Skip to content
← Study library

NCT01805037 · REGISTRY CONDITION SEARCH

Brentuximab Vedotin + Rituximab as Frontline Therapy for Pts w/ CD30+ and/or EBV+ Lymphomas

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

Phase
PHASE1, PHASE2
Status at capture
TERMINATED
Registry last update
2021-09-01

The purpose of this study is to evaluate how safe and effective the combination of two different drugs (brentuximab vedotin and rituximab) is in patients with certain types of lymphoma. This study is for patients who have a type of lymphoma that expresses a tumor marker called CD30 and/or a type that is associated with the Epstein-Barr virus (EBV-related lymphoma) and who have not yet received any treatment for their cancer, except for dose-reduction or discontinuation (stoppage) of medications used to prevent rejection of transplanted organs (for those patients who have undergone transplantation). This study is investigating the combination of brentuximab vedotin and rituximab as a first treatment for lymphoma patients

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: * Histologically confirmed CD30+ and/or EBV+ lymphoid malignancy; in addition, there must be evidence of CD20 expression (at any level) * In cases of post-transplant lymphoproliferative disorder (PTLD) arising in patients who are pharmacologically immunosuppressed, reduction of immunosuppression (RI) must be attempted prior to or in conjunction with enrollment, with the exception of those for whom RI would pose excessive threat of clinically significant graft rejection (as judged by local investigator) * No prior chemotherapy or radiotherapy for PTLD or diffuse large B-cell lymphoma (DLBCL), with the exception of corticosteroids for 10 or fewer days at any dose (no washout period required) * No prior surgical intervention, unless performed for the sake of tissue diagnosis or on an urgent basis for disease-related threat to life, limb, or organ function * Bi-dimensionally measurable disease (at least 1 cm) * Eastern Cooperative Oncology Group (ECOG) performance status =\< 2 * Absolute neutrophil count \>= 750/mcL * Platelets \>= 50,000/mcl * Total bilirubin =\< 2 X institutional upper limit of normal (ULN) * Aspartate aminotransferase (AST) (serum glutamic oxaloacetic transaminase \[SGOT\])/alanine aminotransferase (ALT) (serum pyruvate glutamate transaminase \[SPGT\]) =\< 3 X institutional ULN * Creatinine =\< 2 X institutional ULN * NOTE: Patients who do not meet the above criteria because of disease involvement of the organ in question, or because of acute systemic illness due to lymphoma, may enroll with permission of the study Principal Investigator (PI) and approval from the Data Monitoring Committee; this flexibility be allowed due to the heterogeneity of the patient population, the wide range of complications seen in the initial presentation of EBV-related malignancy, and the frequent difficulty encountered in attempting to clearly document that organ dysfunction is the result of an underlying lymphoproliferative disorder * Women of child-bearing potential and men must agree to use adequate contraception (hormonal or barrier method of birth control; abstinence) prior to study entry, for the duration of study participation, and for 90 days following completion of therapy; should a woman become pregnant or suspect she is pregnant while participating in this study, she should inform her treating physician immediately * A female of child-bearing potential is any woman (regardless of sexual orientation, having undergone a tubal ligation, or remaining celibate by choice) who meets the following criteria: * Has not undergone a hysterectomy or bilateral oophorectomy; or * Has not been naturally postmenopausal for at least 12 consecutive months (i.e., has had menses at any time in the preceding 12 consecutive months) * Patients must be free of any prior malignancies for \>= 1 year; NOTE: the exception to this would be currently treated squamous cell and basal cell carcinoma of the skin, carcinoma in situ of the cervix, breast, or bladder, or surgically removed melanoma in situ of the skin (stage 0) with histologically confirmed free margins of excision; in addition, it is well-recognized that patients at highest risk for EBV-related lymphoma (ie, those with chronic immunosuppression) are also at high risk for various malignancies, both invasive and non-invasive; therefore, exceptions may also be granted on a case-by-case basis, at the discretion of the PI with approval from the Data Monitoring Committee, for those patients with good clinical control of active malignancy, if the EBV-related lymphoma is considered to be a more immediate threat to the subject's health and/or life * Ability to understand and the willingness to sign a written informed consent; all patients must have signed, witnessed informed consent prior to registration Exclusion Criteria: * Chemotherapy (including monoclonal antibodies) or radiotherapy, administered for any condition, within 4 weeks prior to entering the study or incomplete recovery from adverse events due to agents administered more than 4 weeks earlier * Ongoing treatment with any other investigational agents * Known central nervous system (CNS) involvement of lymphoma * History of allergic reactions attributed to compounds of similar chemical or biologic composition to brentuximab vedotin and/or rituximab * Uncontrolled intercurrent illness including, but not limited to, ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, or psychiatric illness/social situations that would limit compliance with study requirements * Known human immunodeficiency virus (HIV) infection * Known John Cunningham (JC) virus infection and/or progressive multifocal leukoencephalopathy (PML) * Clinically active hepatitis A, B, or C infections; NOTE: patients with chronic hepatitis C (HCV) or hepatitis B (HBV) infection may enroll if other laboratory criteria are met; those with HBV surface antigen positivity may enroll only if maintained on appropriate suppressive antiviral therapy, per treating investigator's discretion, for the duration of enrollment in the trial * Pregnancy or active nursing of an infant
healthy Volunteers
false
minimum Age
18 Years
sex
ALL
std Ages
  1. ADULT
  2. OLDER_ADULT
Treatment arms and interventions
arm Groups
  1. description
    INDUCTION: Patients receive brentuximab vedotin IV over 30 minutes once weekly for 3 weeks and rituximab IV once weekly for 4 weeks. Patients unable to achieve CR may receive additional optional consolidation therapy identical to induction therapy. MAINTENANCE THERAPY: Patients receive brentuximab vedotin IV once every 3 weeks and rituximab IV once every 6 weeks. Treatment repeats every 21 days for up to 1 year in the absence of disease progression or unacceptable toxicity.
    intervention Names
    1. Drug: brentuximab vedotin
    2. Biological: rituximab
    3. Other: laboratory biomarker analysis
    label
    Treatment (brentuximab vedotin, rituximab)
    type
    EXPERIMENTAL
interventions
  1. arm Group Labels
    1. Treatment (brentuximab vedotin, rituximab)
    description
    Given IV
    name
    brentuximab vedotin
    other Names
    1. Adcetris
    2. anti-CD30 ADC SGN-35
    3. anti-CD30 antibody-drug conjugate SGN-35
    4. antibody-drug conjugate SGN-35
    5. SGN-35
    type
    DRUG
  2. arm Group Labels
    1. Treatment (brentuximab vedotin, rituximab)
    description
    Given IV
    name
    rituximab
    other Names
    1. IDEC-C2B8
    2. IDEC-C2B8 monoclonal antibody
    3. Mabthera
    4. MOAB IDEC-C2B8
    5. Rituxan
    type
    BIOLOGICAL
  3. arm Group Labels
    1. Treatment (brentuximab vedotin, rituximab)
    description
    Correlative studies
    name
    laboratory biomarker analysis
    type
    OTHER
Study design
allocation
NA
intervention Model
SINGLE_GROUP
masking Info
masking
NONE
primary Purpose
TREATMENT
Enrollment
count
20
type
ACTUAL
Registered outcome plans (not posted results)
primary Outcomes
  1. description
    To identify the recommended phase 2 dose (RP2D)/maximum tolerated dose (MTD) of brentuximab vedotin in combination with rituximab. The dose limiting toxicity monitoring period for brentuximab vedotin and rituximab is first 21 days (during induction).The RP2D/MTD will be defined as the highest dose of brentuximab vedotin that causes dose limiting toxicities (DLTs) in \<2 of 6 patients. The Phase I portion of the study follows a 3+3 design. Brentuximab has two dose levels: Level 1 (starting dose) 1.2 mg/kg IV, and Level -1 (de-escalation dose): 0.8 mg/kg IV. Toxicity will be assessed using the National Cancer Institute (NCI) Common Toxicity Criteria for Adverse Events (CTCAE), version 4.03.
    measure
    For Phase I: The Recommended Phase 2 Dose of Brentuximab Vedotin in Combination With Rituximab.
    time Frame
    The first 21 days of Induction
  2. description
    Dose limiting toxicities (DLT) will be monitored for Phase 1 patients for the first 21 days of Induction (the DLT monitoring period) to evaluate safety. In general, a non-hematologic DLT is defined as any Grade ≥ 3 toxicity, and a hematologic DLT is defined as any Grade ≥ 4 toxicity, both by CTCAE v4.03 criteria.
    measure
    Phase 1: Number of Dose Limiting Toxicities of Brentuximab Vedotin and Rituximab in Patients With Immunosuppressed Lymphoid Malignancies.
    time Frame
    The first 21 days of induction
  3. description
    Overall response will be defined as the detection of Partial Response (PR) or Complete Response (CR) by CT or PET/CT, and/or resolution of marrow-only involvement. Response will be assessed according to the Revised Response Criteria for Malignant Lymphoma (Cheson, et al). CR is defined as a complete disappearance of all detectable clinical evidence of disease and disease-related symptoms, if present before therapy. A post-treatment residual mass of any size is permitted as long as it is PET negative. If a pretreatment PET scan was negative, all lymph nodes and nodal masses must have regressed on CT to normal size. A PR is defined as At least a 50% decrease in sum of the product of the diameters of up to six of the largest dominant nodes or nodal masses. No increase should be observed in the size of other nodes, liver, or spleen.
    measure
    Phase II: Percent of Participants With an Overall Response
    time Frame
    Every 12 weeks for up to 1 year on treatment (Range of cycles attempted from induction, +/- consolidation, + maintenance = 1-17 cycles) Induction = 4 weeks, consolidation = 4 weeks, 1 maintenance cycle = 3 weeks
secondary Outcomes
  1. description
    Toxicity, both frequency and severity, will continue to be measured by monitoring the occurrence of adverse events. Adverse events will be defined as those included in CTCAE v 4.03. AEs that were determined to be at least possibly related to study drug and graded 3, 4, 5 are included here. Grade 1 (mild): the event causes discomfort without disruption of normal daily activities. Grade 2 (moderate): the event causes discomfort that affects normal daily activities. Grade 3 (severe): the event makes the patient unable to perform normal daily activities or significantly affects his/her clinical status. Grade 4 (Life-threatening): the patient was at risk of death at the time of the event. Grade 5 (fatal): the event caused death.
    measure
    Number of Participants With Adverse Events Possibly Related to Study Drug Graded 3, 4, and 5
    time Frame
    From time of treatment to 30 days post discontinuation (range of cycles attempted from induction +/- consolidation, & maintenance = 1-17 cycles) About 1 year Induction = 4 weeks, consolidation = 4 weeks, 1 maintenance cycle = 3 weeks
  2. description
    Study treatment efficacy will be evaluated using PET or CT scan images to determine Progression Free Survival (PFS). PFS is defined as the duration of time from start of treatment to time of progression. Response criteria will be those specified by Cheson, et al as the Revised Response Criteria for Malignant Lymphoma. Progressive Disease (PD) is defined as the appearance of any new lesion more than 1.5 cm in any axis during or at the end of therapy, even if other lesions are decreasing in size, or at least a 50% increase from nadir in the diameter of any previously involved nodes, or in a single involved node, or the size of other lesions. All patients who have had at least one dose of study treatment will be evaluable for PFS with censoring of patients who are lost to follow-up. PFS will be reported as percentage of participants without progression.
    measure
    Percentage of Participants Without Progression (Progression Free Survival (PFS))
    time Frame
    start of treatment to time of progression (up to 2 years after treatment discontinuation)
  3. description
    Overall survival (OS) will be measured from treatment initiation until death from any cause for up to 1 year post-treatment discontinuation. Overall survival is defined as the duration of time from start of treatment to time of death. All patients who have had at least one dose of study treatment will be evaluable for OS. OS will be reported as percentage of participants alive at 2 years post treatment discontinuation, with censoring of patients who are lost to follow-up.
    measure
    Percentage of Participants Alive at 2 Years (Overall Survival)
    time Frame
    From start of treatment to 2 years post treatment discontinuation
  4. description
    The best overall response (BOR) is the best response recorded from the start of the treatment until disease progression/recurrence. Best response assessed by CT or PET/CT according to the Revised Response Criteria for Malignant Lymphoma (Cheson et. al). Responses include Complete Response (CR), Partial Response (PR), and Stable Disease (SD). CR: Complete disappearance of all detectable clinical evidence of disease and disease-related symptoms, if present before therapy. If a pretreatment PET scan was negative, all lymph nodes and nodal masses must have regressed on CT to normal size. PR: At least a 50% decrease in sum of the product of the diameters of up to six of the largest dominant nodes or nodal masses. No increase should be observed in the size of other nodes, liver, or spleen. SD: neither CR or PR, or progressive disease (PD). PD: Appearance of new lesion \> 1.5 cm in any axis, or at least a 50% increase from nadir in the diameter of any previously involved nodes.
    measure
    Number of Participants With Best Overall Response (BOR)
    time Frame
    Every 12 weeks for up to 1 year on treatment (Range of cycles attempted from induction, +/- consolidation, + maintenance = 1-17 cycles) Induction = 4 weeks, consolidation = 4 weeks, 1 maintenance cycle = 3 weeks
  5. description
    EBV activation will be evaluated in all patients who receive at least one dose of study treatment and have an evaluable tissue microarray (TMA) collected at baseline. EBV activation and proliferation will be measured by viral loads from blood collections as measured at time of enrollment and monthly thereafter in all enrolled patients, until completion of study therapy. Epstein Barr Virus (EBV) quantitative PCR is used to an aid in monitoring EBV-related disease. Lab thresholds vary at sites however, labs results are considered either "negative" or "abnormal". Number of participants who experienced EBV activation, i.e an abnormal lab result (YES) and patients who did not experience EBV activation, i.e. a negative lab result (NO) will be reported.
    measure
    Number of Participants With Epstein Barr Virus (EBV) Activation and Number of Participants Without EBV Activation
    time Frame
    Time from start of study treatment to last dose of study drug (Range of cycles attempted from induction, +/- consolidation, + maintenance = 1-17 cycles, up to 1 year) Induction = 4 weeks, consolidation = 4 weeks, 1 maintenance cycle = 3 weeks
  6. description
    Time to initiation of cytotoxic chemotherapy will be defined as the time elapsed between study treatment initiation, and time of first non-targeted cytotoxic chemotherapy (off study treatment). Time to cytotoxic chemotherapy will be evaluated in all patients who receive at least one dose of study treatment.
    measure
    Time to Initiation of Cytotoxic Chemotherapy
    time Frame
    Up to 3 years from treatment discontinuation
  7. description
    Graft rejection will be defined as any of the following: documentation of new or progressive rejection by tissue biopsy of the graft; re-transplantation due to graft rejection; clinical diagnosis of new or progressive graft rejection, since start of treatment on protocol, as given by the patient's transplant physician. Escalation of intensity of immunosuppression will not, by itself, be considered evidence of graft rejection. Note: patients with clinically active graft rejection will not be excluded from trial enrollment, but will not be considered to have treatment emergent graft rejection unless progression of rejection is documented. Rates of graft rejection will be evaluated in all patients who receive at least one dose of study treatment.
    measure
    Number of Participants With Graft Rejection vs Without Graft Rejection
    time Frame
    From start of treatment to 3 years post treatment discontinuation
Full study description
brief Summary
The purpose of this study is to evaluate how safe and effective the combination of two different drugs (brentuximab vedotin and rituximab) is in patients with certain types of lymphoma. This study is for patients who have a type of lymphoma that expresses a tumor marker called CD30 and/or a type that is associated with the Epstein-Barr virus (EBV-related lymphoma) and who have not yet received any treatment for their cancer, except for dose-reduction or discontinuation (stoppage) of medications used to prevent rejection of transplanted organs (for those patients who have undergone transplantation). This study is investigating the combination of brentuximab vedotin and rituximab as a first treatment for lymphoma patients
detailed Description
PRIMARY OBJECTIVES: I. To evaluate the safety of brentuximab vedotin and rituximab in patients with lymphoid malignancies that are cluster of differentiation (CD) 30 positive (+) and/or Epstein-Barr virus (EBV)+, and to determine the recommended phase 2 dose (RP2D) of the combination. (Phase I) II. To evaluate the efficacy, as measured by response rates, of brentuximab vedotin and rituximab in patients with lymphoid malignancies that are CD30+ and/or EBV+. (Phase II) SECONDARY OBJECTIVES: I. To further evaluate the frequency and severity of toxicity. (Phase II) II. To further evaluate the clinical efficacy of the combination of brentuximab vedotin and rituximab, as measured by progression free survival (PFS) and overall survival (OS) at one year after the end of treatment. (Phase II) III. To determine the effects of the combination of brentuximab vedotin and rituximab on markers of EBV activation and proliferation. (Phase II) IV. Further evaluate efficacy as measured by time to cytotoxic chemotherapy. (Phase II) V. Further evaluate efficacy as measured by observed rates of graft rejection. (Phase II) TERTIARY OBJECTIVES: I. To determine whether and to what extent CD30 expression predicts for response and outcome. II. To determine whether and to what extent expression of EBV markers predicts for response and outcome. III. To determine whether changes in serum levels of EBV correlate with response and subsequent loss of response to therapy. OUTLINE: This is a phase I, dose-escalation study of brentuximab vedotin followed by a phase II study. INDUCTION: Patients receive brentuximab vedotin intravenously (IV) over 30 minutes once weekly for 3 weeks and rituximab IV once weekly for 4 weeks. Patients unable to achieve complete remission (CR) may receive additional optional consolidation therapy identical to induction therapy. MAINTENANCE THERAPY: Patients receive brentuximab vedotin IV once every 3 weeks and rituximab IV once every 6 weeks. Treatment repeats every 21 days for up to 1 year in the absence of disease progression or unacceptable toxicity. After completion of study treatment, patients are followed up every 3 months for 1 year, and then every 6 months for 2 years.
Source references
Source notices and limitations
    Discovery and provenance
    1. release id
      ctgov-registry-1336d216cbd1bbff780dac70
      edge id
      nct-edge-360c280f8d32ebf6aa8f
      requested nct id
      NCT01805037
      primary nct id
      NCT01805037
      source kind
      ctgov_condition_query
      source record id
      Source null
      source file sha256
      8b9a346048372591e3ee0de631ceead25528dc1d384a69971d454af93b26921d
      payload sha256
      afed9f92928e14bdbbe2c3d89a06aaf9c092b4c818965f3e0b809f25e4ad563e
      payload
      clinical indication matching status
      condition_index_match_asserted_by_registry_not_reviewed
      end exclusive
      true
      id
      nct-edge-360c280f8d32ebf6aa8f
      link basis
      returned_by_explicit_condition_and_posted_results_filter_query
      nct id
      NCT01805037
      occurrences
      1. context exact
        NCT01805037
        end
        11
        exact text
        NCT01805037
        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/30/protocolSection/identificationModule/nctId
      source kind
      ctgov_condition_query
      source record id
      Source null
      source string basis
      parsed_JSON_string_unmodified
      source string sha256
      6dc385f154e3e171954c016612460d900f949be98a88e97568cac21fc6e170e2
    2. release id
      ctgov-registry-1336d216cbd1bbff780dac70
      edge id
      nct-edge-3fba0f1cc56610b51ab1
      requested nct id
      NCT01805037
      primary nct id
      NCT01805037
      source kind
      ctgov_condition_query
      source record id
      Source null
      source file sha256
      9e542f373b689060c2c6c67507f6e2a629c92470fc1ae13d9359244ba59cb6b8
      payload sha256
      e4fb77fa829308f160cd107c5c886f22196bca38729bfadcf425dd0d56171847
      payload
      clinical indication matching status
      condition_index_match_asserted_by_registry_not_reviewed
      end exclusive
      true
      id
      nct-edge-3fba0f1cc56610b51ab1
      link basis
      returned_by_explicit_condition_and_posted_results_filter_query
      nct id
      NCT01805037
      occurrences
      1. context exact
        NCT01805037
        end
        11
        exact text
        NCT01805037
        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/30/protocolSection/identificationModule/nctId
      source kind
      ctgov_condition_query
      source record id
      Source null
      source string basis
      parsed_JSON_string_unmodified
      source string sha256
      6dc385f154e3e171954c016612460d900f949be98a88e97568cac21fc6e170e2
    3. release id
      ctgov-registry-1336d216cbd1bbff780dac70
      edge id
      nct-edge-5693a96cfa3f15ce9067
      requested nct id
      NCT01805037
      primary nct id
      NCT01805037
      source kind
      ctgov_condition_query
      source record id
      Source null
      source file sha256
      2314ce01316b2d7044d298c6d25eda12e99cc5f44273bc75efed6cd5e03a8c14
      payload sha256
      c3f3ba8683e10d770aaffeffa1cb7f3c227fe5f9ed6b93556c3c2b7ee60684e3
      payload
      clinical indication matching status
      condition_index_match_asserted_by_registry_not_reviewed
      end exclusive
      true
      id
      nct-edge-5693a96cfa3f15ce9067
      link basis
      returned_by_explicit_condition_and_posted_results_filter_query
      nct id
      NCT01805037
      occurrences
      1. context exact
        NCT01805037
        end
        11
        exact text
        NCT01805037
        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/614/protocolSection/identificationModule/nctId
      source kind
      ctgov_condition_query
      source record id
      Source null
      source string basis
      parsed_JSON_string_unmodified
      source string sha256
      6dc385f154e3e171954c016612460d900f949be98a88e97568cac21fc6e170e2
    4. release id
      ctgov-registry-1336d216cbd1bbff780dac70
      edge id
      nct-edge-a6bfef60a845896ced53
      requested nct id
      NCT01805037
      primary nct id
      NCT01805037
      source kind
      ctgov_condition_query
      source record id
      Source null
      source file sha256
      e270600534699a676fe83226e7a7b0f73aeb00c1d0a05cfc115c748864ad8173
      payload sha256
      2c8750f676f0ab270e214f66df047d4ddc21d67287071348253f9a3a59878bf3
      payload
      clinical indication matching status
      condition_index_match_asserted_by_registry_not_reviewed
      end exclusive
      true
      id
      nct-edge-a6bfef60a845896ced53
      link basis
      returned_by_explicit_condition_and_posted_results_filter_query
      nct id
      NCT01805037
      occurrences
      1. context exact
        NCT01805037
        end
        11
        exact text
        NCT01805037
        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/78/protocolSection/identificationModule/nctId
      source kind
      ctgov_condition_query
      source record id
      Source null
      source string basis
      parsed_JSON_string_unmodified
      source string sha256
      6dc385f154e3e171954c016612460d900f949be98a88e97568cac21fc6e170e2
    5. release id
      ctgov-registry-1336d216cbd1bbff780dac70
      edge id
      nct-edge-dcf9814ec7d4baf29eea
      requested nct id
      NCT01805037
      primary nct id
      NCT01805037
      source kind
      ctgov_condition_query
      source record id
      Source null
      source file sha256
      69c40ed34b17434f684079ec5635264bc5ad292871a86b835704fc99fa9d8157
      payload sha256
      22b6a0d9dc606cea32d9e97c4c0472e3da864d63b638332be40c7e511fe23bd7
      payload
      clinical indication matching status
      condition_index_match_asserted_by_registry_not_reviewed
      end exclusive
      true
      id
      nct-edge-dcf9814ec7d4baf29eea
      link basis
      returned_by_explicit_condition_and_posted_results_filter_query
      nct id
      NCT01805037
      occurrences
      1. context exact
        NCT01805037
        end
        11
        exact text
        NCT01805037
        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/63/protocolSection/identificationModule/nctId
      source kind
      ctgov_condition_query
      source record id
      Source null
      source string basis
      parsed_JSON_string_unmodified
      source string sha256
      6dc385f154e3e171954c016612460d900f949be98a88e97568cac21fc6e170e2

    Preserved source evidence · Not medical advice