T-Regulatory Cell Kinetics for Patients Receiving Alemtuzamb and Undergoing Stem Cell Transplantation From HLA Mismatched-Related, or HLA Matched, or One Antigen Mismatched-Unrelated Donors
N/A
N/A
Both
Leukemia, Hodgkin Lymphoma, Non Hodgkin Lymphoma, Myeloproliferative Disorders
Trial Information
T-Regulatory Cell Kinetics for Patients Receiving Alemtuzamb and Undergoing Stem Cell Transplantation From HLA Mismatched-Related, or HLA Matched, or One Antigen Mismatched-Unrelated Donors
To participate in this transplant, the patient will need to have a central line.
Before the transplant we will test the blood for viruses which can cause problems after the
transplant. These viruses include Hepatitis B, cytomegalovirus and HIV. If the patient is
positive for the AIDS virus, they will not be able to undertake the transplant.
Standard therapy: The patient will be given 6 doses of chemotherapy with a drug called Ara C
in high doses (every 12 hours) which will begin 8 days before the stem cell transplant.
Then, another chemotherapy drug called cyclophosphamide will be given in high doses by vein
for two days on the 7th and 6th days before the transplant. A drug called MESNA will be
given with cyclophosphamide. MESNA is used to decrease the side effects caused by
cyclophosphamide. The patient will also receive an antibody called Campath (each day for 4
days before the transplant) to help destroy the immune system so that there is less host
resistance to the growth of the donor cells. Radiation treatment will be given to the entire
body on each day for 4 days before transplant. This will be given 2 times a day for 4 days.
The chemotherapy and radiation treatment will last 8 days. If the patient has a diagnosis of
T-cell Lymphoma, they will not be given the Ara-C.
Extra bone marrow tests may be recommended by the physician to check on the patients
condition, especially if the marrow is slow to grow.
The day after the radiation treatment is completed; the patient will receive the healthy
stem cells by vein. Once in the bloodstream, these stem cells will go to the bone marrow and
should begin to grow.
In prevention of GvHD, the patient will also receive medicine called FK506 as well as low
dose methotrexate. The FK506 will be given intravenously initially starting 2 days before
the transplant and later by mouth (when they are able to take oral medications). This drug
will be given each day for several weeks. Four doses of low dose methotrexate will be given
intravenously. The methotrexate will be given on the day after the transplant, 3, 6 and 11
days after the transplant. If the GVHD cannot be controlled with FK506, other medicines may
need to be given. The doctor will describe these medicines at that time.
Blood samples for research: To study how these cells are working in the patients system,
blood samples will be taken each month for six months, at nine months, at one year, 2 years
and 3 years following transplant. Approximately 6-8 teaspoons of blood will be collected
each time. The total blood drawn for this study over three years should not exceed 1 and 3/4
cups. This amount is considered safe in adults. The amount of blood collected will be
decreased in children and/or in patients where this amount of blood collection would not be
appropriate.
Inclusion Criteria
INCLUSION CRITERIA:
- Patients with acute or chronic leukemia or advanced Hodgkin or non Hodgkin lymphoma
or myelodysplastic/myeloproliferative disease who are unlikely to be cured by
standard chemotherapy treatments. This includes patients who have relapsed after
standard chemotherapy treatments and patients in first remission with unfavorable
prognostic features.
- Using the standard 6 HLA antigen profile (HLA class I, A and B, and HLA class II,
DRB1) a patient must have either a one HLA antigen mismatched related donor or an HLA
matched or one antigen mismatched unrelated donor.
EXCLUSION CRITERIA:
- Patients with a life expectancy (less than or equal to 6 weeks) limited by disease
other than leukemia.
- Patients with symptomatic cardiac failure unrelieved by medical therapy or evidence
of significant cardiac dysfunction by echocardiogram (shortening fraction <20%).
- Patients with severe renal disease (i.e., creatinine greater than 3 times normal for
age).
- Patients with pre-existing severe restrictive pulmonary disease (FVC less than 40% of
predicted).
- Patients with severe hepatic disease (direct bilirubin greater than 3 mg/dl or AST
greater than 500 IU/L).
- Patients with severe personality disorder or mental illness.
- Patients with severe infection that in the estimation of the principal investigator
prohibits the use of ablative chemotherapy.
- Patients who are documented HIV positive.
- Patients with a Karnofsky performance score <70% or Lansky score <50%.
NOTE: Patients who would be excluded from treatment on this protocol strictly for
laboratory abnormalities can be included at the principal investigator's discretion after
consultation with the members of the SCT Policy and Procedures Committee.
Type of Study:
Interventional
Study Design:
Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Outcome Measure:
To define the biologic recovery and behavior of T reg cells for pts undergoing stem cell transplant
Outcome Time Frame:
3 years
Safety Issue:
No
Principal Investigator
Robert Krance, MD
Investigator Role:
Principal Investigator
Investigator Affiliation:
Baylor College of Medicine
Authority:
United States: Institutional Review Board
Study ID:
H-21079-REGALE
NCT ID:
NCT00578539
Start Date:
October 2007
Completion Date:
May 2013
Related Keywords:
- Leukemia
- Hodgkin Lymphoma
- Non Hodgkin Lymphoma
- Myeloproliferative Disorders
- Stem Cell Transplantation
- Hodgkin Disease
- Leukemia
- Lymphoma
- Lymphoma, Non-Hodgkin
- Myeloproliferative Disorders
Name | Location |
|---|---|
| Texas Children's Hospital | Houston, Texas |
