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NCT00368355 · REGISTRY CONDITION SEARCH

T Cell Depletion for Recipients of HLA Haploidentical Related Donor Stem Cell Grafts

Found through the registry condition index, not selected as a treatment recommendation. This discovery collection was restricted to studies with posted results.

Phase
PHASE2
Status at capture
COMPLETED
Registry last update
2020-01-21

Subjects are being asked to participate in this study because treatment of their disease requires them to receive a stem cell transplant. Stem cells or "mother" cells are the source of normal blood cells and lead to recovery of blood counts after bone marrow transplantation (BMT). Unfortunately, there is not a perfectly matched stem cell donor (like a sister or brother) and the subject's disease is considered rapidly progressive and does not permit enough time to identify another donor (like someone from a registry list that is not their relative). We have, however, identified a close relative of the subject's whose stem cells are not a perfect match, but can be used. However, with this type of donor, there is typically an increased risk of developing graft-versus-host disease (GVHD), a high rate of transplant failure, and a longer delay in the recovery of the immune system. GVHD is a serious and sometimes fatal side effect of stem cell transplant. GVHD occurs when the new donor cells (graft) recognizes that the body tissues of the patient (host) are different from those of the donor. When this happens, cells in the graft may attack the host organs, primarily the skin, liver, and intestines. The number of occurrences and harshness of severe GVHD depends on several factors, including the degree of genetic differences between the donor and recipient, the intensity of the pre-treatment conditioning regimen, the quantity of transplanted cells, and the recipient's age. In recipients of mismatched family member or matched unrelated donor stem cell transplants, there is a greater risk of GVHD so that 70-90% of recipients of unchanged marrow will develop severe GVHD which could include symptoms such as marked diarrhea, liver failure, or even death. In an effort to lower the occurrences and severity of graft-versus-host disease in patients and to lower the rate of transplant failure, we would like to specially treat the donor's blood cells to remove cells that are most likely to attack the patient's tissues. This will occur in combination with intense conditioning treatment that the patient will receive before the transplant.

Open the original ClinicalTrials.gov record → · Download preserved record

What did the study report?

Outcomes, safety and baseline populations are separate source sections. Quality-of-life measures appear under their original outcome titles.

flow

Participant flow

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baseline

Baseline characteristics

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outcome · POSTED

Engraftment Rate After Transplant

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outcome · POSTED

Early Post BMT Toxicities

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outcome · POSTED

Severe GVHD Rate

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outcome · POSTED

Patients With Acute GVHD

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outcome · POSTED

Patients With Chronic GVHD

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outcome · NOT POSTED

Immune Reconstitution

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outcome · NOT POSTED

Length of Remission in Patients

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adverse events

Adverse events

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more info

Limitations, agreements, and source contact

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Who could take part
eligibility 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 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), Severe chronic active Epstein Barr virus infection (SCAEBV) with predilection for T- or NK-cell malignancy * 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 m\^2) * 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.
healthy Volunteers
false
maximum Age
55 Years
sex
ALL
std Ages
  1. CHILD
  2. ADULT
Treatment arms and interventions
arm Groups
  1. description
    Subjects will receive transplant conditioning with Ara-C, Cyclophosphamide, Campath-1H, Total Body Irradiation and will then receive T cell depleted stem cell infusion processed by the CLINIMACS Device
    intervention Names
    1. Drug: Ara-C
    2. Drug: Cyclophosphamide
    3. Biological: Campath-1H
    4. Radiation: Total Body Irradiation
    5. Procedure: Stem Cell Infusion
    label
    CLINIMACS Device
    type
    EXPERIMENTAL
  2. description
    Subjects will receive transplant conditioning with Ara-C, Cyclophosphamide, Campath-1H, Total Body Irradiation and will then receive T cell depleted stem cell infusion processed by the ISOLEX Device
    intervention Names
    1. Drug: Ara-C
    2. Drug: Cyclophosphamide
    3. Biological: Campath-1H
    4. Radiation: Total Body Irradiation
    5. Procedure: Stem Cell Infusion
    label
    ISOLEX Device
    type
    EXPERIMENTAL
interventions
  1. arm Group Labels
    1. CLINIMACS Device
    2. ISOLEX Device
    description
    day-8 through day-5 3 g/m2 q 12 hours
    name
    Ara-C
    other Names
    1. cytarabine
    type
    DRUG
  2. arm Group Labels
    1. CLINIMACS Device
    2. ISOLEX Device
    description
    day-7 and day-6 45 mg/kg
    name
    Cyclophosphamide
    other Names
    1. Cytoxan
    type
    DRUG
  3. arm Group Labels
    1. CLINIMACS Device
    2. ISOLEX Device
    description
    day-3 through day-1 Dosing for children: 5 - 15kg : 3mg IV in 30ml NS 15.1 - 30kg : 5mg IV in 50ml NS \>30 kg : 10mg IV in 100ml NS Adults will receive 10mg IV in 100ml NS
    name
    Campath-1H
    other Names
    1. Alemtuzumab
    type
    BIOLOGICAL
  4. arm Group Labels
    1. CLINIMACS Device
    2. ISOLEX Device
    description
    day-4 through day-1 175 cGy x 2 at 24 cGy/min
    name
    Total Body Irradiation
    type
    RADIATION
  5. arm Group Labels
    1. CLINIMACS Device
    2. ISOLEX Device
    description
    Stem cells are infused on day 0
    name
    Stem Cell Infusion
    type
    PROCEDURE
Study design
allocation
NON_RANDOMIZED
intervention Model
SINGLE_GROUP
masking Info
masking
NONE
primary Purpose
TREATMENT
Enrollment
count
46
type
ACTUAL
Registered outcome plans (not posted results)
other Outcomes
  1. description
    To evaluate the effect of T-cell depletion by positive selection for CD34 on immune reconstitution, which will be determined from total lymphocyte count, from T and B cell numbers and from T cell subset analyses.
    measure
    Immune Reconstitution
    time Frame
    1 Year
  2. description
    Median length of remission in patients with high risk leukemia treated with myeloablative chemotherapy, radiotherapy and CD34 selected peripheral blood stem cells from haploidentical related donors using Kaplan-Meier method
    measure
    Length of Remission in Patients
    time Frame
    1 Year
primary Outcomes
  1. description
    Percentage of participants with hematopoietic engraftment post-transplant. Engraftment is defined as the first day absolute neutrophil counts exceeded 0.5 X 10\^9/ml.
    measure
    Engraftment Rate After Transplant
    time Frame
    28 days
secondary Outcomes
  1. description
    Number of participants who experience organ failure or severe infections (defined as Grade III/IV by NCI CTC for Adverse Events (CTCAE), version 2.0)
    measure
    Early Post BMT Toxicities
    time Frame
    100 Days
  2. description
    Percentage of participants with Grade III/IV acute GVHD. Severe GVHD is defined as Grade III/IV acute GVHD.
    measure
    Severe GVHD Rate
    time Frame
    100 Days
  3. description
    Number of participants with acute GVHD graded by the method of Przepiorka et al, which evaluates skin involvement, lower and upper GI, and liver function (bilirubin), each being graded in stages from 0 to 4, where 0 means no acute GVHD, and 4 is the highest stage of acute GVHD
    measure
    Patients With Acute GVHD
    time Frame
    First 100 Days
  4. description
    Number of participants with chronic GVHD graded by the method of Przepiorka et al, which evaluates skin, joints, oral, ocular, hepatic, esophagus, GI, respiratory, platelet, and musculoskeletal involvement, in stages from 0 to 3.
    measure
    Patients With Chronic GVHD
    time Frame
    Up to 1 Year
Full study description
brief Summary
Subjects are being asked to participate in this study because treatment of their disease requires them to receive a stem cell transplant. Stem cells or "mother" cells are the source of normal blood cells and lead to recovery of blood counts after bone marrow transplantation (BMT). Unfortunately, there is not a perfectly matched stem cell donor (like a sister or brother) and the subject's disease is considered rapidly progressive and does not permit enough time to identify another donor (like someone from a registry list that is not their relative). We have, however, identified a close relative of the subject's whose stem cells are not a perfect match, but can be used. However, with this type of donor, there is typically an increased risk of developing graft-versus-host disease (GVHD), a high rate of transplant failure, and a longer delay in the recovery of the immune system. GVHD is a serious and sometimes fatal side effect of stem cell transplant. GVHD occurs when the new donor cells (graft) recognizes that the body tissues of the patient (host) are different from those of the donor. When this happens, cells in the graft may attack the host organs, primarily the skin, liver, and intestines. The number of occurrences and harshness of severe GVHD depends on several factors, including the degree of genetic differences between the donor and recipient, the intensity of the pre-treatment conditioning regimen, the quantity of transplanted cells, and the recipient's age. In recipients of mismatched family member or matched unrelated donor stem cell transplants, there is a greater risk of GVHD so that 70-90% of recipients of unchanged marrow will develop severe GVHD which could include symptoms such as marked diarrhea, liver failure, or even death. In an effort to lower the occurrences and severity of graft-versus-host disease in patients and to lower the rate of transplant failure, we would like to specially treat the donor's blood cells to remove cells that are most likely to attack the patient's tissues. This will occur in combination with intense conditioning treatment that the patient will receive before the transplant.
detailed Description
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.
Source references
Source notices and limitations
    Discovery and provenance
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        exact text
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        start
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      offset unit
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      query cond
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      query disease state id
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      source file
      /Users/arunverma/Documents/ChatGPT/Cancer Statistics Website/research-data/2026-09-10/clinicaltrials-condition/round-0000/raw/cond-peripheral-t-cell-non-hodgkin-lymphoma-000.json
      source file sha256
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      source string sha256
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    Preserved source evidence · Not medical advice