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

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00408681
First Posted: December 7, 2006
Last Update Posted: March 7, 2017
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Collaborator:
National Cancer Institute (NCI)
Information provided by (Responsible Party):
Paul Martin, Fred Hutchinson Cancer Research Center
Results First Submitted: November 23, 2016  
Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment;   Masking: None (Open Label);   Primary Purpose: Supportive Care
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 Small Lymphocytic Lymphoma
Recurrent Wilms Tumor and Other Childhood Kidney Tumors
Recurrent/Refractory Childhood Hodgkin Lymphoma
Refractory Chronic Lymphocytic Leukemia
Refractory Hairy Cell Leukemia
Relapsing Chronic Myelogenous Leukemia
Secondary Acute Myeloid Leukemia
Secondary Myelodysplastic Syndromes
Splenic Marginal Zone Lymphoma
Stage I Multiple Myeloma
Stage II Multiple Myeloma
Stage II Ovarian Epithelial 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 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 IIIA Breast Cancer
Stage IIIB Breast Cancer
Stage IIIC Breast Cancer
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
Interventions: Drug: lithium carbonate
Other: laboratory biomarker analysis

  Participant Flow
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Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
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
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
Patients were enrolled according to eligibility criteria in the protocol.

Reporting Groups
  Description
Treated Patients Patients receive oral lithium carbonate once or twice daily orally. Treatment continues for up to 8 weeks in the absence of disease progression or unacceptable toxicity.

Participant Flow:   Overall Study
    Treated Patients
STARTED   20 
COMPLETED   11 [1] 
NOT COMPLETED   9 
Lack of Efficacy                2 
Adverse Event                7 
[1] Completion was defined as administration of the study product for at least 28 days.



  Baseline Characteristics
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Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
No text entered.

Reporting Groups
  Description
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.

Baseline Measures
   Treated Patients 
Overall Participants Analyzed 
[Units: Participants]
 20 
Age 
[Units: Years]
Mean (Full Range)
 49.5 
 (22 to 63) 
Sex: Female, Male 
[Units: Participants]
Count of Participants
 
Female      13  65.0% 
Male      7  35.0% 
Ethnicity (NIH/OMB) 
[Units: Participants]
Count of Participants
 
Hispanic or Latino      1   5.0% 
Not Hispanic or Latino      19  95.0% 
Unknown or Not Reported      0   0.0% 
Race (NIH/OMB) 
[Units: Participants]
Count of Participants
 
American Indian or Alaska Native      0   0.0% 
Asian      1   5.0% 
Native Hawaiian or Other Pacific Islander      1   5.0% 
Black or African American      1   5.0% 
White      14  70.0% 
More than one race      2  10.0% 
Unknown or Not Reported      1   5.0% 
Region of Enrollment 
[Units: Participants]
Count of Participants
 
United States   20 
Indication for transplantation 
[Units: Participants]
Count of Participants
 
Non-Hodgkin lymphoma   3 
Acute myeloid leukemia   6 
Multiple myeloma   2 
Chronic myeloid leukemia   2 
Acute lymphoid leukemia   3 
Myelodysplastic syndrome   1 
Aplastic anemia   1 
Paroxysmal nocturnal hemoglobinuria   1 
Chronic lymphocytic leukemia   1 
Type of pretransplant conditioning regimen 
[Units: Participants]
Count of Participants
 
Myeloablative   12 
Nonmyeloablative   8 
Graft-versus-host disease (GVHD) prophylaxis regimen 
[Units: Participants]
Count of Participants
 
Cyclosporine and mycophenolate mofetil (MMF)   8 
Tacrolimus and methotrexate   10 
Cyclophosphamide, tacrolimus, MMF   1 
Tacrolimus and mycophenolate mofeftil   1 
Mucosal denudation 
[Units: Participants]
Count of Participants
 
Duodenum alone   7 
Colon alone   7 
Duodenum and colon   3 
Agents given to prevent GVHD at the time of enrollment 
[Units: Participants]
Count of Participants
 
Tacrolimus   8 
Cyclosporine   7 
Mycophenolate mofetil   8 
Agents given to treat GVHD more than 3 days before enrollment in the study 
[Units: Participants]
Count of Participants
 
Infliximab   3 
Rabbit anti-thymocyte globulin   3 
Horse anti-thymocyte globulin   1 
Extracorporeal photopheresis   2 
Mesenchymal stem cells   1 
Mycophenolate mofetil   5 
Tacrolimus   3 
Sirolimus   1 
Cyclosporine   1 
Interval from transplantation to start of study product administration 
[Units: Days]
Median (Full Range)
 90 
 (22 to 215) 
Agents given to treat GVHD within 3 days before or after enrollment 
[Units: Participants]
Count of Participants
 
Methotrexate   1 
Pentostatin   2 
Rabbit anti-thymocyte globulin   4 
Mycophenolate mofetil   1 
Infliximab   2 
Alemtuzumab   1 


  Outcome Measures
  Show All Outcome Measures

1.  Primary:   Functional Recovery   [ Time Frame: at 28 days after starting treatment with the study product ]

2.  Secondary:   Duration of Treatment With the Study Product   [ Time Frame: Up to 6 months ]

3.  Secondary:   Mucosal Anatomic Recovery   [ Time Frame: 2 to 3 weeks after starting treatment with the study product ]

4.  Secondary:   Mucosal Anatomic Recovery   [ Time Frame: 4 weeks after starting treatment with the study product ]

5.  Secondary:   Mucosal Anatomic Recovery   [ Time Frame: 5 weeks after starting treatment with the study product ]

6.  Secondary:   Mucosal Anatomic Recovery   [ Time Frame: 6 to 7 weeks after starting treatment with the study product ]

7.  Secondary:   Mucosal Anatomic Recovery   [ Time Frame: 9 to 11 weeks after starting treatment with the study product ]

8.  Secondary:   Recurrent or Progressive Malignancy   [ Time Frame: 2 years after enrollment ]

9.  Secondary:   Non-relapse Mortality   [ Time Frame: 2 years after enrollment ]

10.  Secondary:   Survival   [ Time Frame: 6 months after enrollment ]

11.  Secondary:   Survival   [ Time Frame: 1 year after enrollment ]

12.  Secondary:   Survival   [ Time Frame: 2 years after enrollment ]

13.  Secondary:   Causes of Death   [ Time Frame: up to 6 years after enrollment ]

14.  Other Pre-specified:   Agents Added to Treat GVHD More Than 3 Days After Enrollment   [ Time Frame: Up to 100 days after enrollment ]


  Serious Adverse Events


  Other Adverse Events


  Limitations and Caveats
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Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
This trial was not controlled in any scientifically valid sense of the term. Clinical management included many changes of treatment other than the use of the study product. The trial had no validated external benchmark for comparisons.


  More Information
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Certain Agreements:  
All Principal Investigators ARE employed by the organization sponsoring the study.


Results Point of Contact:  
Name/Title: Paul J. Martin, M.D.
Organization: Fred Hutchinson Cancer Research Center
phone: 206-667-4798
e-mail: pmartin@fredhutch.org



Responsible Party: Paul Martin, Fred Hutchinson Cancer Research Center
ClinicalTrials.gov Identifier: NCT00408681     History of Changes
Other Study ID Numbers: 2080.00
NCI-2010-00269
First Submitted: December 6, 2006
First Posted: December 7, 2006
Results First Submitted: November 23, 2016
Results First Posted: January 20, 2017
Last Update Posted: March 7, 2017