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NCT00408681 · REGISTRY CONDITION SEARCH

Lithium Carbonate in Treating Patients With Acute Intestinal Graft-Versus-Host-Disease (GVHD) After Donor Stem Cell Transplant

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

Phase
NA
Status at capture
COMPLETED
Registry last update
2017-03-07

RATIONALE: Lithium carbonate may be an effective treatment for intestinal graft-versus-host disease caused by a donor stem cell transplant. PURPOSE: This clinical trial is studying lithium carbonate in treating patients with acute intestinal graft-versus-host-disease after donor stem cell transplant.

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

Functional Recovery

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outcome · POSTED

Duration of Treatment With the Study Product

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outcome · POSTED

Mucosal Anatomic Recovery

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outcome · POSTED

Mucosal Anatomic Recovery

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outcome · POSTED

Mucosal Anatomic Recovery

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outcome · POSTED

Mucosal Anatomic Recovery

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outcome · POSTED

Mucosal Anatomic Recovery

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outcome · POSTED

Recurrent or Progressive Malignancy

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outcome · POSTED

Non-relapse Mortality

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outcome · POSTED

Survival

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outcome · POSTED

Survival

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outcome · POSTED

Survival

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outcome · POSTED

Causes of Death

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outcome · POSTED

Agents Added to Treat GVHD More Than 3 Days After Enrollment

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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
Inclusion Criteria: * Patient with a diagnosis of severe intestinal GVHD that is not improving at any time after initial treatment with glucocorticoids for at least 7 days are eligible for enrollment; measures indicating severity of GVHD will include: a) persistent diarrhea with average daily stool volumes \> 500 mL per day; or b) persistent hemorrhage that is detectable by visual inspection of the stool * Patients with denuded mucosa caused by GVHD are eligible for enrollment, regardless of prior treatment for acute GVHD; denuded mucosa is defined as loss (i.e., erosion or sloughing) of the epithelium in: a) at least one-third of the surface area in a 30 cm colonic segment (i.e., rectosigmoid, descending or transverse colon); or b) at least one fifth of the surface area of the second portion of the duodenum, as estimated by endoscopic evaluation; denuded mucosa must be documented by images of the duodenum and colon and by histologic evaluation of the colon * All subjects must provide written informed consent with the use of forms approved by the Fred Hutchinson Cancer Research Center (FHCRC) Institutional Review Board (IRB) Exclusion Criteria: * Significant renal dysfunction (estimated creatinine clearance \< 30 mL/min) * Persistent or recurrent malignancy * Secondary malignancy * Patients who had autologous or syngeneic marrow transplantation * Presence of any cause of intestinal symptoms or ulceration other than GVHD * Patients with any psychological, familial, sociological or geographical condition potentially hampering compliance with the study protocol will be excluded
healthy Volunteers
false
maximum Age
75 Years
minimum Age
18 Years
sex
ALL
std Ages
  1. ADULT
  2. OLDER_ADULT
Treatment arms and interventions
arm Groups
  1. description
    Patients receive oral lithium carbonate once or twice daily. Treatment continues for up to 8 weeks in the absence of disease progression or unacceptable toxicity.
    intervention Names
    1. Drug: lithium carbonate
    2. Other: laboratory biomarker analysis
    label
    Arm I
    type
    EXPERIMENTAL
interventions
  1. arm Group Labels
    1. Arm I
    description
    Given orally
    name
    lithium carbonate
    other Names
    1. Eskalith
    2. Lithane
    3. Lithium
    4. Lithobid
    5. Lithonate
    6. Lithotabs
    type
    DRUG
  2. arm Group Labels
    1. Arm I
    description
    Correlative studies
    name
    laboratory biomarker analysis
    type
    OTHER
Study design
allocation
NA
intervention Model
SINGLE_GROUP
masking Info
masking
NONE
primary Purpose
SUPPORTIVE_CARE
Enrollment
count
20
type
ACTUAL
Registered outcome plans (not posted results)
other Outcomes
  1. description
    Any systemic medication given in an effort to control graft-versus-host disease
    measure
    Agents Added to Treat GVHD More Than 3 Days After Enrollment
    time Frame
    Up to 100 days after enrollment
primary Outcomes
  1. description
    Functional recovery was defined as partial or complete resolution of gastrointestinal manifestations of acute graft-versus-host disease. Gastrointestinal manifestations of acute graft-versus-host disease include anorexia, nausea, vomiting, diarrhea, abdominal pain and bleeding. Complete response (CR) of intestinal GVHD was defined as the absence of any symptoms referable to intestinal GVHD. Partial response (PR) was defined as clearing of abdominal pain (or withdrawal of opioid analgesic requirements in patients treated for abdominal pain) and of grossly visible bleeding if present, and resolution of diarrhea or decrease in the three day average stool volume by ≥ 500 mL in patients with stool volumes of ≥ 500 mL. Progression of GVHD was defined as an increase in the three day average stool volume by \> 500 mL, or the development of new abdominal pain (or new opioid analgesic requirements) or new intestinal bleeding.
    measure
    Functional Recovery
    time Frame
    at 28 days after starting treatment with the study product
secondary Outcomes
  1. description
    Number of days from beginning of orally administered lithium carbonate to the end of orally administered lithium carbonate
    measure
    Duration of Treatment With the Study Product
    time Frame
    Up to 6 months
  2. description
    Endoscopic evaluation of improvement. Categories include 1) no improvement, 2) regenerative changes, 3) limited improvement, 4) partial improvement and 5) complete response. Endoscopic manifestations of acute graft-versus-host disease include edema, erythema, mucosal ulceration and denudation. Complete mucosal recovery was defined as the appearance of intact mucosa with at least 98% of the luminal surface covered by epithelium. Partial response was defined as the appearance of mostly intact mucosa with at least 80% improvement or less than 10% denuded. Limited response was retrospectively designated to describe visible improvement that was less than partial response. Regenerative change was retrospectively designated to describe early reappearance of mucosal integrity in a previously denuded area but not sufficient to meet criteria for partial response. Failure to respond was defined as failure to meet partial response criteria.
    measure
    Mucosal Anatomic Recovery
    time Frame
    2 to 3 weeks after starting treatment with the study product
  3. description
    Endoscopic evaluation of improvement. Categories include 1) no improvement, 2) regenerative changes, 3) limited improvement, 4) partial improvement and 5) complete response. Endoscopic manifestations of acute graft-versus-host disease include edema, erythema, mucosal ulceration and denudation. Complete mucosal recovery was defined as the appearance of intact mucosa with at least 98% of the luminal surface covered by epithelium. Partial response was defined as the appearance of mostly intact mucosa with at least 80% improvement or less than 10% denuded. Limited response was retrospectively designated to describe visible improvement that was less than partial response. Regenerative change was retrospectively designated to describe early reappearance of mucosal integrity in a previously denuded area but not sufficient to meet criteria for partial response. Failure to respond was defined as failure to meet partial response criteria.
    measure
    Mucosal Anatomic Recovery
    time Frame
    4 weeks after starting treatment with the study product
  4. description
    Endoscopic evaluation of improvement. Categories include 1) no improvement, 2) regenerative changes, 3) limited improvement, 4) partial improvement and 5) complete response. Endoscopic manifestations of acute graft-versus-host disease include edema, erythema, mucosal ulceration and denudation. Complete mucosal recovery was defined as the appearance of intact mucosa with at least 98% of the luminal surface covered by epithelium. Partial response was defined as the appearance of mostly intact mucosa with at least 80% improvement or less than 10% denuded. Limited response was retrospectively designated to describe visible improvement that was less than partial response. Regenerative change was retrospectively designated to describe early reappearance of mucosal integrity in a previously denuded area but not sufficient to meet criteria for partial response. Failure to respond was defined as failure to meet partial response criteria.
    measure
    Mucosal Anatomic Recovery
    time Frame
    5 weeks after starting treatment with the study product
  5. description
    Endoscopic evaluation of improvement. Categories include 1) no improvement, 2) regenerative changes, 3) limited improvement, 4) partial improvement and 5) complete response. Endoscopic manifestations of acute graft-versus-host disease include edema, erythema, mucosal ulceration and denudation. Complete mucosal recovery was defined as the appearance of intact mucosa with at least 98% of the luminal surface covered by epithelium. Partial response was defined as the appearance of mostly intact mucosa with at least 80% improvement or less than 10% denuded. Limited response was retrospectively designated to describe visible improvement that was less than partial response. Regenerative change was retrospectively designated to describe early reappearance of mucosal integrity in a previously denuded area but not sufficient to meet criteria for partial response. Failure to respond was defined as failure to meet partial response criteria.
    measure
    Mucosal Anatomic Recovery
    time Frame
    6 to 7 weeks after starting treatment with the study product
  6. description
    Endoscopic evaluation of improvement. Categories include 1) no improvement, 2) regenerative changes, 3) limited improvement, 4) partial improvement and 5) complete response. Endoscopic manifestations of acute graft-versus-host disease include edema, erythema, mucosal ulceration and denudation. Complete mucosal recovery was defined as the appearance of intact mucosa with at least 98% of the luminal surface covered by epithelium. Partial response was defined as the appearance of mostly intact mucosa with at least 80% improvement or less than 10% denuded. Limited response was retrospectively designated to describe visible improvement that was less than partial response. Regenerative change was retrospectively designated to describe early reappearance of mucosal integrity in a previously denuded area but not sufficient to meet criteria for partial response. Failure to respond was defined as failure to meet partial response criteria.
    measure
    Mucosal Anatomic Recovery
    time Frame
    9 to 11 weeks after starting treatment with the study product
  7. description
    Recurrence or progression of the malignant disease that was the reason for hematopoietic cell transplantation
    measure
    Recurrent or Progressive Malignancy
    time Frame
    2 years after enrollment
  8. description
    Death without prior recurrent or progressive malignancy after transplantation.
    measure
    Non-relapse Mortality
    time Frame
    2 years after enrollment
  9. description
    Patients who were alive at the specified time after enrollment
    measure
    Survival
    time Frame
    6 months after enrollment
  10. description
    Patients who were alive at the specified time point
    measure
    Survival
    time Frame
    1 year after enrollment
  11. description
    Patients who were alive at the specified time point
    measure
    Survival
    time Frame
    2 years after enrollment
  12. description
    Medical condition that made the greatest contribution in causing death
    measure
    Causes of Death
    time Frame
    up to 6 years after enrollment
Full study description
brief Summary
RATIONALE: Lithium carbonate may be an effective treatment for intestinal graft-versus-host disease caused by a donor stem cell transplant. PURPOSE: This clinical trial is studying lithium carbonate in treating patients with acute intestinal graft-versus-host-disease after donor stem cell transplant.
detailed Description
PRIMARY OBJECTIVES: I. To evaluate the effects of lithium on functional and mucosal anatomic recovery in the small or large bowel of patients with acute GVHD. II. Functional recovery will be evaluated according to changes in clinical manifestations of gastrointestinal GVHD. III. Mucosal anatomic recovery will be evaluated by review of results from clinically indicated endoscopic evaluations. SECONDARY OBJECTIVES: I. To assess the tolerability of lithium administration in allogeneic hematopoietic cell transplant recipients. OUTLINE: Patients receive oral lithium carbonate once or twice daily. Treatment continues for up to 8 weeks in the absence of disease progression or unacceptable toxicity.
Source references
references
  1. citation
    Steinbach G, Hockenbery DM, Huls G, Furlong T, Myerson D, Loeb KR, Fann JR, Castilla-Llorente C, McDonald GB, Martin PJ. Pilot study of lithium to restore intestinal barrier function in severe graft-versus-host disease. PLoS One. 2017 Aug 17;12(8):e0183284. doi: 10.1371/journal.pone.0183284. eCollection 2017.
    pmid
    28817727
    type
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Source notices and limitations
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      /studies/1/protocolSection/identificationModule/nctId
      source kind
      ctgov_condition_query
      source record id
      Source null
      source string basis
      parsed_JSON_string_unmodified
      source string sha256
      31c1c9cf14a14d44947efba771bcdcc815e8edb291d024866ec70c2bbcec401f
    9. release id
      ctgov-registry-1336d216cbd1bbff780dac70
      edge id
      nct-edge-7f590baaf143f01cd643
      requested nct id
      NCT00408681
      primary nct id
      NCT00408681
      source kind
      ctgov_condition_query
      source record id
      Source null
      source file sha256
      69c40ed34b17434f684079ec5635264bc5ad292871a86b835704fc99fa9d8157
      payload sha256
      1393ff95640b39663e4390ddc36f7ab9a1efdd01837fc8452392342263df83c3
      payload
      clinical indication matching status
      condition_index_match_asserted_by_registry_not_reviewed
      end exclusive
      true
      id
      nct-edge-7f590baaf143f01cd643
      link basis
      returned_by_explicit_condition_and_posted_results_filter_query
      nct id
      NCT00408681
      occurrences
      1. context exact
        NCT00408681
        end
        11
        exact text
        NCT00408681
        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/20/protocolSection/identificationModule/nctId
      source kind
      ctgov_condition_query
      source record id
      Source null
      source string basis
      parsed_JSON_string_unmodified
      source string sha256
      31c1c9cf14a14d44947efba771bcdcc815e8edb291d024866ec70c2bbcec401f
    10. release id
      ctgov-registry-1336d216cbd1bbff780dac70
      edge id
      nct-edge-85115d2a13290eff491d
      requested nct id
      NCT00408681
      primary nct id
      NCT00408681
      source kind
      ctgov_condition_query
      source record id
      Source null
      source file sha256
      cddcd4e3a59550bc78924062a298c359d8f811413f73f4a4461963aecf3790d6
      payload sha256
      49ccd39ee20168afbfd89272cbd7798caa7f9f9ddbc7866510324fbe6a883337
      payload
      clinical indication matching status
      condition_index_match_asserted_by_registry_not_reviewed
      end exclusive
      true
      id
      nct-edge-85115d2a13290eff491d
      link basis
      returned_by_explicit_condition_and_posted_results_filter_query
      nct id
      NCT00408681
      occurrences
      1. context exact
        NCT00408681
        end
        11
        exact text
        NCT00408681
        start
        0
      offset unit
      unicode_code_points
      query cond
      Juvenile Myelomonocytic Leukemia
      query disease state id
      ds-juvenile-myelomonocytic-leukemia
      source file
      /Users/arunverma/Documents/ChatGPT/Cancer Statistics Website/research-data/2026-09-10/clinicaltrials-condition/round-0000/raw/cond-juvenile-myelomonocytic-leukemia-000.json
      source file sha256
      cddcd4e3a59550bc78924062a298c359d8f811413f73f4a4461963aecf3790d6
      source json pointer
      /studies/29/protocolSection/identificationModule/nctId
      source kind
      ctgov_condition_query
      source record id
      Source null
      source string basis
      parsed_JSON_string_unmodified
      source string sha256
      31c1c9cf14a14d44947efba771bcdcc815e8edb291d024866ec70c2bbcec401f
    11. release id
      ctgov-registry-1336d216cbd1bbff780dac70
      edge id
      nct-edge-9665c4533b0ac7525a3f
      requested nct id
      NCT00408681
      primary nct id
      NCT00408681
      source kind
      ctgov_condition_query
      source record id
      Source null
      source file sha256
      9e542f373b689060c2c6c67507f6e2a629c92470fc1ae13d9359244ba59cb6b8
      payload sha256
      74c9a87bd3add50e60595dad380b30c01c574eb8de40b7020ddedcbfa20db1ff
      payload
      clinical indication matching status
      condition_index_match_asserted_by_registry_not_reviewed
      end exclusive
      true
      id
      nct-edge-9665c4533b0ac7525a3f
      link basis
      returned_by_explicit_condition_and_posted_results_filter_query
      nct id
      NCT00408681
      occurrences
      1. context exact
        NCT00408681
        end
        11
        exact text
        NCT00408681
        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/8/protocolSection/identificationModule/nctId
      source kind
      ctgov_condition_query
      source record id
      Source null
      source string basis
      parsed_JSON_string_unmodified
      source string sha256
      31c1c9cf14a14d44947efba771bcdcc815e8edb291d024866ec70c2bbcec401f
    12. release id
      ctgov-registry-1336d216cbd1bbff780dac70
      edge id
      nct-edge-c84519e8e67b886b6dc5
      requested nct id
      NCT00408681
      primary nct id
      NCT00408681
      source kind
      ctgov_condition_query
      source record id
      Source null
      source file sha256
      8b9a346048372591e3ee0de631ceead25528dc1d384a69971d454af93b26921d
      payload sha256
      7bd9b75ddce75ddfe25d1ac321e8d3adbccc0cee47e0b3a0af2f0c33d805dc06
      payload
      clinical indication matching status
      condition_index_match_asserted_by_registry_not_reviewed
      end exclusive
      true
      id
      nct-edge-c84519e8e67b886b6dc5
      link basis
      returned_by_explicit_condition_and_posted_results_filter_query
      nct id
      NCT00408681
      occurrences
      1. context exact
        NCT00408681
        end
        11
        exact text
        NCT00408681
        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/8/protocolSection/identificationModule/nctId
      source kind
      ctgov_condition_query
      source record id
      Source null
      source string basis
      parsed_JSON_string_unmodified
      source string sha256
      31c1c9cf14a14d44947efba771bcdcc815e8edb291d024866ec70c2bbcec401f

    Preserved source evidence · Not medical advice