Sirolimus, Tacrolimus, Thymoglobulin and Rituximab as Graft-versus-Host-Disease Prophylaxis in Patients Undergoing Haploidentical and HLA Partially Matched Donor Hematopoietic Cell Transplantation

Sponsor
Barbara Ann Karmanos Cancer Institute (Other)
Overall Status
Terminated
CT.gov ID
NCT01116232
Collaborator
National Cancer Institute (NCI) (NIH)
4
1
1
34
0.1

Study Details

Study Description

Brief Summary

This Phase II clinical trial was designed for patients with hematologic malignancies in need of donor peripheral blood stem cell transplant, and have no HLA matched donor. Therefore It will test the efficacy of combining sirolimus, tacrolimus, antithymocyte globulin, and rituximab in preventing graft versus host disease in transplants from HLA Haploidentical and partially mismatched donors.

Condition or Disease Intervention/Treatment Phase
  • Biological: anti-thymocyte globulin
  • Biological: rituximab
  • Drug: sirolimus
  • Drug: tacrolimus
  • Other: laboratory biomarker analysis
  • Procedure: allogeneic hematopoietic stem cell transplantation
  • Procedure: management of therapy complications
  • Procedure: peripheral blood stem cell transplantation
Phase 2

Detailed Description

OBJECTIVES:

Primary

  • Determine the incidence and severity of acute graft-vs-host disease (GVHD) in patients with hematologic malignancies undergoing donor peripheral blood stem cell transplantation who are receiving sirolimus, tacrolimus, anti-thymocyte globulin, and rituximab as GVHD prophylaxis.

  • Assess time to engraftment absolute neutrophil count (> 0.5 x 109/L for 3 consecutive days) and platelet count (> 20 x 109/L for 3 consecutive days) in these patients.

  • Determine the safety, as defined by serious adverse events and adverse events related to this immunosuppressive regimen, in the first 6 months after treatment.

Secondary

  • Assess the incidence of chronic GVHD measured within 2 years after transplantation.

  • Assess overall and disease-free survival at 2 years after transplantation.

  • Examine the incidence of opportunistic infections including fungal infections, pneumocystis carinii pneumonia, and viral infections (cytomegalovirus, varicella zoster virus, herpes simplex virus, BK virus, Epstein-Barr virus, and post-transplant lymphoproliferative disorder).

  • Assess the incidence of thrombotic microangiopathy within 100 days of transplantation.

  • Perform immunocorrelative studies, including T-cell, B-cell, NK-cell, regulatory cell, and allo-reactive T-cell measurement studies via flow cytometry, at 30, 60, 90, and 180 days after transplantation.

OUTLINE: Patients receive rituximab IV on days -7 and 3, tacrolimus IV continuously (may switch to orally when the patient is able to eat) and oral sirolimus beginning on day -3, and anti-thymocyte globulin IV over 6 hours on days -3 to -1. Tacrolimus and sirolimus are tapered at the discretion of the treating physician.

All patients also receive a standard transplant-preparative regimen and undergo transplantation on day 0.

Blood samples are collected before the preparative regimen and at 30, 60, 90, and 180 days after transplantation for correlative immunologic studies.

After completion of study treatment, patients are followed up for 2 years.

Study Design

Study Type:
Interventional
Actual Enrollment :
4 participants
Allocation:
N/A
Intervention Model:
Single Group Assignment
Masking:
None (Open Label)
Primary Purpose:
Supportive Care
Official Title:
A Pilot Phase II Study of Sirolimus, Tacrolimus, Thymoglobulin and Rituximab as Graft-versus-Host-Disease Prophylaxis in Patients Undergoing Haploidentical and HLA Partially Matched Donor Hematopoietic Cell Transplantation
Study Start Date :
Aug 1, 2010
Actual Primary Completion Date :
May 1, 2013
Actual Study Completion Date :
Jun 1, 2013

Arms and Interventions

Arm Intervention/Treatment
Experimental: anti-thymocyte globulin, rituximab, sirolimus, tacrolimus,

anti-thymocyte globulin: Infuse the first dose over a minimum of 6 hours, and subsequent doses over a minimum of 4 hours via a 0.22 micron in-line filter Rituximab: The total dose chosen for this protocol is 28 mg/kg divided in two doses (14 mg/kg on days -7 and +3). Initial infusion: Start rate of 50 mg/hour; For adults, Sirolimus will be administered at 12 mg orally loading dose on day -3, followed by 4 mg orally single morning daily dose (target serum level 3-12 ng/ml by HPLC). Tacrolimus will be administered intravenously at a dose of 0.03 mg/kg (ideal body weight) q 24h by continuous infusion starting on Day -3. Intravenous Tacrolimus will be discontinued once the patient starts eating and the drug will then be given orally at a dose of approximately 4 times the intravenous dose.

Biological: anti-thymocyte globulin
Infuse the first dose over a minimum of 6 hours, and subsequent doses over a minimum of 4 hours via a 0.22 micron in-line filter.

Biological: rituximab
The total dose chosen for this protocol is 28 mg/kg divided in two doses (14 mg/kg on days -7 and +3). Initial infusion: Start rate of 50 mg/hour; if there is no reaction, increase the rate by 50 mg/hour increments every 30 minutes, to a maximum rate of 400 mg/hour. Subsequent infusions: If patient did not tolerate initial infusion follow initial infusion guidelines. If patient tolerated initial infusion, start at 100 mg/hour; if there is no reaction, increase the rate by 100 mg/hour increments every 30 minutes, to a maximum rate of 400 mg/hour. Note: If a reaction occurs, slow or stop the infusion. If the reaction abates, restart infusion at 50% of the previous rate. In patients who tolerated the Rituximab well in the past, a rapid infusion rate can be used over 90 minutes with 20% of the dose administered in the first 30 minutes and the remaining 80% is given over 60 minutes.
Other Names:
  • Rituxan®
  • Drug: sirolimus
    For adults, Sirolimus will be administered at 12 mg orally loading dose on day -3, followed by 4 mg orally single morning daily dose (target serum level 3-12 ng/ml by HPLC).
    Other Names:
  • Rapamune®
  • Drug: tacrolimus
    Tacrolimus will be administered intravenously at a dose of 0.03 mg/kg (ideal body weight) q 24h by continuous infusion starting on Day -3. Intravenous Tacrolimus will be discontinued once the patient starts eating and the drug will then be given orally at a dose of approximately 4 times the intravenous dose.
    Other Names:
  • Prograf
  • Other: laboratory biomarker analysis
    laboratory biomarker analysis

    Procedure: allogeneic hematopoietic stem cell transplantation
    allogeneic hematopoietic stem cell transplantation

    Procedure: management of therapy complications
    management of therapy complications

    Procedure: peripheral blood stem cell transplantation
    peripheral blood stem cell transplantation

    Outcome Measures

    Primary Outcome Measures

    1. Incidence and Severity of Acute Graft-vs-host Disease (GVHD) [During the first six months post transplant]

    2. Time to Engraftment [During the first six months post transplant]

    3. Safety Assessment [During the first six months post transplant]

    Secondary Outcome Measures

    1. Incidence of Chronic GVHD [Within two years after transplant]

    2. Incidence of Infections Including Cytomegalovirus, Epstein-Barr Virus Reactivation, and Post-transplant Lymphoproliferative Disorder [At one year]

    3. Incidence of Thrombotic Microangiopathy [Within 100 days of HCT]

    4. Overall and Disease-free Survival [At 1 year]

    5. Immunocorrelative Studies Pre- and Periodically Post-transplantation [Using flow cytometry at 30, 60, 90, and 180 days post transplant.]

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years to 120 Years
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    DISEASE CHARACTERISTICS:
    • Diagnosis of a hematological malignancy, including:

    • Non-Hodgkin lymphoma

    • Hodgkin lymphoma

    • Acute myeloid leukemia or acute lymphoblastic leukemia

    • Myelodysplastic syndrome (treated or untreated)

    • Chronic myelogenous leukemia

    • Multiple myeloma

    • Chronic lymphocytic leukemia

    • Myelofibrosis and other myeloproliferative disorders

    • No suitable related HLA-matched or unrelated HLA-matched (8/8 or 7/8 matched) donor

    • Available suitable haploidentical or partial-matched unrelated donor (high-resolution molecular HLA typing is mandatory for HLA Class I and II)

    • No more than 4/8 HLA allele or antigen mismatch for a haploidentical-related first-degree family member donor

    • Only 6/8 or 5/8 allele or antigen match for an unrelated donor

    • Scheduled to undergo peripheral blood stem cell transplantation

    • Not receiving bone marrow or ex vivo engineered or processed graft (e.g., CD34+ enrichment, T-cell depletion)

    • No documented uncontrolled CNS disease

    PATIENT CHARACTERISTICS:
    • Karnofsky performance status (PS) 70-100%

    • ECOG PS 0-2

    • Serum bilirubin < 3 times upper limit of normal (ULN)

    • ALT and AST < 3 times ULN

    • Creatinine clearance > 60 mL/min

    • Ejection fraction > 50%

    • Forced vital capacity, FEV_1, or DLCO > 50% predicted

    • Negative pregnancy test

    • Able to cooperate with oral medication intake

    • Patients with coronary heart disease (recent myocardial infarctions, angina, cardiac stent, or bypass surgery in the past 6 months) are eligible provided they are cleared with a stress echo or nuclear myocardial perfusions stress test and a cardiology consult

    • No ascites

    • No HIV positivity

    • No active hepatitis B or C virus infection

    • No known contraindication to the administration of sirolimus, tacrolimus, anti-thymocyte globulin, or rituximab

    PRIOR CONCURRENT THERAPY:
    • See Disease Characteristics

    • Not on home oxygen

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Karmanos Cancer Institute Detroit Michigan United States 48201

    Sponsors and Collaborators

    • Barbara Ann Karmanos Cancer Institute
    • National Cancer Institute (NCI)

    Investigators

    • Principal Investigator: Zaid Al-Kadhimi, M.D., Barbara Ann Karmanos Cancer Institute

    Study Documents (Full-Text)

    None provided.

    More Information

    Additional Information:

    Publications

    None provided.
    Responsible Party:
    Zaid Al-Kadhimi, Principal Investigator, Barbara Ann Karmanos Cancer Institute
    ClinicalTrials.gov Identifier:
    NCT01116232
    Other Study ID Numbers:
    • CDR0000671822
    • P30CA022453
    • U4781s
    • 2009-150
    • NCT01534767
    First Posted:
    May 4, 2010
    Last Update Posted:
    Mar 26, 2019
    Last Verified:
    Mar 1, 2019
    Keywords provided by Zaid Al-Kadhimi, Principal Investigator, Barbara Ann Karmanos Cancer Institute
    Additional relevant MeSH terms:

    Study Results

    Participant Flow

    Recruitment Details Cancer center clinic.
    Pre-assignment Detail
    Arm/Group Title Anti-thymocyte Globulin, Rituximab, Sirolimus, Tacrolimus,
    Arm/Group Description anti-thymocyte globulin: Infuse the first dose over a minimum of 6 hours, and subsequent doses over a minimum of 4 hours via a 0.22 micron in-line filter Rituximab: The total dose chosen for this protocol is 28 mg/kg divided in two doses (14 mg/kg on days -7 and +3). Initial infusion: Start rate of 50 mg/hour; For adults, Sirolimus will be administered at 12 mg orally loading dose on day -3, followed by 4 mg orally single morning daily dose (target serum level 3-12 ng/ml by HPLC). Tacrolimus will be administered intravenously at a dose of 0.03 mg/kg (ideal body weight) q 24h by continuous infusion starting on Day -3. Intravenous Tacrolimus will be discontinued once the patient starts eating and the drug will then be given orally at a dose of approximately 4 times the intravenous dose. peripheral blood stem cell transplantation sirolimus: For adults, will be administered at 12 mg orally loading dose on day -3, follow
    Period Title: Overall Study
    STARTED 4
    COMPLETED 0
    NOT COMPLETED 4

    Baseline Characteristics

    Arm/Group Title Anti-thymocyte Globulin, Rituximab, Sirolimus, Tacrolimus,
    Arm/Group Description anti-thymocyte globulin: Infuse the first dose over a minimum of 6 hours, and subsequent doses over a minimum of 4 hours via a 0.22 micron in-line filter Rituximab: The total dose chosen for this protocol is 28 mg/kg divided in two doses (14 mg/kg on days -7 and +3). Initial infusion: Start rate of 50 mg/hour; For adults, Sirolimus will be administered at 12 mg orally loading dose on day -3, followed by 4 mg orally single morning daily dose (target serum level 3-12 ng/ml by HPLC). Tacrolimus will be administered intravenously at a dose of 0.03 mg/kg (ideal body weight) q 24h by continuous infusion starting on Day -3. Intravenous Tacrolimus will be discontinued once the patient starts eating and the drug will then be given orally at a dose of approximately 4 times the intravenous dose. peripheral blood stem cell transplantation sirolimus: For adults, will be administered at 12 mg orally loading dose on day -3, follow
    Overall Participants 4
    Age (Count of Participants)
    <=18 years
    0
    0%
    Between 18 and 65 years
    4
    100%
    >=65 years
    0
    0%
    Age (years) [Mean (Standard Deviation) ]
    Mean (Standard Deviation) [years]
    50
    (2.82)
    Sex: Female, Male (Count of Participants)
    Female
    2
    50%
    Male
    2
    50%
    Region of Enrollment (participants) [Number]
    United States
    4
    100%

    Outcome Measures

    1. Primary Outcome
    Title Incidence and Severity of Acute Graft-vs-host Disease (GVHD)
    Description
    Time Frame During the first six months post transplant

    Outcome Measure Data

    Analysis Population Description
    Study terminated due to lack of funding, no analysis was done for this protocol due to the fact that only four patients were accrued, no data was collected.
    Arm/Group Title Anti-thymocyte Globulin, Rituximab, Sirolimus, Tacrolimus,
    Arm/Group Description anti-thymocyte globulin: Infuse the first dose over a minimum of 6 hours, and subsequent doses over a minimum of 4 hours via a 0.22 micron in-line filter Rituximab: The total dose chosen for this protocol is 28 mg/kg divided in two doses (14 mg/kg on days -7 and +3). Initial infusion: Start rate of 50 mg/hour; For adults, Sirolimus will be administered at 12 mg orally loading dose on day -3, followed by 4 mg orally single morning daily dose (target serum level 3-12 ng/ml by HPLC). Tacrolimus will be administered intravenously at a dose of 0.03 mg/kg (ideal body weight) q 24h by continuous infusion starting on Day -3. Intravenous Tacrolimus will be discontinued once the patient starts eating and the drug will then be given orally at a dose of approximately 4 times the intravenous dose. peripheral blood stem cell transplantation sirolimus: For adults, will be administered at 12 mg orally loading dose on day -3, follow
    Measure Participants 0
    2. Primary Outcome
    Title Time to Engraftment
    Description
    Time Frame During the first six months post transplant

    Outcome Measure Data

    Analysis Population Description
    Study terminated due to lack of funding, no analysis was done for this protocol due to the fact that only four patients were accrued, no data was collected.
    Arm/Group Title Anti-thymocyte Globulin, Rituximab, Sirolimus, Tacrolimus,
    Arm/Group Description Anti-thymocyte globulin infuse the 1st dose, minimum of 6 hrs subsequent doses minimum of 4 hrs via a 0.22 micron in-line filter Rituximab, total dose is 28 mg/kg divided in 2 doses (14 mg/kg, days -7 & +3) Initial infusion, start rate 50 mg/hour Sirolimus 12 mg orally loading dose on day -3, followed by 4 mg orally single morning daily dose (target serum level 3-12 ng/ml by HPLC). Tacrolimus (IV) dose of 0.03 mg/kg (ideal body weight) every 24hr by continuous infusion starting on Day -3, discontinued once the pt. starts eating & the drug will then be given orally at a dose of approximately 4 times the IV dose. .
    Measure Participants 0
    3. Primary Outcome
    Title Safety Assessment
    Description
    Time Frame During the first six months post transplant

    Outcome Measure Data

    Analysis Population Description
    Study terminated due to lack of funding, no analysis was done for this protocol due to the fact that only four patients were accrued, no data was collected.
    Arm/Group Title Anti-thymocyte Globulin, Rituximab, Sirolimus, Tacrolimus,
    Arm/Group Description anti-thymocyte globulin: Infuse the first dose over a minimum of 6 hours, and subsequent doses over a minimum of 4 hours via a 0.22 micron in-line filter Rituximab: The total dose chosen for this protocol is 28 mg/kg divided in two doses (14 mg/kg on days -7 and +3). Initial infusion: Start rate of 50 mg/hour; For adults, Sirolimus will be administered at 12 mg orally loading dose on day -3, followed by 4 mg orally single morning daily dose (target serum level 3-12 ng/ml by HPLC). Tacrolimus will be administered intravenously at a dose of 0.03 mg/kg (ideal body weight) q 24h by continuous infusion starting on Day -3. Intravenous Tacrolimus will be discontinued once the patient starts eating and the drug will then be given orally at a dose of approximately 4 times the intravenous dose. peripheral blood stem cell transplantation sirolimus: For adults, will be administered at 12 mg orally loading dose on day -3, follow
    Measure Participants 0
    4. Secondary Outcome
    Title Incidence of Chronic GVHD
    Description
    Time Frame Within two years after transplant

    Outcome Measure Data

    Analysis Population Description
    Study terminated due to lack of funding, no analysis was done for this protocol due to the fact that only four patients were accrued, no data was collected.
    Arm/Group Title Anti-thymocyte Globulin, Rituximab, Sirolimus, Tacrolimus,
    Arm/Group Description anti-thymocyte globulin: Infuse the first dose over a minimum of 6 hours, and subsequent doses over a minimum of 4 hours via a 0.22 micron in-line filter Rituximab: The total dose chosen for this protocol is 28 mg/kg divided in two doses (14 mg/kg on days -7 and +3). Initial infusion: Start rate of 50 mg/hour; For adults, Sirolimus will be administered at 12 mg orally loading dose on day -3, followed by 4 mg orally single morning daily dose (target serum level 3-12 ng/ml by HPLC). Tacrolimus will be administered intravenously at a dose of 0.03 mg/kg (ideal body weight) q 24h by continuous infusion starting on Day -3. Intravenous Tacrolimus will be discontinued once the patient starts eating and the drug will then be given orally at a dose of approximately 4 times the intravenous dose. anti-thymocyte globulin: Infuse the first dose over a minimum of 6 hours, and subsequent doses over a minimum of 4 hours via a 0.22 micron in-line filter. rituximab: The total dose chosen
    Measure Participants 0
    5. Secondary Outcome
    Title Incidence of Infections Including Cytomegalovirus, Epstein-Barr Virus Reactivation, and Post-transplant Lymphoproliferative Disorder
    Description
    Time Frame At one year

    Outcome Measure Data

    Analysis Population Description
    Study terminated due to lack of funding, no analysis was done for this protocol due to the fact that only four patients were accrued, no data was collected.
    Arm/Group Title Anti-thymocyte Globulin, Rituximab, Sirolimus, Tacrolimus,
    Arm/Group Description anti-thymocyte globulin: Infuse the first dose over a minimum of 6 hours, and subsequent doses over a minimum of 4 hours via a 0.22 micron in-line filter Rituximab: The total dose chosen for this protocol is 28 mg/kg divided in two doses (14 mg/kg on days -7 and +3). Initial infusion: Start rate of 50 mg/hour; For adults, Sirolimus will be administered at 12 mg orally loading dose on day -3, followed by 4 mg orally single morning daily dose (target serum level 3-12 ng/ml by HPLC). Tacrolimus will be administered intravenously at a dose of 0.03 mg/kg (ideal body weight) q 24h by continuous infusion starting on Day -3. Intravenous Tacrolimus will be discontinued once the patient starts eating and the drug will then be given orally at a dose of approximately 4 times the intravenous dose. anti-thymocyte globulin: Infuse the first dose over a minimum of 6 hours, and subsequent doses over a minimum of 4 hours via a 0.22 micron in-line filter. rituximab: The total dose chosen
    Measure Participants 0
    6. Secondary Outcome
    Title Incidence of Thrombotic Microangiopathy
    Description
    Time Frame Within 100 days of HCT

    Outcome Measure Data

    Analysis Population Description
    Study terminated due to lack of funding, no analysis was done for this protocol due to the fact that only four patients were accrued, no data was collected.
    Arm/Group Title Anti-thymocyte Globulin, Rituximab, Sirolimus, Tacrolimus,
    Arm/Group Description Anti-thymocyte globulin infuse the 1st dose, minimum of 6 hrs subsequent doses minimum of 4 hrs via a 0.22 micron in-line filter Rituximab, total dose is 28 mg/kg divided in 2 doses (14 mg/kg, days -7 & +3) Initial infusion, start rate 50 mg/hour Sirolimus 12 mg orally loading dose on day -3, followed by 4 mg orally single morning daily dose (target serum level 3-12 ng/ml by HPLC). Tacrolimus (IV) dose of 0.03 mg/kg (ideal body weight) every 24hr by continuous infusion starting on Day -3, discontinued once the pt. starts eating & the drug will then be given orally at a dose of approximately 4 times the IV dose. .
    Measure Participants 0
    7. Secondary Outcome
    Title Overall and Disease-free Survival
    Description
    Time Frame At 1 year

    Outcome Measure Data

    Analysis Population Description
    Study terminated due to lack of funding, no analysis was done for this protocol due to the fact that only four patients were accrued, no data was collected.
    Arm/Group Title Anti-thymocyte Globulin, Rituximab, Sirolimus, Tacrolimus,
    Arm/Group Description Anti-thymocyte globulin infuse the 1st dose, minimum of 6 hrs subsequent doses minimum of 4 hrs via a 0.22 micron in-line filter Rituximab, total dose is 28 mg/kg divided in 2 doses (14 mg/kg, days -7 & +3) Initial infusion, start rate 50 mg/hour Sirolimus 12 mg orally loading dose on day -3, followed by 4 mg orally single morning daily dose (target serum level 3-12 ng/ml by HPLC). Tacrolimus (IV) dose of 0.03 mg/kg (ideal body weight) every 24hr by continuous infusion starting on Day -3, discontinued once the pt. starts eating & the drug will then be given orally at a dose of approximately 4 times the IV dose.
    Measure Participants 0
    8. Secondary Outcome
    Title Immunocorrelative Studies Pre- and Periodically Post-transplantation
    Description
    Time Frame Using flow cytometry at 30, 60, 90, and 180 days post transplant.

    Outcome Measure Data

    Analysis Population Description
    Study terminated due to lack of funding, no analysis was done for this protocol due to the fact that only four patients were accrued, no data was collected.
    Arm/Group Title Anti-thymocyte Globulin, Rituximab, Sirolimus, Tacrolimus,
    Arm/Group Description Anti-thymocyte globulin infuse the 1st dose, minimum of 6 hrs subsequent doses minimum of 4 hrs via a 0.22 micron in-line filter Rituximab, total dose is 28 mg/kg divided in 2 doses (14 mg/kg, days -7 & +3) Initial infusion, start rate 50 mg/hour Sirolimus 12 mg orally loading dose on day -3, followed by 4 mg orally single morning daily dose (target serum level 3-12 ng/ml by HPLC). Tacrolimus (IV) dose of 0.03 mg/kg (ideal body weight) every 24hr by continuous infusion starting on Day -3, discontinued once the pt. starts eating & the drug will then be given orally at a dose of approximately 4 times the IV dose. .
    Measure Participants 0

    Adverse Events

    Time Frame
    Adverse Event Reporting Description
    Arm/Group Title Anti-thymocyte Globulin, Rituximab, Sirolimus, Tacrolimus,
    Arm/Group Description anti-thymocyte globulin: Infuse the first dose over a minimum of 6 hours, and subsequent doses over a minimum of 4 hours via a 0.22 micron in-line filter Rituximab: The total dose chosen for this protocol is 28 mg/kg divided in two doses (14 mg/kg on days -7 and +3). Initial infusion: Start rate of 50 mg/hour; For adults, Sirolimus will be administered at 12 mg orally loading dose on day -3, followed by 4 mg orally single morning daily dose (target serum level 3-12 ng/ml by HPLC). Tacrolimus will be administered intravenously at a dose of 0.03 mg/kg (ideal body weight) q 24h by continuous infusion starting on Day -3. Intravenous Tacrolimus will be discontinued once the patient starts eating and the drug will then be given orally at a dose of approximately 4 times the intravenous dose. peripheral blood stem cell transplantation sirolimus: For adults, will be administered at 12 mg orally loading dose on day -3, follow
    All Cause Mortality
    Anti-thymocyte Globulin, Rituximab, Sirolimus, Tacrolimus,
    Affected / at Risk (%) # Events
    Total / (NaN)
    Serious Adverse Events
    Anti-thymocyte Globulin, Rituximab, Sirolimus, Tacrolimus,
    Affected / at Risk (%) # Events
    Total 0/4 (0%)
    Other (Not Including Serious) Adverse Events
    Anti-thymocyte Globulin, Rituximab, Sirolimus, Tacrolimus,
    Affected / at Risk (%) # Events
    Total 0/4 (0%)

    Limitations/Caveats

    Study terminated due to lack of funding. No analysis, patient data on this protocol due to the fact that only four patients was able to be accrued.

    More Information

    Certain Agreements

    All Principal Investigators ARE employed by the organization sponsoring the study.

    There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.

    Results Point of Contact

    Name/Title Zaid Al-Kadhimi, M.D.
    Organization Barbara Ann Karmanos Cancer Institute
    Phone 404-778-5984
    Email zalkadh@emory.edu
    Responsible Party:
    Zaid Al-Kadhimi, Principal Investigator, Barbara Ann Karmanos Cancer Institute
    ClinicalTrials.gov Identifier:
    NCT01116232
    Other Study ID Numbers:
    • CDR0000671822
    • P30CA022453
    • U4781s
    • 2009-150
    • NCT01534767
    First Posted:
    May 4, 2010
    Last Update Posted:
    Mar 26, 2019
    Last Verified:
    Mar 1, 2019