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Trial record 47 of 66 for:    "Viral Infectious Disease" | "Mycophenolic acid"

Rituximab in Preventing Acute Graft-Versus-Host Disease in Patients Undergoing a Donor Stem Cell Transplant for Hematologic Cancer

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ClinicalTrials.gov Identifier: NCT01044745
Recruitment Status : Terminated (Study was closed to accrual for safety related to the frequency of BK infections.)
First Posted : January 8, 2010
Results First Posted : February 26, 2019
Last Update Posted : February 26, 2019
Sponsor:
Collaborator:
National Cancer Institute (NCI)
Information provided by (Responsible Party):
R. Gregory Bociek, MD, University of Nebraska

Study Type Interventional
Study Design Intervention Model: Single Group Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Conditions Accelerated Phase Chronic Myelogenous Leukemia
Adult Acute Lymphoblastic Leukemia in Remission
Adult Acute Myeloid Leukemia in Remission
Adult Nasal Type Extranodal NK/T-cell Lymphoma
Blastic 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
de Novo Myelodysplastic Syndromes
Extranodal Marginal Zone B-cell Lymphoma of Mucosa-associated Lymphoid Tissue
Graft Versus Host Disease
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
Previously Treated Myelodysplastic Syndromes
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 Grade III Lymphomatoid Granulomatosis
Recurrent Adult Immunoblastic Large Cell Lymphoma
Recurrent Adult Lymphoblastic Lymphoma
Recurrent Adult T-cell Leukemia/Lymphoma
Recurrent Cutaneous T-cell Non-Hodgkin 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 Mycosis Fungoides/Sezary Syndrome
Recurrent Small Lymphocytic Lymphoma
Refractory Chronic Lymphocytic Leukemia
Relapsing Chronic Myelogenous Leukemia
Secondary Myelodysplastic Syndromes
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 Immunoblastic Large Cell Lymphoma
Stage I Adult Lymphoblastic Lymphoma
Stage I Adult T-cell Leukemia/Lymphoma
Stage I Chronic Lymphocytic Leukemia
Stage I Cutaneous T-cell Non-Hodgkin Lymphoma
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 Mycosis Fungoides/Sezary Syndrome
Stage I Small Lymphocytic Lymphoma
Stage II Adult T-cell Leukemia/Lymphoma
Stage II Chronic Lymphocytic Leukemia
Stage II Cutaneous T-cell Non-Hodgkin Lymphoma
Stage II Mycosis Fungoides/Sezary Syndrome
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 Immunoblastic Large Cell Lymphoma
Stage III Adult Lymphoblastic Lymphoma
Stage III Adult T-cell Leukemia/Lymphoma
Stage III Chronic Lymphocytic Leukemia
Stage III Cutaneous T-cell Non-Hodgkin Lymphoma
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 III Mycosis Fungoides/Sezary Syndrome
Stage III Small Lymphocytic 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 Immunoblastic Large Cell Lymphoma
Stage IV Adult Lymphoblastic Lymphoma
Stage IV Adult T-cell Leukemia/Lymphoma
Stage IV Chronic Lymphocytic Leukemia
Stage IV Cutaneous T-cell Non-Hodgkin Lymphoma
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 Mycosis Fungoides/Sezary Syndrome
Stage IV Small Lymphocytic Lymphoma
Untreated Adult Acute Lymphoblastic Leukemia
Untreated Adult Acute Myeloid Leukemia
Waldenström Macroglobulinemia
Interventions Drug: rituximab
Drug: mycophenolate mofetil
Drug: tacrolimus
Drug: anti-thymocyte globulin
Procedure: allogeneic hematopoietic stem cell transplantation
Other: laboratory biomarker analysis
Biological: graft versus host disease prophylaxis/therapy
Drug: cyclophosphamide
Drug: fludarabine phosphate
Drug: busulfan
Radiation: total-body irradiation
Biological: graft-versus-tumor induction therapy
Biological: immunosuppressive therapy
Enrollment 20
Recruitment Details  
Pre-assignment Details  
Arm/Group Title Treatment (Rituximab and Allogeneic HCT Transplant)
Hide Arm/Group Description

CONDITIONING REGIMEN: Cyclophosphamide and TBI; targeted busulfan and fludarabine; reduced-dose busulfan and fludarabine; or fludarabine and TBI.

GRAFT-VERSUS-HOST DISEASE PROPHYLAXIS: Rituximab IV days -6, 1, 8, and 15 and anti-thymocyte globulin IV over 6-8 hours on days -3 to -1. Tacrolimus IV continuously and then PO beginning on day -1 and continuing until day 150 followed by a taper until day 180 and mycophenolate mofetil PO or IV twice daily on days -1 to 60.

TRANSPLANTATION: Allogeneic hematopoietic stem cell transplantation on day 0.

laboratory biomarker analysis: Correlative studies

graft versus host disease prophylaxis/therapy: Undergo graft versus host disease prophylaxis/therapy

cyclophosphamide: Given PO or IV

fludarabine phosphate: Given IV

busulfan: Given IV

total-body irradiation: Undergo TBI

graft-versus-tumor induction therapy: Undergo graft-versus-tumor induction therapy

immunosuppressive therapy: Undergo immunosuppressive therapy

Period Title: Overall Study
Started 20
Completed 18
Not Completed 2
Reason Not Completed
Ineiligible             2
Arm/Group Title Treatment (Rituximab and Allogeneic HCT Transplant)
Hide Arm/Group Description

CONDITIONING REGIMEN: Cyclophosphamide and TBI; targeted busulfan and fludarabine; reduced-dose busulfan and fludarabine; or fludarabine and TBI.

GRAFT-VERSUS-HOST DISEASE PROPHYLAXIS: Rituximab IV days -6, 1, 8, and 15 and anti-thymocyte globulin IV over 6-8 hours on days -3 to -1. Tacrolimus IV continuously and then PO beginning on day -1 and continuing until day 150 followed by a taper until day 180 and mycophenolate mofetil PO or IV twice daily on days -1 to 60.

TRANSPLANTATION: Allogeneic hematopoietic stem cell transplantation on day 0.

laboratory biomarker analysis: Correlative studies

graft versus host disease prophylaxis/therapy: Undergo graft versus host disease prophylaxis/therapy

cyclophosphamide: Given PO or IV

fludarabine phosphate: Given IV

busulfan: Given IV

total-body irradiation: Undergo TBI

graft-versus-tumor induction therapy: Undergo graft-versus-tumor induction therapy

immunosuppressive therapy: Undergo immunosuppressive therapy

Overall Number of Baseline Participants 20
Hide Baseline Analysis Population Description
[Not Specified]
Age, Continuous  
Median (Full Range)
Unit of measure:  Years
Number Analyzed 20 participants
39
(21 to 52)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 20 participants
Female
11
  55.0%
Male
9
  45.0%
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
United States Number Analyzed 20 participants
20
1.Primary Outcome
Title Number of Participants With Grades II-IV Acute GVHD
Hide Description Determined with death as a competing risk. Defined and staged using the 1994 consensus conference modifications of the Glucksberg criteria.
Time Frame At day 100
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Treatment (Rituximab and Allogeneic HCT Transplant)
Hide Arm/Group Description:

CONDITIONING REGIMEN: Cyclophosphamide and TBI; targeted busulfan and fludarabine; reduced-dose busulfan and fludarabine; or fludarabine and TBI.

GRAFT-VERSUS-HOST DISEASE PROPHYLAXIS: Rituximab IV days -6, 1, 8, and 15 and anti-thymocyte globulin IV over 6-8 hours on days -3 to -1. Tacrolimus IV continuously and then PO beginning on day -1 and continuing until day 150 followed by a taper until day 180 and mycophenolate mofetil PO or IV twice daily on days -1 to 60.

TRANSPLANTATION: Allogeneic hematopoietic stem cell transplantation on day 0.

laboratory biomarker analysis: Correlative studies

graft versus host disease prophylaxis/therapy: Undergo graft versus host disease prophylaxis/therapy

cyclophosphamide: Given PO or IV

fludarabine phosphate: Given IV

busulfan: Given IV

total-body irradiation: Undergo TBI

graft-versus-tumor induction therapy: Undergo graft-versus-tumor induction therapy

immunosuppressive therapy: Undergo immunosuppressive therapy

Overall Number of Participants Analyzed 20
Measure Type: Count of Participants
Unit of Measure: Participants
16
  80.0%
2.Secondary Outcome
Title Event-free Survival
Hide Description Estimated using Kaplan-Meier estimator.
Time Frame From the date of transplant with relapse/progression or death as censored events, up to 2 years
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Treatment (Rituximab and Allogeneic HCT Transplant)
Hide Arm/Group Description:

CONDITIONING REGIMEN: Cyclophosphamide and TBI; targeted busulfan and fludarabine; reduced-dose busulfan and fludarabine; or fludarabine and TBI.

GRAFT-VERSUS-HOST DISEASE PROPHYLAXIS: Rituximab IV days -6, 1, 8, and 15 and anti-thymocyte globulin IV over 6-8 hours on days -3 to -1. Tacrolimus IV continuously and then PO beginning on day -1 and continuing until day 150 followed by a taper until day 180 and mycophenolate mofetil PO or IV twice daily on days -1 to 60.

TRANSPLANTATION: Allogeneic hematopoietic stem cell transplantation on day 0.

laboratory biomarker analysis: Correlative studies

graft versus host disease prophylaxis/therapy: Undergo graft versus host disease prophylaxis/therapy

cyclophosphamide: Given PO or IV

fludarabine phosphate: Given IV

busulfan: Given IV

total-body irradiation: Undergo TBI

graft-versus-tumor induction therapy: Undergo graft-versus-tumor induction therapy

immunosuppressive therapy: Undergo immunosuppressive therapy

Overall Number of Participants Analyzed 18
Median (Full Range)
Unit of Measure: months
12
(6 to 18)
3.Secondary Outcome
Title Overall Survival
Hide Description Estimated using Kaplan-Meier estimator.
Time Frame From the date of transplant with death from any cause as a censored event, up to 2 years
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Treatment (Rituximab and Allogeneic HCT Transplant)
Hide Arm/Group Description:

CONDITIONING REGIMEN: Cyclophosphamide and TBI; targeted busulfan and fludarabine; reduced-dose busulfan and fludarabine; or fludarabine and TBI.

GRAFT-VERSUS-HOST DISEASE PROPHYLAXIS: Rituximab IV days -6, 1, 8, and 15 and anti-thymocyte globulin IV over 6-8 hours on days -3 to -1. Tacrolimus IV continuously and then PO beginning on day -1 and continuing until day 150 followed by a taper until day 180 and mycophenolate mofetil PO or IV twice daily on days -1 to 60.

TRANSPLANTATION: Allogeneic hematopoietic stem cell transplantation on day 0.

laboratory biomarker analysis: Correlative studies

graft versus host disease prophylaxis/therapy: Undergo graft versus host disease prophylaxis/therapy

cyclophosphamide: Given PO or IV

fludarabine phosphate: Given IV

busulfan: Given IV

total-body irradiation: Undergo TBI

graft-versus-tumor induction therapy: Undergo graft-versus-tumor induction therapy

immunosuppressive therapy: Undergo immunosuppressive therapy

Overall Number of Participants Analyzed 18
Median (Full Range)
Unit of Measure: months
12
(9 to 18)
4.Secondary Outcome
Title Transplant-related Mortality (TRM)
Hide Description Transplant-related mortality (TRM) defined as any mortality after transplantation except mortality from relapsed disease - Reported as a simple percentage.
Time Frame At day 100
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Treatment (Rituximab and Allogeneic HCT Transplant)
Hide Arm/Group Description:

CONDITIONING REGIMEN: Patients receive one of the following conditioning regimens as per the transplant physician: cyclophosphamide and TBI; targeted busulfan and fludarabine; reduced-dose busulfan and fludarabine; or fludarabine and TBI.

GRAFT-VERSUS-HOST DISEASE PROPHYLAXIS: Patients receive rituximab IV on days -6, 1, 8, and 15 and anti-thymocyte globulin IV over 6-8 hours on days -3 to -1. Patients also receive tacrolimus IV continuously and then PO beginning on day -1 and continuing until day 150 followed by a taper until day 180 and mycophenolate mofetil PO or IV twice daily on days -1 to 60.

TRANSPLANTATION: Patients undergo allogeneic hematopoietic stem cell transplantation on day 0.

rituximab: Given IV

mycophenolate mofetil: Given IV or PO

tacrolimus: Given IV

anti-thymocyte globulin: Given IV

allogeneic hematopoietic stem cell transplantation

laboratory biomarker analysis: Correlative studies

graft versus host disease prophyla

Overall Number of Participants Analyzed 18
Measure Type: Count of Participants
Unit of Measure: Participants
0
   0.0%
Time Frame [Not Specified]
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Treatment (Rituximab and Allogeneic HCT Transplant)
Hide Arm/Group Description

CONDITIONING REGIMEN: Cyclophosphamide and TBI; targeted busulfan and fludarabine; reduced-dose busulfan and fludarabine; or fludarabine and TBI.

GRAFT-VERSUS-HOST DISEASE PROPHYLAXIS: Rituximab IV days -6, 1, 8, and 15 and anti-thymocyte globulin IV over 6-8 hours on days -3 to -1. Tacrolimus IV continuously and then PO beginning on day -1 and continuing until day 150 followed by a taper until day 180 and mycophenolate mofetil PO or IV twice daily on days -1 to 60.

TRANSPLANTATION: Allogeneic hematopoietic stem cell transplantation on day 0.

laboratory biomarker analysis: Correlative studies

graft versus host disease prophylaxis/therapy: Undergo graft versus host disease prophylaxis/therapy

cyclophosphamide: Given PO or IV

fludarabine phosphate: Given IV

busulfan: Given IV

total-body irradiation: Undergo TBI

graft-versus-tumor induction therapy: Undergo graft-versus-tumor induction therapy

immunosuppressive therapy: Undergo immunosuppressive therapy

All-Cause Mortality
Treatment (Rituximab and Allogeneic HCT Transplant)
Affected / at Risk (%)
Total   5/20 (25.00%)    
Show Serious Adverse Events Hide Serious Adverse Events
Treatment (Rituximab and Allogeneic HCT Transplant)
Affected / at Risk (%) # Events
Total   10/20 (50.00%)    
Gastrointestinal disorders   
Diarrhea  1 [1]  3/20 (15.00%)  3
vomiting  2 [2]  1/20 (5.00%)  1
anorexia  2  1/20 (5.00%)  1
mucositis oral  2  1/20 (5.00%)  1
ileus  2  1/20 (5.00%)  1
dehydration  2  1/20 (5.00%)  1
Hepatobiliary disorders   
thrombotic event  2 [3]  1/20 (5.00%)  1
Immune system disorders   
Immune system disorders-other  2 [4]  2/20 (10.00%)  2
Infections and infestations   
pneumonitis  2  3/20 (15.00%)  3
sepsis  2  3/20 (15.00%)  3
urinary tract infection  2  1/20 (5.00%)  1
cystitis  2 [5]  3/20 (15.00%)  3
Renal and urinary disorders   
acute kidney injury  2  3/20 (15.00%)  3
hematuria  2  1/20 (5.00%)  1
1
Term from vocabulary, CTCAE
2
Term from vocabulary, CTCAE (3.0)
Indicates events were collected by systematic assessment
[1]
Diarrhea
[2]
vomiting
[3]
hepatic veno-occlusive disease
[4]
graft-versus-host disease
[5]
BK virus cystitis
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
Treatment (Rituximab and Allogeneic HCT Transplant)
Affected / at Risk (%) # Events
Total   16/20 (80.00%)    
Blood and lymphatic system disorders   
Febrile Neutropenia  1 [1]  3/20 (15.00%)  3
Gastrointestinal disorders   
Ascites  1 [2]  1/20 (5.00%)  1
Mucositis - oral  1  3/20 (15.00%)  3
Diarrhea  1  1/20 (5.00%)  1
Nausea  1  1/20 (5.00%)  1
General disorders   
Altered mental status  1  1/20 (5.00%)  1
Immune system disorders   
Immune-system disorders- Other  1 [3]  2/20 (10.00%)  3
Infections and infestations   
Rash  1  2/20 (10.00%)  2
Infection and infestation - Other  1 [4]  1/20 (5.00%)  1
Sepsis  1  5/20 (25.00%)  8
Skin infection  1 [5]  1/20 (5.00%)  1
sinusitis  1  1/20 (5.00%)  1
Lung infection  1 [6]  2/20 (10.00%)  2
Urinary tract infection  1  1/20 (5.00%)  1
Bladder infection  1  1/20 (5.00%)  1
Investigations   
creatinine increased  1  1/20 (5.00%)  1
Weight loss  1 [7]  1/20 (5.00%)  1
blood bilirubin increased  1  2/20 (10.00%)  2
Alanin amintransferase increased  1  1/20 (5.00%)  1
Aspartate aminotransferase  1  1/20 (5.00%)  1
Metabolism and nutrition disorders   
Hypokalemia  1  7/20 (35.00%)  15
Hyponatremia  1  5/20 (25.00%)  6
Hyperglycemia  1  8/20 (40.00%)  14
Hypophosphatemia  1  4/20 (20.00%)  6
dehydration  1  1/20 (5.00%)  1
Anorexia  1  3/20 (15.00%)  3
Hypoalbuminemia  1  4/20 (20.00%)  8
Hypocalcemia  1  2/20 (10.00%)  13
Musculoskeletal and connective tissue disorders   
Muscle weakness  1  1/20 (5.00%)  1
Skin and subcutaneous tissue disorders   
Palmar-plantar erythrodysesthesia syndrome  1 [8]  1/20 (5.00%)  1
Vascular disorders   
Thromboembolic event  1 [9]  2/20 (10.00%)  2
1
Term from vocabulary, CTCAE (3.0)
Indicates events were collected by systematic assessment
[1]
an ANC <1000/mm3 and a single temperature of >38.3 degrees C (101 degrees F) or a sustained temperature of >=38 degrees C (100.4 degrees F) for more than one hour.
[2]
disorder characterized by accumulation of serous or hemorrhagic fluid in the peritoneal cavity.
[3]
GVHD -gut
[4]
Parvovirus
[5]
cellulitis
[6]
pneumonia
[7]
Failure to thrive
[8]
A disorder characterized by redness, marked discomfort, swelling, and tingling in the palms of the hands or the soles of the feet.
[9]
deep vein thrombosis
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There is NOT 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: R. Gregory Bociek, MD
Organization: University of Nebraska Medical Center
Phone: 402-559-5388
EMail: rgbociek@unmc.edu
Layout table for additonal information
Responsible Party: R. Gregory Bociek, MD, University of Nebraska
ClinicalTrials.gov Identifier: NCT01044745     History of Changes
Other Study ID Numbers: 083-09
NCI-2009-01552 ( Registry Identifier: CTRP (Clinical Trial Reporting Program) )
P30CA036727 ( U.S. NIH Grant/Contract )
First Submitted: January 7, 2010
First Posted: January 8, 2010
Results First Submitted: January 23, 2018
Results First Posted: February 26, 2019
Last Update Posted: February 26, 2019