Second or Greater Allogeneic Hematopoietic Stem Cell Transplant Using Reduced Intensity Conditioning (RIC)

This study is currently recruiting participants.
Verified October 2013 by Masonic Cancer Center, University of Minnesota
Sponsor:
Information provided by (Responsible Party):
Masonic Cancer Center, University of Minnesota
ClinicalTrials.gov Identifier:
NCT01666080
First received: July 31, 2012
Last updated: October 9, 2013
Last verified: October 2013

July 31, 2012
October 9, 2013
August 2012
December 2015   (final data collection date for primary outcome measure)
Time to Engraftment [ Time Frame: Day 42 ] [ Designated as safety issue: No ]
Neutrophil engraftment is defined as the first day of three consecutive days where the neutrophil count (absolute neutrophil count) is 500 cells/mm3 (0.5 x 109/L) or greater.
Same as current
Complete list of historical versions of study NCT01666080 on ClinicalTrials.gov Archive Site
  • Incidence of Graft Failure [ Time Frame: Day 42 ] [ Designated as safety issue: No ]
    Graft failure is defined as not accepting donated cells. The donated cells do not make the new white blood cells, red blood cells and platelets.
  • Status of Donor Chimerism [ Time Frame: Day 100, 6 Months, 1 Year ] [ Designated as safety issue: No ]
    A state in bone marrow transplantation in which donor hematopoietic cells and host cells exist compatibly without signs of rejection.
  • Incidence of Acute Graft-Versus-Host Disease (GVHD) [ Time Frame: Day 100 ] [ Designated as safety issue: Yes ]
    Acute Graft-Versus-Host Disease is a severe short-term complication created by infusion of donor cells into a foreign host.
  • Change in Incidence of Chronic Graft-Versus-Host Disease (GVHD) [ Time Frame: 6 Months, 1 Year ] [ Designated as safety issue: Yes ]
    Chronic Graft-Versus-Host Disease is a severe long-term complication created by infusion of donor cells into a foreign host.
  • Incidence of Transplant Related Mortality [ Time Frame: 6 Months ] [ Designated as safety issue: Yes ]
    In the field of transplantation, toxicity is high and all deaths without previous relapse or progression are usually considered as related to transplantation.
  • Incidence of Overall Survival [ Time Frame: 6 Months ] [ Designated as safety issue: No ]

    The percentage of people in a study or treatment group who are alive for a certain period of time after they were diagnosed with or treated for a disease. Also called survival rate.

    Overall survival will be defined as time from date of enrollment to date of death or censored at the date of last documented contact for patients still alive.

  • Incidence of Graft Failure [ Time Frame: Day 42 ] [ Designated as safety issue: No ]
    Graft failure is defined as not accepting donated cells. The donated cells do not make the new white blood cells, red blood cells and platelets.
  • Status of Donor Chimerism [ Time Frame: Day 100, 6 Months, 1 Year ] [ Designated as safety issue: No ]
    A state in bone marrow transplantation in which bone marrow and host cells exist compatibly without signs of graft-versus-host rejection disease.
  • Incidence of Acute Graft-Versus-Host Disease (GVHD) [ Time Frame: Day 100 ] [ Designated as safety issue: Yes ]
    Acute Graft-Versus-Host Disease is a severe short-term complication created by infusion of donor cells into a foreign host.
  • Change in Incidence of Chronic Graft-Versus-Host Disease (GVHD) [ Time Frame: 6 Months, 1 Year ] [ Designated as safety issue: Yes ]
    Chronic Graft-Versus-Host Disease is a severe long-term complication created by infusion of donor cells into a foreign host.
  • Incidence of Transplant Related Mortality [ Time Frame: 6 Months ] [ Designated as safety issue: Yes ]
    In the field of transplantation, toxicity is high and all deaths without previous relapse or progression are usually considered as related to transplantation.
  • Incidence of Overall Survival [ Time Frame: 6 Months ] [ Designated as safety issue: No ]

    The percentage of people in a study or treatment group who are alive for a certain period of time after they were diagnosed with or treated for a disease. Also called survival rate.

    Overall survival will be defined as time from date of enrollment to date of death or censored at the date of last documented contact for patients still alive.

Not Provided
Not Provided
 
Second or Greater Allogeneic Hematopoietic Stem Cell Transplant Using Reduced Intensity Conditioning (RIC)
Second or Greater Allogeneic Hematopoietic Stem Cell Transplant Using Reduced Intensity Conditioning (RIC)

This is a treatment guideline for a second or greater allogeneic hematopoietic stem cell transplant (HSCT) using a reduced intensity conditioning (RIC) in patients with non-malignant or malignant diseases. This regimen, consisting of busulfan, fludarabine, and low dose total body irradiation (TBI), is designed to promote engraftment in patients who failed to achieve an acceptable level of donor-derived engraftment following a previous allogeneic HCT.

There is no research element except the collection of routine clinical data. Patients will consent to allow routine clinical data to be collected and maintained in OnCore, the Masonic Cancer Center's (MCC) clinical database, and specific transplant related endpoints in the University Of Minnesota Blood and Bone Marrow Database as part of the historical database maintained by the department.

Interventional
Not Provided
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
  • Hematologic Disorders
  • Hemoglobinopathies
  • Immunodeficiencies
  • Inherited Metabolic Disorders
  • Drug: Busulfan
    0.4 mg/kg (0.5 mg/kg if <4 years of age) intravenously (IV) every 6 hours on Days -8 and -7.
  • Drug: Fludarabine
    40 mg/m^2 intravenously (IV) over 1 hour on days -6 through -2.
    Other Name: Fludara
  • Radiation: Total body irradiation
    200 cGy on Day -1
  • Biological: Stem cell transplant
    stem cell infusion on day 0
  • Drug: Keppra
    Keppra will be given for seizure prophylaxis during busulfan administration as per the standard institutional protocol.
Patients Receiving Reduced Intensity Conditioning
Includes patients receiving a second or greater allogeneic hematopoietic stem cell transplant (HSCT) using reduced intensity conditioning (RIC). Patients will receive busulfan, fludarabine, total body irradiation and stem cell transplant. Keppra will be given for seizure prophylaxis.
Interventions:
  • Drug: Busulfan
  • Drug: Fludarabine
  • Radiation: Total body irradiation
  • Biological: Stem cell transplant
  • Drug: Keppra
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
30
December 2015
December 2015   (final data collection date for primary outcome measure)

Inclusion Criteria:

  • Diagnosis of any disease for which a second or greater hematopoietic stem cell transplant is needed due to insufficient donor chimerism following hematopoietic recovery after previous HSCT. Determination of "insufficiency of donor chimerism" will be made by the treating transplant physician. Occasionally donor derived engraftment may be present, but sustained aplasia or failed recovery of sufficient hematopoiesis requires administration of a second graft. This intervention may be used for both situations.
  • Donor Availability: Patients considered for transplantation must have a sufficient graft as based on current criteria of the University of Minnesota Blood and Marrow Transplantation Program

    • Transplantation using sufficiently matched related donors (such as matched siblings) or unrelated donors will be considered. Both granulocyte-colony stimulating factor (GCSF) stimulated peripheral blood grafts and bone marrow grafts will be considered, although bone marrow will be the priority.
    • Cord blood grafts, both related and unrelated, are also eligible. As this protocol will use a reduced intensity regimen, this protocol will use the current recommendations of the University of Minnesota for choosing cord blood grafts. If a single cord blood unit cell dose is insufficient, double cord transplantation should be considered if sufficiently matched cord blood units are available. The priority of choosing cord blood donors is based on the current institutional recommendations.
    • Exclusion of Metabolic Disorder or other Inherited Disorder Carrier Status from related donor and unrelated cord blood grafts as appropriate for primary disease.

At the discretion of the treating transplant physician, an allograft from the previous donor may be used, if available.

  • Age, Performance Status, Consent

    • Age: 0 to 55 years
    • Consent: voluntary written consent (adult or parental/guardian)

Exclusion Criteria:

  • Previous irradiation that precludes the safe administration of an additional dose of 200 cGy of total body irradiation (TBI). Radiation Oncology will evaluate all patients who have had previous radiation therapy or TBI for approval to receive an additional 200 cGy of TBI
  • Pregnant or breastfeeding
  • Active, uncontrolled infection - infection that is stable or improving after 1 week of appropriate therapy (4 weeks for presumed or documented fungal infections) will be permitted
  • HIV positive
  • While it would be advantageous to begin therapy on this second transplant regimen > 6 months following a prior myeloablative regimen or >2 months after a reduced intensity regimen, it is recognized that there are circumstances where this may not be practical.
Both
up to 55 Years
No
Contact: Weston P. Miller, M.D. 612-625-2508 mill4991@umn.edu
Contact: Teresa Kvisto, RN 612-273-2924 tkivis1@fairview.org
United States
 
NCT01666080
2012OC065, MT2012-11C
No
Masonic Cancer Center, University of Minnesota
Masonic Cancer Center, University of Minnesota
Not Provided
Principal Investigator: Weston P. Miller, M.D. Masonic Cancer Center, University of Minnesota
Masonic Cancer Center, University of Minnesota
October 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP