<clinical_study>
  <!-- This xml conforms to an XML Schema at:
    https://clinicaltrials.gov/ct2/html/images/info/public.xsd -->
  <required_header>
    <download_date>ClinicalTrials.gov processed this data on September 20, 2023</download_date>
    <link_text>Link to the current ClinicalTrials.gov record.</link_text>
    <url>https://clinicaltrials.gov/ct2/show/NCT01660607</url>
  </required_header>
  <id_info>
    <org_study_id>IRB-21257</org_study_id>
    <secondary_id>SU-09142011-8407</secondary_id>
    <secondary_id>BMT236</secondary_id>
    <secondary_id>1R01HL114591-01</secondary_id>
    <nct_id>NCT01660607</nct_id>
  </id_info>
  <brief_title>Phase 1-2 MAHCT w/ TCell Depleted Graft w/ Simultaneous Infusion Conventional and Regulatory T Cell</brief_title>
  <official_title>Phase 1-2 Trial for Patients With Advanced Hematologic Malignancies Undergoing Myeloablative Allogeneic HCT With a T-cell Depleted Graft With Infusion of Conventional T-cells and Regulatory T-cells</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Everett Meyer</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>National Institutes of Health (NIH)</agency>
      <agency_class>NIH</agency_class>
    </collaborator>
  </sponsors>
  <source>Stanford University</source>
  <oversight_info>
    <has_dmc>Yes</has_dmc>
    <is_fda_regulated_drug>Yes</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
  </oversight_info>
  <brief_summary>
    <textblock>
      For patients with hematologic malignancies undergoing allogeneic myeloablative (MA) HCT with&#xD;
      a T cell depleted graft, the infusion of naturally occurring regulatory T cells with&#xD;
      conventional T cells (T cell add back) in pre-defined doses and ratios will reduce the&#xD;
      incidence of acute graft vs host disease while augmenting the graft vs leukemia effect and&#xD;
      improving immune reconstitution.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Primary Objectives:&#xD;
&#xD;
        -  To determine the efficacy, safety and feasibility of administration of several dose&#xD;
           combinations of conventional T cells (Tcon) and regulatory T cells (Treg) in patients&#xD;
           undergoing allogeneic hematopoietic cell transplantation (HCT) with HLA matched donors&#xD;
           (related or unrelated) using a T cell depleted graft [CD34+ hematopoietic progenitor&#xD;
           cells (&quot;CD34+ HSPC&quot;)], without immune suppression.&#xD;
&#xD;
        -  To determine the maximum tolerated dose of infused regulatory and conventional T cells&#xD;
           in the matched donor setting&#xD;
&#xD;
        -  To determine 1 year event free survival (EFS) post HCT&#xD;
&#xD;
      Secondary Objectives:&#xD;
&#xD;
        -  To determine the 1 year OS in patients undergoing allogeneic HCT with matched donors.&#xD;
&#xD;
        -  To measure the incidence and severity of acute and chronic graft vs host disease (GvHD)&#xD;
&#xD;
        -  To measure incidence of serious infections&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Active, not recruiting</overall_status>
  <start_date>December 2011</start_date>
  <completion_date type="Anticipated">December 2023</completion_date>
  <primary_completion_date type="Anticipated">December 2022</primary_completion_date>
  <phase>Phase 1/Phase 2</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>N/A</allocation>
    <intervention_model>Single Group Assignment</intervention_model>
    <primary_purpose>Treatment</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>GvHD free Relapse free Survival (GRFS)</measure>
    <time_frame>12 months</time_frame>
    <description>GvHD-free is defined as no GvHD symptoms, and relapse free survival is defined as survival at 12 months without relapse.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Dose-limiting toxicity (DLT)</measure>
    <time_frame>28 days</time_frame>
    <description>Dose-limiting Toxicity (DLT) was assessed as:&#xD;
Absolute neutrophil count &lt;500/µL, to 28 day&#xD;
Cytokine release syndrome/acute infusion reactions as CTCAE Grade 3 to 5&#xD;
Grade 3 to 4 acute GvHD. GvHD was staged as follows:&#xD;
1: Skin: rash &lt;25%. Liver: bilirubin (BIL) 2-3mg/dL. Gut: diarrhea (DIA) 500-1000 mL/day&#xD;
2: Skin: rash 25-50%. Liver: BIL 3-6mg/dL. Gut: DIA 1001-1500 mL/day&#xD;
3: Skin: rash &gt; 50%. Liver: BIL 6-15mg/dL. Gut: DIA &gt;1501-2000 mL/day&#xD;
4: Skin: generalized erythroderma. Liver: BIL &gt;15mg/dL. Gut: DIA &gt;2001 mL/day GvHD was graded as follows.&#xD;
1: Skin Stage 1-2; No Liver stage; No Gut stage&#xD;
2: Skin Stage 1-3 ; Liver Stage 1; +/- Gut Stage 1&#xD;
3: Skin Stage 2-3, Liver Stage 2-4; +/- Gut Stage 2-3&#xD;
4: Skin Stage 2-4; Liver Stage 2-4; +/- Gut Stage 2-4 The outcome is reported as the number of participants who received both Treg and Tcon cell infusions and had DLT events, per treatment level, a number without dispersion.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Overall Survival (OS)</measure>
    <time_frame>1 year</time_frame>
    <description>Overall Survival (OS) at 1 year was assessed as the number of participants per treatment level that received the hematopoietic cell transplant (HCT), and remained alive 12 months later, a number without dispersion.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Incidence and Severity of Chronic GvHD</measure>
    <time_frame>2 years</time_frame>
    <description>Incidence and severity of chronic GvHD wil be assessed in participants who received the hematopoietic cell transplant (HCT).&#xD;
Stage of chronic GvHD was assessed as follows.&#xD;
Stage 1: Skin: rash &lt;25% of skin. Liver: bilirubin 2-3mg/dL. Gut: diarrhea 500-1000 mL/day&#xD;
Stage 2: Skin: rash 25-50% of skin. Liver: bilirubin 3-6mg/dL. Gut: diarrhea 1001-1500 mL/day&#xD;
Stage 3: Skin: rash &gt; 50% of skin. Liver: bilirubin 6-15mg/dL. Gut: diarrhea &gt;1501-2000 mL/day&#xD;
Stage 4: Skin: generalized erythroderma. Liver: bilirubin &gt;15mg/dL. Gut: diarrhea &gt;2001 mL/day Grade of chronic GvHD was determined as follows.&#xD;
Grade 1: Skin Stage 1-2; No Liver stage; No Gut stage&#xD;
Grade 2: Skin Stage 1-3 ; Liver Stage 1; +/- Gut Stage 1&#xD;
Grade 3: Skin Stage 2-3, Liver Stage 2-4; +/- Gut Stage 2 to 3&#xD;
Grade 4: Skin Stage 2-4; Liver Stage 2-4; +/- Gut Stage 2 to 4 The outcome is reported as the number of participants by cGvHD grade and treatment level, a number without dispersion.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Incidence of Serious Infections</measure>
    <time_frame>24 months</time_frame>
    <description>The outcome is reported as the number of serious infections per treatment level, in participants who received the hematopoietic cell transplant (HCT), a number without dispersion.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Concomitant Single-agent Immunosuppression</measure>
    <time_frame>2 years</time_frame>
    <description>During Phase 2, stage 1, concomitant single-agent immunosuppression will be assessed as in participants receiving fresh Treg cells. The outcome is reported as number of such participants who received single-agent immunosuppression, by treatment level, a number without dispersion.</description>
  </secondary_outcome>
  <number_of_arms>1</number_of_arms>
  <enrollment type="Actual">68</enrollment>
  <condition>Myeloid Leukemia, Chronic</condition>
  <condition>Acute Myelogenous Leukemia</condition>
  <condition>Myelodysplastic Syndromes (MDS)</condition>
  <condition>Lymphoma, Non-Hodgkin</condition>
  <condition>Acute Lymphoblastic Leukemia (ALL)</condition>
  <condition>Myeloproliferative Syndrome</condition>
  <condition>Acute Myeloid Leukemia</condition>
  <condition>Acute Leukemia</condition>
  <condition>Chronic Myelogenous Leukemia</condition>
  <arm_group>
    <arm_group_label>Dose escalation</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>For the Phase I arm of the study the addition of planned numbers and ratios of Treg compared to Tcon will occur at defined time points after hematopoietic cell infusion. Each cohort will have 3 patients per group. The initial doses and ratios utilized will be 1 x 10^6/kg of T reg cells to 3x10^6/kg of Tcon cells at a 1:3 ratio. In order to progress to the next dose level, there must be no evidence of grade 3 or 4 acute GVHD.</description>
  </arm_group>
  <intervention>
    <intervention_type>Biological</intervention_type>
    <intervention_name>Conventional T cells (Tcon) and Regulatory T cells (Treg)</intervention_name>
    <description>A baseline cell dose of conventional T cells of 1x10^6/kg will be used with escalation to the maximum tolerated dose up to 1x10^7/kg</description>
    <arm_group_label>Dose escalation</arm_group_label>
    <other_name>Purified regulatory T cells</other_name>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Recipient Inclusion Criteria&#xD;
&#xD;
          1. Patients with the following diseases that are histopathologically confirmed are&#xD;
             eligible&#xD;
&#xD;
               -  Acute leukemia, primary refractory or beyond CR1, or minimal residual disease&#xD;
                  (MRD) positivity.&#xD;
&#xD;
               -  High risk acute myeloid leukemia in CR1 with any of the following features:&#xD;
&#xD;
               -  Complex karyotype(≥3 clonal chromosomal abnormalities)&#xD;
&#xD;
               -  Any of the following high risk chromosomal abnormalities:&#xD;
&#xD;
                    -  Monosomal karyotype (-5, 5q-, -7, 7q-)&#xD;
&#xD;
                    -  t(11q23), t(9;11), inv(3), t(3;3) t(6;9) t(9;22)&#xD;
&#xD;
                    -  Normal karyotype with fms-like tyrosine kinase 3 (FLT3)-ITD mutation&#xD;
&#xD;
               -  Other high risk features as determined by molecular studies, or clinical&#xD;
                  presentation as assessed by the treating physician&#xD;
&#xD;
               -  Chronic myelogenous leukemia (accelerated, blast or second chronic phase)&#xD;
&#xD;
               -  Myelodysplastic syndromes&#xD;
&#xD;
               -  Myeloproliferative syndromes&#xD;
&#xD;
               -  Non-Hodgkin lymphoma with poor risk features not suitable for autologous HCT&#xD;
&#xD;
          2. Age ≥18 yo and ≤ 60 yo for patients in Cohort 1 only. At the start of Cohort 2A and&#xD;
             beyond, eligibility will be expanded to allow pediatric patients age ≥ 13 yo.&#xD;
&#xD;
          3. Cardiac ejection fraction ≥ 45%&#xD;
&#xD;
          4. Lung diffusion capacity ≥ 50%&#xD;
&#xD;
          5. Calculated creatinine clearance ≥ 50 cc/min&#xD;
&#xD;
          6. Serum glutamic-pyruvic transaminase( SGPT) and serum glutamic-oxaloacetic transaminase&#xD;
             (SGOT) ≤ 3.0 x ULN (Upper limit of normal), unless elevated secondary to disease.&#xD;
&#xD;
          7. Total bilirubin ≤ 2 x ULN (patients with Gilbert's syndrome may be included at the&#xD;
             discretion of the PI or where hemolysis has been excluded&#xD;
&#xD;
          8. Availability of a HLA matched donor (related or unrelated) defined by Class I (HLA-A&#xD;
             and B) serologic typing (or higher resolution) and Class II (HLA DRB1) molecular&#xD;
             typing. An HLA matched donor is defined for this study to be a sibling that is HLA&#xD;
             matched 6/6; or an unrelated donor that is HLA matched 6/6 or 5/6. A sibling may be a&#xD;
             &quot;half sibling.&quot;&#xD;
&#xD;
          9. Karnofsky performance status ≥70%&#xD;
&#xD;
        Recipient Exclusion Criteria&#xD;
&#xD;
          1. Seropositive for any of the following:&#xD;
&#xD;
             HIV ab; hepatitis B sAg; hepatitis C ab&#xD;
&#xD;
          2. Prior myeloablative therapy or hematopoietic cell transplant&#xD;
&#xD;
          3. Candidate for autologous transplant&#xD;
&#xD;
          4. HIV positive&#xD;
&#xD;
          5. Active uncontrolled bacterial, viral or fungal infection, defined as currently taking&#xD;
             antimicrobial therapy and progression of clinical symptoms.&#xD;
&#xD;
          6. Uncontrolled central nervous system (CNS) disease involvement&#xD;
&#xD;
          7. Pregnant or a lactating female&#xD;
&#xD;
          8. Positive serum or urine beta human chorionic gonadotropin (HCG) test in females of&#xD;
             childbearing potential within 3 weeks of registration&#xD;
&#xD;
          9. Psychosocial circumstances that preclude the patient being able to go through&#xD;
             transplant or participate responsibly in follow up care&#xD;
&#xD;
        Donor Inclusion Criteria&#xD;
&#xD;
          1. Age ≥13 yo and ≤ 75 years&#xD;
&#xD;
          2. Karnofsky performance status of ≥ 70% defined by institutional standards&#xD;
&#xD;
          3. Seronegative for HIV 1 RNA (polymerase chair reaction (PCR); HIV 1 and HIV 2 ab&#xD;
             (antibody); HTLV 1 and HTLV 2 ab; PCR+ or sAg (surface antigen) hepatitis B ; or PCR+&#xD;
             or sAg for hepatitis C; negative for the Treponema pallidum antibody Syphilis screen;&#xD;
             and negative for HIV 1 and hepatitis C by nucleic acid testing (NAT) within 30 days of&#xD;
             apheresis collection. In the case that T pallidum antibody tests are positive, donors&#xD;
             must:&#xD;
&#xD;
               -  Be evaluated and show no evidence of syphilis infection of any stage by physical&#xD;
                  exam and history&#xD;
&#xD;
               -  Have completed effective antibiotic therapy to treat syphilis&#xD;
&#xD;
               -  Have a documented negative non treponemal test (such as RPR) or in the case of a&#xD;
                  positive non treponemal test must be evaluated by an infectious disease expert to&#xD;
                  evaluate for alternative causes of test positivity and confirm no evidence of&#xD;
                  active syphilitic disease&#xD;
&#xD;
          4. Must be 6/6 matched sibling donor as determined by HLA typing&#xD;
&#xD;
          5. Female donors of child-bearing potential must have a negative serum or urine beta-HCG&#xD;
             test within three weeks of mobilization&#xD;
&#xD;
          6. Capable of undergoing leukapheresis, have adequate venous access, and be willing to&#xD;
             undergo insertion of a central catheter should leukapheresis via peripheral vein be&#xD;
             inadequate&#xD;
&#xD;
          7. Agreeable to 2nd donation of Peripheral blood stem cell (PBPC) (or bone marrow&#xD;
             harvest) in the event of graft failure&#xD;
&#xD;
          8. The donor or legal guardian greater than 18 years of age, capable of signing an&#xD;
             institutional review board (IRB-approved consent form.&#xD;
&#xD;
        Donor Exclusion Criteria&#xD;
&#xD;
          1. Evidence of active infection or viral hepatitis&#xD;
&#xD;
          2. HIV positive&#xD;
&#xD;
          3. Medical, physical, or psychological reason that would place the donor at increased&#xD;
             risk for complications from growth factor or leukapheresis&#xD;
&#xD;
          4. Lactating female&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>13 Years</minimum_age>
    <maximum_age>60 Years</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Everett Meyer</last_name>
    <role>Principal Investigator</role>
    <affiliation>Stanford University</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Stanford University School of Medicine Palo Alto, California, United States</name>
      <address>
        <city>Palo Alto</city>
        <state>California</state>
        <zip>94305</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>May 2022</verification_date>
  <study_first_submitted>August 6, 2012</study_first_submitted>
  <study_first_submitted_qc>August 6, 2012</study_first_submitted_qc>
  <study_first_posted type="Estimate">August 8, 2012</study_first_posted>
  <last_update_submitted>May 6, 2022</last_update_submitted>
  <last_update_submitted_qc>May 6, 2022</last_update_submitted_qc>
  <last_update_posted type="Actual">May 10, 2022</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor-Investigator</responsible_party_type>
    <investigator_affiliation>Stanford University</investigator_affiliation>
    <investigator_full_name>Everett Meyer</investigator_full_name>
    <investigator_title>Assistant Professor of Medicine</investigator_title>
  </responsible_party>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Leukemia</mesh_term>
    <mesh_term>Leukemia, Myeloid</mesh_term>
    <mesh_term>Leukemia, Myeloid, Acute</mesh_term>
    <mesh_term>Preleukemia</mesh_term>
    <mesh_term>Precursor Cell Lymphoblastic Leukemia-Lymphoma</mesh_term>
    <mesh_term>Leukemia, Myelogenous, Chronic, BCR-ABL Positive</mesh_term>
    <mesh_term>Lymphoma, Non-Hodgkin</mesh_term>
    <mesh_term>Myelodysplastic Syndromes</mesh_term>
    <mesh_term>Syndrome</mesh_term>
  </condition_browse>
  <patient_data>
    <sharing_ipd>No</sharing_ipd>
  </patient_data>
  <!-- Results have not yet been posted for this study                                          -->
</clinical_study>


download date: ClinicalTrials.gov processed this data on September 20, 2023
link text: Link to the current ClinicalTrials.gov record.
url: https://clinicaltrials.gov/ct2/show/NCT01660607
org study id: IRB-21257
secondary id: SU-09142011-8407
secondary id: BMT236
secondary id: 1R01HL114591-01
nct id: NCT01660607
lead sponsor: 
collaborator: 
has dmc: Yes
is fda regulated drug: Yes
is fda regulated device: No
For patients with hematologic malignancies undergoing allogeneic myeloablative (MA) HCT with
      a T cell depleted graft, the infusion of naturally occurring regulatory T cells with
      conventional T cells (T cell add back) in pre-defined doses and ratios will reduce the
      incidence of acute graft vs host disease while augmenting the graft vs leukemia effect and
      improving immune reconstitution.
Primary Objectives:

        -  To determine the efficacy, safety and feasibility of administration of several dose
           combinations of conventional T cells (Tcon) and regulatory T cells (Treg) in patients
           undergoing allogeneic hematopoietic cell transplantation (HCT) with HLA matched donors
           (related or unrelated) using a T cell depleted graft [CD34+ hematopoietic progenitor
           cells ("CD34+ HSPC")], without immune suppression.

        -  To determine the maximum tolerated dose of infused regulatory and conventional T cells
           in the matched donor setting

        -  To determine 1 year event free survival (EFS) post HCT

      Secondary Objectives:

        -  To determine the 1 year OS in patients undergoing allogeneic HCT with matched donors.

        -  To measure the incidence and severity of acute and chronic graft vs host disease (GvHD)

        -  To measure incidence of serious infections
allocation: N/A
intervention model: Single Group Assignment
primary purpose: Treatment
masking: None (Open Label)
measure: GvHD free Relapse free Survival (GRFS)
time frame: 12 months
description: GvHD-free is defined as no GvHD symptoms, and relapse free survival is defined as survival at 12 months without relapse.
measure: Dose-limiting toxicity (DLT)
time frame: 28 days
description: Dose-limiting Toxicity (DLT) was assessed as:
Absolute neutrophil count <500/µL, to 28 day
Cytokine release syndrome/acute infusion reactions as CTCAE Grade 3 to 5
Grade 3 to 4 acute GvHD. GvHD was staged as follows:
1: Skin: rash <25%. Liver: bilirubin (BIL) 2-3mg/dL. Gut: diarrhea (DIA) 500-1000 mL/day
2: Skin: rash 25-50%. Liver: BIL 3-6mg/dL. Gut: DIA 1001-1500 mL/day
3: Skin: rash > 50%. Liver: BIL 6-15mg/dL. Gut: DIA >1501-2000 mL/day
4: Skin: generalized erythroderma. Liver: BIL >15mg/dL. Gut: DIA >2001 mL/day GvHD was graded as follows.
1: Skin Stage 1-2; No Liver stage; No Gut stage
2: Skin Stage 1-3 ; Liver Stage 1; +/- Gut Stage 1
3: Skin Stage 2-3, Liver Stage 2-4; +/- Gut Stage 2-3
4: Skin Stage 2-4; Liver Stage 2-4; +/- Gut Stage 2-4 The outcome is reported as the number of participants who received both Treg and Tcon cell infusions and had DLT events, per treatment level, a number without dispersion.
measure: Overall Survival (OS)
time frame: 1 year
description: Overall Survival (OS) at 1 year was assessed as the number of participants per treatment level that received the hematopoietic cell transplant (HCT), and remained alive 12 months later, a number without dispersion.
measure: Incidence and Severity of Chronic GvHD
time frame: 2 years
description: Incidence and severity of chronic GvHD wil be assessed in participants who received the hematopoietic cell transplant (HCT).
Stage of chronic GvHD was assessed as follows.
Stage 1: Skin: rash <25% of skin. Liver: bilirubin 2-3mg/dL. Gut: diarrhea 500-1000 mL/day
Stage 2: Skin: rash 25-50% of skin. Liver: bilirubin 3-6mg/dL. Gut: diarrhea 1001-1500 mL/day
Stage 3: Skin: rash > 50% of skin. Liver: bilirubin 6-15mg/dL. Gut: diarrhea >1501-2000 mL/day
Stage 4: Skin: generalized erythroderma. Liver: bilirubin >15mg/dL. Gut: diarrhea >2001 mL/day Grade of chronic GvHD was determined as follows.
Grade 1: Skin Stage 1-2; No Liver stage; No Gut stage
Grade 2: Skin Stage 1-3 ; Liver Stage 1; +/- Gut Stage 1
Grade 3: Skin Stage 2-3, Liver Stage 2-4; +/- Gut Stage 2 to 3
Grade 4: Skin Stage 2-4; Liver Stage 2-4; +/- Gut Stage 2 to 4 The outcome is reported as the number of participants by cGvHD grade and treatment level, a number without dispersion.
measure: Incidence of Serious Infections
time frame: 24 months
description: The outcome is reported as the number of serious infections per treatment level, in participants who received the hematopoietic cell transplant (HCT), a number without dispersion.
measure: Concomitant Single-agent Immunosuppression
time frame: 2 years
description: During Phase 2, stage 1, concomitant single-agent immunosuppression will be assessed as in participants receiving fresh Treg cells. The outcome is reported as number of such participants who received single-agent immunosuppression, by treatment level, a number without dispersion.
arm group label: Dose escalation
arm group type: Experimental
description: For the Phase I arm of the study the addition of planned numbers and ratios of Treg compared to Tcon will occur at defined time points after hematopoietic cell infusion. Each cohort will have 3 patients per group. The initial doses and ratios utilized will be 1 x 10^6/kg of T reg cells to 3x10^6/kg of Tcon cells at a 1:3 ratio. In order to progress to the next dose level, there must be no evidence of grade 3 or 4 acute GVHD.
intervention type: Biological
intervention name: Conventional T cells (Tcon) and Regulatory T cells (Treg)
description: A baseline cell dose of conventional T cells of 1x10^6/kg will be used with escalation to the maximum tolerated dose up to 1x10^7/kg
arm group label: Dose escalation
other name: Purified regulatory T cells
criteria: 
gender: All
minimum age: 13 Years
maximum age: 60 Years
healthy volunteers: Accepts Healthy Volunteers
last name: Everett Meyer
role: Principal Investigator
affiliation: Stanford University
facility: 
country: United States
responsible party type: Sponsor-Investigator
investigator affiliation: Stanford University
investigator full name: Everett Meyer
investigator title: Assistant Professor of Medicine
mesh term: Leukemia
mesh term: Leukemia, Myeloid
mesh term: Leukemia, Myeloid, Acute
mesh term: Preleukemia
mesh term: Precursor Cell Lymphoblastic Leukemia-Lymphoma
mesh term: Leukemia, Myelogenous, Chronic, BCR-ABL Positive
mesh term: Lymphoma, Non-Hodgkin
mesh term: Myelodysplastic Syndromes
mesh term: Syndrome
sharing ipd: No