Hematologic DiseasesPhase 22019-KOE-001NCT04282174
CD34+ Enriched Transplants From HLA-Compatible Patients With Hematologic Malignancies
A Phase 2 study testing CliniMACS, Bone Marrow Transplant and Hyperfractionated Total Body Irradiation in people with Hematologic Diseases and Hematologic Malignancy, run by Baptist Health South Florida at 1 site in United States.
Trial summary
This is a Phase II trial testing disease-specific myeloablative conditioning regimens for preparatory cytoreduction of patients receiving allogeneic HLA-compatible related or unrelated transplants of GCSF-mobilized peripheral blood stem cells (PBSC) depleted of T-cells by positive selection of CD34+ progenitor cells… Read more about this study
- Who is it for?
- Ages Up to 74 yearsHealthy volunteers can take part
- Conditions the study is for
- Hematologic Diseases, Hematologic Malignancy, Acute Lymphoblastic Leukemia
- What is being tested?
- CliniMACS, Bone Marrow Transplant and Hyperfractionated Total Body Irradiation
- Type of treatment
- Injection or infusion, Medical device, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 0 participants
- Where
- 1 siteUnited States
- Study dates
- Sep 2022to 1 Mar 2030
- Phase
- Phase 2
- 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 Up to 74 years
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
Who may be able to join
- Malignant conditions or other life-threatening disorders correctable by transplant for which CD34+ selected, T-cell depleted allogeneic hematopoietic stem cell transplantation is indicated such as:
- Acute myeloid leukemia (AML) in 1st remission - for patients who is AML does not have 'good risk' cytogenetic features (i.e. t8:21, t 15: 17, inv16).
- Secondary AML in 1st remission
- AML in 1st relapse or 2nd remission
- Acute lymphoblastic leukemia (ALL) / Chronic Lymphocytic Leukemia (CLL) in pt remission clinical or molecular features indicating a high risk for relapse; or ALL/CLL 2nd remission
- Chronic myelogenous leukemia (CML) failing to respond to or not tolerating Imatinib or Dasatinib in first chronic phase of disease; CML in accelerated phase, second chronic phase, or in CR after accelerated phase or blast crisis.
Show all 27Show fewer
- Non-Hodgkin's lymphoma with chemo responsive disease in any of the following categories:
- Intermediate or high-grade lymphomas who have failed to achieve a first CR or have relapsed following a 1st remission who are not candidates for autologous transplants.
- Any NHL in remission which is considered not curable with chemotherapy alone and not eligible/appropriate for autologous transplant.
- Myelodysplastic syndrome (MDS): RA/RARS/RCMA with high-risk cytogenetic features or transfusion dependence, as well as RAEB-1 and RAEB-2 and Acute Myelogenous Leukemia (AML) evolved from MDS.
- Chronic myelomonocyte leukemia: CMML-1 and CMML-2.
- Multiple Myeloma with disease in the following categories:
- Patients with relapsed multiple myeloma following autologous stem cell transplantation who have achieved at least partial response following additional chemotherapy.
- Patients with high-risk cytogenetics at diagnosis must have achieved at least a partial response following autologous stem cell transplantation. Patients must have complex karyotype, del l7p, t4; 14 and/or t 4; 16 by Fluorescence in situ hybridization (FISH) and/or del l3 by karyotyping.
- The following inclusion criteria are also required:
- Patient's age includes from birth on to < 74 years old.
- Patients may be of either gender or any ethnic background.
- Patients must have a Karnofsky (adult) Performance Status of at least 70%
- Patients must have adequate organ function measured by:
- Cardiac: asymptomatic or if symptomatic then LVEF at rest must be 50% and must improve with exercise.
- Hepatic: < 3x ULN AST and: s 1.5 total serum bilirubin, unless there is congenital benign hyperbilirubinemia or if the hyperbilirubinemia is directly caused by the disease in which the patient is receiving a transplant (e.g. AML Chloroma obstructing the biliary tree). Patients with higher bilirubin levels due to causes other than active liver disease is also eligible with Pl approval e.g. patients with PNH, Gilbert's disease or other hemolytic disorders.
- Renal: serum creatinine: s; 1.2 mg/di or if serum creatinine is outside the normal range, then CrCl > 40 ml/m in (measured or calculated/estimated).
- Pulmonary: asymptomatic or if symptomatic, DLCO 50% of predicted (corrected for hemoglobin).
- Each patient must be willing to participate as a research subject and must sign an informed consent form.
- Donor Inclusion Criteria
- Each donor must meet criteria outlined by institutional guidelines
- Donor should agree to undergo general anesthesia and bone marrow harvest collection if PBSC yield is inadequate or otherwise not transplantable for whatever reason.
Who cannot join
- Subject Exclusion Criteria
- Female patients who are pregnant or breast-feeding
- Active viral, bacterial or fungal infection
- Patient seropositive for HI V-I /II; HTLV -I /II
- Presence of leukemia in the CNS.
- Donor Exclusion Criteria
- If donors do not meet institutional guidelines, exclusion will be considered.
Trial locations and contacts
1 site in 1 country.
United States1 site
Miami Cancer Institute at Baptist Health, Inc.
Miami, Florida, 33176
About this study
Official title: A Phase II Trial of CD34+ Enriched Transplants From HLA-Compatible Related or Unrelated Donors for Treatment of Patients With Hematologic Malignancies
This is a Phase II trial testing disease-specific myeloablative conditioning regimens for preparatory cytoreduction of patients receiving allogeneic HLA-compatible related or unrelated transplants of GCSF-mobilized peripheral blood stem cells (PBSC) depleted of T-cells by positive selection of CD34+ progenitor cells using the CliniMACS system. The CliniMACS Fractionation system is a method that positively selects CD34+ progenitor cells from PBSC by immunoadsorption of cells binding on anti CD34 monoclonal antibody to paramagnetic beads, which can then be isolated by passage through a magnetized column and released by agitation of beads. Two conditioning regimens have been used successfully with an alternative similar system, isolex, which is no longer being manufactured.
Read the detailed description
For this trial, patients will be put into one of two myeloablative conditioning regimens, based on their disease, stage of disease, and dose of radiation accumulated in the course of treatment. Approximately twenty-four to forty-eight hours after completion of each conditioning regimen, patients will receive a transplant of a CD34+ progenitor cell-enriched, T-cell depleted fraction of GCSF-mobilized PBSC after fractionation on the CliniMACS device, from his/her HLA compatible donor. Due to stringent T-cell depletion, no significant Graft-versus-host disease is anticipated. Should Graft-versus-host disease occur, standard treatment would be initiated per the Transplant Service guidelines.
The purpose of this trial is to evaluate the potential of T-cell depleted Haploidentical Stem Cell Transplant fractionated by the CliniMACS system, when administered for disease targeted cytoreductive regimens, to secure consistent engraftment and hematopoietic reconstitution in HLA-compatible related or unrelated hosts, and to prevent or abrogate acute and chronic forms of Graft-versus-host disease. This study seeks to validate that these pre-transplant conditioning regimens, when administered with a CD34+ progenitor cell enriched, T-cell depleted graft, fractionated in the CliniMACS system, will be associated with a low incidence of non-leukemic mortality.
The sample size is as follows:
Regimen A: Hyperfractionated Total Body Irradiation/Thiotepa/Cyclophosphamide: 100 patients Regimen B: Busulfan/Melphalan/Fludarabine: 100 patients It is anticipated that the accrual will last five years. Patients will be followed for two years following transplantation.
- Conditions
- Hematologic Diseases, Hematologic Malignancy, Acute Lymphoblastic Leukemia, Acute Myeloid Leukemia, Chronic Myelogenous Leukemia, Chronic Lymphocytic Leukemia
- Being tested
- CliniMACS, Bone Marrow Transplant, Hyperfractionated Total Body Irradiation, Thiotepa, Cyclophosphamide
- Medical subject headings
- Hematologic Diseases, Hematologic Neoplasms, Precursor Cell Lymphoblastic Leukemia-Lymphoma, Leukemia, Myeloid, Acute, Leukemia, Myelogenous, Chronic, BCR-ABL Positive, Leukemia, Lymphocytic, Chronic, B-Cell
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CliniMACSDevice
allogeneic Human leukocyte antigen-compatible related or unrelated transplants of GCSF-mobilized peripheral blood stem cells depleted of T-cells by positive selection of CD34+ progenitor cells using the CliniMACS system
Bone Marrow TransplantProcedure or surgery
Bone Marrow Transplant will come from either an HLA matched related sibling or HLA un-related donor
Hyperfractionated Total Body IrradiationDrug
Hyperfractionated Total Body Irradiation is administered at a dose rate of < 20 cGy/minute. Doses of 125 cGy/fraction are administered at a minimum interval of 4 hours between fractions, three times/day for a total of 11 or 12 doses (1375 or 1500 cGy) over 4 days (Day -9, -8, -7 and -6).
ThiotepaDrug
Thiotepa: 5mg/kg/day IV over approximately 4 hr. daily x 2 (Day -5 and Day -4). If scheduling of transplant harvests requires, the dose of Thiotepa may be administered as a single dose of 10mg/kg/day x 1.
CyclophosphamideDrug
Cyclophosphamide: 60 mg/kg/day I V over approximately 30 min daily x 2 days (d -3 and -2). Cyclophosphamide dosing will be adjusted if patient is > 125% of ideal body w eight and will be calculated based on adjusted ideal body weight, as per MCI standard of care guidelines.
BusulfanDrug
0.8 mg/kg every 6 hours x 10 or 12 doses), (depending on disease) with dose modified
MelphalanDrug
Melphalan 70mg/m2/day x 2 days IV over 30 minutes. Dose should be adjusted if patient is > 125% ideal body weight and should be calculated on adjusted ideal body weight per MCI standard of care guidelines. Melphalan will be administered on Days - 7 and -6 for multiple myeloma patients.
FludarabineDrug
Fludarabine 25mg/m2/days x 5 days IV over 30 minutes. Fludarabine may be adjusted in the case of renal toxicity.
In select cases in which the peripheral blood stem cells must be harvested a day later than requested due to a scheduling issue with the donor or Stem Cell Processing Laboratory.
| Study group | Role | What they receive |
|---|---|---|
| Regimen A | Experimental | Regimen A: Hyperfractionated Total Body Irradiation/Thiotepa/Cyclophosphamide: Hyperfractionated total body irradiation to dose of 1375cGy fractions at 4-6 hour intervals three times a day for a total of 11 or 12 doses depending on age and disease risk, followed by Thiotepa 5mg/kg/day x 2 (or 10mg/kg/day x 1) and cyclophosphamide 60mg/kg/day x 2 (or Fludarabine 25mg/m2 x 5 if cyclophosphamide is contraindicated) Receives: Device: CliniMACS; Procedure: Bone Marrow Transplant; Drug: Hyperfractionated Total Body Irradiation; Drug: Thiotepa; Drug: Cyclophosphamide |
| Regimen B | Experimental | Regimen B: Busulfan/Melphalan/Fludarabine: Busulfan 0.8mg/kg/dose every six hours x 10-12 doses (depending on disease), Melphalan 70mg/m2/day x 2 and Fludarabine 25mg/m2/day x 5. Receives: Device: CliniMACS; Procedure: Bone Marrow Transplant; Drug: Busulfan; Drug: Melphalan; Drug: Fludarabine |
What is being measured
The primary outcome is the main question the study is designed to answer.
Assess the change of incidence and severity of chronic GvHD
To assess the incidence and severity of chronic GvHD following T cell depleted, CD34+ progenitor cell enriched transplants fractionated by the CliniMACS system.
Measured: 6 months, 1 year, 2 years
Assess the change of incidence and severity of acute GvHD
To assess the incidence and severity of acute GvHD following T cell depleted, CD34+ progenitor cell enriched transplants fractionated by the CliniMACS system.
Measured: 6 months, 1 year, 2 years
Assess the change of incidence of non-relapse mortality
To assess the incidence of non-relapse mortality (transplant-related mortality) following each cytoreduction regimen and a transplant fractionated by the CliniMACS system.
Measured: 6 months, 1 year, 2 years
Estimate the probability change of survival and disease-free survival (DFS)
To estimate the probability of survival and disease-free survival (DFS) at 6 months, 1 year and 2 years post-transplant for each disease-targeted cytoreduction regimen when used with a T-cell depleted graft fractionated by the CliniMACS system.
Measured: 6 months, 1 year, 2 years
Secondary outcomes (2)
Determine the proportion of patients receiving optimal CD34+; CD3+
To determine the proportion of patients receiving optimal CD34+ (>5x 106/kg) and CD3+ (< 5 x104/kg) cell doses the proportion recurring suboptimal doses (<3 x 106/kg) CD34+ cells; and the proportion of patients receiving CD3+ T-cell doses >5 x 104/kg.
Measured: 6 months, 1 year, 2 years
Correlate doses of CD34+ progenitors and CD3+ T cells with engraftment
To correlate doses of CD34+ progenitors and CD3+ T cells with engraftment, graft vs. host disease and non-relapse mortality.
Measured: 6 months, 1 year, 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Feb 2020
- Study startSep 2022 (estimated)
- Primary completion1 Mar 2030 (estimated)
- Study completion1 Mar 2030 (estimated)
Why it stopped: Study was split into two new studies before the first participant was enrolled.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Hematologic DiseasesStudies 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 2
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Model description
- The two myeloablative conditioning regimens are: Regimen A: Hyperfractionated Total Body Irradiation/Thiotepa/Cyclophosphamide: 100 patients Regimen B: Busulfan/Melphalan/Fludarabine: 100 patients It is anticipated that the accrual will last five years. Patients will be followed for two years following transplantation.
- Masking
- None (open label)
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Baptist Health South Florida
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Guenther Koehne, MD, Principal investigator, Miami Cancer Institute (MCI) at Baptist Health, Inc.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04282174
- Sponsor's protocol ID
- 2019-KOE-001
- Acronym
- 2019-KOE-001
- Status last verified
- Sep 2022
- First submitted
- 17 Feb 2020
- Last updated
- 27 Sep 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 27 Sep 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase II Trial of CD34+ Enriched Transplants From HLA-Compatible Related or Unrelated Donors for Treatment of Patients With Hematologic Malignancies
- ClinicalTrials.gov ID
- NCT04282174
- Acronym / sponsor ID
- 2019-KOE-001 / 2019-KOE-001
- Conditions
- Hematologic Diseases, Hematologic Malignancy, Acute Lymphoblastic Leukemia, Acute Myeloid Leukemia, Chronic Myelogenous Leukemia, Chronic Lymphocytic Leukemia
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: Study was split into two new studies before the first participant was enrolled.
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Baptist Health South FloridaUniversity, hospital or other
- Study start
- Sep 2022 (estimated)
- Primary completion
- 1 Mar 2030 (estimated)
- Study completion
- 1 Mar 2030 (estimated)
- First posted
- 24 Feb 2020 (actual)
- 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 is a Phase II trial testing disease-specific myeloablative conditioning regimens for preparatory cytoreduction of patients receiving allogeneic HLA-compatible related or unrelated transplants of GCSF-mobilized peripheral blood stem cells (PBSC) depleted of T-cells by positive selection of CD34+ progenitor cells using the CliniMACS system. The CliniMACS Fractionation system is a method that positively selects CD34+ progenitor cells from PBSC by immunoadsorption of cells binding on anti CD34 monoclonal antibody to paramagnetic beads, which can then be isolated by passage through a magnetized column and released by agitation of beads. Two conditioning regimens have been used successfully with an alternative similar system, isolex, which is no longer being manufactured.
Detailed description
For this trial, patients will be put into one of two myeloablative conditioning regimens, based on their disease, stage of disease, and dose of radiation accumulated in the course of treatment. Approximately twenty-four to forty-eight hours after completion of each conditioning regimen, patients will receive a transplant of a CD34+ progenitor cell-enriched, T-cell depleted fraction of GCSF-mobilized PBSC after fractionation on the CliniMACS device, from his/her HLA compatible donor. Due to stringent T-cell depletion, no significant Graft-versus-host disease is anticipated. Should Graft-versus-host disease occur, standard treatment would be initiated per the Transplant Service guidelines.
The purpose of this trial is to evaluate the potential of T-cell depleted Haploidentical Stem Cell Transplant fractionated by the CliniMACS system, when administered for disease targeted cytoreductive regimens, to secure consistent engraftment and hematopoietic reconstitution in HLA-compatible related or unrelated hosts, and to prevent or abrogate acute and chronic forms of Graft-versus-host disease. This study seeks to validate that these pre-transplant conditioning regimens, when administered with a CD34+ progenitor cell enriched, T-cell depleted graft, fractionated in the CliniMACS system, will be associated with a low incidence of non-leukemic mortality.
The sample size is as follows:
Regimen A: Hyperfractionated Total Body Irradiation/Thiotepa/Cyclophosphamide: 100 patients Regimen B: Busulfan/Melphalan/Fludarabine: 100 patients It is anticipated that the accrual will last five years. Patients will be followed for two years following transplantation.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- The two myeloablative conditioning regimens are: Regimen A: Hyperfractionated Total Body Irradiation/Thiotepa/Cyclophosphamide: 100 patients Regimen B: Busulfan/Melphalan/Fludarabine: 100 patients It is anticipated that the accrual will last five years. Patients will be followed for two years following transplantation.
| Arm | Type | Receives |
|---|---|---|
| Regimen A | Experimental | Device: CliniMACS, Procedure: Bone Marrow Transplant, Drug: Hyperfractionated Total Body Irradiation, Drug: Thiotepa, Drug: CyclophosphamideRegimen A: Hyperfractionated Total Body Irradiation/Thiotepa/Cyclophosphamide: Hyperfractionated total body irradiation to dose of 1375cGy fractions at 4-6 hour intervals three times a day for a total of 11 or 12 doses depending on age and disease risk, followed by Thiotepa 5mg/kg/day x 2 (or 10mg/kg/day x 1) and cyclophosphamide 60mg/kg/day x 2 (or Fludarabine 25mg/m2 x 5 if cyclophosphamide is contraindicated) |
| Regimen B | Experimental | Device: CliniMACS, Procedure: Bone Marrow Transplant, Drug: Busulfan, Drug: Melphalan, Drug: FludarabineRegimen B: Busulfan/Melphalan/Fludarabine: Busulfan 0.8mg/kg/dose every six hours x 10-12 doses (depending on disease), Melphalan 70mg/m2/day x 2 and Fludarabine 25mg/m2/day x 5. |
Who may qualify
- Ages
- Up to 74 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (27 listed)
- Malignant conditions or other life-threatening disorders correctable by transplant for which CD34+ selected, T-cell depleted allogeneic hematopoietic stem cell transplantation is indicated such as:
- Acute myeloid leukemia (AML) in 1st remission - for patients who is AML does not have 'good risk' cytogenetic features (i.e. t8:21, t 15: 17, inv16).
- Secondary AML in 1st remission
- AML in 1st relapse or 2nd remission
- Acute lymphoblastic leukemia (ALL) / Chronic Lymphocytic Leukemia (CLL) in pt remission clinical or molecular features indicating a high risk for relapse; or ALL/CLL 2nd remission
Key exclusion criteria (7 listed)
- Subject Exclusion Criteria
- Female patients who are pregnant or breast-feeding
- Active viral, bacterial or fungal infection
- Patient seropositive for HI V-I /II; HTLV -I /II
- Presence of leukemia in the CNS.
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 |
|---|---|---|
| CliniMACSallogeneic Human leukocyte antigen-compatible related or unrelated transplants of GCSF-mobilized peripheral blood stem cells depleted of T-cells by positive selection of CD34+ progenitor cells using the CliniMACS system | Device | Regimen A, Regimen B |
| Bone Marrow TransplantBone Marrow Transplant will come from either an HLA matched related sibling or HLA un-related donor | Procedure or surgery | Regimen A, Regimen B |
| Hyperfractionated Total Body IrradiationHyperfractionated Total Body Irradiation is administered at a dose rate of < 20 cGy/minute. Doses of 125 cGy/fraction are administered at a minimum interval of 4 hours between fractions, three times/day for a total of 11 or 12 doses (1375 or 1500 cGy) over 4 days (Day -9, -8, -7 and -6). | Drug | Regimen A |
| ThiotepaThiotepa: 5mg/kg/day IV over approximately 4 hr. daily x 2 (Day -5 and Day -4). If scheduling of transplant harvests requires, the dose of Thiotepa may be administered as a single dose of 10mg/kg/day x 1. | Drug | Regimen A |
| CyclophosphamideCyclophosphamide: 60 mg/kg/day I V over approximately 30 min daily x 2 days (d -3 and -2). Cyclophosphamide dosing will be adjusted if patient is > 125% of ideal body w eight and will be calculated based on adjusted ideal body weight, as per MCI standard of care guidelines. | Drug | Regimen A |
| Busulfan0.8 mg/kg every 6 hours x 10 or 12 doses), (depending on disease) with dose modified | Drug | Regimen B |
| MelphalanMelphalan 70mg/m2/day x 2 days IV over 30 minutes. Dose should be adjusted if patient is > 125% ideal body weight and should be calculated on adjusted ideal body weight per MCI standard of care guidelines. Melphalan will be administered on Days - 7 and -6 for multiple myeloma patients. | Drug | Regimen B |
| FludarabineFludarabine 25mg/m2/days x 5 days IV over 30 minutes. Fludarabine may be adjusted in the case of renal toxicity. In select cases in which the peripheral blood stem cells must be harvested a day later than requested due to a scheduling issue with the donor or Stem Cell Processing Laboratory. | Drug | Regimen B |
Primary outcome
Assess the change of incidence and severity of chronic GvHD
Time frame: 6 months, 1 year, 2 years
To assess the incidence and severity of chronic GvHD following T cell depleted, CD34+ progenitor cell enriched transplants fractionated by the CliniMACS system.
Assess the change of incidence and severity of acute GvHD
Time frame: 6 months, 1 year, 2 years
To assess the incidence and severity of acute GvHD following T cell depleted, CD34+ progenitor cell enriched transplants fractionated by the CliniMACS system.
Assess the change of incidence of non-relapse mortality
Time frame: 6 months, 1 year, 2 years
To assess the incidence of non-relapse mortality (transplant-related mortality) following each cytoreduction regimen and a transplant fractionated by the CliniMACS system.
Estimate the probability change of survival and disease-free survival (DFS)
Time frame: 6 months, 1 year, 2 years
To estimate the probability of survival and disease-free survival (DFS) at 6 months, 1 year and 2 years post-transplant for each disease-targeted cytoreduction regimen when used with a T-cell depleted graft fractionated by the CliniMACS system.
2 secondary outcomes
Determine the proportion of patients receiving optimal CD34+; CD3+
Time frame: 6 months, 1 year, 2 years
Correlate doses of CD34+ progenitors and CD3+ T cells with engraftment
Time frame: 6 months, 1 year, 2 years
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Sep 2022.
- MCI - 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.
Guenther Koehne, MD principal investigator
Miami Cancer Institute (MCI) at Baptist Health, Inc.
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 CliniMACS, Bone Marrow Transplant and Hyperfractionated Total Body Irradiation in people with Hematologic Diseases and Hematologic Malignancy, run by Baptist Health South Florida 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 27 inclusion and 7 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: withdrawn, as of the sponsor's last update on 27 Sep 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.
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?
The study was withdrawn before enrolling participants, so there are no results.
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?
Assess the change of incidence and severity of chronic GvHD (time frame: 6 months, 1 year, 2 years). 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 27 Sep 2022.