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NCT00589563 · REGISTRY CONDITION SEARCH

Sirolimus, Tacrolimus, and Antithymocyte Globulin in Preventing Graft-Versus-Host Disease in Patients Undergoing a Donor Stem Cell Transplant For Hematological Cancer

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
2014-09-10

RATIONALE: Giving chemotherapy and total-body irradiation before a donor peripheral blood stem cell transplant helps stop the growth of cancer cells. It also stops the patient's immune system from rejecting the donor's stem cells. The donated stem cells may replace the patient's immune cells and help destroy any remaining cancer cells (graft-versus-tumor effect). Sometimes the transplanted cells from a donor can also make an immune response against the body's normal cells. Giving tacrolimus, sirolimus, antithymocyte globulin, and methotrexate before and after transplant may stop this from happening. PURPOSE: This phase II trial is studying how well sirolimus, tacrolimus, and antithymocyte globulin work in preventing graft-versus-host disease in patients undergoing a donor stem cell transplant for hematological cancer .

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

Cumulative Incidence of Grade II-IV Acute Graft-Versus-Host Disease (GVHD) at Day 100

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outcome · POSTED

Severity of Acute GVHD

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outcome · POSTED

Time to Absolute Neutrophil Count Recovery (Engraftment)

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outcome · POSTED

Time to Platelet Count Recovery (Engraftment)

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outcome · POSTED

Occurence of Infections Including Cytomegalovirus and Epstein-Barr Virus Reactivation

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outcome · POSTED

Occurrence of Thrombotic Microangiopathy

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outcome · POSTED

Occurence of Sinusoidal Obstructive Syndrome (SOS)

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outcome · POSTED

Non-relapse Mortality at 100 Days Post HSCT

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outcome · POSTED

Non-relapse Mortality at Two Years Post HSCT

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outcome · POSTED

Overall Survival at Two Years Post HSCT

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outcome · POSTED

Event Free Survival at Two Years Post HSCT

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outcome · POSTED

Cumulative Incidence of Chronic GVHD

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outcome · POSTED

Severity of Chronic GVHD

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outcome · POSTED

Incidence of Disease Relapse/Progression at 2 Years Post HSCT

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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
DISEASE CHARACTERISTICS: * Diagnosis of hematological malignancy including any of the following: * Non-Hodgkin lymphoma (NHL) in any complete remission (CR) or partial response (PR) * Hodgkin lymphoma in any CR or PR * Acute myeloid leukemia (AML) or acute lymphoblastic leukemia (ALL) in any CR * Bone marrow blasts \< 20% within 4 weeks of transplant and peripheral blood absolute blast count \< 500/µL on the day of initiation of conditioning for patients with non-CR AML or ALL * Myelodysplastic syndromes (MDS) treated or untreated * Chronic myelogenous leukemia (CML) in chronic or accelerated phase * Multiple myeloma in any CR or PR * Chronic lymphocytic leukemia in CR or PR 2 or greater * Myelofibrosis and other myeloproliferative disorders * Bone marrow blasts \< 20% within 4 weeks of transplant and peripheral blood absolute blast count \< 500/µL on the day of initiation * High-risk disease defined as AML or ALL \> CR1, accelerated phase CML, recurrent aggressive lymphoma, or active lymphoproliferative disease at transplant * Low-risk disease defined as AML or ALL in CR1, chronic phase CML, or low-grade lymphoproliferative disorder with controlled disease at transplant * Must be planning to receive 1 of the following conditioning regimens at City of Hope: * Fludarabine phosphate and melphalan for patients with hematological malignancies and contraindications for conventional myeloablative regimens due to age, co-morbidity, or previous transplant * Fractionated total-body irradiation (FTBI) and etoposide for patients with AML and ALL or CML in accelerated phase * FTBI and cyclophosphamide for patients with NHL, AML, CML, and MDS * Suitable unrelated donor available * HLA-matched or mismatched * Peripheral blood stem cells available * No bone marrow or ex vivo-engineered or processed graft (e.g., CD34-positive, T-cell depletion) * No uncontrolled CNS disease PATIENT CHARACTERISTICS: * Karnofsky performance status (PS) 70-100% or ECOG PS 0-2 * Creatinine \< 1.3 mg/dL or creatinine clearance ≥ 70 mL/min * Ejection fraction \> 45% * Direct bilirubin \< 3 times upper limit of normal (ULN) * ALT and AST \< 3 times ULN * Forced vital capacity, FEV1, and DLCO \> 45% of predicted * Able to cooperate with oral medication intake * No active donor or recipient serology positive for HIV * No known contraindication to administration of sirolimus, tacrolimus, or anti-thymocyte globulin * No active hepatitis B or C * Negative pregnancy test PRIOR CONCURRENT THERAPY: * See Disease Characteristics * Concurrent participation in other clinical trials for prevention or treatment of viral, bacterial, or fungal disease allowed provided agents do not interact with agents used in the current study
healthy Volunteers
false
minimum Age
2 Years
sex
ALL
std Ages
  1. CHILD
  2. ADULT
  3. OLDER_ADULT
Treatment arms and interventions
arm Groups
  1. description
    Fludarabine/Melphalan Conditioning with Sirolimus, Tacrolimus and rabbit anti-thymocyte globulin (+/- methotrexate) for GvHD Prophylaxis
    intervention Names
    1. Biological: anti-thymocyte globulin
    2. Drug: fludarabine phosphate
    3. Drug: melphalan
    4. Drug: methotrexate
    5. Drug: sirolimus
    6. Drug: tacrolimus
    7. Procedure: allogeneic hematopoietic stem cell transplantation
    8. Procedure: hematopoietic stem cell transplantation
    9. Procedure: nonmyeloablative allogeneic hematopoietic stem cell transplantation
    10. Procedure: peripheral blood stem cell transplantation
    11. Radiation: total-body irradiation
    label
    Fludarabine/Melphalan Conditioning
    type
    EXPERIMENTAL
  2. description
    FTBI/Cytoxan Conditioning with Sirolimus, Tacrolimus and rabbit anti-thymocyte globulin (+/- methotrexate) for GvHD Prophylaxis
    intervention Names
    1. Biological: anti-thymocyte globulin
    2. Drug: cyclophosphamide
    3. Drug: methotrexate
    4. Drug: sirolimus
    5. Drug: tacrolimus
    6. Procedure: allogeneic hematopoietic stem cell transplantation
    7. Procedure: hematopoietic stem cell transplantation
    8. Procedure: nonmyeloablative allogeneic hematopoietic stem cell transplantation
    9. Procedure: peripheral blood stem cell transplantation
    10. Radiation: total-body irradiation
    label
    FTBI/Cytoxan Conditioning
    type
    EXPERIMENTAL
  3. description
    FTBI/Etoposide Conditioning with Sirolimus, Tacrolimus and rabbit anti-thymocyte globulin (+/- methotrexate) for GvHD Prophylaxis
    intervention Names
    1. Biological: anti-thymocyte globulin
    2. Drug: etoposide
    3. Drug: methotrexate
    4. Drug: sirolimus
    5. Drug: tacrolimus
    6. Procedure: allogeneic hematopoietic stem cell transplantation
    7. Procedure: hematopoietic stem cell transplantation
    8. Procedure: nonmyeloablative allogeneic hematopoietic stem cell transplantation
    9. Procedure: peripheral blood stem cell transplantation
    10. Radiation: total-body irradiation
    label
    FTBI/Etoposide Conditioning
    type
    EXPERIMENTAL
interventions
  1. arm Group Labels
    1. FTBI/Cytoxan Conditioning
    2. FTBI/Etoposide Conditioning
    3. Fludarabine/Melphalan Conditioning
    description
    0.5 mg/kg on day -3, 1.5 mg/kg on day -2 and 2.5 mg/kg on day -1 or day 0 from stem cell transplant
    name
    anti-thymocyte globulin
    type
    BIOLOGICAL
  2. arm Group Labels
    1. FTBI/Cytoxan Conditioning
    description
    60mg/kg on days -5 and -4 from stem cell transplant
    name
    cyclophosphamide
    type
    DRUG
  3. arm Group Labels
    1. FTBI/Etoposide Conditioning
    description
    60mg/kg on day -4 from stem cell transplant
    name
    etoposide
    type
    DRUG
  4. arm Group Labels
    1. Fludarabine/Melphalan Conditioning
    description
    Fludarabine 25 mg/m2/d from days -9 to -5 from stem cell transplant
    name
    fludarabine phosphate
    type
    DRUG
  5. arm Group Labels
    1. Fludarabine/Melphalan Conditioning
    description
    Melphalan 140 mg/m2 on day -4 from stem cell transplant
    name
    melphalan
    type
    DRUG
  6. arm Group Labels
    1. FTBI/Cytoxan Conditioning
    2. FTBI/Etoposide Conditioning
    3. Fludarabine/Melphalan Conditioning
    description
    For high risk HLA-mismatch transplant only: 5 mg/m2 on days +1, +3 and +6 from stem cell transplant
    name
    methotrexate
    type
    DRUG
  7. arm Group Labels
    1. FTBI/Cytoxan Conditioning
    2. FTBI/Etoposide Conditioning
    3. Fludarabine/Melphalan Conditioning
    description
    Adults: 12 mg loading dose on day -3 from stem cell transplant followed by 4 mg orally single morning daily dose. Pediatric Patients \<40kg: 3 mg/m2 orally on day -3 from stem cell transplant followed by 1 mg/m2 orally single morning daily dose
    name
    sirolimus
    type
    DRUG
  8. arm Group Labels
    1. FTBI/Cytoxan Conditioning
    2. FTBI/Etoposide Conditioning
    3. Fludarabine/Melphalan Conditioning
    description
    0.02 mg/kd/d CIV beginning on day -3 from stem cell transplant
    name
    tacrolimus
    type
    DRUG
  9. arm Group Labels
    1. FTBI/Cytoxan Conditioning
    2. FTBI/Etoposide Conditioning
    3. Fludarabine/Melphalan Conditioning
    description
    The target peripheral blood stem cell dose will be 5-10 x 106/kg actual body weight
    name
    allogeneic hematopoietic stem cell transplantation
    type
    PROCEDURE
  10. arm Group Labels
    1. FTBI/Cytoxan Conditioning
    2. FTBI/Etoposide Conditioning
    3. Fludarabine/Melphalan Conditioning
    description
    The target peripheral blood stem cell dose will be 5-10 x 106/kg actual body weight
    name
    hematopoietic stem cell transplantation
    type
    PROCEDURE
  11. arm Group Labels
    1. FTBI/Cytoxan Conditioning
    2. FTBI/Etoposide Conditioning
    3. Fludarabine/Melphalan Conditioning
    description
    Fludarabine 25 mg/m2/d from days -9 to -5 from stem cell transplant, Melphalan 140 mg/m2 on day -4 from stem cell transplant
    name
    nonmyeloablative allogeneic hematopoietic stem cell transplantation
    type
    PROCEDURE
  12. arm Group Labels
    1. FTBI/Cytoxan Conditioning
    2. FTBI/Etoposide Conditioning
    3. Fludarabine/Melphalan Conditioning
    description
    The target peripheral blood stem cell dose will be 5-10 x 106/kg actual body weight
    name
    peripheral blood stem cell transplantation
    type
    PROCEDURE
Study design
allocation
NON_RANDOMIZED
intervention Model
SINGLE_GROUP
masking Info
masking
NONE
primary Purpose
SUPPORTIVE_CARE
Enrollment
count
32
type
ACTUAL
Registered outcome plans (not posted results)
primary Outcomes
  1. description
    Patients were evaluated for the development of acute GVHD within the first 100 days post HSCT. The cumulative incidence of grade II-IV acute GVHD was determined using competing risk analysis. Competing risks for acute GVHD were death and nonengraftment.
    measure
    Cumulative Incidence of Grade II-IV Acute Graft-Versus-Host Disease (GVHD) at Day 100
    time Frame
    100 Days Post Hematopoietic Stem Cell Transplant (HSCT)
  2. description
    All patients were considered for the evaluation of the severity of acute GVHD.
    measure
    Severity of Acute GVHD
    time Frame
    100 Days Post HSCT
  3. description
    Patients were evaluated for the development of chronic GVHD from 101 days post HSCT to last contact or documented evidence of the disease. The cumulative incidence of chronic GVHD was determined using competing risk analysis. Competing risks for GVHD were death and nonengraftment.
    measure
    Cumulative Incidence of Chronic GVHD
    time Frame
    2 year point estimate was provided.
  4. description
    All Patients were considered for the evaluation of chronic GVHD severity.
    measure
    Severity of Chronic GVHD
    time Frame
    Patients were evaluated until they developed chronic GVHD, a median of 130 days post HSCT
secondary Outcomes
  1. description
    Absolute neutrophil count (ANC) recovery is defined as an ANC of ≥ 0.5 x 10\^9/L (500/mm3) for three consecutive laboratory values obtained on different days
    measure
    Time to Absolute Neutrophil Count Recovery (Engraftment)
    time Frame
    Patients were evaluated until neutrophil recovery, a median of 15 days post HSCT
  2. description
    Platelet recovery is defined as the first date of three consecutive laboratory values ≥ 25 x 10\^9 L obtained on different days.
    measure
    Time to Platelet Count Recovery (Engraftment)
    time Frame
    Patients were evaluated until platelet recovery, a median of 14 days
  3. description
    Participants were monitored throughout the trial (median of 28 months) for various infections/complications.
    measure
    Occurence of Infections Including Cytomegalovirus and Epstein-Barr Virus Reactivation
    time Frame
    Median Follow Up: 28 months (Range: 1-49 months)
  4. description
    Participants were monitored throughout the trial (median of 28 months) for various infections/complications. This is the number of participants who developed TMA.
    measure
    Occurrence of Thrombotic Microangiopathy
    time Frame
    Median Follow Up: 28 Months (Range: 1-49 months)
  5. description
    Participants were monitored throughout the trial (median of 28 months) for various infections/complications. This is the number of participants who developed SOS.
    measure
    Occurence of Sinusoidal Obstructive Syndrome (SOS)
    time Frame
    Median Follow Up: 28 Months (Range: 1-49 Months)
  6. description
    Patients were evaluated for non-relapse mortality (NRM) throughout the study. Non-relapse mortality was considered any death not attributable to relapse or disease progression. The cumulative incidence of NRM was determined using competing risk analysis. Competing risks for NRM were death due to disease progression, relapse and nonengraftment.
    measure
    Non-relapse Mortality at 100 Days Post HSCT
    time Frame
    100 day point estimate was provided
  7. description
    Patients were evaluated for non-relapse mortality (NRM) throughout the study. Non-relapse mortality was considered any death not attributable to relapse or disease progression. The cumulative incidence of NRM was determined using competing risk analysis. Competing risks for NRM were death due to disease progression, relapse and nonengraftment.
    measure
    Non-relapse Mortality at Two Years Post HSCT
    time Frame
    2 year point estimate was provided.
  8. description
    Patients were evaluated for survival (OS) throughout the study. Kaplan Meier estiamtes were calculated for overall survival using time from HSCT to death of any cause or for surviving patients last contact date.
    measure
    Overall Survival at Two Years Post HSCT
    time Frame
    2 year point estimate was provided.
  9. description
    Patients were evaluated for event free survival (EFS) throughout the study. Events were defined as death, relapse, progression, or nonengraftment. Kaplan Meier estimates were calculated as time from HSCT to event.
    measure
    Event Free Survival at Two Years Post HSCT
    time Frame
    2 year point estimate was provided.
  10. description
    Patients were evaluated for relapse/progression post transplant throughout the study. The cumulative incidence of relapse/progression was determined using competing risk analysis. Competing risks for relapse were non-relapse mortality and nonengraftment.
    measure
    Incidence of Disease Relapse/Progression at 2 Years Post HSCT
    time Frame
    2 year point estimate was provided.
Full study description
brief Summary
RATIONALE: Giving chemotherapy and total-body irradiation before a donor peripheral blood stem cell transplant helps stop the growth of cancer cells. It also stops the patient's immune system from rejecting the donor's stem cells. The donated stem cells may replace the patient's immune cells and help destroy any remaining cancer cells (graft-versus-tumor effect). Sometimes the transplanted cells from a donor can also make an immune response against the body's normal cells. Giving tacrolimus, sirolimus, antithymocyte globulin, and methotrexate before and after transplant may stop this from happening. PURPOSE: This phase II trial is studying how well sirolimus, tacrolimus, and antithymocyte globulin work in preventing graft-versus-host disease in patients undergoing a donor stem cell transplant for hematological cancer .
detailed Description
OBJECTIVES: Primary * To determine the incidence and severity of acute- and chronic-graft-versus-host disease (GVHD) after HLA-matched or -mismatched unrelated donor hematopoietic peripheral blood transplantation in patients with hematologic malignancies scheduled to receive immunosuppressive combination of sirolimus, tacrolimus, and anti-thymocyte globulin as GVHD prophylaxis. * To determine the safety of this combination in the first six months post-transplant. Secondary * To determine the time-to-engraftment, non-relapse mortality rate, overall and disease-free survival, incidence of disease relapse, and incidence of opportunistic infections with this GVHD prophylaxis. OUTLINE: Patients are stratified according to conditioning regimen (fludarabine phosphate and melphalan vs fractionated total-body irradiation \[FTBI\] and etoposide vs FTBI and cyclophosphamide) and degree of donor/recipient HLA mismatch (high-risk vs low-risk). * Conditioning regimen: Patients receive 1 of 3 standard conditioning regimens beginning on day -9 or -8 and continuing to day -1 or 0. * Peripheral blood stem cell transplantation: Patients receive HLA-matched or mismatched unrelated donor peripheral blood stem cells on day 0. * Graft-versus-host disease prophylaxis: Patients receive tacrolimus IV continuously beginning on day -3 and then orally when tolerated, oral sirolimus on days -3 and -2, anti-thymocyte globulin IV over 4-8 hours on days -3 to 0, and methotrexate\* IV on days 1, 3, and 6. Tacrolimus and sirolimus continue for 3-6 months (with taper). NOTE: \*Only patients with high-risk HLA mismatch receive treatment with methotrexate. After completion of study therapy, patients are followed periodically for up to 2 years.
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      /studies/36/protocolSection/identificationModule/nctId
      source kind
      ctgov_condition_query
      source record id
      Source null
      source string basis
      parsed_JSON_string_unmodified
      source string sha256
      c80ffd402228d02fbe024f8c7392660ee26e987c72262cf8600520950435c56b
    6. release id
      ctgov-registry-1336d216cbd1bbff780dac70
      edge id
      nct-edge-de74e242dfc708c191fa
      requested nct id
      NCT00589563
      primary nct id
      NCT00589563
      source kind
      ctgov_condition_query
      source record id
      Source null
      source file sha256
      2314ce01316b2d7044d298c6d25eda12e99cc5f44273bc75efed6cd5e03a8c14
      payload sha256
      bfb39d3bb13054635fdd80b0b0fe46e714eb9281f50bb80de3c0f6d104fb74b1
      payload
      clinical indication matching status
      condition_index_match_asserted_by_registry_not_reviewed
      end exclusive
      true
      id
      nct-edge-de74e242dfc708c191fa
      link basis
      returned_by_explicit_condition_and_posted_results_filter_query
      nct id
      NCT00589563
      occurrences
      1. context exact
        NCT00589563
        end
        11
        exact text
        NCT00589563
        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/589/protocolSection/identificationModule/nctId
      source kind
      ctgov_condition_query
      source record id
      Source null
      source string basis
      parsed_JSON_string_unmodified
      source string sha256
      c80ffd402228d02fbe024f8c7392660ee26e987c72262cf8600520950435c56b

    Preserved source evidence · Not medical advice