Acute Myeloid LeukemiaPhase 2NCT02566304
Reduced Intensity Chemotherapy and Radiation Therapy Before Donor Stem Cell Transplant in Treating Patients With Hematologic Malignancies
A Phase 2 study testing Fludarabine, Total-Body Irradiation and T Cell-Depleted Donor Lymphocyte Infusion in people with Acute Myeloid Leukemia and Acute Myeloid Leukemia in Remission, run by Sidney Kimmel Comprehensive Cancer Center at Thomas Jefferson University at 1 site in United States.
Trial summary
This clinical trial studies the use of reduced intensity chemotherapy and radiation therapy before donor stem cell transplant in treating patients with hematologic malignancies. Giving low doses of chemotherapy, such as cyclophosphamide and fludarabine phosphate, before a donor stem cell transplant may help stop the… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Acute Myeloid Leukemia, Acute Myeloid Leukemia in Remission, Aplastic Anemia
- What is being tested?
- Fludarabine, Total-Body Irradiation and T Cell-Depleted Donor Lymphocyte Infusion
- Type of treatment
- Injection or infusion, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 35 participants
- Where
- 1 siteUnited States
- Study dates
- 13 Nov 2015to 13 Feb 2024
- Phase
- Phase 2
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients treated on this study will have:
- Acute myeloid leukemia in morphologic complete remission (CR) not requiring treatment for their disease for 4 weeks
- A history of acute myeloid leukemia (AML) with < 10% residual blasts (use highest count on staging studies) after induction therapy and persisting with < 10% blasts for at least 8 weeks without reinduction and at the time of HSCT
- Refractory anemia (RA) or refractory anemia with ring sideroblasts (RARS) or isolated 5q-
- Refractory anemia with excess blasts (RAEB)-1, refractory cytopenia with multilineage dysplasia (RCMD)+/-ringed sideroblasts (RS), or myelodysplastic syndrome (MDS) not otherwise specified (NOS) with stable disease for at least 3 months
- RAEB-2 must demonstrate chemo-responsiveness; chemo-responsiveness is defined as a persistent blast percentage decrease by at least 5 percentage points to therapy and there must be =< 10% blasts (use highest count on staging studies) after treatment and at the time of transplant
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- Hodgkin or Indolent non-Hodgkin's lymphoma
- Myeloma with < 5% plasma cells in the marrow
- Myeloproliferative disorders (excludes chronic myelomonocytic leukemia [CMML])
- Aplastic anemia
- A hematological or oncological disease (not listed) in which allogeneic HSCT is thought to be beneficial, and the disease is chemoresponsive
- Patients without clear manifestation of their disease status in terms of stage and/or responsiveness should be discussed with the principal investigator (PI) and enrollment analysis should be documented in the study records
- Patients must have a related donor who is human leukocyte antigen (HLA) mismatched at 2, 3, or 4 antigens at the HLA-A; B; C; DR loci in the graft-versus-host disease (GVHD) direction; (patients with related donors who are HLA identical or are a 1-antigen mismatch may be treated on this therapeutic approach, but will have their outcomes will not be part of the statistical aims of the study); the HLA matched related category includes patients with a syngeneic donor
- Patients must have had front line therapy for their disease
- LVEF (left ventricular end diastolic function) of >= 45%
- DLCO (diffusing capacity of the lung for carbon monoxide) >= 45% of predicted corrected for hemoglobin, FEV-1 (forced expiratory volume at 1 second) >= 50% of predicted
- Serum bilirubin =< 1.8
- Aspartate aminotransferase (AST) or alanine aminotransferase (ALT) =< 2.5 X upper limit of normal
- Creatinine clearance of >= 60 mL/min
- HCT-CI/age score =< 5 points (patients with greater than 5 points will be allowed for trial with approval of the PI and the co-PI or his designee; this is an adjustment to account for healthy patients who meet the spirit of this protocol but have histories that result in higher than HCT-CI 5 points; an example is a patient with a solid tumor malignancy in their remote history [adds 3 points to HCT-CI total] where the treatment for the malignancy occurred years to decades before and there has been complete recovery of toxicities)
- Karnofsky performance status (KPS) >= 90% patients older than 70 years, KPS >= 80% patients younger than 70 years
- Patients must be willing to use contraception if they have childbearing potential
Who cannot join
- Performance status < 90% in patients 70 years old or greater, < 80% in patients less than age 70 years
- HCT-CI/age score > 5 points (patients with greater than 5 points will be allowed for trial with approval of the principal investigator and the co-principal investigator or his designee; this is an adjustment to account for healthy patients who meet the spirit of this protocol but have histories that result in higher than HCT-CI 5 points; an example is a patient with a solid tumor malignancy in their remote history [adds 3 points to HCT-CI total] where the treatment for the malignancy occurred years to decades before and there has been complete recovery of toxicities)
- A diagnosis of chronic myelomonocytic leukemia (CMML), unless in morphologic CR
- Human immunodeficiency virus (HIV) positive
- Active involvement of the central nervous system with malignancy
- Inability to obtain informed consent from patient or surrogate
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- Pregnancy
- Patients with life expectancy of =< 6 months for reasons other than their underlying hematologic/oncologic disorder
- Patients who have received alemtuzumab or antithymocyte globulin within 8 weeks of the transplant admission; the absence of these therapies in the medical record will serve as documentation that they were not given
- Patients with evidence of another malignancy, exclusive of a skin cancer that requires only local treatment, should not be enrolled on this protocol
Trial locations and contacts
1 site in 1 country.
United States1 site
Thomas Jefferson University
Philadelphia, Pennsylvania, 19107
About this study
Official title: A Two Step Approach to Non-Myeloablative Allogeneic Hematopoietic Stem Cell Transplantation for Patients With Hematologic Malignancies
This clinical trial studies the use of reduced intensity chemotherapy and radiation therapy before donor stem cell transplant in treating patients with hematologic malignancies. Giving low doses of chemotherapy, such as cyclophosphamide and fludarabine phosphate, before a donor stem cell transplant may help 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). Reducing the intensity of the chemotherapy and radiation may also reduce the side effects of the donor stem cell transplant.
Read the detailed description
PRIMARY OBJECTIVES:
- To demonstrate efficacy of this approach over the historical 2 step reduced intensity conditioning (RIC) approaches in the "vulnerable" population defined as: patients with hematopoietic cell transplant (HCT)-co-morbidity index (CI)/age scores >= 2, but no more than a score of 5 as based on the Sorror et al. data.
SECONDARY OBJECTIVES:
- To compare the non-relapse mortality (NRM) and relapse related mortality (RRM) rates at 1 year for patients treated on this study to the that of patients undergoing haploidentical RIC hematopoietic stem cell transplantation (HSCT) as reported in the literature and as observed in the 2 step RIC trials.
II. To determine the incidence and severity of graft-versus-host disease (GVHD) in patients undergoing treated on the Thomas Jefferson University (TJU) RIC 2 step approach.
III. To evaluate engraftment rates and lymphoid reconstitution in patients treated on the TJU RIC 2 step approach.
OUTLINE:
RIC: Patients receive fludarabine phosphate intravenously (IV) over 60 minutes on days -10 to -8 and cyclophosphamide IV over 2 hours on days -3 and -2. Patients also undergo total body irradiation (TBI) followed by a donor lymphocyte infusion (DLI) on day -6.
TRANSPLANT: Patients undergo cluster of differentiation (CD)34+ peripheral blood stem cell transplant on day 0.
GVHD PROPHYLAXIS: Patients receive tacrolimus orally (PO) beginning day -1 with a taper initiated on day 42 and mycophenolate mofetil IV twice daily (BID) on days -1 to 28 in the absence of GVHD.
After completion of study treatment, patients are followed up for 1 year.
- Conditions
- Acute Myeloid Leukemia, Acute Myeloid Leukemia in Remission, Aplastic Anemia, Chronic Myelomonocytic Leukemia, Hodgkin Lymphoma, Indolent Non-Hodgkin Lymphoma
- Being tested
- Fludarabine, Total-Body Irradiation, T Cell-Depleted Donor Lymphocyte Infusion, Cyclophosphamide, Peripheral Blood Stem Cell Transplantation
- Medical subject headings
- Leukemia, Myeloid, Acute, Anemia, Aplastic, Leukemia, Myelomonocytic, Chronic, Hodgkin Disease, Neoplasms, Myelodysplastic Syndromes, Myeloproliferative Disorders, Multiple Myeloma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
FludarabineDrug
Also called Fludarabine phosphate, Fludara
Given IV
Total-Body IrradiationRadiation
Undergo TBI
T Cell-Depleted Donor Lymphocyte InfusionBiological
Undergo DLI
CyclophosphamideDrug
Also called Endoxan, Cytoxan, Neosar, Procytox
Given IV
Peripheral Blood Stem Cell TransplantationProcedure or surgery
Undergo PBSC transplant
Allogeneic Hematopoietic Stem Cell TransplantationProcedure or surgery
Undergo PBSC transplant
TacrolimusDrug
Also called FK-506, Fujimycin, Prograf, Advograf
Given PO
Also called Mycophenolic acid, MMF, CellCept, Myfortic
Given IV
Laboratory Biomarker AnalysisOther
Correlative studies
| Study group | Role | What they receive |
|---|---|---|
| RIC HSCT, GVHD prophylaxis | Experimental | RIC: Patients receive fludarabine phosphate IV on days -10 to -8 and cyclophosphamide IV on days -3 and -2. Patients also undergo TBI followed by a DLI on day -6.
TRANSPLANT: Patients undergo CD34+ peripheral blood stem cell transplant on day 0.
GVHD PROPHYLAXIS: Patients receive tacrolimus PO beginning day -1 with a taper initiated on day 42 and mycophenolate mofetil IV BID on days -1 to 28 in the absence of GVHD. Receives: Drug: Fludarabine; Radiation: Total-Body Irradiation; Biological: T Cell-Depleted Donor Lymphocyte Infusion; Drug: Cyclophosphamide; Procedure: Peripheral Blood Stem Cell Transplantation; Procedure: Allogeneic Hematopoietic Stem Cell Transplantation; Drug: Tacrolimus; Drug: Mycophenolate mofetil; Other: Laboratory Biomarker Analysis |
What is being measured
The primary outcome is the main question the study is designed to answer.
Overall Survival (OS)
OS will be estimated using Kaplan-Meier curves. The 1-year OS rate and corresponding 95% confidence interval will be estimated from the Kaplan-Meier curve for the OS.
Measured: At 1 year post HSCT
Secondary outcomes (5)
Relapse Related Mortality (RRM)
Will be reported descriptively. RRM may also be estimated using Kaplan Meier curves and/or cumulative incidence analyses.
Measured: At 1 year post HSCT
Non-Relapse Mortality (NRM)
Will be reported descriptively. NRM may also be estimated using Kaplan Meier curves and/or cumulative incidence analyses.
Measured: At 1 year post HSCT
Incidence and Severity of GVHD
Will be reported descriptively
Measured: Up to 1 year post HSCT
Engraftment Rates
Will be reported descriptively
Measured: Up to 1 year post HSCT
Lymphoid Reconstitution
Lymphoid reconstitution will be evaluated monthly to every other month during the first year post HSCT and will be reported descriptively.
Measured: Up to 1 year post HSCT
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Oct 2015 (estimated)
- Study start13 Nov 2015
- Primary completion13 Feb 2024
- Study completion13 Feb 2024
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 Acute Myeloid 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 2
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 35 participants (actual)
Sponsor and investigators
- Lead sponsor
- Sidney Kimmel Comprehensive Cancer Center at Thomas Jefferson University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Usama Gergis, MD, Principal investigator, Thomas Jefferson University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02566304
- Sponsor's protocol ID
- 15D.323
- Other IDs
- 2015-054, NCI-2015-01506, JT 7773
- Status last verified
- Apr 2025
- First submitted
- 30 Sep 2015
- Last updated
- 24 Apr 2025
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 24 Apr 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Two Step Approach to Non-Myeloablative Allogeneic Hematopoietic Stem Cell Transplantation for Patients With Hematologic Malignancies
- ClinicalTrials.gov ID
- NCT02566304
- Acronym / sponsor ID
- 15D.323
- Conditions
- Acute Myeloid Leukemia, Acute Myeloid Leukemia in Remission, Aplastic Anemia, Chronic Myelomonocytic Leukemia, Hodgkin Lymphoma, Indolent Non-Hodgkin Lymphoma
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 35 participants (actual)
- Lead sponsor
- Sidney Kimmel Comprehensive Cancer Center at Thomas Jefferson UniversityUniversity, hospital or other
- Study start
- 13 Nov 2015 (actual)
- Primary completion
- 13 Feb 2024 (actual)
- Study completion
- 13 Feb 2024 (actual)
- First posted
- 2 Oct 2015 (estimated)
- Results
- Posted 20 Mar 2025
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 the use of reduced intensity chemotherapy and radiation therapy before donor stem cell transplant in treating patients with hematologic malignancies. Giving low doses of chemotherapy, such as cyclophosphamide and fludarabine phosphate, before a donor stem cell transplant may help 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). Reducing the intensity of the chemotherapy and radiation may also reduce the side effects of the donor stem cell transplant.
Detailed description
PRIMARY OBJECTIVES:
- To demonstrate efficacy of this approach over the historical 2 step reduced intensity conditioning (RIC) approaches in the "vulnerable" population defined as: patients with hematopoietic cell transplant (HCT)-co-morbidity index (CI)/age scores >= 2, but no more than a score of 5 as based on the Sorror et al. data.
SECONDARY OBJECTIVES:
- To compare the non-relapse mortality (NRM) and relapse related mortality (RRM) rates at 1 year for patients treated on this study to the that of patients undergoing haploidentical RIC hematopoietic stem cell transplantation (HSCT) as reported in the literature and as observed in the 2 step RIC trials.
II. To determine the incidence and severity of graft-versus-host disease (GVHD) in patients undergoing treated on the Thomas Jefferson University (TJU) RIC 2 step approach.
III. To evaluate engraftment rates and lymphoid reconstitution in patients treated on the TJU RIC 2 step approach.
OUTLINE:
RIC: Patients receive fludarabine phosphate intravenously (IV) over 60 minutes on days -10 to -8 and cyclophosphamide IV over 2 hours on days -3 and -2. Patients also undergo total body irradiation (TBI) followed by a donor lymphocyte infusion (DLI) on day -6.
TRANSPLANT: Patients undergo cluster of differentiation (CD)34+ peripheral blood stem cell transplant on day 0.
GVHD PROPHYLAXIS: Patients receive tacrolimus orally (PO) beginning day -1 with a taper initiated on day 42 and mycophenolate mofetil IV twice daily (BID) on days -1 to 28 in the absence of GVHD.
After completion of study treatment, patients are followed up for 1 year.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| RIC HSCT, GVHD prophylaxis | Experimental | Drug: Fludarabine, Radiation: Total-Body Irradiation, Biological: T Cell-Depleted Donor Lymphocyte Infusion, Drug: Cyclophosphamide, Procedure: Peripheral Blood Stem Cell Transplantation, Procedure: Allogeneic Hematopoietic Stem Cell Transplantation, Drug: Tacrolimus, Drug: Mycophenolate mofetil, Other: Laboratory Biomarker AnalysisRIC: Patients receive fludarabine phosphate IV on days -10 to -8 and cyclophosphamide IV on days -3 and -2. Patients also undergo TBI followed by a DLI on day -6. TRANSPLANT: Patients undergo CD34+ peripheral blood stem cell transplant on day 0. GVHD PROPHYLAXIS: Patients receive tacrolimus PO beginning day -1 with a taper initiated on day 42 and mycophenolate mofetil IV BID on days -1 to 28 in the absence of GVHD. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (22 listed)
- Patients treated on this study will have:
- Patients must have a related donor who is human leukocyte antigen (HLA) mismatched at 2, 3, or 4 antigens at the HLA-A; B; C; DR loci in the graft-versus-host disease (GVHD) direction; (patients with related donors who are HLA identical or are a 1-antigen mismatch may be treated on this therapeutic approach, but will have their outcomes will not be part of the statistical aims of the study); the HLA matched related category includes patients with a syngeneic donor
- Patients must have had front line therapy for their disease
- LVEF (left ventricular end diastolic function) of >= 45%
- DLCO (diffusing capacity of the lung for carbon monoxide) >= 45% of predicted corrected for hemoglobin, FEV-1 (forced expiratory volume at 1 second) >= 50% of predicted
Key exclusion criteria (10 listed)
- Performance status < 90% in patients 70 years old or greater, < 80% in patients less than age 70 years
- HCT-CI/age score > 5 points (patients with greater than 5 points will be allowed for trial with approval of the principal investigator and the co-principal investigator or his designee; this is an adjustment to account for healthy patients who meet the spirit of this protocol but have histories that result in higher than HCT-CI 5 points; an example is a patient with a solid tumor malignancy in their remote history [adds 3 points to HCT-CI total] where the treatment for the malignancy occurred years to decades before and there has been complete recovery of toxicities)
- A diagnosis of chronic myelomonocytic leukemia (CMML), unless in morphologic CR
- Human immunodeficiency virus (HIV) positive
- Active involvement of the central nervous system with malignancy
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 |
|---|---|---|
| FludarabineAlso: Fludarabine phosphate, FludaraGiven IV | Drug | RIC HSCT, GVHD prophylaxis |
| Total-Body IrradiationUndergo TBI | Radiation | RIC HSCT, GVHD prophylaxis |
| T Cell-Depleted Donor Lymphocyte InfusionUndergo DLI | Biological | RIC HSCT, GVHD prophylaxis |
| CyclophosphamideAlso: Endoxan, Cytoxan, Neosar, ProcytoxGiven IV | Drug | RIC HSCT, GVHD prophylaxis |
| Peripheral Blood Stem Cell TransplantationUndergo PBSC transplant | Procedure or surgery | RIC HSCT, GVHD prophylaxis |
| Allogeneic Hematopoietic Stem Cell TransplantationUndergo PBSC transplant | Procedure or surgery | RIC HSCT, GVHD prophylaxis |
| TacrolimusAlso: FK-506, Fujimycin, Prograf, AdvografGiven PO | Drug | RIC HSCT, GVHD prophylaxis |
| Mycophenolate mofetilAlso: Mycophenolic acid, MMF, CellCept, MyforticGiven IV | Drug | RIC HSCT, GVHD prophylaxis |
| Laboratory Biomarker AnalysisCorrelative studies | Other | RIC HSCT, GVHD prophylaxis |
Primary outcome
Overall Survival (OS)
Time frame: At 1 year post HSCT
OS will be estimated using Kaplan-Meier curves. The 1-year OS rate and corresponding 95% confidence interval will be estimated from the Kaplan-Meier curve for the OS.
5 secondary outcomes
Relapse Related Mortality (RRM)
Time frame: At 1 year post HSCT
Non-Relapse Mortality (NRM)
Time frame: At 1 year post HSCT
Incidence and Severity of GVHD
Time frame: Up to 1 year post HSCT
Engraftment Rates
Time frame: Up to 1 year post HSCT
Lymphoid Reconstitution
Time frame: Up to 1 year post HSCT
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Apr 2025.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Jefferson University HospitalsLink 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.
Usama Gergis, MD principal investigator
Thomas Jefferson University
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 Fludarabine, Total-Body Irradiation and T Cell-Depleted Donor Lymphocyte Infusion in people with Acute Myeloid Leukemia and Acute Myeloid Leukemia in Remission, run by Sidney Kimmel Comprehensive Cancer Center at Thomas Jefferson University 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 22 inclusion and 10 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 24 Apr 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 20 Mar 2025). 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 (OS) (time frame: At 1 year post HSCT). 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 24 Apr 2025.