A Phase 3 interventional study of Cyclophosphamide and Fludarabine in Acute Myeloid Leukemia, Chronic Lymphocytic Leukemia and Chronic Myeloid Leukemia, sponsored by Dartmouth-Hitchcock Medical Center. Completed at 1 site in United States. Open to participants aged 18 Years to 75 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2026-07-17.
Sponsored by Dartmouth-Hitchcock Medical Center · Phase 3, Interventional, and Treatment
The standard Johns Hopkins' regimen will be used in study subjects, with the use of donor peripheral blood stem cells, rather than marrow. Clinical outcomes will be defined while focusing efforts on immune reconstitution focusing on immune checkpoint regulators after a related haploidentical stem cell transplant.
We propose a clinical trial to define clinical endpoints, including engraftment, 100-day survival and one year survival (Objective #1). We will characterize the incidence, prevalence and function of immune checkpoint regulators in patients' blood and bone marrow following transplantation (Objective #2). We will correlate these laboratory results with clinical outcomes and the incidence of GVHD. As an exploratory aim, in those patients experiencing GVHD and requiring treatment, we will define the frequency/expression of checkpoint regulator expression and correlate these results with the patient's response to GVHD therapy.
3,667 studies on the registry are indexed under Leukemia, Myeloid, Acute; 816 are open to participants now.
This study's enrollment of 21 is below the median of 40 across 3,005 interventional studies indexed under Leukemia, Myeloid, Acute.
Browse Leukemia, Myeloid, Acute studies →Dartmouth-Hitchcock Medical Center is the lead sponsor of 488 studies on the registry; 71 are open to participants now.
Of its 31 completed or terminated interventional studies of FDA-regulated products, 21 (68%) have results posted.
Counted across the registry records on this site, refreshed daily.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
DONOR ELIGIBILITY
DONOR EXCLUSION CRITERIA
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Stem cell (bone marrow) transplants. Allogeneic uses cells from a donor; autologous uses your own cells, collected earlier and given back.
The human immunodeficiency virus, which weakens the immune system.
Many studies now accept people whose HIV is controlled on treatment, judged by the viral load and the CD4 count. Check the limits this study sets.
Hepatitis B is a virus that infects the liver. These are separate tests: HBsAg positive usually means a current infection (a recent vaccination can briefly cause it too); total anti-HBc (HBcAb) positive means an infection now or in the past; HBV DNA measures how much virus is in the blood.
Some studies accept a past infection if HBV DNA is undetectable, sometimes with antiviral medicine during the study. Check what this study allows.
A scale of how much an illness limits everyday activity. For people being assessed to join a study, scores run from 0 (fully active) to 4; lower is more active.
Studies most often ask for 0–1 or 0–2. Your doctor gives the score; the WHO scale uses the same steps. The full scale also has 5, which records death.
The share of blood the heart’s main pumping chamber (the left ventricle) pushes out with each beat, measured by an echocardiogram (heart ultrasound) or a MUGA scan. About 50–70% is normal.
A yellow substance made when red blood cells are broken down, which the liver clears. A high level can mean a problem with the liver or the bile ducts.
Criteria often allow more for people with Gilbert’s syndrome, a harmless inherited condition that raises bilirubin.
The top of the normal range for a blood test, as set by the laboratory that runs it. Each lab prints its own range next to your result.
“≤ 2.5 × ULN” means the result can be up to two and a half times that top value.
Malignancy means cancer. Criteria about another or earlier malignancy ask whether you have had a different cancer, usually within a set number of years.
Some are commonly allowed, such as treated skin cancers other than melanoma and early cancers removed completely — check the exceptions this study lists.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Relapsed: the illness came back after treatment had worked. Refractory: it did not respond to treatment, or stopped responding while still on it.
Allogeneic and autologous transplant
Stem cell (bone marrow) transplants. Allogeneic uses cells from a donor; autologous uses your own cells, collected earlier and given back.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
HIV
The human immunodeficiency virus, which weakens the immune system.
Many studies now accept people whose HIV is controlled on treatment, judged by the viral load and the CD4 count. Check the limits this study sets.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Hepatitis B tests
Hepatitis B is a virus that infects the liver. These are separate tests: HBsAg positive usually means a current infection (a recent vaccination can briefly cause it too); total anti-HBc (HBcAb) positive means an infection now or in the past; HBV DNA measures how much virus is in the blood.
Some studies accept a past infection if HBV DNA is undetectable, sometimes with antiviral medicine during the study. Check what this study allows.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
ECOG performance status
A scale of how much an illness limits everyday activity. For people being assessed to join a study, scores run from 0 (fully active) to 4; lower is more active.
Studies most often ask for 0–1 or 0–2. Your doctor gives the score; the WHO scale uses the same steps. The full scale also has 5, which records death.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
LVEF (left ventricular ejection fraction)
The share of blood the heart’s main pumping chamber (the left ventricle) pushes out with each beat, measured by an echocardiogram (heart ultrasound) or a MUGA scan. About 50–70% is normal.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Bilirubin
A yellow substance made when red blood cells are broken down, which the liver clears. A high level can mean a problem with the liver or the bile ducts.
Criteria often allow more for people with Gilbert’s syndrome, a harmless inherited condition that raises bilirubin.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
ULN (upper limit of normal)
The top of the normal range for a blood test, as set by the laboratory that runs it. Each lab prints its own range next to your result.
“≤ 2.5 × ULN” means the result can be up to two and a half times that top value.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Cancer (malignancy)
Malignancy means cancer. Criteria about another or earlier malignancy ask whether you have had a different cancer, usually within a set number of years.
Some are commonly allowed, such as treated skin cancers other than melanoma and early cancers removed completely — check the exceptions this study lists.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Relapsed and refractory
Relapsed: the illness came back after treatment had worked. Refractory: it did not respond to treatment, or stopped responding while still on it.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Cyclophosphamide, fludarabine, total body irradiation, immune suppression including tacrolimus and cellcept, Granulocyte colony-stimulating factor (G-CSF), and peripheral blood transplant
Drug: Cyclophosphamide · Drug: Fludarabine · Radiation: Total Body Irradiation · Drug: Tacrolimus · Drug: cellcept · Drug: g-csf · Procedure: Peripheral Blood Transplant
14.5 mg/kg for 2 days (days -6, -5) and then 50 mg/kg for two days (days 3, 4)
30 mg/m2 daily for 5 days
200 centigray (cGy) for one day (day -1)
1 mg IV daily, (or the oral equivalent) adjusted to achieve a level between 5 and 15 ng/ml. If there is no evidence of GVHD, discontinue Tacrolimus by Day 180.
dose at 15 mg/kg po three times per day (maximum dose of 3 grams/day). Stop Cellcept at Day 35 following transplantation.
5 mcg/kg/d starting day 5 and continue until Absolute Neutrophil Count (ANC) \> 1000/mcL for 3 days.
cell dose goal: \< 5 x 106 Hematopoietic progenitor cell antigen CD34+ cells/kg recipient weight
Number of Participants Who Survived to 100-Days Post-transplant
Define 100-day survival of subjects
Time frame: 100 days post date of peripheral blood transplant
Number of Participants Who Survived to One Year Post-Transplant.
Define one year survival of subjects
Time frame: One year post date of peripheral blood transplant
Number of Participants Who Experienced a Successful Engraftment
Define number of subjects who experience a successful engraftment: Defined as absolute neutrophil count \> 500/mm3 and platelets \> 20,000/mcl for three consecutive days (count first day as engraftment)
Time frame: Post-peripheral blood transplant
Number of Participants Who Achieved a Response to Treatment at 100 Days
Define response to treatment at 100 days post-peripheral blood transplant. The Standard International Criteria for responses for each disease will be used, based on CIBMTR (Center for International Blood and Marrow Transplant Research) criteria.
Time frame: 100 days post-peripheral blood transplant
Number of Participants Who Achieved a Response to Treatment at One Year
Define response to treatment at one year post-peripheral blood transplant. The Standard International Criteria for responses for each disease will be used, based on CIBMTR (Center for International Blood and Marrow Transplant Research) criteria.
Time frame: One year post-peripheral blood transplant
Number of Participants Who Experienced Toxicities Associated With This Treatment Regimen
Define subjects who experienced toxicities associated with this treatment regimen
Time frame: Post-peripheral blood transplant
Number of Participants Who Had Incidence of Acute GVHD
Define subjects who had incidence of acute GVHD
Time frame: Post-peripheral blood transplant
Number of Participants Who Had Incidence of Chronic GVHD
Define subjects who had incidence of chronic GVHD
Time frame: Post-peripheral blood transplant
Number of Participants Who Experienced Donor-Recipient Chimerism Following Transplant at Days 30, 60, and 90.
Define subjects who experience donor-recipient chimerism following transplant at days 30, 60 and 90. All patients were assessed for donor-recipient chimerism at days 30, 60, and 90, but only one patient experienced chimerism. Day 90 for this patient is reported.
Time frame: Days 30, 60, and 90 post-peripheral blood transplant
Number of Participants Who Experienced Treatment-Related Mortality Within the First 100 Days
Define subjects who experienced treatment-related mortality within the first 100 days post-peripheral blood transplant
Time frame: 100 days post-peripheral blood transplant
Immune Checkpoint Regulators - Incidence
To characterize the incidence of immune checkpoint regulators (V-domain Ig Suppressor of T-cell Activation, cytotoxic T-lymphocyte-associated protein 4 \[CTLA\], Programmed cell death protein 1 \[PD-1\]) during early immune recovery following an allogeneic stem cell transplant.
Time frame: Days 30, 60, and 90 post-transplant
Myeloid-derived Suppressor Cells (MDSCs) After Graft vs. Host Disease (GVHD) Diagnosis - Checkpoint Regulator Expression
In those patients experiencing GVHD, the study team will define the checkpoint regulator expression on MDSCs
Time frame: Post-transplant through study completion or death, assessed up to 3 years post-transplant
MDSCs After GVHD Diagnosis - Peripheral Blood Mononuclear Cells
In those patients experiencing GVHD, the study team will define the peripheral blood mononuclear cells and myeloid subsets.
Time frame: Post-transplant through study completion or death, assessed up to 3 years post-transplant
MDSCs After GVHD Diagnosis - Myeloid Subsets Using Flow Cytometry
In those patients experiencing GVHD, the study team will define the myeloid subsets.
Time frame: Post-transplant through study completion or death, assessed up to 3 years post-transplant
MDSCs After GVHD Diagnosis - Frequency
In those patients experiencing GVHD, the study team will define the MDSCs frequency.
Time frame: Post-transplant through study completion or death, assessed up to 3 years post-transplant
Immune Checkpoint Regulators - Prevalence
To characterize the prevalence of immune checkpoint regulators (VISTA, CTLA-4, PD-1) during early immune recovery following an allogeneic stem cell transplant.
Time frame: Days 30, 60, and 90 post-transplant
Immune Checkpoint Regulators - Function
Flow cytometry will be used to characterize the function of immune checkpoint regulators (VISTA, CTLA-4, PD-1) during early immune recovery following an allogeneic stem cell transplant.
Time frame: Days 30, 60, and 90 post-transplant
21 individuals signed consent. 1 individual was deemed ineligible during screening. Therefore 20 individuals were evaluated for the primary endpoint.
| Milestone | Johns Hopkins' Conditioning Regimen |
|---|---|
| Started | 20 |
| Completed | 18 |
| Not completed | 2 |
| Withdrew: Death | 2 |
Define 100-day survival of subjects
| Participants | Johns Hopkins' Conditioning Regimen |
|---|---|
| Number of Participants Who Survived to 100-Days Post-transplant | 18 |
Define one year survival of subjects
| Participants | Johns Hopkins' Conditioning Regimen |
|---|---|
| Number of Participants Who Survived to One Year Post-Transplant. | 16 |
Define number of subjects who experience a successful engraftment: Defined as absolute neutrophil count \> 500/mm3 and platelets \> 20,000/mcl for three consecutive days (count first day as engraftment)
| Participants | Johns Hopkins' Conditioning Regimen |
|---|---|
| Number of Participants Who Experienced a Successful Engraftment | 18 |
Define response to treatment at 100 days post-peripheral blood transplant. The Standard International Criteria for responses for each disease will be used, based on CIBMTR (Center for International Blood and Marrow Transplant Research) criteria.
| Participants | Johns Hopkins' Conditioning Regimen |
|---|---|
| Number of Participants Who Achieved a Response to Treatment at 100 Days | 16 |
Define response to treatment at one year post-peripheral blood transplant. The Standard International Criteria for responses for each disease will be used, based on CIBMTR (Center for International Blood and Marrow Transplant Research) criteria.
| Participants | Johns Hopkins' Conditioning Regimen |
|---|---|
| Number of Participants Who Achieved a Response to Treatment at One Year | 13 |
Define subjects who experienced toxicities associated with this treatment regimen
| Participants | Johns Hopkins' Conditioning Regimen |
|---|---|
| Number of Participants Who Experienced Toxicities Associated With This Treatment Regimen | 16 |
Define subjects who had incidence of acute GVHD
| Participants | Johns Hopkins' Conditioning Regimen |
|---|---|
| Number of Participants Who Had Incidence of Acute GVHD | 3 |
Define subjects who had incidence of chronic GVHD
| Participants | Johns Hopkins' Conditioning Regimen |
|---|---|
| Number of Participants Who Had Incidence of Chronic GVHD | 9 |
Define subjects who experience donor-recipient chimerism following transplant at days 30, 60 and 90. All patients were assessed for donor-recipient chimerism at days 30, 60, and 90, but only one patient experienced chimerism. Day 90 for this patient is reported.
| Participants | Johns Hopkins' Conditioning Regimen |
|---|---|
| Number of Participants Who Experienced Donor-Recipient Chimerism Following Transplant at Days 30, 60, and 90. | 1 |
Define subjects who experienced treatment-related mortality within the first 100 days post-peripheral blood transplant
| Participants | Johns Hopkins' Conditioning Regimen |
|---|---|
| Number of Participants Who Experienced Treatment-Related Mortality Within the First 100 Days | 2 |
To characterize the incidence of immune checkpoint regulators (V-domain Ig Suppressor of T-cell Activation, cytotoxic T-lymphocyte-associated protein 4 \[CTLA\], Programmed cell death protein 1 \[PD-1\]) during early immune recovery following an allogeneic stem cell transplant.
| Participants | Johns Hopkins' Conditioning Regimen |
|---|---|
| Immune Checkpoint Regulators - Incidence | 0 |
In those patients experiencing GVHD, the study team will define the checkpoint regulator expression on MDSCs
| Participants | Johns Hopkins' Conditioning Regimen |
|---|---|
| Myeloid-derived Suppressor Cells (MDSCs) After Graft vs. Host Disease (GVHD) Diagnosis - Checkpoint Regulator Expression | 0 |
In those patients experiencing GVHD, the study team will define the peripheral blood mononuclear cells and myeloid subsets.
| Participants | Johns Hopkins' Conditioning Regimen |
|---|---|
| MDSCs After GVHD Diagnosis - Peripheral Blood Mononuclear Cells | 0 |
In those patients experiencing GVHD, the study team will define the myeloid subsets.
| Participants | Johns Hopkins' Conditioning Regimen |
|---|---|
| MDSCs After GVHD Diagnosis - Myeloid Subsets Using Flow Cytometry | 0 |
In those patients experiencing GVHD, the study team will define the MDSCs frequency.
| Participants | Johns Hopkins' Conditioning Regimen |
|---|---|
| MDSCs After GVHD Diagnosis - Frequency | 0 |
To characterize the prevalence of immune checkpoint regulators (VISTA, CTLA-4, PD-1) during early immune recovery following an allogeneic stem cell transplant.
| Participants | Johns Hopkins' Conditioning Regimen |
|---|---|
| Immune Checkpoint Regulators - Prevalence | 0 |
Flow cytometry will be used to characterize the function of immune checkpoint regulators (VISTA, CTLA-4, PD-1) during early immune recovery following an allogeneic stem cell transplant.
| Participants | Johns Hopkins' Conditioning Regimen |
|---|---|
| Immune Checkpoint Regulators - Function | 0 |
Collected over Monitoring of all acute toxicities (grade 3 or higher) occurred until the time of discharge (post-transplant). After discharge, until day 100, only serious toxicities (grade 4 or higher) were recorded. All-Cause Mortality was monitored from the time of transplant to three years post-transplant.. Non-serious events are listed at a 0% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Johns Hopkins' Conditioning Regimen | 5/20 (25%) | 3/20 (15%) | 16/20 (80%) |
| Event | Johns Hopkins' Conditioning Regimen |
|---|---|
| Edema LimbsGeneral disorders | 1/20 |
| GI GVHDGastrointestinal disorders | 1/20 |
| Liver GVHDHepatobiliary disorders | 1/20 |
| Skin GVHDSkin and subcutaneous tissue disorders | 1/20 |
| DiarrheaGastrointestinal disorders | 1/20 |
| Platelet count decreasedInvestigations | 1/20 |
| EncephalopathyNervous system disorders | 1/20 |
| Event | Johns Hopkins' Conditioning Regimen |
|---|---|
| AnorexiaBlood and lymphatic system disorders | 15/20 |
| DiarrheaGastrointestinal disorders | 5/20 |
| EdemaGeneral disorders | 4/20 |
| DysrhythmiaCardiac disorders | 3/20 |
| DeliriumPsychiatric disorders | 2/20 |
| DysesthesiaNervous system disorders | 2/20 |
| RigorsGeneral disorders | 1/20 |
| FeverGeneral disorders | 1/20 |
| C. DiffInfections and infestations | 1/20 |
| HematuriaRenal and urinary disorders | 1/20 |
| Age, Categorical(Participants) | Johns Hopkins' Conditioning Regimen |
|---|---|
| <=18 years | 1 |
| Between 18 and 65 years | 9 |
| >=65 years | 10 |
| Age, Continuous(Years) | Johns Hopkins' Conditioning Regimen |
|---|---|
| Mean | 59.55 (18 to 72) |
| Sex: Female, Male(Participants) | Johns Hopkins' Conditioning Regimen |
|---|---|
| Female | 7 |
| Male | 13 |
| Ethnicity (NIH/OMB)(Participants) | Johns Hopkins' Conditioning Regimen |
|---|---|
| Hispanic or Latino | 0 |
| Not Hispanic or Latino | 20 |
| Unknown or Not Reported | 0 |
| Race (NIH/OMB)(Participants) | Johns Hopkins' Conditioning Regimen |
|---|---|
| American Indian or Alaska Native | 0 |
| Asian | 0 |
| Native Hawaiian or Other Pacific Islander | 0 |
| Black or African American | 0 |
| White | 20 |
| More than one race | 0 |
| Unknown or Not Reported | 0 |
| Region of Enrollment(participants) | Johns Hopkins' Conditioning Regimen |
|---|---|
| United States | 20 |
| Number of Evaluable Participants(participants) | Johns Hopkins' Conditioning Regimen |
|---|---|
| Number | 20 |
PDFs hosted by the registry, ClinicalTrials.gov.
Plan to share: No
Ran from Mar 2018 to primary completion in Feb 2025, 82 months.
Of 78 non-industry phase 3 interventional studies under Leukemia, Myeloid, Acute, half reached primary completion within 87 months of starting (the median), counting those still running; a quarter within 66 and three quarters within 111. This study's 82 months is close to that.
Counting every sponsor, half of 120 studies reached it within 74 months; a quarter within 39 and three quarters within 99.
How these figures are worked out, and which studies are left out of them.
This study is completed, as verified in Jan 2026. You cannot join it, but the record below documents what was studied.
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Studies of the drugs tested here: Cyclophosphamide · Fludarabine · Tacrolimus · Mycophenolic Acid · Granulocyte Colony-Stimulating Factor
Dartmouth-Hitchcock Medical Center →