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NCT00594308 · REGISTRY CONDITION SEARCH

In-Vivo Activated T-Cell Depletion to Prevent GVHD

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

Phase
NA
Status at capture
TERMINATED
Registry last update
2014-10-06

The purpose of this study is to compare the effects (good and bad) of the medication basiliximab in combination with cyclosporine with cyclosporine alone for the prevention of graft-versus-host disease. This research is being done because there is no completely safe and effective prevention for graft-versus-host disease. It is known that cyclosporine helps with GVHD but we would like to know if the addition of basiliximab will decrease the incidence and/or severity of GVHD after a transplant known as nonmyeloablative ("mini" 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

Number of Patients With Acute Grade II-IV GVHD

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outcome

Number of Patients Engrafting at Day +30 by Short Tandem Repeat (STR) on Peripheral Blood Mononuclear Cells (PBMC's).

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outcome

Number of Days for Absolute Neutrophil Count to Recover

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outcome

Time to Resolution of Cytopenias: Platelet Transfusion Independence

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outcome

Patients Who Experience Serious Transplant Related Toxicities as Evaluated by Bone Marrow Transplant-adjusted NCI Common Toxicity Criteria.

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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: * Acute myelogenous leukemia, Acute lymphocytic leukemia, Chronic myelogenous leukemia, Chronic lymphocytic leukemia, Myelodysplasia, Non-Hodgkin's Lymphoma, Mantle cell, Hodgkin's Disease, Multiple Myeloma, Myelofibrosis with disease-specific eligibility requirements as outlined in the protocol * Donor Requirement: Must have a fully HLA-matched (10 of 10) related or unrelated donor, eighteen years of age or older, who is capable of undergoing GCSF mobilization and apheresis. Exclusion Criteria: * Active CNS disease (the presence of leukemic blasts in the CSF) * Pregnancy or breast-feeding * SGOT \>3x upper limit of normal * Creatinine \>2 or creatinine clearance \<50cc/hr. * Fractional shortening by echocardiogram not within normal limits per institution * Pulmonary function: DLCO less that 50% of normal predicted, corrected for anemia * Prior allogeneic transplant
healthy Volunteers
false
maximum Age
75 Years
minimum Age
18 Years
sex
ALL
std Ages
  1. ADULT
  2. OLDER_ADULT
Treatment arms and interventions
interventions
  1. description
    60mg/kg/day for two consecutive days (-7,-6).
    name
    Cyclophosphamide
    type
    DRUG
  2. description
    25mg/m2/day for 5 consecutive days
    name
    Fludarabine
    type
    DRUG
  3. description
    3mg/kg/day will be given by continuous intravenous infusion beginning on Day -1.
    name
    Cyclosporine
    type
    DRUG
  4. description
    1000 mg will be administered through day +60 and then discontinued if there is no GVHD.
    name
    Mycophenolate mofetil
    type
    DRUG
  5. description
    20mg , will be given by intravenous infusion (without an in-line filter) over at least 15 minutes beginning 3 days after engraftment.
    name
    Basiliximab
    type
    DRUG
Study design
allocation
NON_RANDOMIZED
intervention Model
SINGLE_GROUP
masking Info
masking
NONE
primary Purpose
TREATMENT
Enrollment
count
10
type
ACTUAL
Registered outcome plans (not posted results)
primary Outcomes
  1. description
    Number of patients with Grade II-IV GVHD according to NMDP/CIBMTR GVHD severity scale. This scale measures the degree of GVHD involvement in the patient's skin (inflammatory skin disease), liver (bilirubin levels) and intestinal tract (amount of diarrhea) as well as the level of decline in a patient's activity and physical abilities.
    measure
    Number of Patients With Acute Grade II-IV GVHD
    time Frame
    until 30 days after stem cell transplant
secondary Outcomes
  1. measure
    Number of Patients Engrafting at Day +30 by Short Tandem Repeat (STR) on Peripheral Blood Mononuclear Cells (PBMC's).
    time Frame
    until 30 days after stem cell transplant
  2. description
    Average number of day per patient for absolute neutrophil count to recover(\> 500/mm3 for 3 consecutive days).
    measure
    Number of Days for Absolute Neutrophil Count to Recover
    time Frame
    From Day -1 (day before stem cell infusion) to Day+20 (20 days after stem cell infusion)
  3. description
    Average number of days per patient for resolution of cytopenias.
    measure
    Time to Resolution of Cytopenias: Platelet Transfusion Independence
    time Frame
    From Day -1 (day before stem cell infusion) to Day +20 (20 days after stem cell infusion)
  4. description
    Number of patients who died due to transplant related toxicities
    measure
    Patients Who Experience Serious Transplant Related Toxicities as Evaluated by Bone Marrow Transplant-adjusted NCI Common Toxicity Criteria.
    time Frame
    up to 2 years after stem cell transplant
Full study description
brief Summary
The purpose of this study is to compare the effects (good and bad) of the medication basiliximab in combination with cyclosporine with cyclosporine alone for the prevention of graft-versus-host disease. This research is being done because there is no completely safe and effective prevention for graft-versus-host disease. It is known that cyclosporine helps with GVHD but we would like to know if the addition of basiliximab will decrease the incidence and/or severity of GVHD after a transplant known as nonmyeloablative ("mini" transplant).
Source references
Source notices and limitations
    Discovery and provenance
    1. release id
      ctgov-registry-1336d216cbd1bbff780dac70
      edge id
      nct-edge-40c1d0259b496a6ed127
      requested nct id
      NCT00594308
      primary nct id
      NCT00594308
      source kind
      ctgov_condition_query
      source record id
      Source null
      source file sha256
      2314ce01316b2d7044d298c6d25eda12e99cc5f44273bc75efed6cd5e03a8c14
      payload sha256
      ff964b86f1a9ae12c9ffe8e95ff465c12dc31c11ea945524c245931d535fe326
      payload
      clinical indication matching status
      condition_index_match_asserted_by_registry_not_reviewed
      end exclusive
      true
      id
      nct-edge-40c1d0259b496a6ed127
      link basis
      returned_by_explicit_condition_and_posted_results_filter_query
      nct id
      NCT00594308
      occurrences
      1. context exact
        NCT00594308
        end
        11
        exact text
        NCT00594308
        start
        0
      offset unit
      unicode_code_points
      query cond
      Plasma Cell Neoplasms
      query disease state id
      ds-plasma-cell-neoplasms
      source file
      /Users/arunverma/Documents/ChatGPT/Cancer Statistics Website/research-data/2026-09-10/clinicaltrials-condition/round-0000/raw/cond-plasma-cell-neoplasms-000.json
      source file sha256
      2314ce01316b2d7044d298c6d25eda12e99cc5f44273bc75efed6cd5e03a8c14
      source json pointer
      /studies/555/protocolSection/identificationModule/nctId
      source kind
      ctgov_condition_query
      source record id
      Source null
      source string basis
      parsed_JSON_string_unmodified
      source string sha256
      89779f8ef1869ad9247c610140fdb561b37430a9c8057a86ffc2795a17405694

    Preserved source evidence · Not medical advice