NCT03314974

Brief Summary

This is a Phase II study of allogeneic hematopoietic stem cell transplant (HCT) using a myeloablative preparative regimen (of either total body irradiation (TBI); or, fludarabine/busulfan for patients unable to receive further radiation). followed by a post-transplant graft-versus-host disease (GVHD) prophylaxis regimen of post-transplant cyclophosphamide (PTCy), tacrolimus (Tac), and mycophenolate mofetil (MMF).

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
300

participants targeted

Target at P75+ for phase_2

Timeline
12mo left

Started Mar 2018

Longer than P75 for phase_2

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress89%
Mar 2018Jun 2027

First Submitted

Initial submission to the registry

October 16, 2017

Completed
3 days until next milestone

First Posted

Study publicly available on registry

October 19, 2017

Completed
5 months until next milestone

Study Start

First participant enrolled

March 30, 2018

Completed
8.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 10, 2026

Completed
1 year until next milestone

Study Completion

Last participant's last visit for all outcomes

June 10, 2027

Expected
Last Updated

June 24, 2025

Status Verified

June 1, 2025

Enrollment Period

8.2 years

First QC Date

October 16, 2017

Last Update Submit

June 23, 2025

Conditions

Acute LeukemiaAcute Myeloid LeukemiaAcute Lymphoblastic LeukemiaLymphomaChronic Myelogenous LeukemiaPlasma Cell LeukemiaMyeloproliferative NeoplasmsMyelofibrosisMyelodysplasiaRefractory AnemiaHigh Risk AnemiaChronic Lymphocytic LeukemiaSmall Lymphocytic LymphomaMarginal Zone B-Cell LymphomaFollicular LymphomaLymphoplasmacytic LymphomaMantle-Cell LymphomaProlymphocytic LeukemiaDiffuse Large Cell Non Hodgkins LymphomaLymphoblastic LymphomaBurkitt LymphomaHigh Grade Non-Hodgkin's Lymphoma, AdultMultiple MyelomaJuvenile Myelomonocytic LeukemiaBiphenotypic/Undifferentiated/Prolymphocytic LeukemiasMRD Positive LeukemiaNatural Killer Cell MalignanciesAcquired Bone Marrow Failure Syndromes

Keywords

AMLALLMDSNHLCLLCMLSLL

Outcome Measures

Primary Outcomes (1)

  • Chronic GVHD - 1 year

    Incidence of chronic GVHD

    1 year

Secondary Outcomes (11)

  • Grade II-IV acute GVHD

    Day +100

  • Chronic GVHD - 2 years

    2 years

  • Relapse

    2 years

  • Overall survival

    2 years

  • Treatment-related mortality

    2 years

  • +6 more secondary outcomes

Study Arms (2)

TBI Regimen

EXPERIMENTAL
Biological: HSCT with TBI Regimen

Non-TBI Regimen

EXPERIMENTAL
Biological: HSCT with Non-TBI Regimen

Interventions

HSCT with TBI RegimenBIOLOGICAL

Day -5 to -2: Total Body Irradiation Day 0: Hematopoietic Stem Cell Transplantation Day +3 to +4: Cyclophosphamide Day +5: Tacrolimus from day +5 until taper day +100 (day +60 for peds if no acute or chronic GVHD present) Day +5: Mycophenolate mofetil through day +35 or 7 days after engraftment, whichever day is later, if no acute GVHD

Also known as: Hematopoietic Stem Cell Transplantation
TBI Regimen
HSCT with Non-TBI RegimenBIOLOGICAL

Day -5 to Day -2: Busulfan and Fludaribine Day 0: Hematopoietic Stem Cell Transplantation Day +3 to +4: Cyclophosphamide Day +5: Tacrolimus from day +5 until taper day +100 (day +60 for peds if no acute or chronic GVHD present) Day +5: Mycophenolate mofetil through day +35 or 7 days after engraftment, whichever day is later, if no acute GVHD

Also known as: Hematopoietic Stem Cell Transplantation
Non-TBI Regimen

Eligibility Criteria

AgeUp to 60 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64)

You may qualify if:

  • Age: ≤ 60 years of age
  • Performance Status: Karnofsky ≥ 70%, Lansky play score ≥ 70
  • Consent: Voluntary written consent (adult or legally authorized representative; or parental/guardian)
  • Adequate Organ Function:
  • Renal: Creatinine \<2x upper limit of normal. Patients above this limit must have creatinine clearance ≥ 40 ml/min/1.73m2 as determined by an age-appropriate method, such as cystatin C GFR.
  • Hepatic: Bilirubin, AST, alkaline phosphatase \<4 times the upper limit of institutional normal
  • Pulmonary: Diffusion capacity of oxygen, corrected for hemoglobin, \> 50% of predicted. For pediatric patients not able to undergo PFTs or diffusion testing: O2 sat of \>95% on room air
  • Cardiac: Absence of decompensated congestive heart failure, or uncontrolled arrhythmia and left ventricular ejection fraction \> 45%. For children not able to cooperate with MUGA or echocardiography, such should be clearly stated in the physician's documentation
  • HIV Status: HIV infection with undetectable viral load. All HIV+ patients must be evaluated by Infectious Disease (ID) and a HIV management plan establish prior to transplantation
  • Women of child bearing potential and sexually active males with partners of child bearing potential must agree to use adequate birth control for the duration of treatment.
  • Donor Availability: Patients considered for transplantation must have a sufficient graft as based on current criteria of the University of Minnesota Blood and Marrow Transplantation Program
  • Eligible Diseases and Status: Patients are eligible unless their treatment is to be guided by a higher priority protocol.
  • Acute Leukemias: Must be in remission by morphology (≤5% blasts). Also a small percentage of blasts that is equivocal between marrow regeneration vs. early relapse are acceptable provided there are no associated cytogenetic markers consistent with relapse.
  • Acute Myeloid Leukemia (AML) and related precursor neoplasms: 2nd or greater complete remission (CR); first complete remission (CR1) in patients \> 60 years old; CR1 in ≤ 60 years old that is NOT considered as favorable-risk.
  • Favorable risk AML is defined as having one of the following:
  • +30 more criteria

You may not qualify if:

  • Chemotherapy refractory large cell and high grade NHL (i.e., progressive disease after \> 2 salvage regimens)
  • CML in blast crisis
  • Large cell lymphoma, mantle cell lymphoma and Hodgkin disease that is progressing on salvage therapy.
  • Active central nervous system malignancy
  • if ≤ 18 years old, prior myeloablative transplant within the last 6 months. If \>18 years old prior myeloablative allotransplant or autologous transplant
  • Active HIV infection or known HIV positive serology
  • active uncontrolled infection
  • Pregnant or breastfeeding. The agents used in this study include Pregnancy Category D: known to cause harm to a fetus. Females of childbearing potential must have a negative pregnancy test prior to starting therapy.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Masonic Cancer Center at University of Minnesota

Minneapolis, Minnesota, 55337, United States

RECRUITING

MeSH Terms

Conditions

Leukemia, Myeloid, AcutePrecursor Cell Lymphoblastic Leukemia-LymphomaLymphomaLeukemia, Myelogenous, Chronic, BCR-ABL PositiveLeukemia, Plasma CellMyeloproliferative DisordersPrimary MyelofibrosisAnemia, Refractory, with Excess of BlastsAnemia, RefractoryLeukemia, Lymphocytic, Chronic, B-CellLymphoma, B-Cell, Marginal ZoneLymphoma, FollicularLymphoma, Mantle-CellLeukemia, ProlymphocyticBurkitt LymphomaMultiple MyelomaLeukemia, Myelomonocytic, Juvenile

Interventions

Hematopoietic Stem Cell Transplantation

Condition Hierarchy (Ancestors)

Leukemia, MyeloidLeukemiaNeoplasms by Histologic TypeNeoplasmsHematologic DiseasesHemic and Lymphatic DiseasesLeukemia, LymphoidLymphoproliferative DisordersLymphatic DiseasesImmunoproliferative DisordersImmune System DiseasesBone Marrow DiseasesChronic DiseaseDisease AttributesPathologic ProcessesPathological Conditions, Signs and SymptomsNeoplasms, Plasma CellAnemiaMyelodysplastic SyndromesLeukemia, B-CellLymphoma, B-CellLymphoma, Non-HodgkinEpstein-Barr Virus InfectionsHerpesviridae InfectionsDNA Virus InfectionsVirus DiseasesInfectionsTumor Virus InfectionsHemostatic DisordersVascular DiseasesCardiovascular DiseasesParaproteinemiasBlood Protein DisordersHemorrhagic DisordersMyelodysplastic-Myeloproliferative Diseases

Intervention Hierarchy (Ancestors)

Stem Cell TransplantationCell TransplantationCell- and Tissue-Based TherapyBiological TherapyTherapeuticsTransplantationSurgical Procedures, Operative

Study Officials

  • Punita Grover, MD

    Masonic Cancer Center, University of Minnesota

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Tamy Grainger

CONTACT

(612)-273-2800tgraing1@fairview.org

Study Design

Study Type
interventional
Phase
phase 2
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

October 16, 2017

First Posted

October 19, 2017

Study Start

March 30, 2018

Primary Completion

June 10, 2026

Study Completion (Estimated)

June 10, 2027

Last Updated

June 24, 2025

Record last verified: 2025-06

Locations

US(1)