in patients receiving a stem cell transplant. The safety of this drug combination will also be studied.
Detailed description
The Study Drugs:
Busulfan is designed to bind to DNA (the genetic material of cells), which may cause cancer cells to die.
Fludarabine is designed to make cancer cells less able to repair damaged DNA. This may increase the likelihood of the cells dying.
Cyclophosphamide is designed to interfere with the multiplication of cancer cells, which may slow or stop their growth and spread throughout the body. This may cause the cancer cells to die. It is also designed to suppress the immune system and help prevent GVHD.
Study Drug Administration and Transplant:
If you are an inpatient, on Day -8 (8 days before the date of transplant), you will receive a low-level test dose of busulfan through a needle in your vein over 1 hour.
If you are an outpatient, on Day -30 through Day -8, you will receive a low-level test dose of busulfan through a needle in your vein over 1 hour each day.
You will be given an anti-seizure drug to help prevent seizures each time you receive busulfan. Your doctor will explain how the drug will be given and the drug's risks. Seizures are a rare but serious side effect of busulfan.
On Days -8, -6, and -4, blood (about 1 teaspoon each time) will then be drawn a total of 11 times for pharmacokinetic (PK) testing. PK testing measures the amount of study drug in the body at different time points. This PK testing will be done to find the dose of busulfan needed for your body size on the other days that you receive busulfan.
On Day -6 through Day -3, you will receive your body-specific dose of busulfan by vein over 3 hours each day. If you cannot have the blood level tests performed for any reason, you will receive the standard busulfan dose. You will receive fludarabine through a needle in your vein over 1 hour on each of these days before you receive busulfan.
On Day 0, you will receive the donor bone marrow or blood stem cells by vein over about 1 hour.
On Day +3 and Day +4, you will receive cyclophosphamide by vein over 3 hours.
On Days +3 thru +5 just before the first dose of cyclophosphamide and then every 4 hours, you will receive mesna by vein over 30 minutes for a total of 10 doses. Mesna is a drug that protects bladder cells from damage by chemotherapy drugs. It is used to decrease the risk of bleeding in the bladder.
Once a day starting on Day +7, you will receive filgrastim (G-CSF -- a drug that helps with the growth of white blood cells) through a needle under your skin until your blood cell levels reach "recovered" levels for 3 days in a row.
Study Visits:
Every day you are in the hospital and at each outpatient visit, you will have a physical exam to check for symptoms of GVHD.
Blood (about 3 teaspoons) will be drawn at least 2 times a week for the first 100 days after the transplant for routine tests.
About 1 month after your transplant, then once every 3 months up to a year, the following tests and procedures will be performed:
- Blood (about 5 tablespoons) will be drawn for routine tests and to check for CMV. Blood draws may be repeated more often, if you doctor thinks it is needed.
- Urine will be collected for routine tests.
- You will have a bone marrow aspirate and biopsy to check the status of the disease.
At Months 1, 2, 3, 6, and 12 after your transplant, blood (about 4 tablespoons) will be drawn to check the status of your immune system.
Tests and procedures may be repeated more often during the study, if your doctor thinks it is needed.
Length of Study:
You will be on study in the hospital for about 4 weeks. You will be taken off study if the disease gets worse or if the study doctor thinks it is in your best interest.
Long-Term Follow-Up:
After the first 24 months, you will receive either a phone call or a letter from the study doctor or your regular doctor 1 time each year to check the status of the disease. If you are contacted by mail, you will be given a self-addressed stamped envelope with which you can return your responses to the doctor.
This is an investigational study. Busulfan is FDA approved and commercially available for the treatment of chronic myelogenous leukemia (CML). Fludarabine is FDA approved and commercially available for the treatment of chronic lymphocytic leukemia (CLL). Cyclophosphamide is FDA approved and commercially available for the treatment of lymphoma. The use of these drugs together for the possible prevention of GVHD is investigational.
Up to 40 participants 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 |
|---|---|---|
| Busulfan + Fludarabine + Cyclophosphamide | Experimental | Drug: Busulfan, Drug: Fludarabine, Drug: CyclophosphamideBusulfan starting dose of 32 mg/m^2 by vein over 3 hours each day. Test dose day -8 (inpatient) or test dose day -30 to day -8 (outpatient) and then, days -6,-5,-4, and -3. Fludarabine dose of 40 mg/m^2 by vein over 1 hour each day on Day -6 through Day -3 before receiving Busulfan. Cyclophosphamide dose of 50 mg/kg by vein over 3 hours on Days 3 and 4. |
Who may qualify
- Ages
- 6 months to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (7 listed)
- Patients with high risk hematological malignancies, including those with induction failure and after treated or untreated relapse.
- HLA-identical sibling or matched unrelated donor transplants not eligible for protocols of higher priority.
- Age 6 months to 75 years.
- Bilirubin </= 1.5 mg/dl, serum glutamate pyruvate transaminase (SGPT) </= 200 IU/ml (unless Gilbert's syndrome).
- Calculated creatinine clearance of >50mL/min using the Cockcroft-Gault equation for adult patients 18 to 70 years old, and the Schwartz equation for pediatric patients 6 months to 17 years old.
Key exclusion criteria (4 listed)
- HIV seropositivity
- Uncontrolled infections.
- 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
- Inability to sign consent
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 |
|---|---|---|
| BusulfanAlso: Bulsulfex™, Myleran®Starting dose of 32 mg/m^2 by vein over 3 hours each day. Test dose day -8 (inpatient) or test dose day -30 to day -8 (outpatient) and then, days -6,-5,-4, and -3. | Drug | Busulfan + Fludarabine + Cyclophosphamide |
| FludarabineAlso: Fludarabine Phosphate, FludaraDose of 40 mg/m^2 by vein over 1 hour each day on Day -6 through Day -3 before receiving Busulfan. | Drug | Busulfan + Fludarabine + Cyclophosphamide |
| CyclophosphamideAlso: Cytoxan®, Neosar®Dose of 50 mg/kg by vein over 3 hours on Days 3 and 4. | Drug | Busulfan + Fludarabine + Cyclophosphamide |
Primary outcome
Cumulative Incidence of Grade II to IV Acute GVHD
Time frame: 100 days post transplant
Graft Versus Host Disease (GVHD) defined as grade 2 to 4 GVHD within first 100 days post transplant. Death or disease progression before diagnosis of GVHD were considered competing risks in the estimation of the incidence of acute GVHD.
Cumulative Incidence of Grade III to IV Acute GVHD
Time frame: 100 days post transplant
Graft Versus Host Disease (GVHD) defined as grade 3 to 4 GVHD within first 100 days post transplant. Death or disease progression before diagnosis of GVHD were considered competing risks in the estimation of the incidence of acute GVHD.
Day-100 Treatment-Related Mortality
Time frame: 100 days post transplant
Treatment-Related Mortality (TRM) was estimated from the date of transplant using the cumulative incidence method to account for competing risks. Disease progression or relapse death were considered competing risk for TRM.
3 secondary outcomes
Rate of Engraftment
Time frame: From engraftment to 60 days post transplant
2-year Progression-Free Survival
Time frame: First 25-35 days post transplant and then every 3 months for a maximum of 2 years
2-year Overall Survival
Time frame: First 25-35 days post transplant and then every 3 months for a maximum of 2 years
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Sep 2016.
- 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.
Amin Alousi, 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 Busulfan, Fludarabine and Cyclophosphamide in people with Hematologic Diseases 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 7 inclusion and 4 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 19 Sep 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 19 Sep 2016). 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?
Cumulative Incidence of Grade II to IV Acute GVHD (time frame: 100 days post transplant). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 Sep 2016.