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Trial record 17 of 25 for:    "Testicular Lymphoma" | "Antirheumatic Agents"

Vorinostat, Tacrolimus, and Methotrexate in Preventing GVHD After Stem Cell Transplant in Patients With Hematological Malignancies

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ClinicalTrials.gov Identifier: NCT01789255
Recruitment Status : Completed
First Posted : February 12, 2013
Results First Posted : November 13, 2015
Last Update Posted : July 24, 2018
Sponsor:
Information provided by (Responsible Party):
National Cancer Institute (NCI)

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 Myeloid Leukemia in Remission
Adult Acute Myeloid Leukemia With 11q23 (MLL) Abnormalities
Adult Acute Myeloid Leukemia With Del(5q)
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)
Adult Grade III Lymphomatoid Granulomatosis
B-cell Chronic Lymphocytic Leukemia
Chronic Myelogenous Leukemia, BCR-ABL1 Positive
Chronic Myelomonocytic Leukemia
Chronic Phase Chronic Myelogenous Leukemia
Contiguous Stage II Adult Burkitt Lymphoma
Contiguous Stage II Adult Diffuse Large Cell Lymphoma
Contiguous Stage II Adult Diffuse Mixed Cell Lymphoma
Contiguous Stage II Adult Diffuse Small Cleaved Cell Lymphoma
Contiguous Stage II Adult Immunoblastic Large Cell Lymphoma
Contiguous Stage II Adult Lymphoblastic Lymphoma
Contiguous Stage II Grade 1 Follicular Lymphoma
Contiguous Stage II Grade 2 Follicular Lymphoma
Contiguous Stage II Grade 3 Follicular Lymphoma
Contiguous Stage II Mantle Cell Lymphoma
Contiguous Stage II Marginal Zone Lymphoma
Contiguous Stage II Small Lymphocytic Lymphoma
Cutaneous B-cell Non-Hodgkin Lymphoma
Extranodal Marginal Zone B-cell Lymphoma of Mucosa-associated Lymphoid Tissue
Graft Versus Host Disease
Intraocular Lymphoma
Myelodysplastic Syndrome With Isolated Del(5q)
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
Post-transplant Lymphoproliferative Disorder
Primary Central Nervous System Hodgkin Lymphoma
Primary Central Nervous System Non-Hodgkin Lymphoma
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 Grade III Lymphomatoid Granulomatosis
Recurrent Adult Hodgkin Lymphoma
Recurrent Adult Immunoblastic Large Cell Lymphoma
Recurrent Adult Lymphoblastic Lymphoma
Recurrent Grade 1 Follicular Lymphoma
Recurrent Grade 2 Follicular Lymphoma
Recurrent Grade 3 Follicular Lymphoma
Recurrent Mantle Cell Lymphoma
Recurrent Marginal Zone Lymphoma
Recurrent Small Lymphocytic Lymphoma
Refractory Anemia
Refractory Anemia With Excess Blasts
Refractory Anemia With Ringed Sideroblasts
Refractory Chronic Lymphocytic Leukemia
Refractory Cytopenia With Multilineage Dysplasia
Refractory Hairy Cell Leukemia
Relapsing Chronic Myelogenous Leukemia
Secondary Central Nervous System Hodgkin Lymphoma
Secondary Central Nervous System Non-Hodgkin Lymphoma
Small Intestine Lymphoma
Splenic Marginal Zone Lymphoma
Stage I Adult Burkitt Lymphoma
Stage I Adult Diffuse Large Cell Lymphoma
Stage I Adult Diffuse Mixed Cell Lymphoma
Stage I Adult Diffuse Small Cleaved Cell Lymphoma
Stage I Adult Hodgkin Lymphoma
Stage I Adult Immunoblastic Large Cell Lymphoma
Stage I Adult Lymphoblastic Lymphoma
Stage I Chronic Lymphocytic Leukemia
Stage I Grade 1 Follicular Lymphoma
Stage I Grade 2 Follicular Lymphoma
Stage I Grade 3 Follicular Lymphoma
Stage I Mantle Cell Lymphoma
Stage I Marginal Zone Lymphoma
Stage I Small Lymphocytic Lymphoma
Stage II Adult Hodgkin Lymphoma
Stage II Chronic Lymphocytic Leukemia
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 Mantle Cell Lymphoma
Stage III Marginal Zone Lymphoma
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 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 Small Lymphocytic Lymphoma
Testicular Lymphoma
Waldenström Macroglobulinemia
Interventions Drug: vorinostat
Drug: tacrolimus
Drug: cyclosporine
Drug: methotrexate
Other: laboratory biomarker analysis
Other: pharmacological study
Enrollment 12
Recruitment Details  
Pre-assignment Details  
Arm/Group Title Supportive Care (Vorinostat, Tacrolimus, Methotrexate)
Hide Arm/Group Description Patients receive vorinostat PO BID on days -10 to 100. Beginning on day -3, patients receive tacrolimus IV continuously or PO BID (or cyclosporine IV continuously or PO in patients unable to tolerate tacrolimus) with taper on days 100-180. Patients also receive methotrexate IV QD on days 1, 3, 6, and 11.
Period Title: Overall Study
Started 12
Completed 12
Not Completed 0
Arm/Group Title Supportive Care (Vorinostat, Tacrolimus, Methotrexate)
Hide Arm/Group Description Patients receive vorinostat PO BID on days -10 to 100. Beginning on day -3, patients receive tacrolimus IV continuously or PO BID (or cyclosporine IV continuously or PO in patients unable to tolerate tacrolimus) with taper on days 100-180. Patients also receive methotrexate IV QD on days 1, 3, 6, and 11.
Overall Number of Baseline Participants 12
Hide Baseline Analysis Population Description
[Not Specified]
Age, Continuous  
Median (Inter-Quartile Range)
Unit of measure:  Years
Number Analyzed 12 participants
49
(45 to 58)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 12 participants
Female
7
  58.3%
Male
5
  41.7%
1.Primary Outcome
Title The Number of Participants That Experience Grade 2-4 Acute GVHD (Graft Versus Host Disease) by Day 100
Hide Description

The incidence of grade 2-4 acute GVHD (Graft Versus Host Disease) by day 100

Grade 2 GVHD: Maculopapular rash covering 25-50% of BSA (Body Surface Area), bilirubin between 3.1-6 mg/dl, and/ or adult stool output between 1000-1500 ml/day (child between 20-30 ml/kg/day).

Grade 3 GVHD: Maculopapular rash covering >50% of BSA, bilirubin between 6.1-15 mg/dl, and/ or adult stool output >1500 ml/day (child >30 ml/kg/day).

Grade 4 GVHD: Generalized erythroderma plus bullous formation and desquamation >5% BSA, bilirubin >15 mg/dl, and/ or severe abdominal pain with or without ileus, or grossly bloody stool.

Time Frame Day 100
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Supportive Care (Vorinostat, Tacrolimus, Methotrexate)
Hide Arm/Group Description:
Patients receive vorinostat PO BID on days -10 to 100. Beginning on day -3, patients receive tacrolimus IV continuously or PO BID (or cyclosporine IV continuously or PO in patients unable to tolerate tacrolimus) with taper on days 100-180. Patients also receive methotrexate IV QD on days 1, 3, 6, and 11.
Overall Number of Participants Analyzed 12
Measure Type: Number
Unit of Measure: participants
2
2.Secondary Outcome
Title Mean Percent of Planned Dose Administered
Hide Description The addition of vorinostat to tacrolimus and methotrexate for GVHD prophylaxis will be considered feasible if 60% or more of the planned doses are administered.
Time Frame Up to day 30
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Supportive Care (Vorinostat, Tacrolimus, Methotrexate)
Hide Arm/Group Description:
Patients receive vorinostat PO BID on days -10 to 100. Beginning on day -3, patients receive tacrolimus IV continuously or PO BID (or cyclosporine IV continuously or PO in patients unable to tolerate tacrolimus) with taper on days 100-180. Patients also receive methotrexate IV QD on days 1, 3, 6, and 11.
Overall Number of Participants Analyzed 12
Mean (Full Range)
Unit of Measure: percent of dose administered
82.5
(53.8 to 100)
3.Secondary Outcome
Title The Percentage of Patients Alive Without GVHD or Use of Steroids
Hide Description The percentage of patients alive without GVHD or use of steroids at 1 year.
Time Frame Up to 1 year
Hide Outcome Measure Data
Hide Analysis Population Description
This trial consisted of an initial pilot phase, funded by the NCI, that enrolled 12 patients (NCT01789255). The trial was extended to enroll an additional 25 patients. The results presented here include information for all 37 patients. The analysis population description for all 37 patients can be found under NCT01790568.
Arm/Group Title Supportive Care (Vorinostat, Tacrolimus, Methotrexate)
Hide Arm/Group Description:
Patients receive vorinostat PO BID on days -10 to 100. Beginning on day -3, patients receive tacrolimus IV continuously or PO BID (or cyclosporine IV continuously or PO in patients unable to tolerate tacrolimus) with taper on days 100-180. Patients also receive methotrexate IV QD on days 1, 3, 6, and 11.
Overall Number of Participants Analyzed 37
Measure Type: Number
Unit of Measure: percentage of patients
47
4.Secondary Outcome
Title The Percentage of Patients Alive at 1 Year
Hide Description The percentage of patients alive at 1 year
Time Frame Up to 1 year
Hide Outcome Measure Data
Hide Analysis Population Description
This trial consisted of an initial pilot phase, funded by the NCI, that enrolled 12 patients (NCT01789255). The trial was extended to enroll an additional 25 patients. The results presented here include information for all 37 patients. The analysis population description for all 37 patients can be found under NCT01790568.
Arm/Group Title Supportive Care (Vorinostat, Tacrolimus, Methotrexate)
Hide Arm/Group Description:
Patients receive vorinostat PO BID on days -10 to 100. Beginning on day -3, patients receive tacrolimus IV continuously or PO BID (or cyclosporine IV continuously or PO in patients unable to tolerate tacrolimus) with taper on days 100-180. Patients also receive methotrexate IV QD on days 1, 3, 6, and 11.
Overall Number of Participants Analyzed 37
Measure Type: Number
Unit of Measure: percentage of patients
76
5.Secondary Outcome
Title The Percentage of Patients With Relapse at 1 Year
Hide Description [Not Specified]
Time Frame Up to 1 year
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Supportive Care (Vorinostat, Tacrolimus, Methotrexate)
Hide Arm/Group Description:
Patients receive vorinostat PO BID on days -10 to 100. Beginning on day -3, patients receive tacrolimus IV continuously or PO BID (or cyclosporine IV continuously or PO in patients unable to tolerate tacrolimus) with taper on days 100-180. Patients also receive methotrexate IV QD on days 1, 3, 6, and 11.
Overall Number of Participants Analyzed 12
Measure Type: Number
Unit of Measure: percentage of patients
19
6.Secondary Outcome
Title Median Ac-H3 Levels in Patients Treated With Vorinostat and Patients Not Treated With Vorinostat
Hide Description Median Ac-H3 levels ( depicted as a ratio of ac-H2 optical density (OD) and beta actin OD) were compared in patients treated with Vorinostat to patients not treated with Vorinostat. Optical Density is a dimensionless unit.
Time Frame Up to day 100
Hide Outcome Measure Data
Hide Analysis Population Description
This trial consisted of an initial pilot phase, funded by the NCI, that enrolled 12 patients (NCT01789255). The trial was extended to enroll an additional 25 patients. The results presented here include information for all 37 patients. The analysis population description for all 37 patients can be found under NCT01790568.
Arm/Group Title Supportive Care (Vorinostat, Tacrolimus, Methotrexate)
Hide Arm/Group Description:
Patients receive vorinostat PO BID on days -10 to 100. Beginning on day -3, patients receive tacrolimus IV continuously or PO BID (or cyclosporine IV continuously or PO in patients unable to tolerate tacrolimus) with taper on days 100-180. Patients also receive methotrexate IV QD on days 1, 3, 6, and 11.
Overall Number of Participants Analyzed 37
Median (Full Range)
Unit of Measure: Ratio
Treated with Vorinostat
0.943
(0.42 to 1.27)
Not Treated with Vorinostat
0.679
(0.19 to 1.01)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Supportive Care (Vorinostat, Tacrolimus, Methotrexate)
Comments [Not Specified]
Type of Statistical Test Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.02642
Comments [Not Specified]
Method Wilcoxon (Mann-Whitney)
Comments [Not Specified]
7.Secondary Outcome
Title Median Plasma Concentration of IL-6 in Patients Treated With Vorinostat and Patients Not Treated With Vorinostat
Hide Description Median plasma concentration of IL-6 (Interleukin-6 cytokine) was compared in patients treated with Vorinostat to those not treated with Vorinostat.
Time Frame Up to day 100
Hide Outcome Measure Data
Hide Analysis Population Description
This trial consisted of an initial pilot phase, funded by the NCI, that enrolled 12 patients (NCT01789255). The trial was extended to enroll an additional 25 patients. The results presented here include information for all 37 patients. The analysis population description for all 37 patients can be found under NCT01790568.
Arm/Group Title Supportive Care (Vorinostat, Tacrolimus, Methotrexate)
Hide Arm/Group Description:
Patients receive vorinostat PO BID on days -10 to 100. Beginning on day -3, patients receive tacrolimus IV continuously or PO BID (or cyclosporine IV continuously or PO in patients unable to tolerate tacrolimus) with taper on days 100-180. Patients also receive methotrexate IV QD on days 1, 3, 6, and 11.
Overall Number of Participants Analyzed 37
Median (Full Range)
Unit of Measure: pg/mL
Treated with Vorinostat
4.2
(0.1 to 22.3)
Not Treated with Vorinostat
7.6
(0.3 to 70.1)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Supportive Care (Vorinostat, Tacrolimus, Methotrexate)
Comments [Not Specified]
Type of Statistical Test Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.028
Comments [Not Specified]
Method Wilcoxon (Mann-Whitney)
Comments [Not Specified]
Time Frame [Not Specified]
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Supportive Care (Vorinostat, Tacrolimus, Methotrexate)
Hide Arm/Group Description Patients receive vorinostat PO BID on days -10 to 100. Beginning on day -3, patients receive tacrolimus IV continuously or PO BID (or cyclosporine IV continuously or PO in patients unable to tolerate tacrolimus) with taper on days 100-180. Patients also receive methotrexate IV QD on days 1, 3, 6, and 11.
All-Cause Mortality
Supportive Care (Vorinostat, Tacrolimus, Methotrexate)
Affected / at Risk (%)
Total   --/--    
Show Serious Adverse Events Hide Serious Adverse Events
Supportive Care (Vorinostat, Tacrolimus, Methotrexate)
Affected / at Risk (%) # Events
Total   7/12 (58.33%)    
Blood and lymphatic system disorders   
Anemia  1/12 (8.33%)  1
Gastrointestinal disorders   
Diarrhea  3/12 (25.00%)  3
Dysphagia  1/12 (8.33%)  1
Nausea  1/12 (8.33%)  1
Vomiting  1/12 (8.33%)  1
General disorders   
Non-cardiac chest pain  2/12 (16.67%)  2
Immune system disorders   
Immune system disorders, Other  1/12 (8.33%)  1
Infections and infestations   
Abdominal infection  1/12 (8.33%)  1
Catheter related infection  1/12 (8.33%)  1
Urinary tract infection  1/12 (8.33%)  1
Metabolism and nutrition disorders   
Dehydration  1/12 (8.33%)  1
Neoplasms benign, malignant and unspecified (incl cysts and polyps)   
Neoplasms benign, malignant and unspecified, Other  3/12 (25.00%)  3
Respiratory, thoracic and mediastinal disorders   
Hypoxia  1/12 (8.33%)  1
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
Supportive Care (Vorinostat, Tacrolimus, Methotrexate)
Affected / at Risk (%) # Events
Total   10/12 (83.33%)    
Blood and lymphatic system disorders   
Anemia  2/12 (16.67%)  2
Gastrointestinal disorders   
Diarrhea  4/12 (33.33%)  4
Dysphagia  1/12 (8.33%)  1
Mucositis oral  3/12 (25.00%)  3
Nausea  3/12 (25.00%)  5
Vomiting  3/12 (25.00%)  4
General disorders   
Non-cardiac chest pain  2/12 (16.67%)  2
Pain  1/12 (8.33%)  1
Immune system disorders   
Immune system disorders, Other  1/12 (8.33%)  1
Infections and infestations   
Abdominal infection  1/12 (8.33%)  1
Catheter related infection  1/12 (8.33%)  1
Urinary tract infection  1/12 (8.33%)  1
Investigations   
Alanine aminotransferase increased  1/12 (8.33%)  1
Blood bilirubin increased  2/12 (16.67%)  3
Creatinine increased  4/12 (33.33%)  5
Lymphocyte count decreased  1/12 (8.33%)  1
Neutrophil count decreased  1/12 (8.33%)  1
Platelet count decreased  8/12 (66.67%)  8
White blood cell decreased  2/12 (16.67%)  2
Metabolism and nutrition disorders   
Dehydration  1/12 (8.33%)  1
Neoplasms benign, malignant and unspecified (incl cysts and polyps)   
Neoplasms benign, malignant and unspecified, Other  3/12 (25.00%)  3
Renal and urinary disorders   
Acute kidney injury  1/12 (8.33%)  1
Respiratory, thoracic and mediastinal disorders   
Hypoxia  1/12 (8.33%)  1
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There IS an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: Pavan Reddy, M.D.
Organization: University of Michigan Comprehensive Cancer Center
Phone: 734-647-5954
EMail: reddypr@umich.edu
Layout table for additonal information
Responsible Party: National Cancer Institute (NCI)
ClinicalTrials.gov Identifier: NCT01789255     History of Changes
Other Study ID Numbers: NCI-2013-00355
NCI-2013-00355 ( Registry Identifier: CTRP (Clinical Trial Reporting Program) )
HUM00070080
UMCC 2012.047 ( Other Identifier: University of Michigan University Hospital )
9330 ( Other Identifier: CTEP )
P30CA046592 ( U.S. NIH Grant/Contract )
First Submitted: February 7, 2013
First Posted: February 12, 2013
Results First Submitted: August 26, 2015
Results First Posted: November 13, 2015
Last Update Posted: July 24, 2018