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Reduced Intensity Conditioning Transplant Using Haploidentical Donors

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT02581007
Recruitment Status : Active, not recruiting
First Posted : October 20, 2015
Last Update Posted : February 25, 2020
Blood and Marrow Transplant Group of Georgia
Information provided by (Responsible Party):
Northside Hospital, Inc.

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.

Condition or disease Intervention/treatment Phase
Chronic Myelogenous Leukemia Acute Myelogenous Leukemia Myelodysplastic Syndrome Acute Lymphocytic Leukemia Chronic Lymphocytic Leukemia Hodgkin's Lymphoma Non-Hodgkin's Lymphoma Myelofibrosis CMML Multiple Myeloma Drug: Fludarabine Drug: Melphalan Drug: Cyclophosphamide Procedure: peripheral blood stem cell transplant Phase 2

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

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Study Type : Interventional  (Clinical Trial)
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 : October 26, 2015
Actual Primary Completion Date : November 5, 2019
Estimated Study Completion Date : May 31, 2020

Arm Intervention/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 Name: Fludara

Drug: Melphalan
Other Name: 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 Name: Cytoxan

Procedure: peripheral blood stem cell transplant
Other Name: HSCT

Primary Outcome Measures :
  1. Graft Rejection [ Time Frame: 100 days ]

Secondary Outcome Measures :
  1. Overall Survival [ Time Frame: 100 days ]
  2. Overall survival [ Time Frame: 1 year ]
  3. Relapse incidence [ Time Frame: 100 days ]
  4. Relapse incidence [ Time Frame: 1 year ]
  5. GVHD incidence [ Time Frame: 100 days ]
  6. GVHD incidence [ Time Frame: 1 year ]

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 75 Years   (Adult, Older Adult)
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT02581007

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United States, Georgia
Northside Hospital
Atlanta, Georgia, United States, 30342
Sponsors and Collaborators
Northside Hospital, Inc.
Blood and Marrow Transplant Group of Georgia
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Principal Investigator: Melhem Solh, MD Northside Hospital
Publications of Results:
Other Publications:

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Responsible Party: Northside Hospital, Inc. Identifier: NCT02581007    
Other Study ID Numbers: NSH 1132
First Posted: October 20, 2015    Key Record Dates
Last Update Posted: February 25, 2020
Last Verified: May 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Keywords provided by Northside Hospital, Inc.:
Additional relevant MeSH terms:
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Leukemia, Myeloid, Acute
Multiple Myeloma
Leukemia, Lymphoid
Leukemia, Lymphocytic, Chronic, B-Cell
Leukemia, Myeloid
Leukemia, Myelogenous, Chronic, BCR-ABL Positive
Precursor Cell Lymphoblastic Leukemia-Lymphoma
Myelodysplastic Syndromes
Neoplasms by Histologic Type
Lymphoproliferative Disorders
Lymphatic Diseases
Immunoproliferative Disorders
Immune System Diseases
Neoplasms, Plasma Cell
Hemostatic Disorders
Vascular Diseases
Cardiovascular Diseases
Blood Protein Disorders
Hematologic Diseases
Hemorrhagic Disorders
Bone Marrow Diseases
Leukemia, B-Cell
Myeloproliferative Disorders