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Stem Cell Transplant for Hematological Malignancy

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.
 
ClinicalTrials.gov Identifier: NCT00176930
Recruitment Status : Terminated (replaced my another study ; Trial re-written as MT2015-29)
First Posted : September 15, 2005
Last Update Posted : January 9, 2020
Sponsor:
Information provided by (Responsible Party):
Masonic Cancer Center, University of Minnesota

Tracking Information
First Submitted Date  ICMJE September 12, 2005
First Posted Date  ICMJE September 15, 2005
Last Update Posted Date January 9, 2020
Actual Study Start Date  ICMJE October 2001
Actual Primary Completion Date December 2019   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: July 10, 2012)
Disease-Free Survival [ Time Frame: Long-term (1 and 2 year) ]
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.
Original Primary Outcome Measures  ICMJE
 (submitted: September 12, 2005)
engraftment failure, time to engraftment, incidence and severity of acute and chronic GVHD, persistence or relapse of malignancy and survival of the recipient.
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: July 10, 2012)
  • Time to Neutrophil Engraftment [ Time Frame: Day 42 ]
    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 ]
    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 ]
    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 ]
    Defined as the return of disease after its apparent recovery/cessation.
  • Overall Survival [ Time Frame: 1 year, 2 years ]
    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 ]
    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.
Original Secondary Outcome Measures  ICMJE Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Stem Cell Transplant for Hematological Malignancy
Official Title  ICMJE Allogeneic Transplant for Hematological Malignancy
Brief Summary

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.

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.

Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE
  • Leukemia, Myeloid, Chronic
  • AML
  • Leukemia, Lymphocytic, Acute
  • MDS
  • Leukemia, Lymphocytic, Chronic
  • JMML
  • Hodgkin's Disease
  • Non-hodgkin's Lymphoma
  • Multiple Myeloma
Intervention  ICMJE
  • 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
Study Arms  ICMJE Experimental: Allogeneic stem cell transplant
Patients receiving cyclophosphamide and total body irradiation (TBI) and transplant, or cyclophosphamide, Busulfan and transplant.
Interventions:
  • Procedure: Stem Cell Transplant
  • Drug: Cyclophosphamide
  • Radiation: Total Body Irradiation
  • Drug: Busulfan
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Terminated
Actual Enrollment  ICMJE
 (submitted: January 6, 2020)
330
Original Enrollment  ICMJE
 (submitted: September 12, 2005)
200
Actual Study Completion Date  ICMJE December 2019
Actual Primary Completion Date December 2019   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE up to 55 Years   (Child, Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT00176930
Other Study ID Numbers  ICMJE 2001LS049
MT2001-02 ( Other Identifier: Blood and Marrow Transplantation Program )
0107M05202 ( Other Identifier: IRB, University of Minnesota )
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Masonic Cancer Center, University of Minnesota
Study Sponsor  ICMJE Masonic Cancer Center, University of Minnesota
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Daniel Weisdorf, MD Masonic Cancer Center, University of Minnesota
PRS Account Masonic Cancer Center, University of Minnesota
Verification Date January 2019

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