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Allogeneic Transplant for Hematological Malignancy


N/A
N/A
55 Years
Open (Enrolling)
Both
Leukemia, Myeloid, Chronic, AML, Leukemia, Lymphocytic, Acute, MDS, Leukemia, Lymphocytic, Chronic, JMML, Hodgkin's Disease, Non-hodgkin's Lymphoma, Multiple Myeloma

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Trial Information

Allogeneic Transplant for Hematological Malignancy


Preparative regimen:

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.


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%.

- Creatinine < or = 2.0 mg/dl for adults; or clearance > 50 ml/min for children

- Bilirubin, AST, ALK < or = 2 x normal.

- Pulmonary function test > 50% of normal.

- Multi Gated Acquisition Scan (MUGA) > or = 45% ejection fraction.

- 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.

- Accelerated Phase: Patients with hematologic peripheral blood or bone marrow findings
meeting standard criteria for chronic myelocytic leukemia (CML), but who present with
or progress to express any of the following findings are considered as having
accelerated phase disease:

- Leukocytosis (WBC greater than 50x10^9/L) uncontrolled by single agent chemotherapy.

- Thrombocytosis (Platelet count greater than 1x10^10/L) uncontrolled by single agent
chemotherapy.

- Anemia (hemoglobin less than 8 grams/dl) uncontrolled by single agent therapy.

- Peripheral blood blast percentage between 5 and 30%, uncontrolled by single agent
chemotherapy.

- Cytogenetic abnormalities in addition to the Philadelphia chromosome at presentation,
or the development of new cytogenetic abnormalities in addition to the Philadelphia
chromosome during observation.

- Splenomegaly uncontrolled by single agent chemotherapy.

- Extramedullary disease.

- Severe, progressive myelofibrosis or osteosclerosis.

- Achievement of a "second chronic phase" after blast crisis.

- 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 will sign informed consent approved by the Committee on the Use
of Human Subjects at the University of Minnesota.

Type of Study:

Interventional

Study Design:

Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

Disease-Free Survival

Outcome Description:

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.

Outcome Time Frame:

Long-term (1 and 2 year)

Safety Issue:

No

Principal Investigator

Daniel Weisdorf, MD

Investigator Role:

Principal Investigator

Investigator Affiliation:

Masonic Cancer Center, University of Minnesota

Authority:

United States: Institutional Review Board

Study ID:

2001LS049

NCT ID:

NCT00176930

Start Date:

August 2001

Completion Date:

December 2016

Related Keywords:

  • Leukemia, Myeloid, Chronic
  • AML
  • Leukemia, Lymphocytic, Acute
  • MDS
  • Leukemia, Lymphocytic, Chronic
  • JMML
  • Hodgkin's Disease
  • Non-Hodgkin's Lymphoma
  • Multiple Myeloma
  • stem cell transplant
  • chronic leukemia
  • acute leukemia
  • irradiation
  • chemotherapy
  • Neoplasms
  • Hodgkin Disease
  • Leukemia
  • Leukemia, Lymphocytic, Chronic, B-Cell
  • Leukemia, Lymphoid
  • Precursor Cell Lymphoblastic Leukemia-Lymphoma
  • Leukemia, Myeloid
  • Leukemia, Myelogenous, Chronic, BCR-ABL Positive
  • Lymphoma
  • Lymphoma, Non-Hodgkin
  • Multiple Myeloma
  • Neoplasms, Plasma Cell
  • Hematologic Neoplasms

Name

Location

Masonic Cancer Center, University of MinnesotaMinneapolis, Minnesota  55455