Reduced Intensity Conditioning Transplant Using Haploidentical Donors

Sponsor
Northside Hospital, Inc. (Other)
Overall Status
Completed
CT.gov ID
NCT02581007
Collaborator
Blood and Marrow Transplant Group of Georgia (Other)
30
Enrollment
1
Location
1
Arm
62.1
Actual Duration (Months)
0.5
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

This trial will evaluate the safety and efficacy of a reduced intensity allogeneic HSCT from partially HLA-mismatched first-degree relatives utilizing PBSC as the stem cell source. The primary objective of the study is to estimate the incidence of graft rejection and acute GVHD. A secondary objective will be to estimate the incidence of the relapse, NRM, OS, chronic GVHD and EFS.

Detailed Description

Patients will receive a haploidentical transpalnt using a fludarabine melphalan prepartive regimen. Patients will get cyclophosphamide on days 3 & 4 post-transplant.

Study Design

Study Type:
Interventional
Actual Enrollment :
30 participants
Allocation:
N/A
Intervention Model:
Single Group Assignment
Masking:
None (Open Label)
Primary Purpose:
Treatment
Official Title:
Reduced Intensity Conditioning and Transplantation of Partially HLA-Mismatched Peripheral Blood Stem Cells for Patients With Hematologic Malignancies
Actual Study Start Date :
Oct 26, 2015
Actual Primary Completion Date :
Nov 5, 2019
Actual Study Completion Date :
Dec 28, 2020

Arms and Interventions

ArmIntervention/Treatment
Experimental: Reduced-Intensity Mismatched Transplant

Fludarabine, Melphalan & Post-transplant cyclophosphamide

Drug: Fludarabine
fludarabine (30mg/m2) given every day starting on Day -6 through Day -2;
Other Names:
  • Fludara
  • Drug: Melphalan
    Other Names:
  • melphalan (140mg/m2) given one time on Day -1.
  • Drug: Cyclophosphamide
    cyclophosphamide (50mg/kg) given every day starting on Day 3 through Day 4.
    Other Names:
  • Cytoxan
  • Procedure: peripheral blood stem cell transplant
    Other Names:
  • HSCT
  • Outcome Measures

    Primary Outcome Measures

    1. Graft Rejection [100 days]

    Secondary Outcome Measures

    1. Overall Survival [100 days]

    2. Overall survival [1 year]

    3. Relapse incidence [100 days]

    4. Relapse incidence [1 year]

    5. GVHD incidence [100 days]

    6. GVHD incidence [1 year]

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years to 75 Years
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    Inclusion Criteria:
    • No available matched related or unrelated donor, OR a matched related or unrelated donor will not be available in time frame necessary to perform potentially curative transplant

    • Availability of 3/6 - 5/6 matched (HLA-A, B, DR) related donor (donor must have negative HLA cross-match in host vs. graft direction)

    • Karnofsky status ≥70%

    • One of the following high-risk malignancies:

    1. Chronic Myelogenous Leukemia: Chronic myelogenous leukemia in chronic phase, resistant or intolerant to available tyrosine kinase inhibitors; Chronic myelogenous leukemia in accelerated phase; Chronic myelogenous leukemia with blast crisis that has entered into a second chronic phase following induction chemotherapy

    2. Acute Myelogenous Leukemia in first or greater remission

    3. Myelodysplastic Syndrome at least one of the following: treatment-related; monosmy 7, complex cytogenetics or other high risk karyotype; IPSS score of 1.0 or greater; neutropenia or cytopenia requiring transfusion not responding to therapy; peripheral or BM blast count of <10%; CMML

    4. Acute lymphocytic leukemia/lymphoblastic lymphoma: 2nd or subsequent complete remission; first complete remission; marrow blasts <5%, but persistence of minimal residual disease by flow cytometry, cytogenetics, or FISH

    5. Chronic Lymphocytic Leukemia/Prolymphocytic Leukemia: previously treated disease that has either relapsed or failed to respond adequately to conventional-dose therapy including purine analogs

    6. Hodgkin's or Non-Hodgkin's Lymphoma (including low-grade, mantle cell, and intermediate-grade/diffuse): previously treated disease that has either relapsed or failed to respond adequately to conventional-dose therapy or autologous transplantation

    7. Myeloproliferative diseases (myelofibrosis, CMML)

    8. Multiple Myeloma with relapse after a prior autologous transplant or eligible for allogeneic HSCT based on other risk factors

    Exclusion Criteria:
    • not be excluded on basis of sex, racial, or ethnic backgrounds

    • poor cardiac function: left ventricular ejection fraction <40%

    • poor pulmonary function: FEV1 and FVC <50% predicted

    • poor liver function: bilirubin >2 mg/dl (not due to hemolysis, Gilbert's or primary malignancy)

    • poor renal function: Creatinine >2.0mg/dl or creatinine clearance (calculated creatinine clearance is permitted) < 40 mL/min based on Traditional Cockcroft-Gault formula: 140 - age (yrs) x Smaller of Actual Weight vs. Ideal Body Weight (kg) / 72 x Serum creatinine (mg/dl)

    • HIV-positive

    • prior allogeneic transplant

    • women of childbearing potential who currently are pregnant or who are not practicing adequate contraception

    • any debilitating medical or psychiatric illness which would preclude their giving informed consent or their receiving optimal treatment and follow-up

    Contacts and Locations

    Locations

    SiteCityStateCountryPostal Code
    1Northside HospitalAtlantaGeorgiaUnited States30342

    Sponsors and Collaborators

    • Northside Hospital, Inc.
    • Blood and Marrow Transplant Group of Georgia

    Investigators

    • Principal Investigator: Melhem Solh, MD, Northside Hospital

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    Responsible Party:
    Northside Hospital, Inc.
    ClinicalTrials.gov Identifier:
    NCT02581007
    Other Study ID Numbers:
    • NSH 1132
    First Posted:
    Oct 20, 2015
    Last Update Posted:
    Aug 31, 2021
    Last Verified:
    Aug 1, 2021

    Study Results

    No Results Posted as of Aug 31, 2021