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NCT Number: NCT02793544

HLA-Mismatched Unrelated Donor Bone Marrow Transplantation With Post-Transplantation Cyclophosphamide

This is a multi-center, single arm Phase II study of hematopoietic cell transplantation (HCT) using human leukocyte antigen (HLA)-mismatched unrelated bone marrow transplantation donors and post-transplantation cyclophosphamide (PTCy), sirolimus and mycophenolate mofetil (MMF) for graft versus host disease (GVHD) prophylaxis in patients with hematologic malignancies.

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Key information

Conditions

Myelodysplastic Syndrome (MDS) Acute Biphenotypic Leukemia (ABL) Acute Lymphoblastic Leukemia (ALL)/T Lymphoblastic Lymphoma Acute Myelogenous Leukemia (AML) Acute Undifferentiated Leukemia (AUL) Bone Marrow Diseases Chemotherapy-sensitive Lymphoma Chronic Disease Chronic Lymphocytic Leukemia (CLL) Disease Attributes Hematologic Diseases Hemic and Lymphatic Diseases Immune System Diseases Immunoproliferative Disorders Leukemia Leukemia, B-Cell Leukemia, Biphenotypic, Acute Leukemia, Lymphocytic, Chronic, B-Cell Leukemia, Lymphoid Leukemia, Myeloid Leukemia, Myeloid, Acute Lymphatic Diseases Lymphoproliferative Disorders Myelodysplastic Syndromes Neoplasms Neoplasms by Histologic Type Pathologic Processes Pathological Conditions, Signs and Symptoms Precursor Cell Lymphoblastic Leukemia-Lymphoma

Age range

15 year–70 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

Shands HealthCare & University of Florida, Gainesville, Florida, United States

Loading trial locations.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Age ≥ 15 years and < 71 years at the time of signing the informed consent form
  • Partially HLA-mismatched unrelated donor: HLA typing will be performed at high resolution (allele level) for the HLA-A, -B, -C, and -DRB1 loci; a minimum match of 4/8 at HLA-A, -B, -C, and -DRB1 is required
  • Product planned for infusion is bone marrow
  • Disease and disease status:
  • Acute Leukemias or T lymphoblastic lymphoma in 1st or subsequent complete remission (CR): Acute lymphoblastic leukemia (ALL)/T lymphoblastic lymphoma; acute myelogenous leukemia (AML); acute biphenotypic leukemia (ABL); acute undifferentiated leukemia (AUL)
  • Myelodysplastic Syndrome (MDS), fulfilling the following criteria: Subjects with de novo MDS who have or have previously had Intermediate-2 or High risk disease as determined by the International Prognostic Scoring System (IPSS). Current Intermediate-2 or High risk disease is not a requirement; Subjects must have < 20% bone marrow blasts, assessed within 60 days of informed consent; Subjects may have received prior therapy for the treatment of MDS prior to enrollment
  • Chronic Lymphocytic Leukemia (CLL) in CR if RIC is to be used; in CR or partial response (PR) if FIC is to be used
  • Chronic myeloid leukemia (CML) in 1st or subsequent chronic phase characterized by <10% blasts in the blood or bone marrow.
  • Chemotherapy-sensitive lymphoma in status other than 1st CR
  • Performance status: Karnofsky or Lansky score ≥ 60% (Appendix A)
  • Adequate organ function defined as:
  • Cardiac: left ventricular ejection fraction (LVEF) at rest ≥ 35% (RIC cohort) or LVEF at rest ≥ 40% (FIC cohort), or left ventricular shortening fraction (LVFS) ≥ 25%
  • Pulmonary: diffusing capacity of the lungs for carbon monoxide (DLCO), forced expiratory volume (FEV1), forced vital capacity (FVC) ≥ 50% predicted by pulmonary function tests (PFTs)
  • Hepatic: total bilirubin ≤ 2.5 mg/dL, and alanine aminotransferase (ALT), aspartate aminotransferase (AST), and alkaline phosphatase (ALP) < 5 x upper limit of (ULN) (unless disease related)
  • Renal: serum creatinine (SCr) within normal range for age (see table 2.3). If SCr is outside normal range for age, creatinine clearance (CrCl) > 40 mL/min/1.73m2 must be obtained (measured by 24-hour (hr) urine specimen or nuclear glomerular filtration rate (GFR), or calculated GFR (by Cockcroft-Gault formula for those aged ≥ 18 years; by Original Schwartz estimate for those < 18 years))
  • Subjects ≥ 18 years of age must have the ability to give informed consent according to applicable regulatory and local institutional requirements. Legal guardian permission must be obtained for subjects < 18 years of age. Pediatric subjects will be included in age appropriate discussion in order to obtain assent.
  • Subjects with documentation of confirmed HIV-1 infection (i.e. HIV-positive), and a hematologic malignancy who meets all other eligibility requirements must:
  • Receive only RIC regimen (i.e. Regimen A)
  • Be willing to comply with effective antiretroviral therapy (ARV)
  • Have achieved a sustained virologic response for 12 weeks after cessation of hepatitis C antiviral treatment (in HIV-positive subjects with hepatitis C)

Exclusion criteria

  • HLA-matched related or 8/8 allele matched (HLA-A, -B, -C, -DRB1) unrelated donor available. This exclusion does not apply to HIV-positive subjects who have a CCR5delta32 homozygous donor.
  • Autologous HCT < 3 months prior to the time of signing the informed consent form
  • Females who are breast-feeding or pregnant
  • HIV-positive subjects:
  • Acquired immunodeficiency syndrome (AIDS) related syndromes or symptoms that may pose an excessive risk for transplantation-related morbidity as determined by the Treatment Review Committee (see Appendix D).
  • Untreatable HIV infection due to multidrug ARV resistance. Subjects with a detectable or standard viral load > 750 copies/mL should be evaluated with an HIV drug resistance test (HIV-1 genotype). The results should be included as part of the ARV review (described in Appendix D).
  • May not be currently prescribed ritonavir, cobacistat and/or zidovudine
  • Current uncontrolled bacterial, viral or fungal infection (currently taking medication with evidence of progression of clinical symptoms or radiologic findings)
  • Prior allogeneic HCT
  • History of primary idiopathic myelofibrosis
  • MDS subjects may not receive RIC and must be < 50 years of age at the time of signing the informed consent form

Treatment and study plan

Fludarabine

Drug
  • Fludarabine 30 mg/m2/day (adjusted for renal function) is administered over a 30-60 minute IV infusion on Days -6 through -2 (maximum cumulative dose, 150 mg/m2).
  • The body surface area (BSA) for fludarabine dosing is based on adjusted ideal body weight (IBW) (Appendix K).
  • creatinine clearance may change during the days fludarabine is given. Adjustment in fludarabine dose due to creatinine changes during conditioning is permitted.

Other names: Fludara®

Cyclophosphamide 14.5 mg/kg/day IV on Days -6, -5

Drug
  • Cy 14.5 mg/kg/day is administered as a 1-2 hour IV infusion on Days -6 and -5 after hydration.
  • Use of Mesna and dosing will be done according to institutional standards. A recommended approach is as follows: Mesna IV dose of ≥ 80% of the total daily dose of Cy and given in divided doses 30 minutes before and at 3, 6, and 8-9 hours after completion of Cy.
  • Hydration prior to Cy may be given according to institutional guideline.
  • Cy and mesna are dosed according to adjusted IBW (Appendix K), unless the subject weighs less than IBW, in which case these drugs will be dosed according to actual weight.

Other names: Cytoxan®

Total Body Irradiation (TBI) 200cGy on Day -1

Radiation
  • 200 cGy TBI is administered in a single fraction on Day -1.
  • Radiation sources, dose rates, and shielding follow institutional practice.

Infusion of non-T-cell depleted bone marrow on Day 0

Procedure
  • On Day 0, the harvested bone marrow is infused.
  • Donor bone marrow will be harvested with a target yield of 4 x 108 nucleated cells/kg recipient weight.
  • The lowest acceptable nucleated cells yield is 1.5 x 108 cells/kg recipient weight.

busulfan

Drug
  • Busulfan ≥ 9mg/kg total dose (IV or PO) on Days -6, -5, -4, -3 (PK monitoring required to achieve a daily area under the curve (AUC) target of 4800-5300 μM*min (Perkins et al., 2012))
  • Busulfan dosing is based on adjusted IBW (Appendix K)

Other names: Busulfex®

Cyclophosphamide 50mg/kg/day IV on Days -2,-1

Drug
  • Cy 50mg/kg/day is administered as a 1-2 hour IV infusion on Days -2 and -1 after hydration.
  • Use of Mesna and dosing will be done according to institutional standards. A recommended approach is as follows: Mesna IV dose of ≥ 80% of the total daily dose of Cy and given in divided doses 30 minutes before and at 3, 6, and 8-9 hours after completion of Cy.
  • Hydration prior to Cy may be given according to institutional guideline.
  • Cy and mesna are dosed according to adjusted IBW (Appendix K), unless the subject weighs less than IBW, in which case these drugs will be dosed according to actual weight.

Other names: Cytoxan®

Cyclophosphamide 50mg/kg/day IV on Days -5,-4

Drug
  • Cy 50mg/kg/day is administered as a 1-2 hour IV infusion on Days -5 and -4 after hydration.
  • Use of Mesna and dosing will be done according to institutional standards. A recommended approach is as follows: Mesna IV dose of ≥ 80% of the total daily dose of Cy and given in divided doses 30 minutes before and at 3, 6, and 8-9 hours after completion of Cy.
  • Hydration prior to Cy may be given according to institutional guideline.
  • Cy and mesna are dosed according to adjusted IBW (Appendix K), unless the subject weighs less than IBW, in which case these drugs will be dosed according to actual weight.

Other names: Cytoxan®

Total Body Irradiation (TBI) 200cGy twice a day on Days -3, -2, -1

Radiation
  • 200cGy TBI is administered in twice daily on Days -3, -2, and -1.
  • Radiation sources, dose rates, and shielding follow institutional practice.

Post-HCT Cyclophosphamide 50mg/kg IV on Day+3, +4

Drug
  • Cy 50mg/kg IV, over 1-2 hours (depending on volume), is given on Day+3 (ideally between 60 and 72 hours after bone marrow infusion) and on Day+4 (approximately 24 hours after Day+3 Cy).
  • Hydration with Cy, management of volume status, and monitoring for hemorrhagic cystitis will follow institutional standards.
  • Mesna is required. Mesna IV dose must be ≥ 80% of the total daily dose of Cy and given in divided doses 30 minutes before and at 3, 6, and 8-9 hours after completion of Cy.
  • Cy is dosed according to IBW, unless the subject weighs less than IBW, in which case these drugs will be dosed according to actual body weight.

sirolimus

Drug
  • Sirolimus dosing is based on adjusted IBW (Appendix K).
  • Sirolimus prophylaxis is discontinued after the last dose on Day+180, or may be continued if there is GVHD.

For subjects ≥ 18 years old:

  • A one-time sirolimus loading dose, 6 mg PO, is given on Day+5, at least 24 hours after Cy completion.
  • Sirolimus is then continued at a maintenance dose (starting dose 2 mg PO QD), with dose adjustments to maintain a trough of 5 - 15 ng/mL as measured by high performance liquid chromatography (HPLC) or immunoassay.

For subjects < 18 years old:

  • A one-time sirolimus loading dose, 3 mg/m2 PO with the dose not to exceed 6 mg, is given on Day+5, at least 24 hours after Cy completion.
  • Sirolimus is then continued at a maintenance dose (starting dose 1 mg/m2 PO QD, maximum 2 mg PO QD), with dose adjustments to maintain a trough of 5 - 15 ng/mL as measured by HPLC or immunoassay.

Other names: rapamycin, Rapamune®

Mycophenolate mofetil

Drug

MMF begins on Day+5, at least 24 hours after completion of PTCy. MMF dose is 15 mg/kg PO TID (adjusted IBW (Appendix K)) with total daily dose not to exceed 3 grams (i.e. maximum 1 g PO TID).

An equivalent IV dose (1:1 conversion) may instead be given. MMF prophylaxis is discontinued after the last dose on Day+35, or may be continued if there is GVHD.

Other names: MMF, Cellcept®

G-CSF

Drug

Granulocyte-colony stimulating factor (G-CSF): filgrastim or a biosimilar begins on Day+5 at a dose of 5 mcg/kg/day (actual body weight) IV or subcutaneously (SC) (rounding to the nearest vial dose is allowed), until the absolute neutrophil count (ANC) is ≥ 1,000/mm3 over the course of 3 consecutive days.

Additional G-CSF may be administered as warranted.

Other names: filgrastim

Pre-HCT Mesna on Days -6 and -5

Drug

Use of Mesna and dosing will be done according to institutional standards. A recommended approach is as follows: Mesna IV dose of ≥ 80% of the total daily dose of Cy and given in divided doses 30 minutes before and at 3, 6, and 8-9 hours after completion of Cy.

Mesna is dosed according to adjusted IBW (Appendix K), unless the subject weighs less than IBW, in which case Mesna will be dosed according to actual weight.

Pre-HCT Mesna on Days -2 and -1

Drug

Use of Mesna and dosing will be done according to institutional standards. A recommended approach is as follows: Mesna IV dose of ≥ 80% of the total daily dose of Cy and given in divided doses 30 minutes before and at 3, 6, and 8-9 hours after completion of Cy.

Mesna is dosed according to adjusted IBW (Appendix K), unless the subject weighs less than IBW, in which case Mesna will be dosed according to actual weight.

Pre-HCT Mesna on Days -5 and -4

Drug

Use of Mesna and dosing will be done according to institutional standards. A recommended approach is as follows: Mesna IV dose of ≥ 80% of the total daily dose of Cy and given in divided doses 30 minutes before and at 3, 6, and 8-9 hours after completion of Cy.

Mesna is dosed according to adjusted IBW (Appendix K), unless the subject weighs less than IBW, in which case Mesna will be dosed according to actual weight.

Post-HCT Mesna

Drug

Mesna is required. Mesna IV dose must be ≥ 80% of the total daily dose of Cy and given in divided doses 30 minutes before and at 3, 6, and 8-9 hours after completion of Cy on Day+3 and Day+4.

Mesna is dosed according to IBW, unless the subject weighs less than IBW, in which case Mesna will be dosed according to actual body weight.

Primary outcomes

  1. Overall Survival

    Time frame: 365 days post transplant

    Death from any cause. The time to this event is the time from HCT to death, loss to follow-up, or end of study (whichever comes first).

    The overall survival probability and 90% CI will be calculated by the Kaplan Meier product limit estimator.

Secondary outcomes

  1. Progression-free Survival

    Time frame: 180 days and 365 days post-transplant

    Time from HCT until the documentation of disease progression / relapse or death due to any cause, whichever occurs first. Progression-free survival probability and 90% CI will be calculated by the Kaplan Meier product limit estimator.

  2. Transplant-related Mortality

    Time frame: 100 days, 180 days, and 365 days post-transplant

    Death without evidence of disease progression or recurrence. A cumulative incidence will be computed along with a 90% CI.

  3. Cumulative Incidence of Neutrophil Recovery

    Time frame: 100 days and 365 days post transplant

    Achieving a donor derived ANC ≥ 500/mm3 for 3 consecutive laboratory values on different days. A cumulative incidence will be computed along with a 90% CI.

  4. Cumulative Incidence of Platelet Recovery

    Time frame: 100 days and 365 days post transplant

    Achieving a platelet count ≥ 20,000/μL for 3 consecutive laboratory values on different days (with no platelet transfusions in the preceding seven days). A cumulative incidence will be computed along with a 90% CI.

  5. Cumulative Incidence of Acute GVHD

    Time frame: 100 days post-transplant

    Any skin, gastrointestinal or liver abnormalities fulfilling the BMT CTN Manual of Operations (2013) criteria of grades II-IV acute GVHD. A cumulative incidence will be computed along with a 90% CI.

    Any skin, gastrointestinal or liver abnormalities fulfilling the BMT CTN Manual of Operations (2013) criteria of grades III-IV acute GVHD. A cumulative incidence will be computed along with a 90% CI.

  6. Grades II-IV Acute GVHD

    Time frame: 100 days

    Any skin, gastrointestinal or liver abnormalities fulfilling the BMT CTN Manual of Operations (2013) criteria of grades II-IV acute GVHD. A cumulative incidence will be computed along with a 90% CI.

  7. Grades III-IV Acute GVHD

    Time frame: 100 days

    Any skin, gastrointestinal or liver abnormalities fulfilling the BMT CTN Manual of Operations (2013) criteria of grades III-IV acute GVHD. A cumulative incidence will be computed along with a 90% CI.

  8. Cumulative Incidence of Chronic GVHD

    Time frame: 180 days and 365 days post-transplant

    Per National Institutes of Health (NIH) Consensus Criteria and includes organ involvement and severity, and overall global composite score (mild/moderate/severe). A cumulative incidence will be computed along with a 90% CI. Death from any cause. The time to this event is the time from HCT to death, loss to follow-up, or end of study (whichever comes first).

    The overall survival probability and 90% CI will be calculated by the Kaplan Meier product limit estimator.

  9. Cumulative Incidences of Viral Reactivations and Infections: Grade 2-3 CMV Reactivation or Infection

    Time frame: 100 days, 180 days, and 365 days

    Grade 2: Clinically active CMV infection (e.g. symptoms, cytopenias) or CMV Viremia not decreasing by at least 2/3 of the baseline value after 2 weeks of therapy; Grade 3: CMV end-organ involvement (pneumonitis, enteritis, retinitis). A cumulative incidence will be computed along with a 90% CI. Death from any cause. The time to this event is the time from HCT to death, loss to follow-up, or end of study (whichever comes first).

    The overall survival probability and 90% CI will be calculated by the Kaplan Meier product limit estimator.

  10. Cumulative Incidences of Viral Reactivations and Infections: Grade 3 CMV Infection

    Time frame: 100 days, 180 days, and 365 days

    CMV end-organ involvement (pneumonitis, enteritis, retinitis) ). A cumulative incidence will be computed along with a 90% CI. Death from any cause. The time to this event is the time from HCT to death, loss to follow-up, or end of study (whichever comes first). The overall survival probability and 90% CI will be calculated by the Kaplan Meier product limit estimator.

  11. Cumulative Incidences of Viral Reactivations and Infections: Grade 2-3 EBV Infection

    Time frame: 100 days, 180 days, and 365 days

    Grade 2: EBV reactivation requiring institution of therapy with rituximab; Grade 3: EBV post-transplant lymphoproliferative disorder). A cumulative incidence will be computed along with a 90% CI. Death from any cause. The time to this event is the time from HCT to death, loss to follow-up, or end of study (whichever comes first). The overall survival probability and 90% CI will be calculated by the Kaplan Meier product limit estimator.

  12. Cumulative Incidences of Viral Reactivations and Infections: Grade 2 BK Virus Infection

    Time frame: 100 days, 180 days, 365 days

    BK viremia or viruria with clinical consequence requiring prolonged therapy and/or surgical intervention). A cumulative incidence will be computed along with a 90% CI.

  13. Cumulative Incidences of Viral Reactivations and Infections: Grade 2-3 Adenovirus Infection

    Time frame: 100 days, 180 days, and 365 days

    Grade 2: Adenoviral URI, viremia, or symptomatic viruria requiring treatment; Grade 3: ADV with end-organ involvement (except conjunctivitis and upper respiratory tract) ). A cumulative incidence will be computed along with a 90% CI. Death from any cause. The time to this event is the time from HCT to death, loss to follow-up, or end of study (whichever comes first). The overall survival probability and 90% CI will be calculated by the Kaplan Meier product limit estimator.

  14. Cumulative Incidences of Viral Reactivations and Infections: Grade 2 HHV-6 Infection

    Time frame: 100 days, 180 days, 365 days

    Clinically active HHV-6 infection (e.g. symptoms, cytopenias) or HHV-6 viremia without viral load decline 0.5 log after 2 weeks of therapy). A cumulative incidence will be computed along with a 90% CI.

  15. Cumulative Incidence of Relapse/Progression

    Time frame: 180 days and 365 days post-transplant

    Defined by either morphological, cytogenetic/molecular or radiological evidence of disease consistent with pre-HCT features. A cumulative incidence will be computed along with a 90% CI. Death from any cause. The time to this event is the time from HCT to death, loss to follow-up, or end of study (whichever comes first). The overall survival probability and 90% CI will be calculated by the Kaplan Meier product limit estimator.

  16. Cumulative Incidences of Thrombotic Microangiopathy (TMA) and Hepatic Veno-occlusive Disease (VOD)/Sinusoidal Obstruction Syndrome (SOS)

    Time frame: 365 days post transplant

    TMA is defined as (Ho et al., 2005):

    • RBC fragmentation and >2 schistocytes per high-power field on peripheral smear
    • Concurrent increased serum LDH above institutional baseline
    • Concurrent renal and/or neurologic dysfunction without other explanation
    • Negative direct and indirect Coombs test results A cumulative incidence will be computed along with a 90% CI.

    VOD/SOS is defined as: In the first 20 days after HCT, the presence of ≥2 of the following: 1. Bilirubin >2 mg/Dl, 2. Hepatomegaly or pain in right upper quadrant, 3. Weight gain (>2% basal weight).

    A cumulative incidence will be computed along with a 90% CI.

  17. Cumulative Incidence of Primary Graft Failure

    Time frame: 56 days post-transplant

    Lack of donor-derived neutrophil engraftment. The frequency of subjects experiencing primary graft failure by 56 days will be described.

  18. Donor Chimerism

    Time frame: 28 days, 56 days, 100 days, 180 days, and 365 days post-transplant

    Peripheral blood chimerism (% of donor chimerism) in whole blood (unsorted). The degree of donor chimerism will be summarized using descriptive statistics.

  19. Peripheral Blood Chimerism

    Time frame: 56 days post-transplant

    The frequency of subjects with Peripheral blood (unsorted) chimerism>95% at 56 days will be described.

  20. Proportion of Subjects Proceeding to Transplant

    Time frame: Pre-HCT

    The proportion of subjects proceeding to HCT after informed consent.

  21. Time From Search to Donor Identification

    Time frame: Pre-HCT

    Time from search to donor identification Time from preliminary search to formal donor activation.

  22. Donor Selection Characteristics: HLA Match

    Time frame: Pre-HCT

    Number of matched donor and recipient HLA allele pairs. A matched donor would have 8/8 HLA allele pairs matching; mismatched donors listed below have one to four mismatched HLA allele pairs at HLA-A, -B, -C, or -DRB1.

  23. Donor Selection Characteristics: Donor Age

    Time frame: Pre-HCT

    Donor age

  24. Donor Selection Characteristics: Donor Age, Categorical

    Time frame: Pre-HCT

    Donor age, categorical

  25. Donor Selection Characteristics: Donor Weight

    Time frame: Pre-HCT

    Donor weight

  26. Donor Selection Characteristics: Donor Sex

    Time frame: Pre-HCT

    Donor sex

  27. Donor Selection Characteristics: Donor and Recipient Sex

    Time frame: Pre-HCT

    Donor-recipient sex match

  28. Donor Selection Characteristics: Donor and Recipient CMV Serostatus

    Time frame: Pre-HCT

    Donor-recipient Cytomegalovirus (CMV) serostatus match

  29. Donor Selection Characteristics: Donor and Recipient ABO Blood Match

    Time frame: Pre-HCT

    Donor-recipient ABO group match

  30. Donor Clonal Hematopoiesis

    Time frame: 100 days and 365 days post-transplant

    The proportion of subjects developing donor clonal hematopoiesis

  31. Subgroup Analysis of HIV-positive Subjects

    Time frame: 365 days post transplant

    If CCR5delta32 homozygous donors are successfully found and used for one or more HIV-positive subjects, a descriptive analysis of baseline characteristics and outcomes for those HIV-positive subjects will be conducted, including the viral load detected over time obtained from collected samples.

Sponsors and collaborators

Lead sponsor

Center for International Blood and Marrow Transplant Research

Network

Collaborators

  • National Marrow Donor Program

Registry information

Official study title

A Multi-Center, Phase II Trial of HLA-Mismatched Unrelated Donor Bone Marrow Transplantation With Post-Transplantation Cyclophosphamide for Patients With Hematologic Malignancies

Important dates

Study start
2016
Primary completion
2020
Study completion
2020
First posted
Jun 8, 2016
Registry last updated
Aug 6, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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