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Trial record 5 of 23 for:    CD20 Fred Hutchinson

Rituximab in Treating Patients Undergoing Donor Peripheral Blood Stem Cell Transplant for Relapsed or Refractory B-cell Lymphoma

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.
 
ClinicalTrials.gov Identifier: NCT00867529
Recruitment Status : Completed
First Posted : March 23, 2009
Results First Posted : May 22, 2017
Last Update Posted : January 2, 2018
Sponsor:
Collaborators:
American Cancer Society, Inc.
National Cancer Institute (NCI)
Information provided by (Responsible Party):
David Maloney, Fred Hutchinson Cancer Research Center

Study Type Interventional
Study Design Intervention Model: Single Group Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Conditions B-cell Adult Acute Lymphoblastic Leukemia
B-cell Childhood Acute Lymphoblastic Leukemia
B-cell Chronic Lymphocytic Leukemia
Childhood Burkitt Lymphoma
Childhood Diffuse Large Cell Lymphoma
Childhood Immunoblastic Large Cell Lymphoma
Cutaneous B-cell Non-Hodgkin Lymphoma
Extranodal Marginal Zone B-cell Lymphoma of Mucosa-associated Lymphoid Tissue
Intraocular Lymphoma
Nodal Marginal Zone B-cell Lymphoma
Post-transplant Lymphoproliferative Disorder
Recurrent Adult Acute Lymphoblastic 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 Childhood Acute Lymphoblastic Leukemia
Recurrent Childhood Grade III Lymphomatoid Granulomatosis
Recurrent Childhood Large Cell Lymphoma
Recurrent Childhood Lymphoblastic Lymphoma
Recurrent Childhood Small Noncleaved Cell 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
Recurrent/Refractory Childhood Hodgkin Lymphoma
Refractory Chronic Lymphocytic Leukemia
Refractory Hairy Cell Leukemia
Small Intestine Lymphoma
Splenic Marginal Zone Lymphoma
Testicular Lymphoma
Waldenström Macroglobulinemia
Interventions Biological: rituximab
Procedure: peripheral blood stem cell transplantation
Procedure: nonmyeloablative allogeneic hematopoietic stem cell transplantation
Other: pharmacological study
Other: laboratory biomarker analysis
Enrollment 63
Recruitment Details  
Pre-assignment Details  
Arm/Group Title Treatment (Rituximab Pre- and Post-transplant)
Hide Arm/Group Description

Patients receive rituximab IV, pre- and post-transplant, on days -3, 10, 24, and 38. Patients undergo donor peripheral blood stem cell transplant on day 0. Treatment continues in the absence of disease progression or unacceptable toxicity.

rituximab: Given IV

peripheral blood stem cell transplantation: Undergo nonmyeloablative allogeneic peripheral blood/hematopoietic stem cell transplantation

nonmyeloablative allogeneic hematopoietic stem cell transplantation: Undergo nonmyeloablative allogeneic peripheral blood/hematopoietic stem cell transplantation

pharmacological study: Correlative studies

laboratory biomarker analysis: Correlative studies

Period Title: Overall Study
Started 63
Completed 63
Not Completed 0
Arm/Group Title Treatment (Rituximab Pre- and Post-transplant)
Hide Arm/Group Description

Patients receive rituximab IV, pre- and post-transplant, on days -3, 10, 24, and 38. Patients undergo donor peripheral blood stem cell transplant on day 0. Treatment continues in the absence of disease progression or unacceptable toxicity.

rituximab: Given IV

peripheral blood stem cell transplantation: Undergo nonmyeloablative allogeneic peripheral blood/hematopoietic stem cell transplantation

nonmyeloablative allogeneic hematopoietic stem cell transplantation: Undergo nonmyeloablative allogeneic peripheral blood/hematopoietic stem cell transplantation

pharmacological study: Correlative studies

laboratory biomarker analysis: Correlative studies

Overall Number of Baseline Participants 63
Hide Baseline Analysis Population Description
[Not Specified]
Age, Categorical  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 63 participants
<=18 years
0
   0.0%
Between 18 and 65 years
57
  90.5%
>=65 years
6
   9.5%
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 63 participants
Female
20
  31.7%
Male
43
  68.3%
Ethnicity (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 63 participants
Hispanic or Latino
5
   7.9%
Not Hispanic or Latino
58
  92.1%
Unknown or Not Reported
0
   0.0%
Race (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 63 participants
American Indian or Alaska Native
1
   1.6%
Asian
2
   3.2%
Native Hawaiian or Other Pacific Islander
0
   0.0%
Black or African American
0
   0.0%
White
58
  92.1%
More than one race
0
   0.0%
Unknown or Not Reported
2
   3.2%
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
United States Number Analyzed 63 participants
63
1.Primary Outcome
Title Disease Relapse Rate
Hide Description Number of patients with relapsed/progressive disease post-transplant. The effectiveness of pre- and post-transplant rituximab in decreasing the rate of relapse will be evaluated.
Time Frame At 18 months
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Treatment (Rituximab Pre- and Post-transplant)
Hide Arm/Group Description:

Patients receive rituximab IV, pre- and post-transplant, on days -3, 10, 24, and 38. Patients undergo donor peripheral blood stem cell transplant on day 0. Treatment continues in the absence of disease progression or unacceptable toxicity.

rituximab: Given IV

peripheral blood stem cell transplantation: Undergo nonmyeloablative allogeneic peripheral blood/hematopoietic stem cell transplantation

nonmyeloablative allogeneic hematopoietic stem cell transplantation: Undergo nonmyeloablative allogeneic peripheral blood/hematopoietic stem cell transplantation

pharmacological study: Correlative studies

laboratory biomarker analysis: Correlative studies

Overall Number of Participants Analyzed 63
Measure Type: Count of Participants
Unit of Measure: Participants
18
  28.6%
2.Secondary Outcome
Title Incidence and Severity of Acute and Chronic GVHD Evaluated Per an Adapted Version of Common Terminology Criteria for Adverse Events (CTCAE) Version 2.0
Hide Description

Number of patients who developed acute/chronic GVHD post-transplant. A chronic GVHD diagnosis ≥1 manifestation that is distinctive for chronic GVHD, as opposed to acute GVHD.

aGVHD Stages

Skin:

a maculopapular eruption involving < 25% BSA a maculopapular eruption involving 25 - 50% BSA generalized erythroderma generalized erythroderma with bullous formation and often with desquamation

Liver:

bilirubin 2.0 - 3.0 mg/100 mL bilirubin 3 - 5.9 mg/100 mL bilirubin 6 - 14.9 mg/100 mL bilirubin > 15 mg/100 mL

Gut:

Diarrhea is graded 1 - 4 in severity. Nausea and vomiting and/or anorexia caused by GVHD is assigned as 1 in severity. The severity of gut involvement is assigned to the most severe involvement noted. Patients with visible bloody diarrhea are at least stage 2 gut and grade 3 overall.

aGVHD Grades Grade III: Stage 2 - 4 gut involvement and/or stage 2 - 4 liver involvement Grade IV: Pattern and severity of GVHD similar to grade 3 with extreme constitutional symptoms or death

Time Frame Through day +100 after transplant
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Treatment (Rituximab Pre- and Post-transplant)
Hide Arm/Group Description:

Patients receive rituximab IV, pre- and post-transplant, on days -3, 10, 24, and 38. Patients undergo donor peripheral blood stem cell transplant on day 0. Treatment continues in the absence of disease progression or unacceptable toxicity.

rituximab: Given IV

peripheral blood stem cell transplantation: Undergo nonmyeloablative allogeneic peripheral blood/hematopoietic stem cell transplantation

nonmyeloablative allogeneic hematopoietic stem cell transplantation: Undergo nonmyeloablative allogeneic peripheral blood/hematopoietic stem cell transplantation

pharmacological study: Correlative studies

laboratory biomarker analysis: Correlative studies

Overall Number of Participants Analyzed 63
Measure Type: Count of Participants
Unit of Measure: Participants
17
  27.0%
3.Secondary Outcome
Title Overall Survival and Progression-free Survival
Hide Description Number of patients surviving and number of patients surviving without progressive/relapsed disease, post-transplant.
Time Frame At 6 months and then every year thereafter, up to 18 months
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Treatment (Rituximab Pre- and Post-transplant)
Hide Arm/Group Description:

Patients receive rituximab IV, pre- and post-transplant, on days -3, 10, 24, and 38. Patients undergo donor peripheral blood stem cell transplant on day 0. Treatment continues in the absence of disease progression or unacceptable toxicity.

rituximab: Given IV

peripheral blood stem cell transplantation: Undergo nonmyeloablative allogeneic peripheral blood/hematopoietic stem cell transplantation

nonmyeloablative allogeneic hematopoietic stem cell transplantation: Undergo nonmyeloablative allogeneic peripheral blood/hematopoietic stem cell transplantation

pharmacological study: Correlative studies

laboratory biomarker analysis: Correlative studies

Overall Number of Participants Analyzed 63
Measure Type: Count of Participants
Unit of Measure: Participants
PFS - 6 Months
48
  76.2%
PFS - 1 Year
39
  61.9%
PFS - 1.5 Years
34
  54.0%
OS - 6 Months
52
  82.5%
OS - 1 Year
44
  69.8%
OS - 1.5 Years
36
  57.1%
4.Secondary Outcome
Title Rate of Graft Rejection and Graft Failure
Hide Description Number of patients experiencing graft rejection and/or graft failure
Time Frame 18 Months
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Treatment (Rituximab Pre- and Post-transplant)
Hide Arm/Group Description:

Patients receive rituximab IV, pre- and post-transplant, on days -3, 10, 24, and 38. Patients undergo donor peripheral blood stem cell transplant on day 0. Treatment continues in the absence of disease progression or unacceptable toxicity.

rituximab: Given IV

peripheral blood stem cell transplantation: Undergo nonmyeloablative allogeneic peripheral blood/hematopoietic stem cell transplantation

nonmyeloablative allogeneic hematopoietic stem cell transplantation: Undergo nonmyeloablative allogeneic peripheral blood/hematopoietic stem cell transplantation

pharmacological study: Correlative studies

laboratory biomarker analysis: Correlative studies

Overall Number of Participants Analyzed 63
Measure Type: Count of Participants
Unit of Measure: Participants
Graft Rejection
1
   1.6%
Graft Failure
0
   0.0%
5.Secondary Outcome
Title Time to Engraftment
Hide Description Median time from transplant to engraftment.
Time Frame 18 Months
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Treatment (Rituximab Pre- and Post-transplant)
Hide Arm/Group Description:

Patients receive rituximab IV, pre- and post-transplant, on days -3, 10, 24, and 38. Patients undergo donor peripheral blood stem cell transplant on day 0. Treatment continues in the absence of disease progression or unacceptable toxicity.

rituximab: Given IV

peripheral blood stem cell transplantation: Undergo nonmyeloablative allogeneic peripheral blood/hematopoietic stem cell transplantation

nonmyeloablative allogeneic hematopoietic stem cell transplantation: Undergo nonmyeloablative allogeneic peripheral blood/hematopoietic stem cell transplantation

pharmacological study: Correlative studies

laboratory biomarker analysis: Correlative studies

Overall Number of Participants Analyzed 63
Median (Full Range)
Unit of Measure: Days
10
(0 to 48)
Time Frame AEs: Conditioning through Day 100; SAEs: Conditioning through Day 200
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Treatment (Rituximab Pre- and Post-transplant)
Hide Arm/Group Description

Patients receive rituximab IV, pre- and post-transplant, on days -3, 10, 24, and 38. Patients undergo donor peripheral blood stem cell transplant on day 0. Treatment continues in the absence of disease progression or unacceptable toxicity.

rituximab: Given IV

peripheral blood stem cell transplantation: Undergo nonmyeloablative allogeneic peripheral blood/hematopoietic stem cell transplantation

nonmyeloablative allogeneic hematopoietic stem cell transplantation: Undergo nonmyeloablative allogeneic peripheral blood/hematopoietic stem cell transplantation

pharmacological study: Correlative studies

laboratory biomarker analysis: Correlative studies

All-Cause Mortality
Treatment (Rituximab Pre- and Post-transplant)
Affected / at Risk (%)
Total   --/--    
Show Serious Adverse Events Hide Serious Adverse Events
Treatment (Rituximab Pre- and Post-transplant)
Affected / at Risk (%) # Events
Total   5/63 (7.94%)    
Infections and infestations   
Death Due to Infection *  2/63 (3.17%)  2
Sepsis and Tachycardia *  1/63 (1.59%)  1
Sepsis, Respiratory Failure, Mental Status Change *  1/63 (1.59%)  1
Respiratory, thoracic and mediastinal disorders   
Multiple Pulmonary Emboli *  1/63 (1.59%)  1
Suspected Pulmonary Embolism *  1/63 (1.59%)  1
*
Indicates events were collected by non-systematic assessment
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
Treatment (Rituximab Pre- and Post-transplant)
Affected / at Risk (%) # Events
Total   15/63 (23.81%)    
Hepatobiliary disorders   
Elevated Bilirubin   4/63 (6.35%)  4
Renal and urinary disorders   
Elevated Creatinine   5/63 (7.94%)  5
Respiratory, thoracic and mediastinal disorders   
ARDS *  3/63 (4.76%)  3
Diffuse Alveolar Hemorrhage *  3/63 (4.76%)  3
Hypoxia *  11/63 (17.46%)  12
Indicates events were collected by systematic assessment
*
Indicates events were collected by non-systematic assessment
Certain Agreements
All Principal Investigators ARE employed by the organization sponsoring the study.
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: David G Maloney, MD PhD
Organization: Fred Hutch
EMail: dmaloney@fredhutch.org
Layout table for additonal information
Responsible Party: David Maloney, Fred Hutchinson Cancer Research Center
ClinicalTrials.gov Identifier: NCT00867529     History of Changes
Other Study ID Numbers: 2226.00
NCI-2010-00107 ( Registry Identifier: CTRP (Clinical Trial Reporting Program) )
2226
2226.00 ( Other Identifier: Fred Hutchinson Cancer Research Center/University of Washington Cancer Consortium )
P01CA078902 ( U.S. NIH Grant/Contract )
P30CA015704 ( U.S. NIH Grant/Contract )
First Submitted: March 20, 2009
First Posted: March 23, 2009
Results First Submitted: April 14, 2017
Results First Posted: May 22, 2017
Last Update Posted: January 2, 2018