Stem Cell Transplant for Hematological Malignancy

This study is currently recruiting participants. (see Contacts and Locations)
Verified May 2014 by Masonic Cancer Center, University of Minnesota
Sponsor:
Information provided by (Responsible Party):
Masonic Cancer Center, University of Minnesota
ClinicalTrials.gov Identifier:
NCT00176930
First received: September 12, 2005
Last updated: May 15, 2014
Last verified: May 2014
  Purpose

The purpose of this study is to develop a standard of care treatment using allogeneic stem cells for patients with cancers of the blood.

The protocol was revised to reflect that this study is considered "treatment guidelines", rather than a research study.


Condition Intervention
Leukemia, Myeloid, Chronic
AML
Leukemia, Lymphocytic, Acute
MDS
Leukemia, Lymphocytic, Chronic
JMML
Hodgkin's Disease
Non-hodgkin's Lymphoma
Multiple Myeloma
Procedure: Stem Cell Transplant
Drug: Cyclophosphamide
Radiation: Total Body Irradiation
Drug: Busulfan

Study Type: Interventional
Study Design: Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Allogeneic Transplant for Hematological Malignancy

Resource links provided by NLM:


Further study details as provided by Masonic Cancer Center, University of Minnesota:

Primary Outcome Measures:
  • Disease-Free Survival [ Time Frame: Long-term (1 and 2 year) ] [ Designated as safety issue: No ]
    is the length of time during and after medication or treatment during which the disease being treated (usually cancer) does not get worse. It is sometimes used as a metric to study the health of a person with a disease to try to determine how well a new treatment is working.


Secondary Outcome Measures:
  • Time to Neutrophil 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.

  • Incidence of Acute Graft-Versus-Host Disease [ Time Frame: Day 100 ] [ Designated as safety issue: No ]
    Acute Graft-Versus-Host Disease (aGVHD) is a severe short-term complication created by infusion of donor cells into a foreign host.

  • Incidence of Chronic GVHD [ Time Frame: After Day 100 ] [ Designated as safety issue: No ]
    Chronic Graft-Versus-Host Disease is a severe long-term complication created by infusion of donor cells into a foreign host.

  • Persistence or relapse of malignancy [ Time Frame: 1 year ] [ Designated as safety issue: No ]
    Defined as the return of disease after its apparent recovery/cessation.

  • Overall Survival [ Time Frame: 1 year, 2 years ] [ 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, such as cancer.

  • Engraftment 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.


Estimated Enrollment: 350
Study Start Date: October 2001
Estimated Study Completion Date: December 2016
Estimated Primary Completion Date: December 2016 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Allogeneic stem cell transplant
Patients receiving cyclophosphamide and total body irradiation (TBI) and transplant, or cyclophosphamide, Busulfan and transplant.
Procedure: Stem Cell Transplant
Certain cancers can be treated by giving patients stem cells that come from someone else. This is called a stem-cell transplant. As part of the transplant process, patients receive high doses of chemotherapy and/or radiation to treat their underlying disease, such as cancer. As one of its effects, this treatment also kills the healthy stem cells that are already in the marrow. The transplant provides new stem cells for the patient from a healthy donor; that replace the bone marrow and allow the blood counts to recover. (Allowable sources of stem cells = related or unrelated bone marrow or peripheral blood, for Busulfan/cyclophosphamide/ATG preparative chemo only, umbilical cord blood is also permitted.)
Other Name: Bone Marrow Transplant.
Drug: Cyclophosphamide
60 mg/kg intravenously (IV) Days -6 and -5 or 50 mg/kg/day IV Days -5 through -2.
Other Name: Cytoxan
Radiation: Total Body Irradiation
On Day -4, -3, -2, -1 total body irradiation is given twice daily.
Other Name: Radiation therapy
Drug: Busulfan
When not receiving total body irradiation, administered Days -9 through -6, 0.8 mg/kg/dose by intravenous dosing every 6 hours.
Other Names:
  • Busulfex
  • Myleran

Detailed Description:

Preparative regimen using total body irradiation (TBI) and cyclophosphamide:

  1. on day -6 and -5: cyclophosphamide is given,
  2. on day -4, -3, -2, and -1: TBI is given,
  3. on day 0: stem cell or bone marrow is infused.

Alternate preparative therapy for patients not able to receive TBI

The chemotherapy (cyclophosphamide and busulfan) is given with the intent of destroying the bone marrow, eliminating any cancerous and preparing for the transplant of the donor's blood stem cells by suppressing the immune system.

l. Ten days before the transplant (Day 10), subjects will be admitted to the bone marrow transplant unit and placed in isolation to reduce exposure to infections. Isolation will be continued until adequate numbers of cells are present in the blood to fight infection.

2. On day -9, -8, -7, -6 busulfan is given.

3. On day -5, -4, -3, -2 cyclophosphamide is given.

4. On day -1 no therapy is given (day of rest).

5. On day 0 the donor stem cells are given intravenously. Additional cells may be given on day +1 or 2 as needed.

Transplant:

Subjects will be admitted to the bone marrow transplant unit and put in isolation to reduce exposure to infectious agents. During this time, they will receive the preparative treatment outlined above. Once they have received the preparative regimen, stem cells will be obtained from the donor and given intravenously.

The new stem cells will replace the bone marrow that was damaged by the treatment for the cancer.

Isolation will be continued until adequate numbers of cells are present in the blood to fight infection. Subjects will then be transferred from the bone marrow transplant unit and discharged from the hospital when medically ready. Subjects will be expected to return for follow-up to the bone marrow transplant clinic at specific dates as determined by their physician.

  Eligibility

Ages Eligible for Study:   up to 55 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Donor will be <75 years of age and in good health.
  • Recipients will be < or = 55 years, will have normal organ function (excluding bone marrow) and will have a Karnofsky activity assessment > or = 90%.
  • Recipients with related or unrelated donor matched at the HLA A, B, DRB1 loci, or mismatched related or unrelated (if < 35 years old) at a single HLA A, B, DRB1 locus.
  • Recipients will be eligible in one of the following disease categories
  • Chronic myelogenous leukemia in accelerated phase or in post blast crisis second or greater chronic phase; or in chronic phase but intolerant of or resistant to tyrosine kinase inhibitors.
  • Acute myelocytic leukemia in first or greater remission, or first, second or third relapse.
  • Acute lymphocytic leukemia in the 2nd or greater bone marrow remission.
  • High risk children will be transplanted in first remission if they meet criteria
  • Myelodysplastic syndrome.
  • Myeloproliferative Diseases - (i.e. myelofibrosis, chronic myelomonocytic leukemia (CMML))
  • Juvenile myelomonocytic leukemia
  • Chronic lymphocytic leukemia
  • Advanced non-Hodgkin's (NHL).
  • Advanced Hodgkin's disease beyond PR2 (> CR3, > PR3).
  • Multiple Myeloma after initial therapy.
  • Donors and recipients signed informed consent

Exclusion Criteria

donors and recipients should meet the following test criteria.

  • required for donors:

    • anti-HIV, Hepatitis B, surface antigen, anti-HCV, CMV, HSV, EBV serologies, pre-priming.
    • CBC, platelet count each day of apheresis, day 0 (or 1 or 2 as needed)
  • required for recipients:

    • anti-HIV, Hepatitis B, surface antigen, anti-HCV, CMV, HSV, EBV serologies, pre-transplant.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00176930

Contacts
Contact: Timothy Krepski 612-273-2800 tkrepski1@fairview.org

Locations
United States, Minnesota
Masonic Cancer Center, University of Minnesota Recruiting
Minneapolis, Minnesota, United States, 55455
Contact: Daniel Weisdorf, MD    612-624-3101    weisd001@umn.edu   
Sponsors and Collaborators
Masonic Cancer Center, University of Minnesota
Investigators
Principal Investigator: Daniel Weisdorf, MD Masonic Cancer Center, University of Minnesota
  More Information

No publications provided

Responsible Party: Masonic Cancer Center, University of Minnesota
ClinicalTrials.gov Identifier: NCT00176930     History of Changes
Obsolete Identifiers: NCT00393133
Other Study ID Numbers: 2001LS049, MT2001-02, 0107M05202
Study First Received: September 12, 2005
Last Updated: May 15, 2014
Health Authority: United States: Institutional Review Board

Keywords provided by Masonic Cancer Center, University of Minnesota:
stem cell transplant
chronic leukemia
acute leukemia
irradiation
chemotherapy

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

ClinicalTrials.gov processed this record on August 25, 2014