LeukemiaPhase 3BuCyvsBUFluNCT00774280
Busulfan Plus Cyclophosphamide vs Fludarabine as a Conditioning Regimen
A Phase 3 study testing BuCy vs BuFlu in people with Leukemia and Myelodysplastic Syndrome, run by Cooperative Study Group A for Hematology at 1 site in South Korea.
Trial summary
1. At the same time of registration, patients will be randomized to one of the two conditioning therapy groups; Arm I (intravenous busulfan plus cyclophosphamide; BuCy) or Arm II (intravenous busulfan plus fludarabine; BuFlu). 2. Randomization will be a stratified permuted-block design. Read more about this study
- Who is it for?
- Ages 15 to 70 years
- Conditions the study is for
- Leukemia, Myelodysplastic Syndrome
- What is being tested?
- BuCy vs BuFlu
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 130 participants
- Where
- 1 siteSouth Korea
- Study dates
- May 2002to Dec 2010
- Phase
- Phase 3
- Are there results?
- None posted in the registry
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 15 to 70 years
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Patients with acute leukemia, chronic myelogenous leukemia, myelodysplastic syndrome, and other hematologic malignancies.
- Patients should have an HLA-identical or one-locus mismatched sibling, family or unrelated donor.
- Patients should be 15 years of age or older, but younger than 70 years.
Who cannot join
- Patients have major illness or organ failure.
- Patients have a psychiatric disorder or mental deficiency severe as to make compliance with the treatment unlike, and making informed consent impossible.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Randomized Comparison of Once-daily Intravenous Busulfan Plus Cyclophosphamide Versus Fludarabine as a Conditioning Regimen for Allogeneic Hematopoietic Cell Transplantation in Leukemia and Myelodysplastic Syndrome
- At the same time of registration, patients will be randomized to one of the two conditioning therapy groups; Arm I (intravenous busulfan plus cyclophosphamide; BuCy) or Arm II (intravenous busulfan plus fludarabine; BuFlu).
- Randomization will be a stratified permuted-block design. 2.1The patients will be stratified into standard risk vs. high risk group, and related vs. unrelated donor. Standard risk group will be defined as follows: patients with acute leukemia in first remission, CML in chronic phase, and MDS (RA or RARS categories). High risk group will be defined as follows: patients with acute leukemia in relapse or in second or subsequent remission, CML in accelerated or blastic phase, and MDS (CMMoL or RAEB categories).
2.2.Pre-assigned block size is 8.
Read the detailed description
- TREATMENT PLAN
- The patients will be admitted to laminar air flow room.
- The patients will have triple lumen Hickman central venous catheter (CVC) placed. Vancomycin 1 gm IV immediately prior to CVC placement and 1 gm q 12 hours for 3 doses. Chest X-ray should be taken after CVC placement to confirm the location of CVC and absence of pneumothorax.
- Lumbar puncture will be done and intrathecal preservative free methotrexate 10 ㎎/㎡ (not to exceed 12 ㎎ total) will be given. Folinic acid 15 ㎎ will be given po or IV 24 hours after intrathecal methotrexate and q 6 hours for a total of 4 doses.
- Menstruating women will be given norethindrone (Norlutate) 10 ㎎ po daily.
- The preparatory regimen is as follows:
- Conditioning therapy will start on day -7 in patients who are randomized to receive intravenous busulfan (Busulfex®; Orphan Medical, Minnetonka, MN) plus cyclophosphamide. Busulfex 3.2 ㎎/㎏ will be administered once daily for 4 days (days -7 to -4) followed by cyclophosphamide 60 ㎎/㎏ in D5W 200 ㎖ i.v. over 1-2 hours on days -3 and -2. Busulfex will be diluted in normal saline 500 ㎖ and infused over 3 hours by pump through a central venous catheter The doses of Busulfex and cyclophosphamide will be calculated using following guideline: 1) if actual body weight (ABW) of the patient is less or equal to ideal body weight (IBW), ABW will be used. 2) if ABW is greater than IBW but by less than 20%, then IBW will be used. 3) if ABW is greater than IBW by more or equal to 20 %, then the dose will be based on; IBW + 25 % (ABW-IBW). IBW is calculated as follows: 50 ㎏ + 2.3 ㎏ (Height in inch - 60) in male, and 45.5 ㎏ +2.3 ㎏ (Height in inch -60) (1 inch= 2.54 ㎝).
- Conditioning therapy will start on day -7 in patients who are randomized to receive Busulfex plus fludarabine (Fludara®, Schering AG, Berlin, Germany). Busulfex 3.2 ㎎/㎏ will be administered once daily for 4 days (days -7 to -4) and fludarabine 30 ㎎/㎡ will be infused intravenously over 30 minutes in D5W 100 ㎖ for 5 consecutive days (days -6 to -2). The dose of Busulfex will be calculated using above-mentioned guideline (see 5.5.1). The dose of fludarabine will be calculated using ABW.
- GVHD prophylaxis
- All patients will receive cyclosporine 1.5 ㎎/㎏ in NS 100 ㎖ i.v. over 2-4 hours q 12 hrs (dose of cyclosporine rounded to nearest 5 ㎎) starting day -1 at 9 a.m. Cyclosporine dose will be adjusted to provide appropriate level and according to the change of renal function (see Appendix II).
- When the patients can tolerate oral medications, cyclosporine can be given p.o. 3 ㎎/㎏ (or two times the i.v. dose) q 12 hrs.
- Cyclosporine dose will be decreased by 10 % every month starting day 60 of BMT provided that there is no clinical evidence of GVHD.
- In addition to cyclosporine, methotrexate 15 ㎎/㎡ will be given intravenously on day 1 and 10 ㎎/㎡ on days 3, 6, and 11. The dose of methotrexate will be decreased or omitted according to the guideline provided in Appendix III.
- Methotrexate will not be given to patients with acute leukemia or MDS who will receive hematopoietic cell graft from an HLA-matched sibling donor
- Bone marrow cell infusion
- For ABO matched or minor mismatched transplantation, premedication with Avil 45.5mg I.v. push and tylenol 600 ㎎ p.o. will be given. Stem cell will be infused over 1-2 hrs.
- For major ABO mismatched transplantation, premedication with Avil 45.5 ㎎ i.v. push, tylenol 600 ㎎ p.o., 10 % mannitol 100 g i.v. over 4 hrs will be started 30 min before stem cell infusion, and hydrocortisone 250 ㎎ i.v. will be given immediately before and 30 min of stem cell infusion.
- Supportive cares.
- Dilantin 15 ㎎/㎏ (ABW) in NS 200 ㎖ i.v. over 1 hour for loading on day -8, then 200 ㎎ p.o. bid through day -5. Dilantin dose should be adjusted to provide therapeutic level.
- Allopurinol 300 ㎎/day p.o. qd day -8 to -2.
- Nystatin powder to groin, axilla, and perianal area bid from day -8 until absolute neutrophil count (ANC) > 3,000/㎕.
- Sodium bicarbonate/saline mouthwash qid until mucositis is resolved.
- Fluconazole 100 ㎎/day p.o. qd until ANC > 3,000/㎕.
- Ciprofloxacin 500 ㎎ p.o. bid (for selective bowel decontamination) until ANC > 3,000/㎕. With the first fever spike, ciprofloxacin will be discontinued and broad spectrum antibiotics will be begun.
- Hydration will be done with 0.9 % NS at 100 ㎖/hour while the patients are receiving busulfan.
- IV Immunoglobulin 500 ㎎/㎏ (ABW) i.v. over 6 hours every other week starting day -7 until day 120, then every month until day 180.
- Prophylaxis against Herpes simplex virus will include acyclovir 250 ㎎/㎡ in D5W 100 ㎖ i.v. q 8 hours starting at day -7. When the patient can tolerate oral medication, acyclovir will be given 200 ㎎ p.o. tid until day 180.
- Prophylaxis against Pneumocystis carinii will include Bactrim SS 2 tablets p.o. bid with folinic acid 7.5 ㎎ p.o. bid, 2 days weekly, starting after engraftment through day 360.
- Amoxacillin 250 ㎎ p.o. bid starting at day 70 through day 360.
- G-CSF administration.
- Starting day 5, G-CSF 300 ㎍ in 100 ㎖ of D5W will be given i.v. over 3 hours daily until ANC > 3,000/㎕.
- If ANC drops below 1,000/㎕, G-CSF administration will resume and continue until ANC > 3,000/㎕.
- In patients with acute leukemia or CML in blastic crisis, intrathecal methotrexate administration will be resumed after the patient recovered platelet count to over 50,000/㎕. Methotrexate 10 ㎎/㎡ (not to exceed 12 ㎎ total) will be given intrathecally once every 2 weeks for three times (total four doses including one given before preparatory regimen). Folinic acid 15 ㎎ will be given p.o. or i.v. 24 hours after intrathecal methotrexate and q 6 hours for a total of 4 doses.
- Conditions
- Leukemia, Myelodysplastic Syndrome
- Being tested
- BuCy vs BuFlu
- Medical subject headings
- Leukemia, Myelodysplastic Syndromes
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
BuCy vs BuFluDrug
Also called busulfan plus cyclophosphamide versus fludarabine
Arm 1:BuCy Arm 2:BuFlu
| Study group | Role | What they receive |
|---|---|---|
| ArmI(BuCy) | No intervention | * Intravenous busulfan (Busulfex®; Orphan Medical, Minnetonka, MN) 3.2 ㎎/㎏ in normal saline 500 ㎖ i.v. over 3 hours on days -7 to -4
* Cyclophosphamide 60 ㎎/㎏ in D5W 200 ㎖ i.v. over 1-2 hours on days -3 and -2 Receives: Drug: BuCy vs BuFlu |
| Arm II (BuFlu) | No intervention | * Intravenous busulfan 3.2 ㎎/㎏ in normal saline 500 ㎖ i.v. over 3 hours on days -7 to -4.
* Fludarabine (Fludara®, Schering AG, Berlin, Germany) 30 ㎎/㎡ i.v. over 30 minutes in D5W 100 ㎖ on days -6 to -2 Receives: Drug: BuCy vs BuFlu |
What is being measured
The primary outcome is the main question the study is designed to answer.
related toxicities of two different conditioning regimens, intravenous once-daily busulfan plus cyclophosphamide (BuCy) vs. fludarabine (BuFlu) for allogeneic hematopoietic cell transplantation (HCT) in leukemia and myelodysplastic syndrome
Measured: 8years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Oct 2008 (estimated)
- Study startMay 2002
- Primary completionNov 2009
- Study completionDec 2010
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for LeukemiaStudies of the same condition, open and under way.
- 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 130 participants (actual)
Sponsor and investigators
- Lead sponsor
- Cooperative Study Group A for Hematology
- Sponsor type
- Research network
- Investigators
- Je-Hwan Lee, Doctor, Principal investigator, Asan Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00774280
- Sponsor's protocol ID
- C-005
- Acronym
- BuCyvsBUFlu
- Status last verified
- Feb 2011
- First submitted
- 15 Oct 2008
- Last updated
- 14 Feb 2011
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Lee JH, Joo YD, Kim H, Ryoo HM, Kim MK, Lee GW, Lee JH, Lee WS, Park JH, Bae SH, Hyun MS, Kim DY, Kim SD, Min YJ, Lee KH. Randomized trial of myeloablative conditioning regimens: busulfan plus cyclophosphamide versus busulfan plus fludarabine. J Clin Oncol. 2013 Feb 20;31(6):701-9. doi: 10.1200/JCO.2011.40.2362. Epub 2012 Nov 5.
PubMed 23129746
Study at a glance
From the registry record, last updated by the sponsor on 14 Feb 2011. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Randomized Comparison of Once-daily Intravenous Busulfan Plus Cyclophosphamide Versus Fludarabine as a Conditioning Regimen for Allogeneic Hematopoietic Cell Transplantation in Leukemia and Myelodysplastic Syndrome
- ClinicalTrials.gov ID
- NCT00774280
- Acronym / sponsor ID
- BuCyvsBUFlu / C-005
- Conditions
- Leukemia, Myelodysplastic Syndrome
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 130 participants (actual)
- Lead sponsor
- Cooperative Study Group A for HematologyResearch network
- Study start
- May 2002
- Primary completion
- Nov 2009 (actual)
- Study completion
- Dec 2010 (actual)
- First posted
- 17 Oct 2008 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
- At the same time of registration, patients will be randomized to one of the two conditioning therapy groups; Arm I (intravenous busulfan plus cyclophosphamide; BuCy) or Arm II (intravenous busulfan plus fludarabine; BuFlu).
- Randomization will be a stratified permuted-block design. 2.1The patients will be stratified into standard risk vs. high risk group, and related vs. unrelated donor. Standard risk group will be defined as follows: patients with acute leukemia in first remission, CML in chronic phase, and MDS (RA or RARS categories). High risk group will be defined as follows: patients with acute leukemia in relapse or in second or subsequent remission, CML in accelerated or blastic phase, and MDS (CMMoL or RAEB categories).
2.2.Pre-assigned block size is 8.
Detailed description
- TREATMENT PLAN
- The patients will be admitted to laminar air flow room.
- The patients will have triple lumen Hickman central venous catheter (CVC) placed. Vancomycin 1 gm IV immediately prior to CVC placement and 1 gm q 12 hours for 3 doses. Chest X-ray should be taken after CVC placement to confirm the location of CVC and absence of pneumothorax.
- Lumbar puncture will be done and intrathecal preservative free methotrexate 10 ㎎/㎡ (not to exceed 12 ㎎ total) will be given. Folinic acid 15 ㎎ will be given po or IV 24 hours after intrathecal methotrexate and q 6 hours for a total of 4 doses.
- Menstruating women will be given norethindrone (Norlutate) 10 ㎎ po daily.
- The preparatory regimen is as follows:
- Conditioning therapy will start on day -7 in patients who are randomized to receive intravenous busulfan (Busulfex®; Orphan Medical, Minnetonka, MN) plus cyclophosphamide. Busulfex 3.2 ㎎/㎏ will be administered once daily for 4 days (days -7 to -4) followed by cyclophosphamide 60 ㎎/㎏ in D5W 200 ㎖ i.v. over 1-2 hours on days -3 and -2. Busulfex will be diluted in normal saline 500 ㎖ and infused over 3 hours by pump through a central venous catheter The doses of Busulfex and cyclophosphamide will be calculated using following guideline: 1) if actual body weight (ABW) of the patient is less or equal to ideal body weight (IBW), ABW will be used. 2) if ABW is greater than IBW but by less than 20%, then IBW will be used. 3) if ABW is greater than IBW by more or equal to 20 %, then the dose will be based on; IBW + 25 % (ABW-IBW). IBW is calculated as follows: 50 ㎏ + 2.3 ㎏ (Height in inch - 60) in male, and 45.5 ㎏ +2.3 ㎏ (Height in inch -60) (1 inch= 2.54 ㎝).
- Conditioning therapy will start on day -7 in patients who are randomized to receive Busulfex plus fludarabine (Fludara®, Schering AG, Berlin, Germany). Busulfex 3.2 ㎎/㎏ will be administered once daily for 4 days (days -7 to -4) and fludarabine 30 ㎎/㎡ will be infused intravenously over 30 minutes in D5W 100 ㎖ for 5 consecutive days (days -6 to -2). The dose of Busulfex will be calculated using above-mentioned guideline (see 5.5.1). The dose of fludarabine will be calculated using ABW.
- GVHD prophylaxis
- All patients will receive cyclosporine 1.5 ㎎/㎏ in NS 100 ㎖ i.v. over 2-4 hours q 12 hrs (dose of cyclosporine rounded to nearest 5 ㎎) starting day -1 at 9 a.m. Cyclosporine dose will be adjusted to provide appropriate level and according to the change of renal function (see Appendix II).
- When the patients can tolerate oral medications, cyclosporine can be given p.o. 3 ㎎/㎏ (or two times the i.v. dose) q 12 hrs.
- Cyclosporine dose will be decreased by 10 % every month starting day 60 of BMT provided that there is no clinical evidence of GVHD.
- In addition to cyclosporine, methotrexate 15 ㎎/㎡ will be given intravenously on day 1 and 10 ㎎/㎡ on days 3, 6, and 11. The dose of methotrexate will be decreased or omitted according to the guideline provided in Appendix III.
- Methotrexate will not be given to patients with acute leukemia or MDS who will receive hematopoietic cell graft from an HLA-matched sibling donor
- Bone marrow cell infusion
- For ABO matched or minor mismatched transplantation, premedication with Avil 45.5mg I.v. push and tylenol 600 ㎎ p.o. will be given. Stem cell will be infused over 1-2 hrs.
- For major ABO mismatched transplantation, premedication with Avil 45.5 ㎎ i.v. push, tylenol 600 ㎎ p.o., 10 % mannitol 100 g i.v. over 4 hrs will be started 30 min before stem cell infusion, and hydrocortisone 250 ㎎ i.v. will be given immediately before and 30 min of stem cell infusion.
- Supportive cares.
- Dilantin 15 ㎎/㎏ (ABW) in NS 200 ㎖ i.v. over 1 hour for loading on day -8, then 200 ㎎ p.o. bid through day -5. Dilantin dose should be adjusted to provide therapeutic level.
- Allopurinol 300 ㎎/day p.o. qd day -8 to -2.
- Nystatin powder to groin, axilla, and perianal area bid from day -8 until absolute neutrophil count (ANC) > 3,000/㎕.
- Sodium bicarbonate/saline mouthwash qid until mucositis is resolved.
- Fluconazole 100 ㎎/day p.o. qd until ANC > 3,000/㎕.
- Ciprofloxacin 500 ㎎ p.o. bid (for selective bowel decontamination) until ANC > 3,000/㎕. With the first fever spike, ciprofloxacin will be discontinued and broad spectrum antibiotics will be begun.
- Hydration will be done with 0.9 % NS at 100 ㎖/hour while the patients are receiving busulfan.
- IV Immunoglobulin 500 ㎎/㎏ (ABW) i.v. over 6 hours every other week starting day -7 until day 120, then every month until day 180.
- Prophylaxis against Herpes simplex virus will include acyclovir 250 ㎎/㎡ in D5W 100 ㎖ i.v. q 8 hours starting at day -7. When the patient can tolerate oral medication, acyclovir will be given 200 ㎎ p.o. tid until day 180.
- Prophylaxis against Pneumocystis carinii will include Bactrim SS 2 tablets p.o. bid with folinic acid 7.5 ㎎ p.o. bid, 2 days weekly, starting after engraftment through day 360.
- Amoxacillin 250 ㎎ p.o. bid starting at day 70 through day 360.
- G-CSF administration.
- Starting day 5, G-CSF 300 ㎍ in 100 ㎖ of D5W will be given i.v. over 3 hours daily until ANC > 3,000/㎕.
- If ANC drops below 1,000/㎕, G-CSF administration will resume and continue until ANC > 3,000/㎕.
- In patients with acute leukemia or CML in blastic crisis, intrathecal methotrexate administration will be resumed after the patient recovered platelet count to over 50,000/㎕. Methotrexate 10 ㎎/㎡ (not to exceed 12 ㎎ total) will be given intrathecally once every 2 weeks for three times (total four doses including one given before preparatory regimen). Folinic acid 15 ㎎ will be given p.o. or i.v. 24 hours after intrathecal methotrexate and q 6 hours for a total of 4 doses.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| ArmI(BuCy) | No intervention | Drug: BuCy vs BuFlu* Intravenous busulfan (Busulfex®; Orphan Medical, Minnetonka, MN) 3.2 ㎎/㎏ in normal saline 500 ㎖ i.v. over 3 hours on days -7 to -4 * Cyclophosphamide 60 ㎎/㎏ in D5W 200 ㎖ i.v. over 1-2 hours on days -3 and -2 |
| Arm II (BuFlu) | No intervention | Drug: BuCy vs BuFlu* Intravenous busulfan 3.2 ㎎/㎏ in normal saline 500 ㎖ i.v. over 3 hours on days -7 to -4. * Fludarabine (Fludara®, Schering AG, Berlin, Germany) 30 ㎎/㎡ i.v. over 30 minutes in D5W 100 ㎖ on days -6 to -2 |
Who may qualify
- Ages
- 15 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (3 listed)
- Patients with acute leukemia, chronic myelogenous leukemia, myelodysplastic syndrome, and other hematologic malignancies.
- Patients should have an HLA-identical or one-locus mismatched sibling, family or unrelated donor.
- Patients should be 15 years of age or older, but younger than 70 years.
Key exclusion criteria (2 listed)
- Patients have major illness or organ failure.
- Patients have a psychiatric disorder or mental deficiency severe as to make compliance with the treatment unlike, and making informed consent impossible.
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 |
|---|---|---|
| BuCy vs BuFluAlso: busulfan plus cyclophosphamide versus fludarabineArm 1:BuCy Arm 2:BuFlu | Drug | Arm II (BuFlu), ArmI(BuCy) |
Primary outcome
related toxicities of two different conditioning regimens, intravenous once-daily busulfan plus cyclophosphamide (BuCy) vs. fludarabine (BuFlu) for allogeneic hematopoietic cell transplantation (HCT) in leukemia and myelodysplastic syndrome
Time frame: 8years
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Feb 2011.
- Derived from this study: PubMed 23129746Lee JH, Joo YD, Kim H, Ryoo HM, Kim MK, Lee GW, Lee JH, Lee WS, Park JH, Bae SH, Hyun MS, Kim DY, Kim SD, Min YJ, Lee KH. Randomized trial of myeloablative conditioning regimens: busulfan plus cyclophosphamide versus busulfan plus fludarabine. J Clin Oncol. 2013 Feb 20;31(6):701-9. doi: 10.1200/JCO.2011.40.2362. Epub 2012 Nov 5.
- BuCy vs BuFluLink 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.
Je-Hwan Lee, Doctor principal investigator
Asan Medical 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 BuCy vs BuFlu in people with Leukemia and Myelodysplastic Syndrome, run by Cooperative Study Group A for Hematology at 1 site in South Korea.
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 3 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 14 Feb 2011. 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 South Korea. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
related toxicities of two different conditioning regimens, intravenous once-daily busulfan plus cyclophosphamide (BuCy) vs. fludarabine (BuFlu) for allogeneic hematopoietic cell transplantation (HCT) in leukemia and myelodysplastic syndrome (time frame: 8years). 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 NCT00774280, 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 14 Feb 2011.