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

Conditions

Accelerated Phase Chronic Myelogenous Leukemia, Adult Acute Lymphoblastic Leukemia in Remission, Adult Acute Myeloid Leukemia in Remission, Adult Acute Myeloid Leukemia With 11q23 (MLL) Abnormalities, Adult Acute Myeloid Leukemia With Inv(16)(p13;q22), Adult Acute Myeloid Leukemia With t(15;17)(q22;q12), Adult Acute Myeloid Leukemia With t(16;16)(p13;q22), Adult Acute Myeloid Leukemia With t(8;21)(q22;q22), Atypical Chronic Myeloid Leukemia, Breakpoint Cluster Region-abl Translocation (BCR-ABL) Negative, Blastic Phase Chronic Myelogenous Leukemia, Childhood Acute Lymphoblastic Leukemia in Remission, Childhood Acute Myeloid Leukemia in Remission, Childhood Chronic Myelogenous Leukemia, Childhood Myelodysplastic Syndromes, Chronic Eosinophilic Leukemia, Chronic Myelomonocytic Leukemia, Chronic Neutrophilic Leukemia, Chronic Phase Chronic Myelogenous Leukemia, de Novo Myelodysplastic Syndromes, Disseminated Neuroblastoma, Extranodal Marginal Zone B-cell Lymphoma of Mucosa-associated Lymphoid Tissue, Gastrointestinal Complications, Juvenile Myelomonocytic Leukemia, Myelodysplastic/Myeloproliferative Neoplasm, Unclassifiable, Nodal Marginal Zone B-cell Lymphoma, Noncontiguous Stage II Adult Burkitt Lymphoma, Noncontiguous Stage II Adult Diffuse Large Cell Lymphoma, Noncontiguous Stage II Adult Diffuse Mixed Cell Lymphoma, Noncontiguous Stage II Adult Diffuse Small Cleaved Cell Lymphoma, Noncontiguous Stage II Adult Immunoblastic Large Cell Lymphoma, Noncontiguous Stage II Adult Lymphoblastic Lymphoma, Noncontiguous Stage II Grade 1 Follicular Lymphoma, Noncontiguous Stage II Grade 2 Follicular Lymphoma, Noncontiguous Stage II Grade 3 Follicular Lymphoma, Noncontiguous Stage II Mantle Cell Lymphoma, Noncontiguous Stage II Marginal Zone Lymphoma, Noncontiguous Stage II Small Lymphocytic Lymphoma, Poor Prognosis Metastatic Gestational Trophoblastic Tumor, Previously Treated Childhood Rhabdomyosarcoma, Primary Myelofibrosis, Recurrent Adult Acute Lymphoblastic Leukemia, Recurrent Adult Acute Myeloid Leukemia, Recurrent Adult Burkitt Lymphoma, Recurrent Adult Diffuse Large Cell Lymphoma, Recurrent Adult Diffuse Mixed Cell Lymphoma, Recurrent Adult Diffuse Small Cleaved Cell Lymphoma, Recurrent Adult Hodgkin Lymphoma, Recurrent Adult Immunoblastic Large Cell Lymphoma, Recurrent Adult Lymphoblastic Lymphoma, Recurrent Childhood Acute Lymphoblastic Leukemia, Recurrent Childhood Acute Myeloid Leukemia, Recurrent Childhood Large Cell Lymphoma, Recurrent Childhood Lymphoblastic Lymphoma, Recurrent Childhood Rhabdomyosarcoma, Recurrent Childhood Small Noncleaved Cell Lymphoma, Recurrent Cutaneous T-cell Non-Hodgkin Lymphoma, Recurrent Grade 1 Follicular Lymphoma, Recurrent Grade 2 Follicular Lymphoma, Recurrent Grade 3 Follicular Lymphoma, Recurrent Malignant Testicular Germ Cell Tumor, Recurrent Mantle Cell Lymphoma, Recurrent Marginal Zone Lymphoma, Recurrent Mycosis Fungoides/Sezary Syndrome, Recurrent Neuroblastoma, Recurrent Ovarian Epithelial Cancer, Recurrent Ovarian Germ Cell Tumor, Recurrent/Refractory Childhood Hodgkin Lymphoma, Recurrent Small Lymphocytic Lymphoma, Recurrent Wilms Tumor and Other Childhood Kidney Tumors, Refractory Chronic Lymphocytic Leukemia, Refractory Hairy Cell Leukemia, Relapsing Chronic Myelogenous Leukemia, Secondary Acute Myeloid Leukemia, Secondary Myelodysplastic Syndromes, Splenic Marginal Zone Lymphoma, Stage IIIA Breast Cancer, Stage III Adult Burkitt Lymphoma, Stage III Adult Diffuse Large Cell Lymphoma, Stage III Adult Diffuse Mixed Cell Lymphoma, Stage III Adult Diffuse Small Cleaved Cell Lymphoma, Stage III Adult Hodgkin Lymphoma, Stage III Adult Immunoblastic Large Cell Lymphoma, Stage III Adult Lymphoblastic Lymphoma, Stage IIIB Breast Cancer, Stage IIIC Breast Cancer, Stage III Chronic Lymphocytic Leukemia, Stage III Grade 1 Follicular Lymphoma, Stage III Grade 2 Follicular Lymphoma, Stage III Grade 3 Follicular Lymphoma, Stage III Malignant Testicular Germ Cell Tumor, Stage III Mantle Cell Lymphoma, Stage III Marginal Zone Lymphoma, Stage III Multiple Myeloma, Stage III Ovarian Epithelial Cancer, Stage III Small Lymphocytic Lymphoma, Stage II Multiple Myeloma, Stage II Ovarian Epithelial Cancer, Stage I Multiple Myeloma, Stage IV Adult Burkitt Lymphoma, Stage IV Adult Diffuse Large Cell Lymphoma, Stage IV Adult Diffuse Mixed Cell Lymphoma, Stage IV Adult Diffuse Small Cleaved Cell Lymphoma, Stage IV Adult Hodgkin Lymphoma, Stage IV Adult Immunoblastic Large Cell Lymphoma, Stage IV Adult Lymphoblastic Lymphoma, Stage IV Breast Cancer, Stage IV Chronic Lymphocytic Leukemia, Stage IV Grade 1 Follicular Lymphoma, Stage IV Grade 2 Follicular Lymphoma, Stage IV Grade 3 Follicular Lymphoma, Stage IV Mantle Cell Lymphoma, Stage IV Marginal Zone Lymphoma, Stage IV Ovarian Epithelial Cancer, Stage IV Small Lymphocytic Lymphoma

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.

Gideon Steinbach, David M. Hockenbery, Gerwin Huls, Terry Furlong, David Myerson et al. (10 authors)

PLoS ONE2017-08-1719 citations

10.1371/journal.pone.0183284

Interventions

DRUGlithium carbonate

Given orally

OTHERlaboratory biomarker analysis

Correlative studies

Study design

Allocation

NA

Intervention model

SINGLE_GROUP

Primary purpose

SUPPORTIVE_CARE

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

18 Years to 75 Years

Healthy volunteers

No

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

Design outcomes

Primary

Measure	Time frame	Description
Functional Recovery	at 28 days after starting treatment with the study product	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.

Secondary

Measure	Time frame	Description
Mucosal Anatomic Recovery	2 to 3 weeks after starting treatment with the study product	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.
Recurrent or Progressive Malignancy	2 years after enrollment	Recurrence or progression of the malignant disease that was the reason for hematopoietic cell transplantation
Non-relapse Mortality	2 years after enrollment	Death without prior recurrent or progressive malignancy after transplantation.
Survival	6 months after enrollment	Patients who were alive at the specified time after enrollment
Causes of Death	up to 6 years after enrollment	Medical condition that made the greatest contribution in causing death
Duration of Treatment With the Study Product	Up to 6 months	Number of days from beginning of orally administered lithium carbonate to the end of orally administered lithium carbonate

Other

Measure	Time frame	Description
Agents Added to Treat GVHD More Than 3 Days After Enrollment	Up to 100 days after enrollment	Any systemic medication given in an effort to control graft-versus-host disease

Countries

United States

Participant flow

Recruitment details

Patients with severe gastrointestinal acute graft-versus-host disease with or without mucosal denudation identified by endoscopy were recruited from a hospitalized population of patients who had recent allogeneic hematopoietic cell transplantation.

Pre-assignment details

Patients were enrolled according to eligibility criteria in the protocol.

Participants by arm

Arm	Count
Treated Patients Patients received oral lithium carbonate once or twice daily. Treatment continued for up to 8 weeks in the absence of disease progression or unacceptable toxicity.	20
Total	20

Withdrawals & dropouts

Period	Reason	FG000
Overall Study	Adverse Event	7
Overall Study	Lack of Efficacy	2

Baseline characteristics

Characteristic	Treated Patients
Age, Continuous	49.5 years
Agents given to prevent GVHD at the time of enrollment Cyclosporine	7 Participants
Agents given to prevent GVHD at the time of enrollment Mycophenolate mofetil	8 Participants
Agents given to prevent GVHD at the time of enrollment Tacrolimus	8 Participants
Agents given to treat GVHD more than 3 days before enrollment in the study Cyclosporine	1 Participants
Agents given to treat GVHD more than 3 days before enrollment in the study Extracorporeal photopheresis	2 Participants
Agents given to treat GVHD more than 3 days before enrollment in the study Horse anti-thymocyte globulin	1 Participants
Agents given to treat GVHD more than 3 days before enrollment in the study Infliximab	3 Participants
Agents given to treat GVHD more than 3 days before enrollment in the study Mesenchymal stem cells	1 Participants
Agents given to treat GVHD more than 3 days before enrollment in the study Mycophenolate mofetil	5 Participants
Agents given to treat GVHD more than 3 days before enrollment in the study Rabbit anti-thymocyte globulin	3 Participants
Agents given to treat GVHD more than 3 days before enrollment in the study Sirolimus	1 Participants
Agents given to treat GVHD more than 3 days before enrollment in the study Tacrolimus	3 Participants
Agents given to treat GVHD within 3 days before or after enrollment Alemtuzumab	1 Participants
Agents given to treat GVHD within 3 days before or after enrollment Infliximab	2 Participants
Agents given to treat GVHD within 3 days before or after enrollment Methotrexate	1 Participants
Agents given to treat GVHD within 3 days before or after enrollment Mycophenolate mofetil	1 Participants
Agents given to treat GVHD within 3 days before or after enrollment Pentostatin	2 Participants
Agents given to treat GVHD within 3 days before or after enrollment Rabbit anti-thymocyte globulin	4 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	1 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	19 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	0 Participants
Graft-versus-host disease (GVHD) prophylaxis regimen Cyclophosphamide, tacrolimus, MMF	1 Participants
Graft-versus-host disease (GVHD) prophylaxis regimen Cyclosporine and mycophenolate mofetil (MMF)	8 Participants
Graft-versus-host disease (GVHD) prophylaxis regimen Tacrolimus and methotrexate	10 Participants
Graft-versus-host disease (GVHD) prophylaxis regimen Tacrolimus and mycophenolate mofeftil	1 Participants
Indication for transplantation Acute lymphoid leukemia	3 Participants
Indication for transplantation Acute myeloid leukemia	6 Participants
Indication for transplantation Aplastic anemia	1 Participants
Indication for transplantation Chronic lymphocytic leukemia	1 Participants
Indication for transplantation Chronic myeloid leukemia	2 Participants
Indication for transplantation Multiple myeloma	2 Participants
Indication for transplantation Myelodysplastic syndrome	1 Participants
Indication for transplantation Non-Hodgkin lymphoma	3 Participants
Indication for transplantation Paroxysmal nocturnal hemoglobinuria	1 Participants
Interval from transplantation to start of study product administration	90 days
Mucosal denudation Colon alone	7 Participants
Mucosal denudation Duodenum alone	7 Participants
Mucosal denudation Duodenum and colon	3 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants
Race (NIH/OMB) Asian	1 Participants
Race (NIH/OMB) Black or African American	1 Participants
Race (NIH/OMB) More than one race	2 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	1 Participants
Race (NIH/OMB) Unknown or Not Reported	1 Participants
Race (NIH/OMB) White	14 Participants
Region of Enrollment United States	20 Participants
Sex: Female, Male Female	13 Participants
Sex: Female, Male Male	7 Participants
Type of pretransplant conditioning regimen Myeloablative	12 Participants
Type of pretransplant conditioning regimen Nonmyeloablative	8 Participants

Adverse events

Event type	EG000 affected / at risk
deaths Total, all-cause mortality	— / —
other Total, other adverse events	11 / 20
serious Total, serious adverse events	12 / 20

Outcome results

Primary

Functional Recovery

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.

Time frame: at 28 days after starting treatment with the study product

Arm	Measure	Category	Value (COUNT_OF_PARTICIPANTS)
Treated Patients	Functional Recovery	Complete clinical response	10 Participants
Treated Patients	Functional Recovery	Partial clinical response	1 Participants
Treated Patients	Functional Recovery	No response or clinical progression	6 Participants
Treated Patients	Functional Recovery	Death before day 28	3 Participants

Secondary

Causes of Death

Medical condition that made the greatest contribution in causing death

Time frame: up to 6 years after enrollment

Arm	Measure	Group	Value (COUNT_OF_PARTICIPANTS)
Treated Patients	Causes of Death	Recurrent or progressive malignancy	2 Participants
Treated Patients	Causes of Death	Acute graft-versus-host disease	11 Participants
Treated Patients	Causes of Death	Chronic GVHD with bronchiolitis obliterans	2 Participants
Treated Patients	Causes of Death	Infection	7 Participants
Treated Patients	Causes of Death	Multiorgan failure	2 Participants
Treated Patients	Causes of Death	Diffuse alveolar hemorrhage	1 Participants
Treated Patients	Causes of Death	Hemolytic uremic syndrome	1 Participants

Secondary

Duration of Treatment With the Study Product

Number of days from beginning of orally administered lithium carbonate to the end of orally administered lithium carbonate

Time frame: Up to 6 months

Arm	Measure	Value (MEDIAN)
Treated Patients	Duration of Treatment With the Study Product	30.5 days

Secondary

Mucosal Anatomic Recovery

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.

Time frame: 5 weeks after starting treatment with the study product

Population: Only 1 patient had endoscopic evaluation during this time window.

Arm	Measure	Category	Value (COUNT_OF_PARTICIPANTS)
Treated Patients	Mucosal Anatomic Recovery	Partial improvement	1 Participants
Treated Patients	Mucosal Anatomic Recovery	Complete response	0 Participants

Secondary

Mucosal Anatomic Recovery

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.

Time frame: 6 to 7 weeks after starting treatment with the study product

Population: Only 3 patients had endoscopic evaluation during this time window.

Arm	Measure	Category	Value (COUNT_OF_PARTICIPANTS)
Treated Patients	Mucosal Anatomic Recovery	Partial improvement	0 Participants
Treated Patients	Mucosal Anatomic Recovery	Complete response	3 Participants

Secondary

Mucosal Anatomic Recovery

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.

Time frame: 2 to 3 weeks after starting treatment with the study product

Population: Only 8 of the 20 enrolled patients had endoscopic evaluation during this time window.

Arm	Measure	Category	Value (COUNT_OF_PARTICIPANTS)
Treated Patients	Mucosal Anatomic Recovery	No improvement	3 Participants
Treated Patients	Mucosal Anatomic Recovery	Regenerative changes	3 Participants
Treated Patients	Mucosal Anatomic Recovery	Partial improvement	2 Participants

Secondary

Mucosal Anatomic Recovery

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.

Time frame: 4 weeks after starting treatment with the study product

Population: Only 2 patients had endoscopic evaluation during this time window.

Arm	Measure	Category	Value (COUNT_OF_PARTICIPANTS)
Treated Patients	Mucosal Anatomic Recovery	Limited improvement	1 Participants
Treated Patients	Mucosal Anatomic Recovery	Partial improvement	1 Participants

Secondary

Mucosal Anatomic Recovery

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.

Time frame: 9 to 11 weeks after starting treatment with the study product

Population: Only 4 patients had endoscopic evaluation during this time window.

Arm	Measure	Category	Value (COUNT_OF_PARTICIPANTS)
Treated Patients	Mucosal Anatomic Recovery	Partial improvement	2 Participants
Treated Patients	Mucosal Anatomic Recovery	Complete response	2 Participants

Secondary

Non-relapse Mortality

Death without prior recurrent or progressive malignancy after transplantation.

Time frame: 2 years after enrollment

Arm	Measure	Value (COUNT_OF_PARTICIPANTS)
Treated Patients	Non-relapse Mortality	13 Participants

Secondary

Recurrent or Progressive Malignancy

Recurrence or progression of the malignant disease that was the reason for hematopoietic cell transplantation

Time frame: 2 years after enrollment

Arm	Measure	Value (COUNT_OF_PARTICIPANTS)
Treated Patients	Recurrent or Progressive Malignancy	1 Participants

Secondary

Survival

Patients who were alive at the specified time point

Time frame: 2 years after enrollment

Arm	Measure	Value (COUNT_OF_PARTICIPANTS)
Treated Patients	Survival	7 Participants

Secondary

Survival

Patients who were alive at the specified time after enrollment

Time frame: 6 months after enrollment

Arm	Measure	Value (COUNT_OF_PARTICIPANTS)
Treated Patients	Survival	10 Participants

Secondary

Survival

Patients who were alive at the specified time point

Time frame: 1 year after enrollment

Arm	Measure	Value (COUNT_OF_PARTICIPANTS)
Treated Patients	Survival	8 Participants

Other Pre-specified

Agents Added to Treat GVHD More Than 3 Days After Enrollment

Any systemic medication given in an effort to control graft-versus-host disease

Time frame: Up to 100 days after enrollment

Arm	Measure	Group	Value (COUNT_OF_PARTICIPANTS)
Treated Patients	Agents Added to Treat GVHD More Than 3 Days After Enrollment	Methotrexate	1 Participants
Treated Patients	Agents Added to Treat GVHD More Than 3 Days After Enrollment	Pentostatin	1 Participants
Treated Patients	Agents Added to Treat GVHD More Than 3 Days After Enrollment	Rabbit anti-thymocyte globulin	5 Participants
Treated Patients	Agents Added to Treat GVHD More Than 3 Days After Enrollment	Mycophenolate mofetil	4 Participants
Treated Patients	Agents Added to Treat GVHD More Than 3 Days After Enrollment	Tacrolimus	2 Participants
Treated Patients	Agents Added to Treat GVHD More Than 3 Days After Enrollment	Infliximab	4 Participants
Treated Patients	Agents Added to Treat GVHD More Than 3 Days After Enrollment	Etanercept	1 Participants
Treated Patients	Agents Added to Treat GVHD More Than 3 Days After Enrollment	Alemtuzumab	1 Participants
Treated Patients	Agents Added to Treat GVHD More Than 3 Days After Enrollment	Sirolimus	6 Participants

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

Conditions

Brief summary

Detailed description

Related papers

Interventions

Sponsors

Study design

Eligibility

Inclusion criteria

Exclusion criteria

Design outcomes

Primary

Secondary

Other

Countries

Participant flow

Recruitment details

Pre-assignment details

Participants by arm

Withdrawals & dropouts

Baseline characteristics

Adverse events

Outcome results

Functional Recovery

Causes of Death

Duration of Treatment With the Study Product

Mucosal Anatomic Recovery

Mucosal Anatomic Recovery

Mucosal Anatomic Recovery

Mucosal Anatomic Recovery

Mucosal Anatomic Recovery

Non-relapse Mortality

Recurrent or Progressive Malignancy

Survival

Survival

Survival

Agents Added to Treat GVHD More Than 3 Days After Enrollment