NCT02145039

Brief Summary

This is a treatment guideline for HLA-Haploidentical hematopoietic stem cell transplant (HSCT) using a reduced intensity conditioning (RIC) regimen. This regimen, consisting of fludarabine, cyclophosphamide and low dose total body irradiation (TBI), is designed for the treatment of patients with advanced and/or high risk diseases.

Trial Health

57
Monitor

Trial Health Score

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

Enrollment
2

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Oct 2014

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
terminated

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

First Submitted

Initial submission to the registry

May 20, 2014

Completed
2 days until next milestone

First Posted

Study publicly available on registry

May 22, 2014

Completed
4 months until next milestone

Study Start

First participant enrolled

October 1, 2014

Completed
3.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2018

Completed
1 year until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2019

Completed
12 months until next milestone

Results Posted

Study results publicly available

December 26, 2019

Completed
Last Updated

December 26, 2019

Status Verified

December 1, 2019

Enrollment Period

3.3 years

First QC Date

May 20, 2014

Results QC Date

October 10, 2019

Last Update Submit

December 12, 2019

Conditions

Acute LeukemiasBurkitt's LymphomaChronic Myelogenous Leukemia

Keywords

Acute Lymphoblastic Leukemia (ALL)Acute Myelogenous Leukemia (AML)Burkitt's lymphomaNatural killer cell malignanciesChronic myelogenous leukemiaMyelodysplastic syndromeLarge-cell lymphomaHodgkin lymphomaMultiple myelomaChronic lymphocytic leukemia (CLL)Small lymphocytic lymphoma (SLL)Marginal zone B-cell lymphomaFollicular lymphomaLymphoplasmacytic lymphomaMantle-cell lymphomaProlymphocytic leukemiaRefractory leukemiaMyelodysplastic syndrome (MDS)Bone marrow failure syndromesMyeloproliferative syndromes

Outcome Measures

Primary Outcomes (1)

  • 2 Year Survival

    Percentage of patients that survive 2 years post-transplant

    2 years

Secondary Outcomes (5)

  • Number of Patients With Hematopoietic Engraftment

    42 days

  • Number of Patients With Chimerism

    100 days

  • Number of Patients Experiencing Acute Graft-versus-host Disease by 100 Days

    100 days

  • Number of Patients Experiencing Chronic Graft-versus-host Disease by 1 Year

    1 year

  • Number of Patients Experiencing Transplant Related Mortality (TRM)

    6 months

Study Arms (1)

Haploidentical stem cell transplant

EXPERIMENTAL

This is a treatment guideline for HLA-Haploidentical hematopoietic stem cell transplant (HSCT) using a reduced intensity conditioning (RIC) regimen. This regimen consists of fludarabine, cyclophosphamide and low dose total body irradiation (TBI).

Drug: FludarabineDrug: CyclophosphamideRadiation: Total Body IrradiationBiological: Haploidentical stem cell transplant

Interventions

FludarabineDRUG

Fludarabine 30 mg/m2 IV over 30-60 minutes on days -6 through -2 before transplant.

Also known as: Fludara
Haploidentical stem cell transplant
CyclophosphamideDRUG

Cyclophosphamide 14.5 mg/kg IV over 1-2 hours on days -6 and -5 before transplant and Cyclophosphamide 50 mg/kg IV on days 3 and 4 post-transplant.

Haploidentical stem cell transplant
Total Body IrradiationRADIATION

TBI 200cGy on day -1 before transplant.

Also known as: TBI
Haploidentical stem cell transplant
Haploidentical stem cell transplantBIOLOGICAL

Non-T-cell depleted bone marrow infusion

Also known as: HSCT
Haploidentical stem cell transplant

Eligibility Criteria

AgeUp to 74 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • Must be \<75 years old with no 7/8 or 8/8 HLA-matched sibling donor
  • One or more potential related mismatched donors (e.g. biologic parent (s) or siblings (full or half) or children). Low resolution using DNA based typing at HLA-A, -B and -DRB1 for potential haploidentical donors is required.
  • All diseases listed below are advanced hematologic malignancies not curable by conventional chemotherapy. Responses to conventional treatment range from zero to 30% but are typically short lived.
  • Acute Lymphoblastic Leukemia (ALL) in first complete remission (CR1) that is NOT considered favorable-risk.
  • Acute Myelogenous Leukemia (AML) in first complete remission (CR1) that is NOT considered as favorable-risk.
  • Acute Leukemias in 2nd or subsequent CR
  • Biphenotypic/Undifferentiated/Prolymphocytic Leukemias in first or subsequent CR, adult T-cell leukemia/lymphoma in first or subsequent CR
  • Burkitt's lymphoma in CR2 or subsequent CR
  • Natural killer cell malignancies after response to initial therapy
  • Chronic myelogenous leukemia: all types except refractory blast crisis.
  • Large-cell lymphoma, Hodgkin lymphoma and multiple myeloma with chemotherapy sensitive disease that has failed or patients who are ineligible for an autologous transplant.
  • Chronic lymphocytic leukemia/small lymphocytic lymphoma (CLL/SLL), marginal zone B-cell lymphoma, follicular lymphoma, which have progressed within 12 months of achieving a partial or complete remission.
  • Lymphoplasmacytic lymphoma, mantle-cell lymphoma, prolymphocytic leukemia are eligible after initial therapy if chemotherapy sensitive.
  • Refractory leukemia or MDS These patients may be taken to transplant in aplasia after induction or re-induction chemotherapy or radiolabeled antibody.
  • Bone marrow failure syndromes, except for Fanconi Anemia
  • +12 more criteria

You may not qualify if:

  • Available and clinically suitable 5-6/6 HLA-A, B, DRB1 matched sibling donor
  • Pregnant or breastfeeding
  • Evidence of HIV infection or known HIV positive serology
  • Current active serious infection
  • Unless in post-chemotherapy and radioimmunoconjugated antibody induced aplasia, when he/she would be eligible, patients with acute leukemia in morphologic relapse/ persistent disease defined as \> 5% blasts in normocellular bone marrow OR any % blasts if blasts have unique morphologic markers (e.g. Auer rods) or associated cytogenetic markers that allows morphologic relapse to be distinguished are not eligible.
  • Chronic myeloid leukemia (CML) in refractory blast crisis
  • Large cell lymphoma, mantle cell lymphoma and Hodgkin disease that is progressive on salvage therapy. Stable disease is acceptable to move forward provided it is non-bulky.
  • active central nervous system malignancy

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of Minnesota Masonic Cancer Center

Minneapolis, Minnesota, 55455, United States

Location

MeSH Terms

Conditions

Burkitt LymphomaLeukemia, Myelogenous, Chronic, BCR-ABL PositivePrecursor Cell Lymphoblastic Leukemia-LymphomaLeukemia, Myeloid, AcuteMyelodysplastic SyndromesDendritic Cell Sarcoma, InterdigitatingHodgkin DiseaseMultiple MyelomaLeukemia, Lymphocytic, Chronic, B-CellLymphoma, B-Cell, Marginal ZoneLymphoma, FollicularLymphoma, Mantle-CellLeukemia, ProlymphocyticLeukemiaBone Marrow Failure Disorders

Interventions

fludarabinefludarabine phosphateCyclophosphamideWhole-Body Irradiation

Condition Hierarchy (Ancestors)

Epstein-Barr Virus InfectionsHerpesviridae InfectionsDNA Virus InfectionsVirus DiseasesInfectionsTumor Virus InfectionsLymphoma, B-CellLymphoma, Non-HodgkinLymphomaNeoplasms by Histologic TypeNeoplasmsLymphoproliferative DisordersLymphatic DiseasesHemic and Lymphatic DiseasesImmunoproliferative DisordersImmune System DiseasesLeukemia, MyeloidMyeloproliferative DisordersBone Marrow DiseasesHematologic DiseasesChronic DiseaseDisease AttributesPathologic ProcessesPathological Conditions, Signs and SymptomsLeukemia, LymphoidHistiocytic Disorders, MalignantHistiocytosisNeoplasms, Plasma CellHemostatic DisordersVascular DiseasesCardiovascular DiseasesParaproteinemiasBlood Protein DisordersHemorrhagic DisordersLeukemia, B-Cell

Intervention Hierarchy (Ancestors)

Phosphoramide MustardsNitrogen Mustard CompoundsMustard CompoundsHydrocarbons, HalogenatedHydrocarbonsOrganic ChemicalsPhosphoramidesOrganophosphorus CompoundsRadiotherapyTherapeuticsInvestigative Techniques

Results Point of Contact

Title
Dr. Claudio Brunstein
Organization
University of Minnesota Cancer Center
bruns072@umn.edu
612-625-8942

Study Officials

  • Claudio Brunstein, MD

    University of Minnesota

    PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee
Yes

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

May 20, 2014

First Posted

May 22, 2014

Study Start

October 1, 2014

Primary Completion

January 1, 2018

Study Completion

January 1, 2019

Last Updated

December 26, 2019

Results First Posted

December 26, 2019

Record last verified: 2019-12

Locations

US(1)