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Completed

NCT Number: NCT02581007

Reduced Intensity Conditioning Transplant Using Haploidentical Donors

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.

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Key information

About this study

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

Who can participate

Healthy volunteers accepted: No

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

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:
  • 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
  • Acute Myelogenous Leukemia in first or greater remission
  • 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
  • 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
  • Chronic Lymphocytic Leukemia/Prolymphocytic Leukemia: previously treated disease that has either relapsed or failed to respond adequately to conventional-dose therapy including purine analogs
  • 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
  • Myeloproliferative diseases (myelofibrosis, CMML)
  • 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

Treatment and study plan

Fludarabine

Drug

fludarabine (30mg/m2) given every day starting on Day -6 through Day -2;

Other names: Fludara

melphalan

Drug

Other names: melphalan (140mg/m2) given one time on Day -1.

Cyclophosphamide

Drug

cyclophosphamide (50mg/kg) given every day starting on Day 3 through Day 4.

Other names: Cytoxan

Peripheral Blood Stem Cell Transplant

Procedure

Other names: HSCT

Primary outcomes

  1. Graft Rejection

    Time frame: 100 days

    Measurement of donor cells vs. recipient cells

Secondary outcomes

  1. Overall Survival

    Time frame: 2 years

    Number of participants still alive 2 years after transplant

  2. Relapse Incidence

    Time frame: 2 years

    Number of patients with disease reoccurrence at 1 and 2 years post-transplant

  3. GVHD Incidence

    Time frame: 100 days

    The number of participants that developed graft-versus-host-disease before or at 100 days after transplant

Sponsors and collaborators

Lead sponsor

Northside Hospital, Inc.

Other

Collaborators

  • Blood and Marrow Transplant Group of Georgia

Registry information

Official study title

Reduced Intensity Conditioning and Transplantation of Partially HLA-Mismatched Peripheral Blood Stem Cells for Patients With Hematologic Malignancies

Important dates

Study start
2015
Primary completion
2019
Study completion
2020
First posted
Oct 20, 2015
Registry last updated
Apr 27, 2023

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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