Acute Lymphoblastic LeukemiaEarly Phase 1NCT02181478
Intra-Osseous Co-Transplant of UCB and hMSC
A Early Phase 1 study testing cyclophosphamide, fludarabine phosphate and total-body irradiation in people with Acute Lymphoblastic Leukemia and Acute Myelogenous Leukemia, run by Case Comprehensive Cancer Center at 1 site in United States.
Trial summary
This clinical trial studies intra-osseous donor umbilical cord blood and mesenchymal stromal cell co-transplant in treating patients with hematologic malignancies. Giving low doses of chemotherapy and total-body irradiation before a co-transplant of donor umbilical cord blood and mesenchymal stromal cells into the… Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Acute Lymphoblastic Leukemia, Acute Myelogenous Leukemia, Myelodysplastic Syndromes
- What is being tested?
- cyclophosphamide, fludarabine phosphate and total-body irradiation
- 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
- 6 participants
- Where
- 1 siteUnited States
- Study dates
- 22 Jul 2015to 7 Feb 2020
- Phase
- Early Phase 1
- 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 18 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients must have one of the following malignancies:
- Acute myelogenous leukemia (AML): high-risk AML including:
- Antecedent hematological disease (e.g., myelodysplasia [MDS])
- Treatment-related leukemia
- Complete remission (first complete remission [CR1]) with poor-risk cytogenetics or molecular markers (e.g. fms-related tyrosine kinase 3 [Flt 3] mutation, 11q23, del 5, del 7, complex cytogenetics)
- Second complete remission (CR2) or third complete remission (CR3)
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- Induction failure or first relapse with either
- ≤ 10% blasts in the marrow and/or
- ≤ 5% blasts in the peripheral blood
- Acute lymphoblastic leukemia (ALL)
- High-risk CR1 including:
- Poor-risk cytogenetics (e.g., Philadelphia chromosome t(9;22)or 11q23 rearrangements)
- Presence of minimal disease by flow cytometry after 2 or more cycles of chemotherapy
- No complete remission (CR) within 4 weeks of initial treatment
- Induction failure
- CR2 or CR3 with either:
- ≤ 10% blasts in the marrow and/or
- ≤ 5% blasts in the peripheral blood
- Myelodysplastic syndromes (MDS), Intermediate-1 (INT-1), intermediate-2 (INT-2) or high Revised International Prognostic Scoring System (IPSS-R) score that has failed at least 1 first line therapy
- Myelofibrosis (MF):
- Intermediate-2 or high risk by Dynamic International Prognostic Scoring System (DIPSS)-plus
- Monosomal karyotype
- Presence of inv(3)/i(17q) abnormalities
- Other unfavorable karyotype OR leukocytes ≥40 X 10^9/L AND
- Circulating blasts ≤ 9%
- Relapsed or refractory lymphoid malignancies (including non-Hodgkin lymphoma, Hodgkin lymphoma and chronic lymphocytic leukemia) meeting the following criteria:
- Disease status: stable disease, partial remission or 2nd and 3rd complete remission
- Chronic myelogenous leukemia (CML) in second chronic phase after accelerated or blast crisis; blast crisis defined as:
- Blast count ≥ 20% in the peripheral blood or bone marrow
- Large foci of blasts on bone marrow
- Presence of extra-medullary blastic infiltrate (myeloid sarcoma or chloroma)
- Recipients of prior autologous or allogeneic transplant are eligible, as long as at least 3 months have passed since the transplant, and the patient fulfills other eligibility criteria
- Eastern Cooperative Oncology Group (ECOG) performance status ≤2
- Candidates for reduced intensity conditioning regimens
- Patients who do not have HLA-matched (defined as matched in HLA A, B, C, and DRB1) related or unrelated donors, those who elect to undergo UCB even if they have a MRD or MUD, or patients who require a UCB either for emergency indications such as primary graft failure.
- Cord Blood Units available through NMDP with the following minimal criteria:
- HLA Match: 4/6 or better match (HLA A, B, DRB1)
- Cell dose: Minimum of 2.0x107TNC/kg pre thaw
- Concurrent therapy for extramedullary leukemia or central nervous system (CNS) lymphoma: concurrent therapy or prophylaxis for testicular leukemia, CNS leukemia, and CNS lymphoma including standard intrathecal chemotherapy and/or radiation therapy will be allowed as clinically indicated; such treatment may continue until the planned course is completed; subjects must be in CNS remission at the time of protocol enrollment if there is a history of CNS involvement
- Subjects must have a back-up umbilical cord on the registry in addition to the umbilical cord being used in this study
- Subjects must have the ability to understand and the willingness to sign a written informed consent document
Who cannot join
- Patients with inadequate Organ Function as defined by:
- Creatinine clearance < 30 ml/min
- Bilirubin ≥ 2 x institutional upper limit of normal
- Aspartate aminotransferase (AST) (serum glutamic oxaloacetic transaminase [SGOT]) ≥ 2 x institutional upper limit of normal
- Alanine aminotransferase (ALT) (serum glutamate pyruvate transaminase [SGPT]) ≥ 2 x institutional upper limit of normal
- Corrected diffusing capacity of the lung for carbon monoxide (DLCOcorr) < 40% normal
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- Left ventricular ejection fraction < 35%
- Patients with uncontrolled inter-current illness including, but not limited to ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, or psychiatric illness/social situations that would limit compliance with study requirements
- Pregnant or breastfeeding women are excluded from this study
Trial locations and contacts
1 site in 1 country.
United States1 site
Case Comprehensive Cancer Center
Cleveland, Ohio, 44106-5065
About this study
Official title: Intra-osseous Co-transplant of Cord Blood and Mesenchymal Stromal Cells: A Feasibility Study
This clinical trial studies intra-osseous donor umbilical cord blood and mesenchymal stromal cell co-transplant in treating patients with hematologic malignancies. Giving low doses of chemotherapy and total-body irradiation before a co-transplant of donor umbilical cord blood and mesenchymal stromal cells into the bone (intra-osseous) helps stop the growth of cancer cells. It may also stop the patient's immune system from rejecting the donor's stem cells. The donated stem cells may replace the patient's immune cells and help destroy any remaining cancer cells (graft-versus-tumor effect). Sometimes the transplanted cells from a donor can also make an immune response against the body's normal cells. Giving cyclosporine and mycophenolate mofetil at the time of transplant may stop this from happening.
Read the detailed description
PRIMARY OBJECTIVES:
- To estimate the feasibility of combining intra-osseous umbilical cord blood (UCB) hematopoietic stem cells and human mesenchymal stromal cells (hMSC) following reduced intensity conditioning (RIC).
SECONDARY OBJECTIVES:
- To estimate the time to engraftment of intra-osseous (IO) UCB transplant combined with hMSC following RIC.
II. To estimate the safety profile of IO UBC transplant combined with hMSC.
OUTLINE:
REDUCED INTENSITY CONDITIONING: Patients receive cyclophosphamide intravenously (IV) over 2 hours on day -6 and fludarabine phosphate IV on days -6 to -2 and undergo total body irradiation (TBI) on day -1.
GRAFT-VERSUS-HOST DISEASE (GVHD) PROPHYLAXIS: Patients receive cyclosporine orally (PO) or IV over 2 hours every 12 hours on beginning on days -5 to 100 with taper beginning on day 100 and mycophenolate mofetil IV or PO twice daily (BID) on days -5 to 100.
TRANSPLANT: Patients undergo intra-osseous UCB and hMSC co-transplant on day 0.
After completion of study treatment, patients are followed up at days 28 and 100, and then at 6, 9, and 12 months.
- Conditions
- Acute Lymphoblastic Leukemia, Acute Myelogenous Leukemia, Myelodysplastic Syndromes, Myelofibrosis, Relapsed Non-Hodgkin Lymphoma, Refractory Non-Hodgkin Lymphoma
- Being tested
- cyclophosphamide, fludarabine phosphate, total-body irradiation, cyclosporine, mycophenolate mofetil
- Keywords
- Total Body Irradiation, Human Mesenchymal Stromal Cells, hMSC, Cyclophosphamide, Fludarabine, Dimethyl Sulfoxide, DMSO, Cyclosporine, Mycophenolate Mofetil, MMF, Granulocyte- Colony Stimulating Factor, G-CSF, GVHD, Cancer, feasibility
- Medical subject headings
- Precursor Cell Lymphoblastic Leukemia-Lymphoma, Leukemia, Myeloid, Acute, Myelodysplastic Syndromes, Primary Myelofibrosis, Lymphoma, Non-Hodgkin, Hodgkin Disease, Leukemia, Lymphocytic, Chronic, B-Cell, Leukemia, Myelogenous, Chronic, BCR-ABL Positive
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
cyclophosphamideDrug
Also called CPM, CTX, Cytoxan, Endoxan
All patients will receive a single IV dose of 50 mg/kg of cyclophosphamide on day -6
Also called 2-F-ara-AMP, Beneflur, Fludara
Given by IV during prep at 40mg/m2 for 5 days
total-body irradiationRadiation
Also called TBI
Undergo single fraction of reduced intensity conditioning (RIC) regimen of 200 cGy TBI without shielding on day -1
cyclosporineDrug
Also called ciclosporin, cyclosporin, cyclosporin A, CYSP
Initiated in patients on the day -5. Cyclosporine will be administered orally or intravenously at 2 mg/kg/dose every 12 hours for 2-hour period. Cyclosporine will continue until day +100
Also called Cellcept, MMF
Given at 1g intravenously or orally twice daily from day -5 to +100, or as clinically indicated.
umbilical cord blood transplantationProcedure or surgery
Also called cord blood transplantation, transplantation, umbilical cord blood, UCB transplantation
Following RIC, on day T+0, dimethylsulphoxide will be removed from the cord blood cells and given as transplant.
mesenchymal stem cell transplantationProcedure or surgery
Also called hMSC transplantation
The total dosage of hMSC will be 2x10^6cells/kg (+/-20%).
| Study group | Role | What they receive |
|---|---|---|
| Treatment (intra-osseous UCB with hMSC co-transplant) | Experimental | REDUCED INTENSITY CONDITIONING (RIC):
Flu/Cy/TBI: Patients receive cyclophosphamide IV over 2 hours on day -6 and fludarabine phosphate IV on days -6 to -2 and undergo total-body irradiation on day -1.
Flu/Mel: Patients receive fludarabine daily on days -5 to -2, a single dose of melphalan on day -2, and ATG on day -3 and day-2.
GVHD PROPHYLAXIS: Patients receive cyclosporine PO or IV over 2 hours every 12 hours on beginning on days -5 to 100 with taper beginning on day 100 and mycophenolate mofetil IV or PO BID on days -5 to 100.
TRANSPLANT: Patients undergo a co-transplantation of an intra-osseous umbilical cord blood transplantation and a mesenchymal stem cell transplantation on day 0. Receives: Drug: cyclophosphamide; Drug: fludarabine phosphate; Radiation: total-body irradiation; Drug: cyclosporine; Drug: mycophenolate mofetil; Procedure: umbilical cord blood transplantation; Procedure: mesenchymal stem cell transplantation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of patients with BM cellularity failure: Measure of feasibility
Primary graft failure is defined by <10% BM cellularity in bone marrow biopsies. Failure in more than 30% of patients will indicate unfeasibility of treatment
Measured: 42 days after transplant
Number of patients with ANC failure without evidence of disease: Measure of feasibility
Primary graft failure is defined by <500 ANC cell/ul in bone marrow biopsies. Failure in more than 30% of patients will indicate unfeasibility of treatment
Measured: 42 days after transplant
Number of patients with hematopoietic recovery without evidence of donor umbilical cord blood engraftment: Measure of feasibility
Primary graft failure is defined by hematopoietic recovery with <10% donor cell chimerism. Failure in more than 30% of patients will indicate unfeasibility of treatment
Measured: 42 days after transplant
Number of patients with hematopoietic recovery without evidence of donor umbilical cord blood engraftment: Measure of feasibility
Primary graft failure is defined by hematopoietic recovery with <40% donor cell chimerism. Failure in more than 30% of patients will indicate unfeasibility of treatment
Measured: 100 days after transplant
Secondary outcomes (5)
Incidence of toxicities assessed using National Cancer Institute Common Terminology Criteria for Adverse Events version 4.0
Descriptive statistics will be used.
Measured: Up to 12 months
Rate of neutrophil recovery
The rate of neutrophil recovery and median time of recovery will be estimated using the methods of Kaplan and Meier.
Measured: Up to 12 months
Rate of platelet recovery
The rate of platelet recovery and median time of recovery will be estimated using the methods of Kaplan and Meier.
Measured: Up to 12 months
Median time of neutrophil recovery
The median time of neutrophil recovery will be estimated using the methods of Kaplan and Meier.
Measured: Up to 12 months
Median time of platelet recovery
The median time of platelet recovery will be estimated using the methods of Kaplan and Meier.
Measured: Up to 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Jul 2014 (estimated)
- Study start22 Jul 2015
- Primary completion19 Dec 2019
- Study completion7 Feb 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Acute Lymphoblastic LeukemiaStudies of the same condition, open and under way.
- More trials run by Case Comprehensive 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
- Early Phase 1
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 6 participants (actual)
Sponsor and investigators
- Lead sponsor
- Case Comprehensive Cancer Center
- Sponsor type
- University, hospital or other
- Collaborators
- National Cancer Institute (NCI)
- Responsible party
- Principal investigator, Marcos de Lima, Case Comprehensive Cancer Center
- Investigators
- Leland Metheny, MD, Principal investigator, Case Comprehensive Cancer Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02181478
- Sponsor's protocol ID
- CASE1Z14
- Other IDs
- NCI-2014-01316, CASE1Z14, P30CA043703
- Status last verified
- Dec 2020
- First submitted
- 2 Jul 2014
- Last updated
- 4 Dec 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 4 Dec 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Intra-osseous Co-transplant of Cord Blood and Mesenchymal Stromal Cells: A Feasibility Study
- ClinicalTrials.gov ID
- NCT02181478
- Acronym / sponsor ID
- CASE1Z14
- Conditions
- Acute Lymphoblastic Leukemia, Acute Myelogenous Leukemia, Myelodysplastic Syndromes, Myelofibrosis, Relapsed Non-Hodgkin Lymphoma, Refractory Non-Hodgkin Lymphoma
- Keywords
- Total Body Irradiation, Human Mesenchymal Stromal Cells, hMSC, Cyclophosphamide, Fludarabine, Dimethyl Sulfoxide, DMSO, Cyclosporine
- Phase
- Early Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 6 participants (actual)
- Lead sponsor
- Case Comprehensive Cancer CenterUniversity, hospital or other
- Collaborators
- National Cancer Institute (NCI)
- Study start
- 22 Jul 2015 (actual)
- Primary completion
- 19 Dec 2019 (actual)
- Study completion
- 7 Feb 2020 (actual)
- First posted
- 4 Jul 2014 (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.
This clinical trial studies intra-osseous donor umbilical cord blood and mesenchymal stromal cell co-transplant in treating patients with hematologic malignancies. Giving low doses of chemotherapy and total-body irradiation before a co-transplant of donor umbilical cord blood and mesenchymal stromal cells into the bone (intra-osseous) helps stop the growth of cancer cells. It may also stop the patient's immune system from rejecting the donor's stem cells. The donated stem cells may replace the patient's immune cells and help destroy any remaining cancer cells (graft-versus-tumor effect). Sometimes the transplanted cells from a donor can also make an immune response against the body's normal cells. Giving cyclosporine and mycophenolate mofetil at the time of transplant may stop this from happening.
Detailed description
PRIMARY OBJECTIVES:
- To estimate the feasibility of combining intra-osseous umbilical cord blood (UCB) hematopoietic stem cells and human mesenchymal stromal cells (hMSC) following reduced intensity conditioning (RIC).
SECONDARY OBJECTIVES:
- To estimate the time to engraftment of intra-osseous (IO) UCB transplant combined with hMSC following RIC.
II. To estimate the safety profile of IO UBC transplant combined with hMSC.
OUTLINE:
REDUCED INTENSITY CONDITIONING: Patients receive cyclophosphamide intravenously (IV) over 2 hours on day -6 and fludarabine phosphate IV on days -6 to -2 and undergo total body irradiation (TBI) on day -1.
GRAFT-VERSUS-HOST DISEASE (GVHD) PROPHYLAXIS: Patients receive cyclosporine orally (PO) or IV over 2 hours every 12 hours on beginning on days -5 to 100 with taper beginning on day 100 and mycophenolate mofetil IV or PO twice daily (BID) on days -5 to 100.
TRANSPLANT: Patients undergo intra-osseous UCB and hMSC co-transplant on day 0.
After completion of study treatment, patients are followed up at days 28 and 100, and then at 6, 9, and 12 months.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Treatment (intra-osseous UCB with hMSC co-transplant) | Experimental | Drug: cyclophosphamide, Drug: fludarabine phosphate, Radiation: total-body irradiation, Drug: cyclosporine, Drug: mycophenolate mofetil, Procedure: umbilical cord blood transplantation, Procedure: mesenchymal stem cell transplantationREDUCED INTENSITY CONDITIONING (RIC): Flu/Cy/TBI: Patients receive cyclophosphamide IV over 2 hours on day -6 and fludarabine phosphate IV on days -6 to -2 and undergo total-body irradiation on day -1. Flu/Mel: Patients receive fludarabine daily on days -5 to -2, a single dose of melphalan on day -2, and ATG on day -3 and day-2. GVHD PROPHYLAXIS: Patients receive cyclosporine PO or IV over 2 hours every 12 hours on beginning on days -5 to 100 with taper beginning on day 100 and mycophenolate mofetil IV or PO BID on days -5 to 100. TRANSPLANT: Patients undergo a co-transplantation of an intra-osseous umbilical cord blood transplantation and a mesenchymal stem cell transplantation on day 0. |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (41 listed)
- Patients must have one of the following malignancies:
Key exclusion criteria (9 listed)
- Patients with inadequate Organ Function as defined by:
- Left ventricular ejection fraction < 35%
- Patients with uncontrolled inter-current illness including, but not limited to ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, or psychiatric illness/social situations that would limit compliance with study requirements
- Pregnant or breastfeeding women are excluded from this study
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 |
|---|---|---|
| cyclophosphamideAlso: CPM, CTX, Cytoxan, EndoxanAll patients will receive a single IV dose of 50 mg/kg of cyclophosphamide on day -6 | Drug | Treatment (intra-osseous UCB with hMSC co-transplant) |
| fludarabine phosphateAlso: 2-F-ara-AMP, Beneflur, FludaraGiven by IV during prep at 40mg/m2 for 5 days | Drug | Treatment (intra-osseous UCB with hMSC co-transplant) |
| total-body irradiationAlso: TBIUndergo single fraction of reduced intensity conditioning (RIC) regimen of 200 cGy TBI without shielding on day -1 | Radiation | Treatment (intra-osseous UCB with hMSC co-transplant) |
| cyclosporineAlso: ciclosporin, cyclosporin, cyclosporin A, CYSPInitiated in patients on the day -5. Cyclosporine will be administered orally or intravenously at 2 mg/kg/dose every 12 hours for 2-hour period. Cyclosporine will continue until day +100 | Drug | Treatment (intra-osseous UCB with hMSC co-transplant) |
| mycophenolate mofetilAlso: Cellcept, MMFGiven at 1g intravenously or orally twice daily from day -5 to +100, or as clinically indicated. | Drug | Treatment (intra-osseous UCB with hMSC co-transplant) |
| umbilical cord blood transplantationAlso: cord blood transplantation, transplantation, umbilical cord blood, UCB transplantationFollowing RIC, on day T+0, dimethylsulphoxide will be removed from the cord blood cells and given as transplant. | Procedure or surgery | Treatment (intra-osseous UCB with hMSC co-transplant) |
| mesenchymal stem cell transplantationAlso: hMSC transplantationThe total dosage of hMSC will be 2x10^6cells/kg (+/-20%). | Procedure or surgery | Treatment (intra-osseous UCB with hMSC co-transplant) |
Primary outcome
Number of patients with BM cellularity failure: Measure of feasibility
Time frame: 42 days after transplant
Primary graft failure is defined by <10% BM cellularity in bone marrow biopsies. Failure in more than 30% of patients will indicate unfeasibility of treatment
Number of patients with ANC failure without evidence of disease: Measure of feasibility
Time frame: 42 days after transplant
Primary graft failure is defined by <500 ANC cell/ul in bone marrow biopsies. Failure in more than 30% of patients will indicate unfeasibility of treatment
Number of patients with hematopoietic recovery without evidence of donor umbilical cord blood engraftment: Measure of feasibility
Time frame: 42 days after transplant
Primary graft failure is defined by hematopoietic recovery with <10% donor cell chimerism. Failure in more than 30% of patients will indicate unfeasibility of treatment
Number of patients with hematopoietic recovery without evidence of donor umbilical cord blood engraftment: Measure of feasibility
Time frame: 100 days after transplant
Primary graft failure is defined by hematopoietic recovery with <40% donor cell chimerism. Failure in more than 30% of patients will indicate unfeasibility of treatment
5 secondary outcomes
Incidence of toxicities assessed using National Cancer Institute Common Terminology Criteria for Adverse Events version 4.0
Time frame: Up to 12 months
Rate of neutrophil recovery
Time frame: Up to 12 months
Rate of platelet recovery
Time frame: Up to 12 months
Median time of neutrophil recovery
Time frame: Up to 12 months
Median time of platelet recovery
Time frame: Up to 12 months
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 4 Dec 2020.
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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.
Leland Metheny, MD principal investigator
Case Comprehensive Cancer Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Early Phase 1 study testing cyclophosphamide, fludarabine phosphate and total-body irradiation in people with Acute Lymphoblastic Leukemia and Acute Myelogenous Leukemia, run by Case Comprehensive 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 41 inclusion and 9 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 4 Dec 2020. 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?
Early Phase 1 (sometimes called Phase 0) studies give a very small amount of a treatment to a few people, mainly to see how the body handles it.
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?
Number of patients with BM cellularity failure: Measure of feasibility (time frame: 42 days after transplant). The study lists 4 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 4 Dec 2020.