Reduced Intensity Conditioning Transplant Using Haploidentical Donors

Northside Hospital, Inc. (Other)
Overall Status
Completed ID
Blood and Marrow Transplant Group of Georgia (Other)
Actual Duration (Months)
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:
Actual Enrollment :
30 participants
Intervention Model:
Single Group Assignment
None (Open Label)
Primary Purpose:
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

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


    Ages Eligible for Study:
    18 Years to 75 Years
    Sexes Eligible for Study:
    Accepts Healthy Volunteers:
    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


    SiteCityStateCountryPostal Code
    1Northside HospitalAtlantaGeorgiaUnited States30342

    Sponsors and Collaborators

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


    • Principal Investigator: Melhem Solh, MD, Northside Hospital

    Study Documents (Full-Text)

    None provided.

    More Information


    Responsible Party:
    Northside Hospital, Inc. Identifier:
    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