Skip to content
← Study library

NCT00089011 · REGISTRY CONDITION SEARCH

Tacrolimus and Mycophenolate Mofetil in Preventing Graft-Versus-Host Disease in Patients Who Have Undergone Total-Body Irradiation With or Without Fludarabine Phosphate Followed by Donor Peripheral Blood Stem Cell Transplant for Hematologic 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
2020-01-29

This phase II trial studies how well tacrolimus and mycophenolate mofetil works in preventing graft-versus-host disease in patients who have undergone total-body irradiation (TBI) with or without fludarabine phosphate followed by donor peripheral blood stem cell transplant for hematologic cancer. Giving low doses of chemotherapy, such as fludarabine phosphate, and TBI 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 system 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 and mycophenolate mofetil after the transplant may stop this from happening.

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.

Who could take part
eligibility Criteria
Inclusion Criteria: * Patient must be not eligible for conventional allogeneic hematopoietic cell transplantation (HCT) and must have disease expected to be stable for at least 100 days without chemotherapy; patients with hematologic malignancies treatable with HCT or with a B cell malignancy except those curable with autologous transplant will be included; patients not eligible for active disease specific protocols may be enrolled in this protocol; patients will include the following * Diffuse large B cell non-Hodgkin lymphoma (NHL) and other aggressive lymphomas - not eligible for conventional myeloablative HCT or after autologous HCT * Low grade NHL- with \< 6 months duration of complete response (CR) between courses of conventional therapy * Mantle cell NHL- may be treated in first CR * Chronic lymphocytic leukemia (CLL) - must have either 1) failed to meet National Cancer Institute (NCI) Working Group criteria for complete or partial response after therapy with a regimen containing fludarabine phosphate (FLU) (or another nucleoside analog, e.g. 2-chlorodeoxyadenosine \[2-CDA\], pentostatin) or experience disease relapse within 12 months after completing therapy with a regimen containing FLU (or another nucleoside analog); 2) failed FLU-cyclophosphamide (CY)-Rituximab (FCR) combination chemotherapy at any time point; or 3) have "17p deletion" cytogenetic abnormality; patients should have received induction chemotherapy but could be transplanted in 1st CR; 4) patients with a diagnosis of CLL (or small lymphocytic lymphoma) or a diagnosis of CLL that progresses to prolymphocytic leukemia (PLL), or T-cell CLL or PLL * Hodgkin lymphoma (HL) - must have received and failed frontline therapy; patients must have failed or were not eligible for autologous transplant * Multiple myeloma (MM) - following a planned autologous transplant or equivalent high-dose therapy without a graft, or following a failed prior autograft * Acute myeloid leukemia (AML) - must have \< 5% marrow blasts at the time of transplant * Acute lymphoblastic leukemia (ALL) - must have \< 5% marrow blasts at the time of transplant * Chronic myelogenous leukemia (CML) - patients will be accepted beyond first chronic phase (CP1) if they have received previous myelosuppressive chemotherapy or HCT, and have \< 5% marrow blasts at time of transplant * Myelodysplastic syndromes/myeloproliferative disorders (MDS/MPD) - must have received previous myelosuppressive chemotherapy or HCT, and have \< 5% marrow blasts at time of transplant * Waldenstrom's macroglobulinemia - must have failed 2 courses of therapy * Myelosuppressive chemotherapy must be discontinued three weeks prior to conditioning with the exception of hydroxyurea or imatinib * Patients \< 12 years old must be approved by both the participating institutions' patient review committee such as the Patient Care Conference (PCC) at the Fred Hutchinson Cancer Research Center (FHCRC) and the FHCRC principal investigator * Patient who refused to be treated on a conventional HCT protocol; for this inclusion criterion, transplants must be approved by both the participating institution's patient review committee such as the Patient Care Conference (PCC) at the FHCRC and the FHCRC principal investigators * Patients with human leukocyte antigen (HLA)-matched related donors * Patients with renal failure are eligible; however, patients with renal compromise (serum creatinine \> 2.0) will likely have further compromise in renal function and may require hemodialysis (which may be permanent) due to the need to maintain adequate serum tacrolimus levels * DONOR: Related donor who is HLA genotypically identical at least at one haplotype and may be phenotypically or genotypically identical at the allele level at HLA-A, -B, -C, -DRB1, and -DQB1 * DONOR: Donor must consent to filgrastim (G-CSF) administration and leukapheresis * DONOR: Donor must have adequate veins for leukapheresis or agree to placement of central venous catheter (femoral, subclavian) Exclusion Criteria: * Eligible for a high priority curative autologous transplant * Patient with rapidly progressive, aggressive NHL unless in minimal disease state * Patients with chronic myelomonocytic leukemia (CMML) * Life expectancy severely limited by diseases other than malignancy * Any current central nervous system (CNS) involvement with disease refractory to intrathecal chemotherapy * Presence of circulating leukemic blasts (in the peripheral blood) detected by standard pathology for patients with AML, ALL or CML * Fertile men or women unwilling to use contraceptives during and for up to 12 months post treatment * Female patients who are pregnant or breastfeeding * Human immunodeficiency virus (HIV)-positive patients * Patients with active non-hematologic malignancies (except non-melanoma skin cancers); this exclusion does not apply to patients with non-hematologic malignancies that do not require therapy * Patients with a history of non-hematologic malignancies (except non-melanoma skin cancers) currently in a complete remission, who are less than 5 years from the time of complete remission, and have a \> 20% risk of disease recurrence; this exclusion does not apply to patients with non-hematologic malignancies that do not require therapy * Fungal pneumonia with radiological progression after receipt of amphotericin formulation or mold-active azoles for greater than 1 month * Karnofsky score \< 50 for adult patients * Lansky-Play performance score \< 50 for pediatric patients * Symptomatic coronary artery disease or ejection fraction \< 35% or other cardiac failure requiring therapy (or, if unable to obtain ejection fraction, shortening fraction of \< 26%); ejection fraction is required if age \> 50 years or there is a history of anthracycline exposure or history of cardiac disease; patients with a shortening fraction \< 26% may be enrolled if approved by a cardiologist * Poorly controlled hypertension * Diffusing capacity of the lung for carbon monoxide (DLCO) \< 30%, total lung capacity (TLC) \< 30%, forced expiratory volume in one second (FEV1) \< 30% and/or receiving supplementary continuous oxygen; the FHCRC principal investigator (PI) of the study must approve enrollment of all patients with pulmonary nodules * Liver function abnormalities: Patients with clinical or laboratory evidence of liver disease would be evaluated for the cause of liver disease, its clinical severity in terms of liver function, and the degree of portal hypertension; patients will be excluded if they are found to have fulminant liver failure, cirrhosis of the liver with evidence of portal hypertension or bridging fibrosis, alcoholic hepatitis, esophageal varices, a history of bleeding esophageal varices, hepatic encephalopathy, uncorrectable hepatic synthetic dysfunction evinced by prolongation of the prothrombin time, ascites related to portal hypertension, bacterial or fungal liver abscess, biliary obstruction, chronic viral hepatitis with total serum bilirubin \> 3 mg/dL, and symptomatic biliary disease * Patients with active bacterial or fungal infections unresponsive to medical therapy * DONOR: Age less than 12 years * DONOR: Identical twin * DONOR: Pregnancy * DONOR: Infection with HIV * DONOR: Known allergy to filgrastim (G-CSF) * DONOR: Current serious systemic illness that would result in increased risk for G-CSF mobilization and harvest of peripheral blood stem cells (PBSC)
healthy Volunteers
false
maximum Age
74 Years
sex
ALL
std Ages
  1. CHILD
  2. ADULT
  3. OLDER_ADULT
Treatment arms and interventions
arm Groups
  1. description
    Patients receive fludarabine phosphate IV on days -4 to -2 and undergo TBI on day 0.
    intervention Names
    1. Drug: fludarabine phosphate
    2. Radiation: total-body irradiation
    3. Other: laboratory biomarker analysis
    label
    Arm I (nonmyeloablative conditioning with fludarabine and TBI)
    type
    EXPERIMENTAL
  2. description
    Patients undergo TBI on day 0. All patients then undergo allogeneic peripheral blood stem cell transplantation on day 0 and receive tacrolimus PO every 12 hours on days -3 to 180, with taper on day 56, or tacrolimus IV if unable to tolerate PO; and mycophenolate mofetil PO every 12 hours on days 0-27 or mycophenolate mofetil IV if unable to tolerate PO.
    intervention Names
    1. Radiation: total-body irradiation
    2. Drug: mycophenolate mofetil
    3. Drug: tacrolimus
    4. Procedure: peripheral blood stem cell transplantation
    5. Procedure: nonmyeloablative allogeneic hematopoietic stem cell transplantation
    6. Other: laboratory biomarker analysis
    label
    Arm II (nonmyeloablative conditioning with TBI)
    type
    EXPERIMENTAL
interventions
  1. arm Group Labels
    1. Arm I (nonmyeloablative conditioning with fludarabine and TBI)
    description
    Given IV
    name
    fludarabine phosphate
    other Names
    1. 2-F-ara-AMP
    2. Beneflur
    3. Fludara
    type
    DRUG
  2. arm Group Labels
    1. Arm I (nonmyeloablative conditioning with fludarabine and TBI)
    2. Arm II (nonmyeloablative conditioning with TBI)
    description
    Undergo radiotherapy
    name
    total-body irradiation
    other Names
    1. TBI
    type
    RADIATION
  3. arm Group Labels
    1. Arm II (nonmyeloablative conditioning with TBI)
    description
    Given IV or PO
    name
    mycophenolate mofetil
    other Names
    1. Cellcept
    2. MMF
    type
    DRUG
  4. arm Group Labels
    1. Arm II (nonmyeloablative conditioning with TBI)
    description
    Given IV or PO
    name
    tacrolimus
    other Names
    1. FK 506
    2. Prograf
    type
    DRUG
  5. arm Group Labels
    1. Arm II (nonmyeloablative conditioning with TBI)
    description
    Undergo allogeneic peripheral blood stem cell transplant
    name
    peripheral blood stem cell transplantation
    other Names
    1. PBPC transplantation
    2. PBSC transplantation
    3. peripheral blood progenitor cell transplantation
    4. transplantation, peripheral blood stem cell
    type
    PROCEDURE
  6. arm Group Labels
    1. Arm II (nonmyeloablative conditioning with TBI)
    description
    Undergo allogeneic peripheral blood stem cell transplant
    name
    nonmyeloablative allogeneic hematopoietic stem cell transplantation
    type
    PROCEDURE
  7. arm Group Labels
    1. Arm I (nonmyeloablative conditioning with fludarabine and TBI)
    2. Arm II (nonmyeloablative conditioning with TBI)
    description
    Correlative studies
    name
    laboratory biomarker analysis
    type
    OTHER
Study design
allocation
NON_RANDOMIZED
intervention Model
PARALLEL
masking Info
masking
NONE
primary Purpose
TREATMENT
Enrollment
count
150
type
ACTUAL
Registered outcome plans (not posted results)
primary Outcomes
  1. description
    Number of patients who developed acute/chronic GVHD post-transplant. aGVHD Stages Skin: a maculopapular eruption involving \< 25% BSA a maculopapular eruption involving 25 - 50% BSA generalized erythroderma generalized erythroderma with bullous formation and often with desquamation Liver: bilirubin 2.0 - 3.0 mg/100 mL bilirubin 3 - 5.9 mg/100 mL bilirubin 6 - 14.9 mg/100 mL bilirubin \> 15 mg/100 mL Gut: Diarrhea is graded 1 - 4 in severity. Nausea and vomiting and/or anorexia caused by GVHD is assigned as 1 in severity. The severity of gut involvement is assigned to the most severe involvement noted. Patients with visible bloody diarrhea are at least stage 2 gut and grade 3 overall. aGVHD Grades Grade III: Stage 2 - 4 gut involvement and/or stage 2 - 4 liver involvement Grade IV: Pattern and severity of GVHD similar to grade 3 with extreme constitutional symptoms or death
    measure
    Incidence of Grade III/IV GVHD
    time Frame
    Day 180 post-transplantation
  2. description
    Number of patients who developed chronic extensive GVHD post-transplant. The diagnosis of chronic GVHD requires at least one manifestation that is distinctive for chronic GVHD as opposed to acute GVHD. In all cases, infection and others causes must be ruled out in the differential diagnosis of chronic GVHD.
    measure
    Incidence of Chronic Extensive GVHD
    time Frame
    Day 180 post-transplantation
secondary Outcomes
  1. description
    Number of patients who rejected their graft. Rejection is defined as the inability to detect or loss of detection of greater than 5% donor T cells (CD3+) as a proportion of the total T cell population, respectively, after nonmyeloablative HCT.
    measure
    Incidences of Graft Rejection
    time Frame
    Day 180 post-transplantation
  2. description
    Number of patients surviving post-transplant.
    measure
    Overall Survival
    time Frame
    At 1 year after conditioning
  3. description
    Number of patients who developed acute/chronic GVHD post-transplant. aGVHD Stages Skin: a maculopapular eruption involving \< 25% BSA a maculopapular eruption involving 25 - 50% BSA generalized erythroderma generalized erythroderma with bullous formation and often with desquamation Liver: bilirubin 2.0 - 3.0 mg/100 mL bilirubin 3 - 5.9 mg/100 mL bilirubin 6 - 14.9 mg/100 mL bilirubin \> 15 mg/100 mL Gut: Diarrhea is graded 1 - 4 in severity. Nausea and vomiting and/or anorexia caused by GVHD is assigned as 1 in severity. The severity of gut involvement is assigned to the most severe involvement noted. Patients with visible bloody diarrhea are at least stage 2 gut and grade 3 overall. aGVHD Grades Grade II: Stage 1 - 3 skin and/or stage 1 gut involvement and/or stage 1 liver involvement Grade III: Stage 2 - 4 gut involvement and/or stage 2 - 4 liver involvement Grade IV: Pattern and severity of GVHD similar to grade 3 with extreme constitutional symptoms or death
    measure
    Incidences of Grades II-IV Acute GVHD
    time Frame
    Day 180 post-transplantation
  4. description
    Relapse/Progression criteria: CML New cytogenetic abnormality and/or development of accelerated phase or blast crisis. The criteria for accelerated phase will be defined as unexplained fever \>38.3°C, new clonal cytogenetic abnormalities in addition to a single Ph-positive chromosome, marrow blasts and promyelocytes \>20%. CMML, AML, ALL \>30% BM blasts w/ deteriorating performance status, or worsening of anemia, neutropenia, or thrombocytopenia. CLL ≥1 of: Physical exam/imaging studies ≥50% increase or new, circulating lymphocytes by morphology and/or flow cytometry ≥50% increase, and lymph node biopsy w/ Richter's transformation. NHL \>25% increase in the sum of the products of the perpendicular diameters of marker lesions, or the appearance of new lesions. MM ≥100% increase of the serum myeloma protein from its lowest level, or reappearance of myeloma peaks that had disappeared w/ treatment; or definite increase in the size or number of plasmacytomas or lytic bone lesions.
    measure
    Rates of Disease Progression
    time Frame
    Up to 5 years
  5. description
    Number of patients who expired with relapsed/progressive disease.
    measure
    Rates of Relapse-related Mortality
    time Frame
    Up to 5 years
  6. description
    Number of patients that received prednisone treatment of chronic GVHD, and number of days for which they received prednisone.
    measure
    Rate and Duration of Steroid Use for the Treatment of Chronic GVHD
    time Frame
    Up to 5 years
Full study description
brief Summary
This phase II trial studies how well tacrolimus and mycophenolate mofetil works in preventing graft-versus-host disease in patients who have undergone total-body irradiation (TBI) with or without fludarabine phosphate followed by donor peripheral blood stem cell transplant for hematologic cancer. Giving low doses of chemotherapy, such as fludarabine phosphate, and TBI 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 system 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 and mycophenolate mofetil after the transplant may stop this from happening.
detailed Description
PRIMARY OBJECTIVES: I. To estimate the incidence of grade III/IV graft-versus-host disease (GVHD) after conditioning with 200 centigray (cGy) TBI alone or Fludarabine (fludarabine phosphate)/200 cGy TBI followed by tacrolimus (Tac)/mycophenolate mofetil (MMF) immunosuppression in patients with hematologic malignancies. II. To estimate the incidence of chronic extensive GVHD. SECONDARY OBJECTIVES: I. To estimate the incidences of graft rejection. II. To estimate overall survival 1-year after conditioning. III. To evaluate the incidences of grades II-IV acute GVHD. IV. To evaluate the rates of disease progression and/or relapse-related mortality. V. To estimate the rate and duration of steroid use for the treatment of chronic GVHD. OUTLINE: Patients are assigned to 1 of 2 treatment arms. ARM I (nonmyeloablative conditioning with fludarabine phosphate and TBI): Patients receive fludarabine phosphate intravenously (IV) on days -4 to -2 and undergo TBI on day 0. ARM II (nonmyeloablative conditioning with TBI): Patients undergo TBI on day 0. All patients then undergo allogeneic peripheral blood stem cell transplantation on day 0 and receive tacrolimus orally (PO) every 12 hours on days -3 to 180, with taper on day 56, or tacrolimus IV if unable to tolerate PO; and mycophenolate mofetil PO every 12 hours on days 0-27 or mycophenolate mofetil IV if unable to tolerate PO. Treatment continues in the absence of disease progression or unacceptable toxicity. After completion of study treatment, patients are followed up every 6 months for 2 years and then annually for 3 years.
Source references
references
  1. citation
    Cooper JP, Storer BE, Granot N, Gyurkocza B, Sorror ML, Chauncey TR, Shizuru J, Franke GN, Maris MB, Boyer M, Bruno B, Sahebi F, Langston AA, Hari P, Agura ED, Lykke Petersen S, Maziarz RT, Bethge W, Asch J, Gutman JA, Olesen G, Yeager AM, Hubel K, Hogan WJ, Maloney DG, Mielcarek M, Martin PJ, Flowers MED, Georges GE, Woolfrey AE, Deeg JH, Scott BL, McDonald GB, Storb R, Sandmaier BM. Allogeneic hematopoietic cell transplantation with non-myeloablative conditioning for patients with hematologic malignancies: Improved outcomes over two decades. Haematologica. 2021 Jun 1;106(6):1599-1607. doi: 10.3324/haematol.2020.248187.
    pmid
    32499241
    type
    DERIVED
Source notices and limitations
    Discovery and provenance
    1. release id
      ctgov-registry-1336d216cbd1bbff780dac70
      edge id
      nct-edge-0735c48da957b78f13bc
      requested nct id
      NCT00089011
      primary nct id
      NCT00089011
      source kind
      ctgov_condition_query
      source record id
      Source null
      source file sha256
      f61b5b8281f834a98709317598003056a2aa82c9b92a292e3623f400c9c3291b
      payload sha256
      533680c272815ce3d1bbcd36dec5aca043367c3103ec6fc2155c22cd396a1424
      payload
      clinical indication matching status
      condition_index_match_asserted_by_registry_not_reviewed
      end exclusive
      true
      id
      nct-edge-0735c48da957b78f13bc
      link basis
      returned_by_explicit_condition_and_posted_results_filter_query
      nct id
      NCT00089011
      occurrences
      1. context exact
        NCT00089011
        end
        11
        exact text
        NCT00089011
        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-001.json
      source file sha256
      f61b5b8281f834a98709317598003056a2aa82c9b92a292e3623f400c9c3291b
      source json pointer
      /studies/70/protocolSection/identificationModule/nctId
      source kind
      ctgov_condition_query
      source record id
      Source null
      source string basis
      parsed_JSON_string_unmodified
      source string sha256
      05b331067994aba2ed702d142b2df44aee07f90d7217ce37e9e865c29533ab13
    2. release id
      ctgov-registry-1336d216cbd1bbff780dac70
      edge id
      nct-edge-74888548263efdd786f6
      requested nct id
      NCT00089011
      primary nct id
      NCT00089011
      source kind
      ctgov_condition_query
      source record id
      Source null
      source file sha256
      e270600534699a676fe83226e7a7b0f73aeb00c1d0a05cfc115c748864ad8173
      payload sha256
      ae2f6a6e0f1b341347cce2bdf3949801b1b62ba8b7727eede9bac69b1783bb12
      payload
      clinical indication matching status
      condition_index_match_asserted_by_registry_not_reviewed
      end exclusive
      true
      id
      nct-edge-74888548263efdd786f6
      link basis
      returned_by_explicit_condition_and_posted_results_filter_query
      nct id
      NCT00089011
      occurrences
      1. context exact
        NCT00089011
        end
        11
        exact text
        NCT00089011
        start
        0
      offset unit
      unicode_code_points
      query cond
      Peripheral T-Cell Non-Hodgkin Lymphoma
      query disease state id
      ds-peripheral-t-cell-non-hodgkin-lymphoma
      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
      e270600534699a676fe83226e7a7b0f73aeb00c1d0a05cfc115c748864ad8173
      source json pointer
      /studies/137/protocolSection/identificationModule/nctId
      source kind
      ctgov_condition_query
      source record id
      Source null
      source string basis
      parsed_JSON_string_unmodified
      source string sha256
      05b331067994aba2ed702d142b2df44aee07f90d7217ce37e9e865c29533ab13
    3. release id
      ctgov-registry-1336d216cbd1bbff780dac70
      edge id
      nct-edge-7b2e17327a56c81940ff
      requested nct id
      NCT00089011
      primary nct id
      NCT00089011
      source kind
      ctgov_condition_query
      source record id
      Source null
      source file sha256
      a6089e8b15d43633ec778b2a5c464ada1207289beea2ae90de3e4bbe04b32186
      payload sha256
      cf448d6237a52864506bac3a341270dd6645882f4053cec9f4d834aa39ca8cd3
      payload
      clinical indication matching status
      condition_index_match_asserted_by_registry_not_reviewed
      end exclusive
      true
      id
      nct-edge-7b2e17327a56c81940ff
      link basis
      returned_by_explicit_condition_and_posted_results_filter_query
      nct id
      NCT00089011
      occurrences
      1. context exact
        NCT00089011
        end
        11
        exact text
        NCT00089011
        start
        0
      offset unit
      unicode_code_points
      query cond
      Acute Undifferentiated Leukemia
      query disease state id
      ds-acute-undifferentiated-leukemia
      source file
      /Users/arunverma/Documents/ChatGPT/Cancer Statistics Website/research-data/2026-09-10/clinicaltrials-condition/round-0000/raw/cond-acute-undifferentiated-leukemia-000.json
      source file sha256
      a6089e8b15d43633ec778b2a5c464ada1207289beea2ae90de3e4bbe04b32186
      source json pointer
      /studies/58/protocolSection/identificationModule/nctId
      source kind
      ctgov_condition_query
      source record id
      Source null
      source string basis
      parsed_JSON_string_unmodified
      source string sha256
      05b331067994aba2ed702d142b2df44aee07f90d7217ce37e9e865c29533ab13
    4. release id
      ctgov-registry-1336d216cbd1bbff780dac70
      edge id
      nct-edge-7ee55c4b9ca48bec11cc
      requested nct id
      NCT00089011
      primary nct id
      NCT00089011
      source kind
      ctgov_condition_query
      source record id
      Source null
      source file sha256
      9e542f373b689060c2c6c67507f6e2a629c92470fc1ae13d9359244ba59cb6b8
      payload sha256
      829af1f9636ea4c4a120307518f081abaac094341e1204c7458533f9b702e60c
      payload
      clinical indication matching status
      condition_index_match_asserted_by_registry_not_reviewed
      end exclusive
      true
      id
      nct-edge-7ee55c4b9ca48bec11cc
      link basis
      returned_by_explicit_condition_and_posted_results_filter_query
      nct id
      NCT00089011
      occurrences
      1. context exact
        NCT00089011
        end
        11
        exact text
        NCT00089011
        start
        0
      offset unit
      unicode_code_points
      query cond
      Testicular Cancer
      query disease state id
      ds-testicular-cancer
      source file
      /Users/arunverma/Documents/ChatGPT/Cancer Statistics Website/research-data/2026-09-10/clinicaltrials-condition/round-0000/raw/cond-testicular-cancer-000.json
      source file sha256
      9e542f373b689060c2c6c67507f6e2a629c92470fc1ae13d9359244ba59cb6b8
      source json pointer
      /studies/60/protocolSection/identificationModule/nctId
      source kind
      ctgov_condition_query
      source record id
      Source null
      source string basis
      parsed_JSON_string_unmodified
      source string sha256
      05b331067994aba2ed702d142b2df44aee07f90d7217ce37e9e865c29533ab13
    5. release id
      ctgov-registry-1336d216cbd1bbff780dac70
      edge id
      nct-edge-8335630435c7c8369686
      requested nct id
      NCT00089011
      primary nct id
      NCT00089011
      source kind
      ctgov_condition_query
      source record id
      Source null
      source file sha256
      193739e64f77123de4344901c9970a0996a667fa587f14135380bef3ae38e11d
      payload sha256
      19b940ec04384bb212b7e1130242ca063dad2b5e952f57057a4dbf5bb5f92f22
      payload
      clinical indication matching status
      condition_index_match_asserted_by_registry_not_reviewed
      end exclusive
      true
      id
      nct-edge-8335630435c7c8369686
      link basis
      returned_by_explicit_condition_and_posted_results_filter_query
      nct id
      NCT00089011
      occurrences
      1. context exact
        NCT00089011
        end
        11
        exact text
        NCT00089011
        start
        0
      offset unit
      unicode_code_points
      query cond
      Childhood Chronic Myeloid Leukemia
      query disease state id
      ds-chronic-myeloid-leukemia-pediatric
      source file
      /Users/arunverma/Documents/ChatGPT/Cancer Statistics Website/research-data/2026-09-10/clinicaltrials-condition/round-0000/raw/cond-childhood-chronic-myeloid-leukemia-000.json
      source file sha256
      193739e64f77123de4344901c9970a0996a667fa587f14135380bef3ae38e11d
      source json pointer
      /studies/62/protocolSection/identificationModule/nctId
      source kind
      ctgov_condition_query
      source record id
      Source null
      source string basis
      parsed_JSON_string_unmodified
      source string sha256
      05b331067994aba2ed702d142b2df44aee07f90d7217ce37e9e865c29533ab13
    6. release id
      ctgov-registry-1336d216cbd1bbff780dac70
      edge id
      nct-edge-bc12996071d46417c3a6
      requested nct id
      NCT00089011
      primary nct id
      NCT00089011
      source kind
      ctgov_condition_query
      source record id
      Source null
      source file sha256
      69c40ed34b17434f684079ec5635264bc5ad292871a86b835704fc99fa9d8157
      payload sha256
      8c9ef28eb72a311904e9c8d21c55a68966d1df9eba5256490bc6594f63e5cbb0
      payload
      clinical indication matching status
      condition_index_match_asserted_by_registry_not_reviewed
      end exclusive
      true
      id
      nct-edge-bc12996071d46417c3a6
      link basis
      returned_by_explicit_condition_and_posted_results_filter_query
      nct id
      NCT00089011
      occurrences
      1. context exact
        NCT00089011
        end
        11
        exact text
        NCT00089011
        start
        0
      offset unit
      unicode_code_points
      query cond
      Small Intestine Cancer
      query disease state id
      ds-small-intestine-cancer
      source file
      /Users/arunverma/Documents/ChatGPT/Cancer Statistics Website/research-data/2026-09-10/clinicaltrials-condition/round-0000/raw/cond-small-intestine-cancer-000.json
      source file sha256
      69c40ed34b17434f684079ec5635264bc5ad292871a86b835704fc99fa9d8157
      source json pointer
      /studies/133/protocolSection/identificationModule/nctId
      source kind
      ctgov_condition_query
      source record id
      Source null
      source string basis
      parsed_JSON_string_unmodified
      source string sha256
      05b331067994aba2ed702d142b2df44aee07f90d7217ce37e9e865c29533ab13
    7. release id
      ctgov-registry-1336d216cbd1bbff780dac70
      edge id
      nct-edge-d64981f58572264f59a0
      requested nct id
      NCT00089011
      primary nct id
      NCT00089011
      source kind
      ctgov_condition_query
      source record id
      Source null
      source file sha256
      a4be8fb2a7db9247bdfed231ef84ae19b3babbe8d619ebf7403cceb730eae2d4
      payload sha256
      00932e57875a90287d680ff8730815ef13a61f8d9cccceaffbc2c568f1eaa71f
      payload
      clinical indication matching status
      condition_index_match_asserted_by_registry_not_reviewed
      end exclusive
      true
      id
      nct-edge-d64981f58572264f59a0
      link basis
      returned_by_explicit_condition_and_posted_results_filter_query
      nct id
      NCT00089011
      occurrences
      1. context exact
        NCT00089011
        end
        11
        exact text
        NCT00089011
        start
        0
      offset unit
      unicode_code_points
      query cond
      Childhood Myelodysplastic Neoplasms
      query disease state id
      ds-myelodysplastic-neoplasms-pediatric
      source file
      /Users/arunverma/Documents/ChatGPT/Cancer Statistics Website/research-data/2026-09-10/clinicaltrials-condition/round-0000/raw/cond-childhood-myelodysplastic-neoplasms-000.json
      source file sha256
      a4be8fb2a7db9247bdfed231ef84ae19b3babbe8d619ebf7403cceb730eae2d4
      source json pointer
      /studies/69/protocolSection/identificationModule/nctId
      source kind
      ctgov_condition_query
      source record id
      Source null
      source string basis
      parsed_JSON_string_unmodified
      source string sha256
      05b331067994aba2ed702d142b2df44aee07f90d7217ce37e9e865c29533ab13
    8. release id
      ctgov-registry-1336d216cbd1bbff780dac70
      edge id
      nct-edge-e2125c50fd027e2f8251
      requested nct id
      NCT00089011
      primary nct id
      NCT00089011
      source kind
      ctgov_condition_query
      source record id
      Source null
      source file sha256
      8b9a346048372591e3ee0de631ceead25528dc1d384a69971d454af93b26921d
      payload sha256
      6081717841ac4439f28dc5ef72fe257631c1cb3d420ef9ae3aeb006107f6d81d
      payload
      clinical indication matching status
      condition_index_match_asserted_by_registry_not_reviewed
      end exclusive
      true
      id
      nct-edge-e2125c50fd027e2f8251
      link basis
      returned_by_explicit_condition_and_posted_results_filter_query
      nct id
      NCT00089011
      occurrences
      1. context exact
        NCT00089011
        end
        11
        exact text
        NCT00089011
        start
        0
      offset unit
      unicode_code_points
      query cond
      Hairy Cell Leukemia
      query disease state id
      ds-hairy-cell-leukemia
      source file
      /Users/arunverma/Documents/ChatGPT/Cancer Statistics Website/research-data/2026-09-10/clinicaltrials-condition/round-0000/raw/cond-hairy-cell-leukemia-000.json
      source file sha256
      8b9a346048372591e3ee0de631ceead25528dc1d384a69971d454af93b26921d
      source json pointer
      /studies/51/protocolSection/identificationModule/nctId
      source kind
      ctgov_condition_query
      source record id
      Source null
      source string basis
      parsed_JSON_string_unmodified
      source string sha256
      05b331067994aba2ed702d142b2df44aee07f90d7217ce37e9e865c29533ab13

    Preserved source evidence · Not medical advice