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CompletedNCT03480360Updated Jul 17, 2026Results posted

Haploidentical Allogeneic Peripheral Blood Transplantation: Examining Checkpoint Immune Regulators' Expression

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

Phase
Phase 3
Study type
Interventional
Enrollment
21
Allocation
Not applicable
Ages
18 Years to 75 Years
Sex
All
01

Study summary

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.

Read the detailed description

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.

02

Conditions studied

  • Acute Myeloid Leukemia
  • Chronic Lymphocytic Leukemia
  • Chronic Myeloid Leukemia
  • Myelodysplasia
  • Myeloproliferative Disorder
  • Myelofibrosis
  • Lymphoma
  • Lymphoma, Non-Hodgkin
  • Plasma Cell Disorder

Keywords

  • haploidentical
  • transplant
  • peripheral blood
  • allogeneic
03

Who can participate

Ages eligible
18 Years to 75 Years
Sexes eligible
All
Accepts healthy volunteers
Yes

Inclusion criteria

  • Age: less than 75 years
  • The patient must be approved for transplant by the treating transplant physician. This includes completion of their pre-transplant workup, as directed by standard Dartmouth-Hitchcock Medical Center (DHMC) Standard Operating Procedure (SOP) (DHMC SOP - Pre-transplant Evaluation of allogeneic recipient (Appendix).
  • The patient must have a disease (listed below) with treatment-responsiveness that the treating transplant physician believes will benefit from an allogeneic stem cell transplant. The diseases include:
  • Acute leukemia - Acute Myeloid Leukemia, Acute Lymphocytic Leukemia
  • Chronic leukemia - Chronic Myeloid Leukemia, Chronic Lymphocytic Leukemia
  • Myelodysplasia
  • Myeloproliferative disorder
  • Myelofibrosis
  • Lymphoma - Non-Hodgkin's Lymphoma or Hodgkin's disease
  • Plasma cell disorder, including myeloma, Waldenstrom's Macroglobulinemia
  • Donor availability- the patient must have an identified RELATED haplo-identical donor
  • No Human Immunodeficiency Virus infection or active hepatitis B or C
  • Eastern Cooperative Oncology Group performance status: 0-2
  • Diffusing capacity of carbon monoxide (DLCO) greater than or equal to 40 % predicted
  • Left ventricular ejection fraction greater than or equal to 40%
  • Serum bilirubin \< 2x upper limit of normal; transaminases \< 3x normal at the time of transplant
  • No active or uncontrollable infection
  • In female, a negative pregnancy test if experiencing menstrual periods
  • No major organ dysfunction precluding transplantation
  • No evidence of an active malignancy that would limit the patient's survival to less than 2 years. (If there is any question, the PI can make a decision).

Exclusion criteria

Exclusion Criteria:

  • Psychiatric disorder or a mental deficiency of the patient that is sufficiently severe to make compliance with the treatment unlikely, and making informed consent impossible.
  • Major anticipated illness or organ failure incompatible with survival from bone marrow transplant.
  • History of refractory systemic infection

DONOR ELIGIBILITY

  • Human leukocyte antigen (HLA) haplo-identical matched related.
  • The donor must be healthy and must be willing to serve as a donor, based on standard National Marrow Donor Program (NMDP) guidelines and DHMC SOP - Donor Evaluation (Appendix)
  • The donor must have no significant co-morbidities that would put the donor at marked increased risk
  • There is no age restriction for the donor
  • Informed consent must be signed by donor

DONOR EXCLUSION CRITERIA

  • The NMDP guidelines for exclusion criteria will be used (Appendix). In addition, the following donors are NOT eligible:
  • Pregnant or lactating donor
  • HIV or active Hep B or C in the donor
  • Donor unfit to receive G-CSF and undergo apheresis
  • A donor with a psychiatric disorder or mental deficiency that makes compliance with the procedure unlikely and informed consent impossible
04

Study design

Phase
Phase 3
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrollment
21 participants (actual)

Study arms

  • Other
    Johns Hopkins' conditioning regimen

    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

Interventions

  • DrugCyclophosphamide

    14.5 mg/kg for 2 days (days -6, -5) and then 50 mg/kg for two days (days 3, 4)

  • DrugFludarabine

    30 mg/m2 daily for 5 days

  • RadiationTotal Body Irradiation

    200 centigray (cGy) for one day (day -1)

  • DrugTacrolimus

    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.

  • Drugcellcept

    dose at 15 mg/kg po three times per day (maximum dose of 3 grams/day). Stop Cellcept at Day 35 following transplantation.

  • Drugg-csf

    5 mcg/kg/d starting day 5 and continue until Absolute Neutrophil Count (ANC) \> 1000/mcL for 3 days.

  • ProcedurePeripheral Blood Transplant

    cell dose goal: \< 5 x 106 Hematopoietic progenitor cell antigen CD34+ cells/kg recipient weight

05

What researchers measure

Primary outcomes

  1. 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

  2. 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

  3. 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

  4. 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

  5. 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

  6. 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

  7. Number of Participants Who Had Incidence of Acute GVHD

    Define subjects who had incidence of acute GVHD

    Time frame: Post-peripheral blood transplant

  8. Number of Participants Who Had Incidence of Chronic GVHD

    Define subjects who had incidence of chronic GVHD

    Time frame: Post-peripheral blood transplant

  9. 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

  10. 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

Secondary outcomes

  1. 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

  2. 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

  3. 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

  4. 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

  5. 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

  6. 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

  7. 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

06

Results

Posted Jul 23, 2024

Participant flow

21 individuals signed consent. 1 individual was deemed ineligible during screening. Therefore 20 individuals were evaluated for the primary endpoint.

Participant flow — Overall Study
MilestoneJohns Hopkins' Conditioning Regimen
Started20
Completed18
Not completed2
Withdrew: Death2

Outcome measures

PrimaryNumber 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
Reported as:
Count of participants · Participants
Number of Participants Who Survived to 100-Days Post-transplant
ParticipantsJohns Hopkins' Conditioning Regimen
Number of Participants Who Survived to 100-Days Post-transplant18
PrimaryNumber 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
Reported as:
Count of participants · Participants
Number of Participants Who Survived to One Year Post-Transplant.
ParticipantsJohns Hopkins' Conditioning Regimen
Number of Participants Who Survived to One Year Post-Transplant.16
PrimaryNumber 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
Reported as:
Count of participants · Participants
Number of Participants Who Experienced a Successful Engraftment
ParticipantsJohns Hopkins' Conditioning Regimen
Number of Participants Who Experienced a Successful Engraftment18
PrimaryNumber 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
Reported as:
Count of participants · Participants
Number of Participants Who Achieved a Response to Treatment at 100 Days
ParticipantsJohns Hopkins' Conditioning Regimen
Number of Participants Who Achieved a Response to Treatment at 100 Days16
PrimaryNumber 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
Reported as:
Count of participants · Participants
Number of Participants Who Achieved a Response to Treatment at One Year
ParticipantsJohns Hopkins' Conditioning Regimen
Number of Participants Who Achieved a Response to Treatment at One Year13
PrimaryNumber 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
Reported as:
Count of participants · Participants
Number of Participants Who Experienced Toxicities Associated With This Treatment Regimen
ParticipantsJohns Hopkins' Conditioning Regimen
Number of Participants Who Experienced Toxicities Associated With This Treatment Regimen16
PrimaryNumber of Participants Who Had Incidence of Acute GVHD

Define subjects who had incidence of acute GVHD

Time frame:
Post-peripheral blood transplant
Reported as:
Count of participants · Participants
Number of Participants Who Had Incidence of Acute GVHD
ParticipantsJohns Hopkins' Conditioning Regimen
Number of Participants Who Had Incidence of Acute GVHD3
PrimaryNumber of Participants Who Had Incidence of Chronic GVHD

Define subjects who had incidence of chronic GVHD

Time frame:
Post-peripheral blood transplant
Reported as:
Count of participants · Participants
Number of Participants Who Had Incidence of Chronic GVHD
ParticipantsJohns Hopkins' Conditioning Regimen
Number of Participants Who Had Incidence of Chronic GVHD9
PrimaryNumber 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
Reported as:
Count of participants · Participants
Number of Participants Who Experienced Donor-Recipient Chimerism Following Transplant at Days 30, 60, and 90.
ParticipantsJohns Hopkins' Conditioning Regimen
Number of Participants Who Experienced Donor-Recipient Chimerism Following Transplant at Days 30, 60, and 90.1
PrimaryNumber 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
Reported as:
Count of participants · Participants
Number of Participants Who Experienced Treatment-Related Mortality Within the First 100 Days
ParticipantsJohns Hopkins' Conditioning Regimen
Number of Participants Who Experienced Treatment-Related Mortality Within the First 100 Days2
SecondaryImmune 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
Reported as:
Count of participants · Participants
Immune Checkpoint Regulators - Incidence
ParticipantsJohns Hopkins' Conditioning Regimen
Immune Checkpoint Regulators - Incidence0
SecondaryMyeloid-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
Reported as:
Count of participants · Participants
Myeloid-derived Suppressor Cells (MDSCs) After Graft vs. Host Disease (GVHD) Diagnosis - Checkpoint Regulator Expression
ParticipantsJohns Hopkins' Conditioning Regimen
Myeloid-derived Suppressor Cells (MDSCs) After Graft vs. Host Disease (GVHD) Diagnosis - Checkpoint Regulator Expression0
SecondaryMDSCs 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
Reported as:
Count of participants · Participants
MDSCs After GVHD Diagnosis - Peripheral Blood Mononuclear Cells
ParticipantsJohns Hopkins' Conditioning Regimen
MDSCs After GVHD Diagnosis - Peripheral Blood Mononuclear Cells0
SecondaryMDSCs 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
Reported as:
Count of participants · Participants
MDSCs After GVHD Diagnosis - Myeloid Subsets Using Flow Cytometry
ParticipantsJohns Hopkins' Conditioning Regimen
MDSCs After GVHD Diagnosis - Myeloid Subsets Using Flow Cytometry0
SecondaryMDSCs 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
Reported as:
Count of participants · Participants
MDSCs After GVHD Diagnosis - Frequency
ParticipantsJohns Hopkins' Conditioning Regimen
MDSCs After GVHD Diagnosis - Frequency0
SecondaryImmune 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
Reported as:
Count of participants · Participants
Immune Checkpoint Regulators - Prevalence
ParticipantsJohns Hopkins' Conditioning Regimen
Immune Checkpoint Regulators - Prevalence0
SecondaryImmune 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
Reported as:
Count of participants · Participants
Immune Checkpoint Regulators - Function
ParticipantsJohns Hopkins' Conditioning Regimen
Immune Checkpoint Regulators - Function0

Adverse events

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.

Adverse event summary by group
GroupDeathsSeriousOther
Johns Hopkins' Conditioning Regimen5/20 (25%)3/20 (15%)16/20 (80%)
Most frequent serious events
Most frequent serious events
EventJohns Hopkins' Conditioning Regimen
Edema LimbsGeneral disorders1/20
GI GVHDGastrointestinal disorders1/20
Liver GVHDHepatobiliary disorders1/20
Skin GVHDSkin and subcutaneous tissue disorders1/20
DiarrheaGastrointestinal disorders1/20
Platelet count decreasedInvestigations1/20
EncephalopathyNervous system disorders1/20
Most frequent other events
Showing 10 of 16
Most frequent other events
EventJohns Hopkins' Conditioning Regimen
AnorexiaBlood and lymphatic system disorders15/20
DiarrheaGastrointestinal disorders5/20
EdemaGeneral disorders4/20
DysrhythmiaCardiac disorders3/20
DeliriumPsychiatric disorders2/20
DysesthesiaNervous system disorders2/20
RigorsGeneral disorders1/20
FeverGeneral disorders1/20
C. DiffInfections and infestations1/20
HematuriaRenal and urinary disorders1/20

Baseline characteristics

Age, Categorical
Age, Categorical(Participants)Johns Hopkins' Conditioning Regimen
<=18 years1
Between 18 and 65 years9
>=65 years10
Age, Continuous
Age, Continuous(Years)Johns Hopkins' Conditioning Regimen
Mean59.55 (18 to 72)
Sex: Female, Male
Sex: Female, Male(Participants)Johns Hopkins' Conditioning Regimen
Female7
Male13
Ethnicity (NIH/OMB)
Ethnicity (NIH/OMB)(Participants)Johns Hopkins' Conditioning Regimen
Hispanic or Latino0
Not Hispanic or Latino20
Unknown or Not Reported0
Race (NIH/OMB)
Race (NIH/OMB)(Participants)Johns Hopkins' Conditioning Regimen
American Indian or Alaska Native0
Asian0
Native Hawaiian or Other Pacific Islander0
Black or African American0
White20
More than one race0
Unknown or Not Reported0
Region of Enrollment
Region of Enrollment(participants)Johns Hopkins' Conditioning Regimen
United States20
Number of Evaluable Participants
Number of Evaluable Participants(participants)Johns Hopkins' Conditioning Regimen
Number20
07

Study locations

1 site
  • Dartmouth Hitchcock Medical Center, Norris Cotton Cancer Center
    Lebanon, New Hampshire 03756, United States
08

References and documents

Publications

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  • Solomon SR, Sizemore CA, Sanacore M, Zhang X, Brown S, Holland HK, Morris LE, Bashey A. Haploidentical transplantation using T cell replete peripheral blood stem cells and myeloablative conditioning in patients with high-risk hematologic malignancies who lack conventional donors is well tolerated and produces excellent relapse-free survival: results of a prospective phase II trial. Biol Blood Marrow Transplant. 2012 Dec;18(12):1859-66. doi: 10.1016/j.bbmt.2012.06.019. Epub 2012 Aug 1. PubMed 22863841 ↗
  • Ciurea SO, Zhang MJ, Bacigalupo AA, Bashey A, Appelbaum FR, Aljitawi OS, Armand P, Antin JH, Chen J, Devine SM, Fowler DH, Luznik L, Nakamura R, O'Donnell PV, Perales MA, Pingali SR, Porter DL, Riches MR, Ringden OT, Rocha V, Vij R, Weisdorf DJ, Champlin RE, Horowitz MM, Fuchs EJ, Eapen M. Haploidentical transplant with posttransplant cyclophosphamide vs matched unrelated donor transplant for acute myeloid leukemia. Blood. 2015 Aug 20;126(8):1033-40. doi: 10.1182/blood-2015-04-639831. Epub 2015 Jun 30. PubMed 26130705 ↗
  • Luznik L, O'Donnell PV, Symons HJ, Chen AR, Leffell MS, Zahurak M, Gooley TA, Piantadosi S, Kaup M, Ambinder RF, Huff CA, Matsui W, Bolanos-Meade J, Borrello I, Powell JD, Harrington E, Warnock S, Flowers M, Brodsky RA, Sandmaier BM, Storb RF, Jones RJ, Fuchs EJ. HLA-haploidentical bone marrow transplantation for hematologic malignancies using nonmyeloablative conditioning and high-dose, posttransplantation cyclophosphamide. Biol Blood Marrow Transplant. 2008 Jun;14(6):641-50. doi: 10.1016/j.bbmt.2008.03.005. PubMed 18489989 ↗
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  • Giralt S, Logan B, Rizzo D, Zhang MJ, Ballen K, Emmanouilides C, Nath R, Parker P, Porter D, Sandmaier B, Waller EK, Barker J, Pavletic S, Weisdorf D. Reduced-intensity conditioning for unrelated donor progenitor cell transplantation: long-term follow-up of the first 285 reported to the national marrow donor program. Biol Blood Marrow Transplant. 2007 Jul;13(7):844-52. doi: 10.1016/j.bbmt.2007.03.011. Epub 2007 May 24. PubMed 17580263 ↗
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  • Parmesar K, Raj K. Haploidentical Stem Cell Transplantation in Adult Haematological Malignancies. Adv Hematol. 2016;2016:3905907. doi: 10.1155/2016/3905907. Epub 2016 May 30. PubMed 27313619 ↗
  • Luznik L, Engstrom LW, Iannone R, Fuchs EJ. Posttransplantation cyclophosphamide facilitates engraftment of major histocompatibility complex-identical allogeneic marrow in mice conditioned with low-dose total body irradiation. Biol Blood Marrow Transplant. 2002;8(3):131-8. doi: 10.1053/bbmt.2002.v8.pm11939602. PubMed 11939602 ↗
  • Ciurea SO, Mulanovich V, Saliba RM, Bayraktar UD, Jiang Y, Bassett R, Wang SA, Konopleva M, Fernandez-Vina M, Montes N, Bosque D, Chen J, Rondon G, Alatrash G, Alousi A, Bashir Q, Korbling M, Qazilbash M, Parmar S, Shpall E, Nieto Y, Hosing C, Kebriaei P, Khouri I, Popat U, de Lima M, Champlin RE. Improved early outcomes using a T cell replete graft compared with T cell depleted haploidentical hematopoietic stem cell transplantation. Biol Blood Marrow Transplant. 2012 Dec;18(12):1835-44. doi: 10.1016/j.bbmt.2012.07.003. Epub 2012 Jul 11. PubMed 22796535 ↗
  • Chang YJ, Zhao XY, Huang XJ. Immune reconstitution after haploidentical hematopoietic stem cell transplantation. Biol Blood Marrow Transplant. 2014 Apr;20(4):440-9. doi: 10.1016/j.bbmt.2013.11.028. Epub 2013 Dec 4. PubMed 24315844 ↗
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Study documents

  • Protocol and statistical analysis plan · Mar 4, 2019

Documents are hosted by the registry — open the source record to download them.

Individual participant data

Plan to share: No

09

Registry details

Key details

Study ID
NCT03480360
Lead sponsor
Dartmouth-Hitchcock Medical Center
Responsible party
Kenneth Meehan (Principal Investogator- Kenneth Meehan, MD Staff Physician, Dartmouth-Hitchcock Medical Center) — Principal investigator
First posted
Mar 29, 2018
Start date
Mar 28, 2018
Primary completion
Feb 14, 2025
Completion
Oct 17, 2025
Results posted
Jul 23, 2024
Last update
Jul 17, 2026

Study contacts

Kenneth Meehan, MD
principal investigator · Dartmouth-Hitchcock Medical Center

Oversight

Data monitoring committee
Yes
FDA-regulated drug
Yes
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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