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CD-34 Selection for Ex-vivo T-Cell Depletion of Mobilized Peripheral Blood Stem Cells for Recipients of HLA Haploidentical Related Donor Stem Cell Grafts Receiving Intensive Conditioning


Phase 2
N/A
55 Years
Open (Enrolling)
Both
Acute Lymphoblastic Leukemia, Non Hodgkins Lymphoma, Myelodysplastic Syndrome, Acute Myeloid Leukemia, Chronic Myelogenous Leukemia, Hemophagocytic Lymphohistiocytosis (HLH), Familial Hemophagocytic Lymphohistiocytosis (FLH), Viral-associated Hemophagocytic Syndrome (VAHS), X-linked Lymphoproliferative Disease (XLP)

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Trial Information

CD-34 Selection for Ex-vivo T-Cell Depletion of Mobilized Peripheral Blood Stem Cells for Recipients of HLA Haploidentical Related Donor Stem Cell Grafts Receiving Intensive Conditioning


To participate in this study, the subject will need to have a central line (a thin plastic
catheter or tube that is placed during surgery into one of the large veins in the neck or
chest).

Also before treatment can begin, we will test the subject's blood for viruses which can
cause problems after the transplant.

Before treatment can begin, stem cells will be collected from the donor that has been
selected as the best match for the subject. White blood cells will be collected from the
donor. The cells will then be mixed with a special protein called a CD34 antibody that binds
to the stem cells which will then be separated out from the white blood cells by a special
machine called a CLINIMACs CD34 Reagent System in the laboratory. This is an investigational
and experimental device which is not approved by the FDA. Although this device is not
approved for use in this country, it has been in use for years and is approved in other
countries. The stem cells will be collected and frozen before we start to give chemotherapy.

TREATMENT PLAN

To prepare the subject's body for transplantation, the subject will be given high dose
chemotherapy (also called a conditioning treatment) for 8 days prior to the transplant as
follows:

The subject will be given a drug called Ara-C in high doses through the central line every
12 hours starting 8 days before transplant (called day - 8) until 5 days before transplant
(called day - 5). Starting one day after receiving the first Ara-C dose (day - 7), we will
add a drug called cyclophosphamide once a day to the treatment for the next two days. This
will be given in high doses (also through the central line). Also on day - 7, we will add a
drug called MESNA. MESNA is used to decrease the side effects caused by cyclophosphamide.
After the medication treatment is finished (day - 4), radiation treatment will be given to
the entire body twice a day for 4 days. The chemotherapy and radiation treatment will last 8
days. If the subject has abnormal cells in the spinal fluid, 6 extra daily doses of
radiation treatment may be given to the head. This would be done before any of the drugs are
given and before the subject is admitted for transplant.

NOTE: Depending on the subjects health status, the doctor may decide the subject should not
receive Ara-C. If this is a possibility, the doctor will discuss this with the subject.

On the second day of radiation (day -3), the subject will receive CAMPATH-1H as a daily
4-hour IV (intravenous, by vein). The subject will receive this infusion once a day for a
total of three days. CAMPATH 1H is a special type of protein called an antibody, that works
against certain types of blood cells. CAMPATH 1H is important because it stays active in the
body for a long time after infusion, which means it may work longer at preventing GVHD
symptoms.

The day after the radiation treatment is completed (day 0), the subject will receive the
specially selected donor stem cells. Once in the bloodstream, the cells will go to the bone
marrow and should begin to grow. If the subject is at risk for developing GVHD or if the
subject begins to develop GVHD, the doctor will prescribe medicines to help prevent or treat
this side effect. The doctor will describe these medicines at that time.

To learn more about the way the new cells are growing blood will be taken for research
purposes at approximately 3 months, 6 months, 9 months, and a year after the transplant. On
day 100, the subject will have the same tests/evaluations the subject has been experiencing
since the transplant, however, the subject will also have a bone marrow aspirate (we take a
sample of bone marrow to evaluate the disease and GVHD status). For patients who do not
develop GVHD, they may have an additional bone marrow aspirate on day 180 (about 2 months
after the previous one).

After day 365, the subject will be asked to return to the clinic once a year for
evaluations. These evaluations will be similar to the ones the subject had on day 100.

Inclusion Criteria


INCLUSION CRITERIA:

- Lack of suitable conventional donor (i.e. 5/6 or 6/6 related or 5/6 or 6/6 unrelated
donor) or presence of a rapidly progressive disease not permitting time to identify
an unrelated donor

- Age less than or equal to 55 years of age

- Patients with high risk ALL in CR1 or ALL or high grade (stage III or IV) NHL after
first relapse or with primary refractory disease or minimal residual diseases.

- Myelodysplastic syndrome

- Patients with high risk AML in CR1 (complement receptor 1) or after first relapse or
with primary refractory disease or minimal residual disease.

- CML

- Hemophagocytic lymphohistiocytosis (HLH), familial hemophagocytic lymphohistiocytosis
(FLH), viral-associated hemophagocytic syndrome (VAHS), X-linked lymphoproliferative
disease (XLP)

- Donor cells should be collected and frozen before conditioning starts

EXCLUSION CRITERIA:

- Patients with a life expectancy (< / = 6 weeks) limited by diseases other than
leukemia

- Patients with symptomatic cardiac disease, or evidence of significant cardiac disease
by echocardiogram (i.e., shortening fraction < 25%)

- Patients with severe renal disease (i.e., creatinine clearance less than 40 cc/1.73
m2)

- Patients with pre-existing severe restrictive pulmonary disease (FVC less than 40% of
predicted)

- Patients with severe hepatic disease (direct bilirubin greater than 3 ug/dl or SGPT
(serum glutamic-pyruvic transaminase) greater than 500 ug/dl)

- Patients with severe personality disorder or mental illness

- Patients with a severe infection that on evaluation by the Principal Investigator
precludes ablative chemotherapy or successful transplantation

- Patients with documented HIV positivity

'High risk' ALL or AML refers to those acute leukemias identified by the presence of
specific biologic features, which predict high likelihood of failure to conventional
chemotherapy. As biologic features of high risk disease evolve with improvement of
conventional chemotherapy, it is not practical to define this indication with any further
specificity. Therefore, high risk AML/ALL will be determined by the primary physician.

Type of Study:

Interventional

Study Design:

Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

Number of patients with severe acute GVHD

Outcome Time Frame:

100 days

Safety Issue:

Yes

Principal Investigator

Robert A. Krance, MD

Investigator Role:

Principal Investigator

Investigator Affiliation:

Baylor College of Medicine

Authority:

United States: Institutional Review Board

Study ID:

H-8701-MOHEL

NCT ID:

NCT00368355

Start Date:

April 2000

Completion Date:

December 2018

Related Keywords:

  • Acute Lymphoblastic Leukemia
  • Non Hodgkins Lymphoma
  • Myelodysplastic Syndrome
  • Acute Myeloid Leukemia
  • Chronic Myelogenous Leukemia
  • Hemophagocytic Lymphohistiocytosis (HLH)
  • Familial Hemophagocytic Lymphohistiocytosis (FLH)
  • Viral-associated Hemophagocytic Syndrome (VAHS)
  • X-linked Lymphoproliferative Disease (XLP)
  • haploidenticalstem cell transplant
  • acute lymphoblastic leukemia
  • Non Hodgkins Lymphoma
  • Myelodysplastic Syndrome
  • Acute myeloid leukemia
  • Chronic myelogenous leukemia
  • Hemophagocytic lymphohistiocytosis (HLH)
  • Familial hemophagocytic lymphohistiocytosis (FLH)
  • Viral-associated hemophagocytic syndrome (VAHS)
  • X-linked lymphoproliferative disease (XLP)
  • Leukemia
  • Leukemia, Lymphoid
  • Precursor Cell Lymphoblastic Leukemia-Lymphoma
  • Leukemia, Myeloid, Acute
  • Leukemia, Myeloid
  • Leukemia, Myelogenous, Chronic, BCR-ABL Positive
  • Lymphohistiocytosis, Hemophagocytic
  • Lymphoma
  • Lymphoma, Non-Hodgkin
  • Lymphoproliferative Disorders
  • Myelodysplastic Syndromes
  • Preleukemia

Name

Location

The Methodist HospitalHouston, Texas  77030
Texas Children's HosptialHouston, Texas  77030