Myeloid Hematological MalignanciesUCAMLNCT01247701
Umbilical Cord Blood Transplant for Children With Myeloid Hematological Malignancies
A study testing Busulfan, Cyclophosphamide and Fludarabine in people with Myeloid Hematological Malignancies, run by Baylor College of Medicine at 1 site in United States.
Trial summary
In this study, the investigators will use busulfan and cyclophosphamide (BuCy) backbone with the addition of fludarabine as the preparative Stem Cell Transplant (SCT) regimen. As an attempt to improve engraftment rate and reduce infections, the investigators are going to incorporate fludarabine in the conditioning… Read more about this study
- Who is it for?
- Ages Up to 17 years
- Conditions the study is for
- Myeloid Hematological Malignancies
- What is being tested?
- Busulfan, Cyclophosphamide and Fludarabine
- Type of treatment
- Injection or infusion, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 16 participants
- Where
- 1 siteUnited States
- Study dates
- Nov 2010to Oct 2019
- Phase
- Interventional
- 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 Up to 17 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- Patients with a myeloid hematologic malignancy (acute myelogenous leukemia, secondary myelogenous leukemia or myelodysplastic syndrome) unlikely to be cure by standard chemotherapy. This includes patients who have relapsed after standard chemotherapy treatments and patients in first remission with unfavorable prognostics features.
- Related or Unrelated Umbilical Cord Blood Unit with 0-1 antigen mismatch at HLA-A and B (at low resolution) and DRB1 (at high resolution), with a total nucleated cell dose of ≥ 4 x 10^7/kg.
- Lansky/Karnofsky scores at least 60.
- Written informed consent and/or signed assent line from patient, parent or guardian.
- Negative pregnancy test, if applicable.
Who cannot join
- Patients with uncontrolled infections. For bacterial infections, patients must be receiving definitive therapy and have no signs of progressing infection for 72 hours prior to enrollment. For fungal infections, patients must be receiving definitive systemic antifungal therapy and have no signs of progressing infection for 1 week prior to enrollment. Progressing infection is defined as hemodynamic instability attributable to sepsis or new symptoms, worsening physical signs or radiographic findings attributable to infection. Persisting fever without other signs or symptoms will not be interpreted as progressing infection.
- Severe renal disease (Creatinine > 3X normal for age).
- Severe hepatic disease (direct bilirubin > 3 mg/dL or SGOT > 500).
- Patient has DLCO < 50% predicted or FEV1 < 50% of predicted, if applicable.
- Patients with symptomatic cardiac failure unrelieved by medical therapy or evidence of significant cardiac dysfunction by echocardiogram (shortening fraction < 20%).
- HIV positive.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Umbilical Cord Blood Transplant for Children With Myeloid Hematological Malignancies (UCAML)
In this study, the investigators will use busulfan and cyclophosphamide (BuCy) backbone with the addition of fludarabine as the preparative Stem Cell Transplant (SCT) regimen. As an attempt to improve engraftment rate and reduce infections, the investigators are going to incorporate fludarabine in the conditioning regimen. The use of a BuCy backbone has been widely used and comparable to total body irradiation and cyclophosphamide (Cy/TBI) regimen.
Encouraging data on adding fludarabine to the SCT regimen have been reported. A fludarabine-based, conditioning regimen, with adequate immunosuppressive activity could conceivably allow engraftment of stem cells from alternative donors in hematologic malignancies patients with acceptable engraftment rates and low transplant-related mortality. Regimen-related toxicity is believed to be a major contributing factor to GVHD. Therefore this approach may also lead to reduced GVHD, as some investigators have suggested.
In an attempt to decrease the rate of viral infection and reactivation, the investigators will avoid ATG (Thymoglobulin) / Campath (anti-CD52), and instead administer Mycophenolate Mofetil (MMF). The addition of fludarabine should compensate any increase risk of graft failure with the removal of the ATG/Campath. The investigators anticipate that the removal of ATG/Campath will facilitate immune reconstitution more efficiently after receiving a UCBT.
Read the detailed description
The following will be given as the conditioning regimen for the transplant:
BUSULFAN: Busulfan (intravenous BUSULFEX) dosing will be as follows: patients <12 kg: 1.1 mg/kg/dose IV every 6 hours for 16 doses total; patients >12 kg: 0.8 mg/kg/dose IV every 6 hours for 16 doses. Administration and pharmacokinetic monitoring will be performed as per standard practice. Anticonvulsants will be given in accordance with standard Blood and Marrow Transplant Program recommendations.
CYCLOPHOSPHAMIDE: Cyclophosphamide (50 mg/kg/dose) will be given IV on Days -5, - 4, -3, and -2 over 1 hour. The total dose to be given over 4 days is 200 mg/kg. Mesna will be given in accordance with standard Blood and Marrow Transplant.
FLUDARABINE: Fludarabine will be given IV daily over 1 hour for 3 days. Dosing will be as follows: for patients ≤ 10 kg: 1.3 mg/kg; for patients > 10 kg: 40 mg/m2. Preparation, administration and monitoring will be according to standard practice procedure
POST-TRANSPLANT IMMUNOSUPPRESSION:
- CSA will begin on Day -3. For children < 40 kg, the initial dose will be 2.5 mg/kg IV over 2 hours every 12 hours. Dose adjustments will be made to maintain levels above 200 ng/mL. Levels will be done on Day 0 and then as clinical indicated. CSA will be tapered per institutional SOP. Once the patient can tolerate oral medications and has a normal gastrointestinal transit time, CSA will be converted to an oral form.
- MMF will begin on Day 0 at a dose of 15 mg/Kg IV or orally TID, and will be discontinued on Day +45 unless GVHD is present.
CNS Disease: Patients with CNS relapse or primary CNS disease that is symptomatic or associated to radiological changes will receive additional irradiation to the craniospinal axis.
SUPPORTIVE CARE:
- Supportive care will be provided as per standard practice of the Blood and Marrow Stem Cell Transplant program at the Texas Children's Hospital, including all prophylactic and therapeutic clinical care issues. These practices may be modified if necessary for any individual patient in order to provide optimum care for that particular patient.
- IVIG: Intravenous immunoglobulin (500 mg/kg per dose) will be given monthly until discontinuation of GVHD therapy and documentation of antibody production.
- CB-CTLs: Patients enrolled in this protocol may also be eligible for infusion of CB-derived multivirus-specific CTL to provide virus-specific immune reconstitution and treatment of viral infections after CBT.
EVALUATIONS DURING THE STUDY:
Screening Procedures; Pre-HCT:
- Physical examination
- Pregnancy test
- Complete blood count and chemistries
- Electrocardiogram
- Echocardiograph
- PT/PTT/Fibrinogen/Anti-Thrombin III/von Willebrand Factor
- Viral tests
- Bone marrow aspirate and biopsy/Lumbar puncture
- Renal Function (GFR)
- Lumbar puncture will be performed
- Pulmonary Function test
EVALUATIONS BETWEEN DAY 0 AND DAY 100:
- Physical examination
- Complete blood count and chemistries
- Lytes/BUN/Cr
- Peripheral blood for STRs or FISH analysis for molecular diagnostics
- Lymphocyte phenotype testing and lymphoproliferative responses
- Bone marrow aspirate and biopsy for assessment of leukemia status and UCB engraftment
- Lumbar puncture
- Immunoglobulins
EVALUATIONS AFTER DAY 100:
- Physical examination
- Complete blood count and chemistries
- Lytes/BUN/Cr
- Serum chemistries
- Peripheral blood with assessment of engraftment by STRs or FISH analysis and enzyme levels
- Echocardiograph with LVEF
- Bone marrow aspirate and biopsy assessment of leukemia status and UCB engraftment
- Lymphocyte phenotype testing (CD3, CD4, CD8, CD19 and CD56) and lymphoproliferative responses
- Immunoglobulins
FOLLOW-UP INTERVAL:
Patients will be seen in the hospital everyday until discharge. After discharge from the hospital, the patient will be following on the BMT clinics on a regular basis as recommended by the primary physician.
- Conditions
- Myeloid Hematological Malignancies
- Being tested
- Busulfan, Cyclophosphamide, Fludarabine, Cord Blood Stem Cell Infusion
- Keywords
- UCB, Umbilical Cord Blood, Transplant, Umbilical Cord Blood Transplant, Cord Blood Stem Cell Transplantation, Pediatric, Myeloid Hematological Malignancies, Busulfan, Cytoxan, Cyclophosphamide, Fludarabine
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
BusulfanDrug
Also called Busulfex
Busulfan dosing will be as follows: Patients < 12 kg: 1.1 mg/kg/dose IV every 6 hours for 16 doses total; patients > 12 kg: 0.8 mg/kg/dose IV every 6 hours for 16 doses. It will be given on Days -9, -8, -7 and -6.
CyclophosphamideDrug
Also called CTX, Cytoxan
Cyclophosphamide (50 mg/kg/dose) will be given IV on Days -5, - 4, -3, and -2 over 1 hour. The total dose to be given over 4 days is 200 mg/kg.
FludarabineDrug
Also called Fludera
Fludarabine will be given IV daily over 1 hour for 3 days. Dosing will be as follows: for patients ≤ 10 kg: 1.3 mg/kg; for patients > 10 kg: 40 mg/m^2.
Cord Blood Stem Cell InfusionProcedure or surgery
The cord blood stem cells will be infused on Day 0.
| Study group | Role | What they receive |
|---|---|---|
| Umbilical Cord Blood Transplant | Experimental | Busulfan,Cyclophosphamide, Fludarabine, Cord Blood Stem Cell Infusion Receives: Drug: Busulfan; Drug: Cyclophosphamide; Drug: Fludarabine; Procedure: Cord Blood Stem Cell Infusion |
What is being measured
The primary outcome is the main question the study is designed to answer.
Overall Survival at 100 Days, 1 Year, and 3 Years After Umbilical Cord Blood Transplant in Pediatric Patients.
To determine the overall survival rate at 1 year after umbilical cord blood transplant in pediatric patients with myeloid hematological malignancies.
Measured: 100 days, 1 year, and 3 years
Secondary outcomes (6)
Number of Participants With Severe Acute GVHD Grade III-IV
Number of participants with acute GVHD graded by the method of Przepiorka et al, which evaluates skin involvement, lower and upper GI, and liver function (bilirubin), each being graded in stages from 0 to 4, where 0 means no acute GVHD, and 4 is the highest stage of acute GVHD.
Measured: Day 100
Number of Participants With Chronic GvHD
Number of participants with chronic GVHD graded by the method of Przepiorka et al, which evaluates skin, joints, oral, ocular, hepatic, esophagus, GI, respiratory, platelet, and musculoskeletal involvement, in stages from 0 to 3.
Measured: 1 year
Number of Participants With Relapse Rate After Transplant
To assess relapse rate at 1 and 3 years after transplant. Cumulative incidence of relapse was calculated from the date of umbilical cord blood transplant using the competing risk method as described in Gray(1988) with death prior to relapse as the competing risk. Participants still alive without a date of relapse were censored at the time of the last follow-up.
Measured: 1 and 3 years
Number of Participants With Donor Engraftment After Transplant.
To evaluate donor engraftment at 100 days, 6, 9, 12, 24, and 36 months after transplant.
Measured: 100 days, 6, 9, 12, 24 and 36 months
Number of Participants With Platelet Engraftment
Achievement of untransfused platelet count > 20 x 10^9/L on three consecutive days
Measured: Day 180
Number of Participants With Neutrophil Engraftment
Achievement of absolute neutrophil count > 0.5 x 10^9/L on three consecutive days
Measured: Day 42
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Nov 2010 (estimated)
- Study startNov 2010
- Primary completionOct 2019
- Study completionOct 2019
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 Myeloid Hematological MalignanciesStudies of the same condition, open and under way.
- More trials run by Baylor College of MedicineThe 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 N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 16 participants (actual)
Sponsor and investigators
- Lead sponsor
- Baylor College of Medicine
- Sponsor type
- University, hospital or other
- Collaborators
- Center for Cell and Gene Therapy, Baylor College of Medicine
- Responsible party
- Principal investigator, Caridad Martinez, Baylor College of Medicine
- Investigators
- Caridad A Martinez, MD, Principal investigator, Baylor College of MedicineRobert A Krance, MD, Principal investigator, Baylor College of Medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01247701
- Sponsor's protocol ID
- 26558-UCAML
- Acronym
- UCAML
- Status last verified
- May 2022
- First submitted
- 22 Nov 2010
- Last updated
- 8 Jun 2022
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 8 Jun 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Umbilical Cord Blood Transplant for Children With Myeloid Hematological Malignancies (UCAML)
- ClinicalTrials.gov ID
- NCT01247701
- Acronym / sponsor ID
- UCAML / 26558-UCAML
- Conditions
- Myeloid Hematological Malignancies
- Keywords
- UCB, Umbilical Cord Blood, Transplant, Umbilical Cord Blood Transplant, Cord Blood Stem Cell Transplantation, Pediatric, Myeloid Hematological Malignancies, Busulfan
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 16 participants (actual)
- Lead sponsor
- Baylor College of MedicineUniversity, hospital or other
- Collaborators
- Center for Cell and Gene Therapy, Baylor College of Medicine
- Study start
- Nov 2010
- Primary completion
- Oct 2019 (actual)
- Study completion
- Oct 2019 (actual)
- First posted
- 24 Nov 2010 (estimated)
- Results
- Posted 8 Jun 2022
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
In this study, the investigators will use busulfan and cyclophosphamide (BuCy) backbone with the addition of fludarabine as the preparative Stem Cell Transplant (SCT) regimen. As an attempt to improve engraftment rate and reduce infections, the investigators are going to incorporate fludarabine in the conditioning regimen. The use of a BuCy backbone has been widely used and comparable to total body irradiation and cyclophosphamide (Cy/TBI) regimen.
Encouraging data on adding fludarabine to the SCT regimen have been reported. A fludarabine-based, conditioning regimen, with adequate immunosuppressive activity could conceivably allow engraftment of stem cells from alternative donors in hematologic malignancies patients with acceptable engraftment rates and low transplant-related mortality. Regimen-related toxicity is believed to be a major contributing factor to GVHD. Therefore this approach may also lead to reduced GVHD, as some investigators have suggested.
In an attempt to decrease the rate of viral infection and reactivation, the investigators will avoid ATG (Thymoglobulin) / Campath (anti-CD52), and instead administer Mycophenolate Mofetil (MMF). The addition of fludarabine should compensate any increase risk of graft failure with the removal of the ATG/Campath. The investigators anticipate that the removal of ATG/Campath will facilitate immune reconstitution more efficiently after receiving a UCBT.
Detailed description
The following will be given as the conditioning regimen for the transplant:
BUSULFAN: Busulfan (intravenous BUSULFEX) dosing will be as follows: patients <12 kg: 1.1 mg/kg/dose IV every 6 hours for 16 doses total; patients >12 kg: 0.8 mg/kg/dose IV every 6 hours for 16 doses. Administration and pharmacokinetic monitoring will be performed as per standard practice. Anticonvulsants will be given in accordance with standard Blood and Marrow Transplant Program recommendations.
CYCLOPHOSPHAMIDE: Cyclophosphamide (50 mg/kg/dose) will be given IV on Days -5, - 4, -3, and -2 over 1 hour. The total dose to be given over 4 days is 200 mg/kg. Mesna will be given in accordance with standard Blood and Marrow Transplant.
FLUDARABINE: Fludarabine will be given IV daily over 1 hour for 3 days. Dosing will be as follows: for patients ≤ 10 kg: 1.3 mg/kg; for patients > 10 kg: 40 mg/m2. Preparation, administration and monitoring will be according to standard practice procedure
POST-TRANSPLANT IMMUNOSUPPRESSION:
- CSA will begin on Day -3. For children < 40 kg, the initial dose will be 2.5 mg/kg IV over 2 hours every 12 hours. Dose adjustments will be made to maintain levels above 200 ng/mL. Levels will be done on Day 0 and then as clinical indicated. CSA will be tapered per institutional SOP. Once the patient can tolerate oral medications and has a normal gastrointestinal transit time, CSA will be converted to an oral form.
- MMF will begin on Day 0 at a dose of 15 mg/Kg IV or orally TID, and will be discontinued on Day +45 unless GVHD is present.
CNS Disease: Patients with CNS relapse or primary CNS disease that is symptomatic or associated to radiological changes will receive additional irradiation to the craniospinal axis.
SUPPORTIVE CARE:
- Supportive care will be provided as per standard practice of the Blood and Marrow Stem Cell Transplant program at the Texas Children's Hospital, including all prophylactic and therapeutic clinical care issues. These practices may be modified if necessary for any individual patient in order to provide optimum care for that particular patient.
- IVIG: Intravenous immunoglobulin (500 mg/kg per dose) will be given monthly until discontinuation of GVHD therapy and documentation of antibody production.
- CB-CTLs: Patients enrolled in this protocol may also be eligible for infusion of CB-derived multivirus-specific CTL to provide virus-specific immune reconstitution and treatment of viral infections after CBT.
EVALUATIONS DURING THE STUDY:
Screening Procedures; Pre-HCT:
- Physical examination
- Pregnancy test
- Complete blood count and chemistries
- Electrocardiogram
- Echocardiograph
- PT/PTT/Fibrinogen/Anti-Thrombin III/von Willebrand Factor
- Viral tests
- Bone marrow aspirate and biopsy/Lumbar puncture
- Renal Function (GFR)
- Lumbar puncture will be performed
- Pulmonary Function test
EVALUATIONS BETWEEN DAY 0 AND DAY 100:
- Physical examination
- Complete blood count and chemistries
- Lytes/BUN/Cr
- Peripheral blood for STRs or FISH analysis for molecular diagnostics
- Lymphocyte phenotype testing and lymphoproliferative responses
- Bone marrow aspirate and biopsy for assessment of leukemia status and UCB engraftment
- Lumbar puncture
- Immunoglobulins
EVALUATIONS AFTER DAY 100:
- Physical examination
- Complete blood count and chemistries
- Lytes/BUN/Cr
- Serum chemistries
- Peripheral blood with assessment of engraftment by STRs or FISH analysis and enzyme levels
- Echocardiograph with LVEF
- Bone marrow aspirate and biopsy assessment of leukemia status and UCB engraftment
- Lymphocyte phenotype testing (CD3, CD4, CD8, CD19 and CD56) and lymphoproliferative responses
- Immunoglobulins
FOLLOW-UP INTERVAL:
Patients will be seen in the hospital everyday until discharge. After discharge from the hospital, the patient will be following on the BMT clinics on a regular basis as recommended by the primary physician.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Umbilical Cord Blood Transplant | Experimental | Drug: Busulfan, Drug: Cyclophosphamide, Drug: Fludarabine, Procedure: Cord Blood Stem Cell InfusionBusulfan,Cyclophosphamide, Fludarabine, Cord Blood Stem Cell Infusion |
Who may qualify
- Ages
- Up to 17 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (5 listed)
- Patients with a myeloid hematologic malignancy (acute myelogenous leukemia, secondary myelogenous leukemia or myelodysplastic syndrome) unlikely to be cure by standard chemotherapy. This includes patients who have relapsed after standard chemotherapy treatments and patients in first remission with unfavorable prognostics features.
- Related or Unrelated Umbilical Cord Blood Unit with 0-1 antigen mismatch at HLA-A and B (at low resolution) and DRB1 (at high resolution), with a total nucleated cell dose of ≥ 4 x 10^7/kg.
- Lansky/Karnofsky scores at least 60.
- Written informed consent and/or signed assent line from patient, parent or guardian.
- Negative pregnancy test, if applicable.
Key exclusion criteria (6 listed)
- Patients with uncontrolled infections. For bacterial infections, patients must be receiving definitive therapy and have no signs of progressing infection for 72 hours prior to enrollment. For fungal infections, patients must be receiving definitive systemic antifungal therapy and have no signs of progressing infection for 1 week prior to enrollment. Progressing infection is defined as hemodynamic instability attributable to sepsis or new symptoms, worsening physical signs or radiographic findings attributable to infection. Persisting fever without other signs or symptoms will not be interpreted as progressing infection.
- Severe renal disease (Creatinine > 3X normal for age).
- Severe hepatic disease (direct bilirubin > 3 mg/dL or SGOT > 500).
- Patient has DLCO < 50% predicted or FEV1 < 50% of predicted, if applicable.
- Patients with symptomatic cardiac failure unrelieved by medical therapy or evidence of significant cardiac dysfunction by echocardiogram (shortening fraction < 20%).
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: BusulfexBusulfan dosing will be as follows: Patients < 12 kg: 1.1 mg/kg/dose IV every 6 hours for 16 doses total; patients > 12 kg: 0.8 mg/kg/dose IV every 6 hours for 16 doses. It will be given on Days -9, -8, -7 and -6. | Drug | Umbilical Cord Blood Transplant |
| CyclophosphamideAlso: CTX, CytoxanCyclophosphamide (50 mg/kg/dose) will be given IV on Days -5, - 4, -3, and -2 over 1 hour. The total dose to be given over 4 days is 200 mg/kg. | Drug | Umbilical Cord Blood Transplant |
| FludarabineAlso: FluderaFludarabine will be given IV daily over 1 hour for 3 days. Dosing will be as follows: for patients ≤ 10 kg: 1.3 mg/kg; for patients > 10 kg: 40 mg/m^2. | Drug | Umbilical Cord Blood Transplant |
| Cord Blood Stem Cell InfusionThe cord blood stem cells will be infused on Day 0. | Procedure or surgery | Umbilical Cord Blood Transplant |
Primary outcome
Overall Survival at 100 Days, 1 Year, and 3 Years After Umbilical Cord Blood Transplant in Pediatric Patients.
Time frame: 100 days, 1 year, and 3 years
To determine the overall survival rate at 1 year after umbilical cord blood transplant in pediatric patients with myeloid hematological malignancies.
6 secondary outcomes
Number of Participants With Severe Acute GVHD Grade III-IV
Time frame: Day 100
Number of Participants With Chronic GvHD
Time frame: 1 year
Number of Participants With Relapse Rate After Transplant
Time frame: 1 and 3 years
Number of Participants With Donor Engraftment After Transplant.
Time frame: 100 days, 6, 9, 12, 24 and 36 months
Number of Participants With Platelet Engraftment
Time frame: Day 180
Number of Participants With Neutrophil Engraftment
Time frame: Day 42
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Jun 2022.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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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.
Caridad A Martinez, MD principal investigator
Baylor College of Medicine
Robert A Krance, MD principal investigator
Baylor College of Medicine
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Busulfan, Cyclophosphamide and Fludarabine in people with Myeloid Hematological Malignancies, run by Baylor College of Medicine 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 5 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 8 Jun 2022. 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.
Are results available for this study?
Yes. Results are posted in the registry (first posted 8 Jun 2022). 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?
Overall Survival at 100 Days, 1 Year, and 3 Years After Umbilical Cord Blood Transplant in Pediatric Patients. (time frame: 100 days, 1 year, and 3 years). 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 8 Jun 2022.