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Trial record 1 of 1 for:    NCT02581007
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RIC Transplant Using Haplo Donors

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ClinicalTrials.gov Identifier: NCT02581007
Recruitment Status : Recruiting
First Posted : October 20, 2015
Last Update Posted : June 29, 2018
Sponsor:
Collaborator:
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.

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 30 participants
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
Study Start Date : November 2015
Estimated Primary Completion Date : October 2018
Estimated Study Completion Date : December 2019


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 ]


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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
Criteria

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 ClinicalTrials.gov identifier (NCT number): NCT02581007


Contacts
Contact: Melhem Solh, MD 404-255-1930 msolh@bmtga.com
Contact: Stacey Brown 404-851-8238 stacey.brown@Northside.com

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

Publications of Results:
Other Publications:

Responsible Party: Northside Hospital, Inc.
ClinicalTrials.gov Identifier: NCT02581007     History of Changes
Other Study ID Numbers: NSH 1132
First Posted: October 20, 2015    Key Record Dates
Last Update Posted: June 29, 2018
Last Verified: March 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Keywords provided by Northside Hospital, Inc.:
CML
AML
MDS
ALL
CLL/CPL
HD
NHL
MPS
CMML
MM

Additional relevant MeSH terms:
Lymphoma
Leukemia
Multiple Myeloma
Myelodysplastic Syndromes
Preleukemia
Lymphoma, Non-Hodgkin
Leukemia, Lymphoid
Leukemia, Lymphocytic, Chronic, B-Cell
Leukemia, Myeloid
Hodgkin Disease
Leukemia, Myelogenous, Chronic, BCR-ABL Positive
Primary Myelofibrosis
Leukemia, Myeloid, Acute
Precursor Cell Lymphoblastic Leukemia-Lymphoma
Neoplasms by Histologic Type
Neoplasms
Lymphoproliferative Disorders
Lymphatic Diseases
Immunoproliferative Disorders
Immune System Diseases
Neoplasms, Plasma Cell
Hemostatic Disorders
Vascular Diseases
Cardiovascular Diseases
Paraproteinemias
Blood Protein Disorders
Hematologic Diseases
Hemorrhagic Disorders
Bone Marrow Diseases
Precancerous Conditions