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Safety And Efficacy of Sub-Myeloablative Allogeneic Stem Cell Transplantation For Patients With Myeloproliferative Disorder (MPD), Myelodysplastic Syndrome (MDS), Acute Myelogenous Leukemia (AML) or Chronic Myelogenous Leukemia

Phase 2
Not Enrolling
Chronic Myeloproliferative Disorders, Leukemia, Myelodysplastic Syndromes

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Trial Information

Safety And Efficacy of Sub-Myeloablative Allogeneic Stem Cell Transplantation For Patients With Myeloproliferative Disorder (MPD), Myelodysplastic Syndrome (MDS), Acute Myelogenous Leukemia (AML) or Chronic Myelogenous Leukemia

We expect that the patient's participation in this study will last approximately 18 months
to 2 years.

Before treatment begins, they will be evaluated to confirm they meet the requirements of
this study. The evaluation includes HIV testing, HIV (Human Immunodeficiency Virus) is the
virus that causes Acquired Immune Deficiency Syndrome (AIDS). If the patient is HIV
positive, they will not be able to be treated on this protocol.

The patient will need to have a central line. This is a thin plastic catheter or tube that
is placed during surgery into one of the large veins in the chest or neck. Central lines are
used to give medications IV (intravenous, by vein) or to take blood samples without having
to endure frequent needle sticks.

After admission to the hospital the subject will receive:

Day -6: a single dose of total body irradiation

Day -5 to Day -2 Chemotherapy: Fludarabine plus Campath 1H through a catheter inserted into
a vein (IV)

Day -2: FK506 given IV over a 24 hour period until the patient can take medication by mouth.
When they can take oral medication they will take this medication by mouth every 12 hours.

Day -1 : a day of rest

Day 0: the stem cell transplant (infusion) will be given

Day +7: G-CSF will be given by subcutaneous injection until your white blood cells
(granulocytes) are greater than 1000/ul.

After transplantation, they will be evaluated as follows. Routine history, physical
examination, blood tests and radiology studies will be done as needed for clinical care.
Bone marrow aspirate and biopsy will be done on or about day 30, 60 and 100, 180 and then
yearly and as needed.

Inclusion Criteria


- Myelodysplastic syndrome with IPSS score > 0.(Appendix B) Or

- Myeloproliferative disorders

- Primary Myelofibrosis with Lile score of 1 or 2 (Appendix C)

- Polycythemia Vera or Essential Thrombocythemia transformed to AML or
Myelofibrosis and PV "spent phase" or

- Acute myelogenous leukemia or

- Chronic myelogenous leukemia

- Available Healthy Donor without any contraindications for donation. 5/6 or 6/6
related donor or 5/6 or 6/6 unrelated donor (molecular typing for DRB1)

- Able to give informed consent


- Patient is pregnant or lactating or unwilling to use contraceptives.

- HIV positive patient

- Uncontrolled intercurrent infection

- Unstable angina and uncompensated congestive heart failure (Zubrod of 3 or greater)

- Severe chronic pulmonary disease requiring oxygen (Zubrod of 3 or greater)

- Hemodialysis dependent.

- Active hepatitis or cirrhosis with total bilirubin, SGOT, and SGPT greater than 3 x

- Concurrent solid organ malignancy not in remission, except for Stage 0 or A prostate

- Unstable cerebral vascular disease or recent hemorrhagic stroke (less than 6 months)

- Active CNS disease from hematological disorder.

Type of Study:


Study Design:

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

Outcome Measure:

Day 100 Non-relapse mortality,

Outcome Description:

Safety and feasibility of submyeloablative conditioning as a preparative regimen for blood stem cell transplantation

Outcome Time Frame:

100 days

Safety Issue:


Principal Investigator

George Carrum, MD

Investigator Role:

Principal Investigator

Investigator Affiliation:

Baylor College of Medicine


United States: Food and Drug Administration

Study ID:




Start Date:

December 2001

Completion Date:

April 2007

Related Keywords:

  • Chronic Myeloproliferative Disorders
  • Leukemia
  • Myelodysplastic Syndromes
  • polycythemia vera
  • essential thrombocythemia
  • de novo myelodysplastic syndromes
  • previously treated myelodysplastic syndromes
  • secondary myelodysplastic syndromes
  • primary myelofibrosis
  • chronic myelogenous leukemia
  • adult acute myeloid leukemia with 11q23 (MLL) abnormalities
  • adult acute myeloid leukemia with inv(16)(p13;q22)
  • adult acute myeloid leukemia with t(15;17)(q22;q12)
  • adult acute myeloid leukemia with t(16;16)(p13;q22)
  • adult acute myeloid leukemia with t(8;21)(q22;q22)
  • childhood myelodysplastic syndromes
  • Leukemia
  • Leukemia, Myeloid, Acute
  • Leukemia, Myeloid
  • Leukemia, Myelogenous, Chronic, BCR-ABL Positive
  • Myelodysplastic Syndromes
  • Preleukemia
  • Myeloproliferative Disorders



Texas Children's Hospital Houston, Texas  
The Methodist Hospital Houston, Texas  77030