Trial Outcomes & Findings for Chemotherapy, Total-Body Irradiation, Rituximab, and Donor Stem Cell Transplant in Treating Patients With B-Cell Non-Hodgkin's Lymphoma or Chronic Lymphocytic Leukemia (NCT NCT00425802)
NCT ID: NCT00425802
Last Updated: 2017-10-31
Results Overview
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
61 participants
Primary outcome timeframe
1 year
Results posted on
2017-10-31
Participant Flow
Protocol Open to Accrual 11/28/2006 Protocol Closed to Accrual 4/22/2014 Primary Completion Date 10/28/2016 Recruitment Location is the medical clinic
Participant milestones
| Measure |
Treatment
This is a phase 2 study of a treatment regimen consisting of a non-myeloablative (NMA) conditioning regimen incorporating low dose chemotherapy and low dose radiation as well as peri-transplant Rituximab and the transplantation of peripheral blood stem cells (PBSC) or bone marrow if PBSC collection not possible from an HLA compatible related or unrelated donor in patients with B cell lymphoid malignancies including diffuse large cell (DLC) and mantle cell non-Hodgkin's lymphoma (NHL), indolent B cell NHL, or chronic lymphocytic leukemia (CLL).
|
|---|---|
|
Overall Study
STARTED
|
61
|
|
Overall Study
COMPLETED
|
61
|
|
Overall Study
NOT COMPLETED
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Chemotherapy, Total-Body Irradiation, Rituximab, and Donor Stem Cell Transplant in Treating Patients With B-Cell Non-Hodgkin's Lymphoma or Chronic Lymphocytic Leukemia
Baseline characteristics by cohort
| Measure |
Treatment
n=61 Participants
This is a phase 2 study of a treatment regimen consisting of a non-myeloablative (NMA) conditioning regimen incorporating low dose chemotherapy and low dose radiation as well as peri-transplant Rituximab and the transplantation of peripheral blood stem cells (PBSC) or bone marrow if PBSC collection not possible from an HLA compatible related or unrelated donor in patients with B cell lymphoid malignancies including diffuse large cell (DLC) and mantle cell non-Hodgkin's lymphoma (NHL), indolent B cell NHL, or chronic lymphocytic leukemia (CLL).
|
|---|---|
|
Age, Continuous
|
54 years
n=5 Participants
|
|
Sex: Female, Male
Female
|
11 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
50 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
2 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
59 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Black or African American
|
1 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
59 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
1 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
61 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: 1 yearPopulation: Data for the remaining 10 patients was not fully collected or analyzed for publication
Outcome measures
| Measure |
Treatment
n=51 Participants
This is a phase 2 study of a treatment regimen consisting of a non-myeloablative (NMA) conditioning regimen incorporating low dose chemotherapy and low dose radiation as well as peri-transplant Rituximab and the transplantation of peripheral blood stem cells (PBSC) or bone marrow if PBSC collection not possible from an HLA compatible related or unrelated donor in patients with B cell lymphoid malignancies including diffuse large cell (DLC) and mantle cell non-Hodgkin's lymphoma (NHL), indolent B cell NHL, or chronic lymphocytic leukemia (CLL).
|
|---|---|
|
Overall Survival at 1 Year
|
90 percentage of participants
Interval 81.0 to 98.0
|
SECONDARY outcome
Timeframe: 2 yearsPopulation: Data for the remaining 10 patients was not fully collected or analyzed for publication
Outcome measures
| Measure |
Treatment
n=51 Participants
This is a phase 2 study of a treatment regimen consisting of a non-myeloablative (NMA) conditioning regimen incorporating low dose chemotherapy and low dose radiation as well as peri-transplant Rituximab and the transplantation of peripheral blood stem cells (PBSC) or bone marrow if PBSC collection not possible from an HLA compatible related or unrelated donor in patients with B cell lymphoid malignancies including diffuse large cell (DLC) and mantle cell non-Hodgkin's lymphoma (NHL), indolent B cell NHL, or chronic lymphocytic leukemia (CLL).
|
|---|---|
|
Time to Neutrophil Engraftment
|
15 days
Interval 10.0 to 25.0
|
SECONDARY outcome
Timeframe: 1 yearPopulation: Data for the remaining 10 patients was not fully collected or analyzed for publication
Outcome measures
| Measure |
Treatment
n=51 Participants
This is a phase 2 study of a treatment regimen consisting of a non-myeloablative (NMA) conditioning regimen incorporating low dose chemotherapy and low dose radiation as well as peri-transplant Rituximab and the transplantation of peripheral blood stem cells (PBSC) or bone marrow if PBSC collection not possible from an HLA compatible related or unrelated donor in patients with B cell lymphoid malignancies including diffuse large cell (DLC) and mantle cell non-Hodgkin's lymphoma (NHL), indolent B cell NHL, or chronic lymphocytic leukemia (CLL).
|
|---|---|
|
Time to Platelet Engraftment
|
12 days
Interval 6.0 to 40.0
|
SECONDARY outcome
Timeframe: 100 daysPopulation: Data for the remaining 10 patients was not fully collected or analyzed for publication
Outcome measures
| Measure |
Treatment
n=51 Participants
This is a phase 2 study of a treatment regimen consisting of a non-myeloablative (NMA) conditioning regimen incorporating low dose chemotherapy and low dose radiation as well as peri-transplant Rituximab and the transplantation of peripheral blood stem cells (PBSC) or bone marrow if PBSC collection not possible from an HLA compatible related or unrelated donor in patients with B cell lymphoid malignancies including diffuse large cell (DLC) and mantle cell non-Hodgkin's lymphoma (NHL), indolent B cell NHL, or chronic lymphocytic leukemia (CLL).
|
|---|---|
|
Incidence of Moderate to Severe Grades II to IV Graft Versus Host Disease (GVHD) at 100 Days
|
18 percentage of patients
Interval 7.0 to 29.0
|
SECONDARY outcome
Timeframe: 1 yearPopulation: Data for the remaining 10 patients was not fully collected or analyzed for publication
Outcome measures
| Measure |
Treatment
n=51 Participants
This is a phase 2 study of a treatment regimen consisting of a non-myeloablative (NMA) conditioning regimen incorporating low dose chemotherapy and low dose radiation as well as peri-transplant Rituximab and the transplantation of peripheral blood stem cells (PBSC) or bone marrow if PBSC collection not possible from an HLA compatible related or unrelated donor in patients with B cell lymphoid malignancies including diffuse large cell (DLC) and mantle cell non-Hodgkin's lymphoma (NHL), indolent B cell NHL, or chronic lymphocytic leukemia (CLL).
|
|---|---|
|
Incidence of Chronic GVHD at 1 Year
|
14 percentage of participants
Interval 3.0 to 24.0
|
SECONDARY outcome
Timeframe: 3 monthsPopulation: Data for the remaining 10 patients was not fully collected or analyzed for publication
Outcome measures
| Measure |
Treatment
n=51 Participants
This is a phase 2 study of a treatment regimen consisting of a non-myeloablative (NMA) conditioning regimen incorporating low dose chemotherapy and low dose radiation as well as peri-transplant Rituximab and the transplantation of peripheral blood stem cells (PBSC) or bone marrow if PBSC collection not possible from an HLA compatible related or unrelated donor in patients with B cell lymphoid malignancies including diffuse large cell (DLC) and mantle cell non-Hodgkin's lymphoma (NHL), indolent B cell NHL, or chronic lymphocytic leukemia (CLL).
|
|---|---|
|
Immune Reconstruction/CD4+ Count at 3 Months
|
253 cells/microliters
Interval 160.0 to 343.0
|
SECONDARY outcome
Timeframe: 2 yearsPopulation: Data for the remaining 10 patients was not fully collected or analyzed for publication
Outcome measures
| Measure |
Treatment
n=51 Participants
This is a phase 2 study of a treatment regimen consisting of a non-myeloablative (NMA) conditioning regimen incorporating low dose chemotherapy and low dose radiation as well as peri-transplant Rituximab and the transplantation of peripheral blood stem cells (PBSC) or bone marrow if PBSC collection not possible from an HLA compatible related or unrelated donor in patients with B cell lymphoid malignancies including diffuse large cell (DLC) and mantle cell non-Hodgkin's lymphoma (NHL), indolent B cell NHL, or chronic lymphocytic leukemia (CLL).
|
|---|---|
|
Response to Treatment
Complete Response
|
22 Participants
|
|
Response to Treatment
Partial Response
|
17 Participants
|
|
Response to Treatment
Stable Disease
|
11 Participants
|
|
Response to Treatment
Progression of Disease
|
1 Participants
|
SECONDARY outcome
Timeframe: 6 monthsPopulation: Data for the remaining 10 patients was not fully collected or analyzed for publication
Outcome measures
| Measure |
Treatment
n=51 Participants
This is a phase 2 study of a treatment regimen consisting of a non-myeloablative (NMA) conditioning regimen incorporating low dose chemotherapy and low dose radiation as well as peri-transplant Rituximab and the transplantation of peripheral blood stem cells (PBSC) or bone marrow if PBSC collection not possible from an HLA compatible related or unrelated donor in patients with B cell lymphoid malignancies including diffuse large cell (DLC) and mantle cell non-Hodgkin's lymphoma (NHL), indolent B cell NHL, or chronic lymphocytic leukemia (CLL).
|
|---|---|
|
Immune Reconstruction/CD4+ Count at 6 Months
|
312 cells/microliter
Interval 174.0 to 457.0
|
SECONDARY outcome
Timeframe: 1 yearPopulation: Data for the remaining 10 patients was not fully collected or analyzed for publication
Outcome measures
| Measure |
Treatment
n=51 Participants
This is a phase 2 study of a treatment regimen consisting of a non-myeloablative (NMA) conditioning regimen incorporating low dose chemotherapy and low dose radiation as well as peri-transplant Rituximab and the transplantation of peripheral blood stem cells (PBSC) or bone marrow if PBSC collection not possible from an HLA compatible related or unrelated donor in patients with B cell lymphoid malignancies including diffuse large cell (DLC) and mantle cell non-Hodgkin's lymphoma (NHL), indolent B cell NHL, or chronic lymphocytic leukemia (CLL).
|
|---|---|
|
Immune Reconstruction/CD4+ Count at 1 Year
|
333 cells/microliter
Interval 18.0 to 1317.0
|
Adverse Events
Treatment
Serious events: 26 serious events
Other events: 59 other events
Deaths: 9 deaths
Serious adverse events
| Measure |
Treatment
n=61 participants at risk
This is a phase 2 study of a treatment regimen consisting of a non-myeloablative (NMA) conditioning regimen incorporating low dose chemotherapy and low dose radiation as well as peri-transplant Rituximab and the transplantation of peripheral blood stem cells (PBSC) or bone marrow if PBSC collection not possible from an HLA compatible related or unrelated donor in patients with B cell lymphoid malignancies including diffuse large cell (DLC) and mantle cell non-Hodgkin's lymphoma (NHL), indolent B cell NHL, or chronic lymphocytic leukemia (CLL).
|
|---|---|
|
Investigations
Hyperbilirubinemia
|
1.6%
1/61 • 2 years
|
|
Hepatobiliary disorders
Cholecystitis
|
1.6%
1/61 • 2 years
|
|
Psychiatric disorders
Confusion
|
1.6%
1/61 • 2 years
|
|
General disorders
Death Not Otherwise Specified
|
1.6%
1/61 • 2 years
|
|
General disorders
Death not assoc w CTCAE term - Disease progression
|
4.9%
3/61 • 2 years
|
|
Metabolism and nutrition disorders
Dehydration
|
1.6%
1/61 • 2 years
|
|
Gastrointestinal disorders
Dysphagia
|
1.6%
1/61 • 2 years
|
|
Gastrointestinal disorders
Diarrhea
|
14.8%
9/61 • 2 years
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnea
|
1.6%
1/61 • 2 years
|
|
Nervous system disorders
Encephalopathy
|
1.6%
1/61 • 2 years
|
|
General disorders
Gait disturbance
|
1.6%
1/61 • 2 years
|
|
General disorders
Fatigue
|
1.6%
1/61 • 2 years
|
|
Blood and lymphatic system disorders
Febrile Neutropenia
|
3.3%
2/61 • 2 years
|
|
General disorders
Fever (in the absence of neutropenia)
|
13.1%
8/61 • 2 years
|
|
Gastrointestinal disorders
Gastrointestinal, other
|
1.6%
1/61 • 2 years
|
|
Metabolism and nutrition disorders
Hyperglycemia
|
1.6%
1/61 • 2 years
|
|
Vascular disorders
Hypotension
|
1.6%
1/61 • 2 years
|
|
Respiratory, thoracic and mediastinal disorders
Hypoxia
|
4.9%
3/61 • 2 years
|
|
Infections and infestations
Infection - catheter related
|
3.3%
2/61 • 2 years
|
|
Respiratory, thoracic and mediastinal disorders
Pneumonia
|
3.3%
2/61 • 2 years
|
|
Infections and infestations
Infection, other
|
11.5%
7/61 • 2 years
|
|
Gastrointestinal disorders
Mucositis - oral
|
1.6%
1/61 • 2 years
|
|
Nervous system disorders
Neurology - other
|
1.6%
1/61 • 2 years
|
|
Nervous system disorders
Sensory neuropathy
|
1.6%
1/61 • 2 years
|
|
Eye disorders
Ocular/visual - other
|
1.6%
1/61 • 2 years
|
|
Eye disorders
Ophthalmoplegia/Diplopia (double vision)
|
1.6%
1/61 • 2 years
|
|
Investigations
Lymphocytopenia
|
1.6%
1/61 • 2 years
|
|
Nervous system disorders
Headache
|
1.6%
1/61 • 2 years
|
|
Gastrointestinal disorders
Pain - oral cavity
|
1.6%
1/61 • 2 years
|
|
Vascular disorders
Phlebitis
|
1.6%
1/61 • 2 years
|
|
Skin and subcutaneous tissue disorders
Rash/desquamation
|
6.6%
4/61 • 2 years
|
|
Renal and urinary disorders
Renal failure
|
1.6%
1/61 • 2 years
|
|
Cardiac disorders
Restrictive cardiomyopathy
|
1.6%
1/61 • 2 years
|
|
General disorders
Chills
|
1.6%
1/61 • 2 years
|
|
Nervous system disorders
Seizure
|
1.6%
1/61 • 2 years
|
|
Metabolism and nutrition disorders
Hyponatremia
|
1.6%
1/61 • 2 years
|
Other adverse events
| Measure |
Treatment
n=61 participants at risk
This is a phase 2 study of a treatment regimen consisting of a non-myeloablative (NMA) conditioning regimen incorporating low dose chemotherapy and low dose radiation as well as peri-transplant Rituximab and the transplantation of peripheral blood stem cells (PBSC) or bone marrow if PBSC collection not possible from an HLA compatible related or unrelated donor in patients with B cell lymphoid malignancies including diffuse large cell (DLC) and mantle cell non-Hodgkin's lymphoma (NHL), indolent B cell NHL, or chronic lymphocytic leukemia (CLL).
|
|---|---|
|
Infections and infestations
Infection, other
|
4.9%
3/61 • 2 years
|
|
Metabolism and nutrition disorders
Hyperglycemia
|
42.6%
26/61 • 2 years
|
|
Investigations
Creatinine
|
41.0%
25/61 • 2 years
|
|
Investigations
Alanine Aminotransferase
|
21.3%
13/61 • 2 years
|
|
Investigations
Aspartate Aminotransferase
|
21.3%
13/61 • 2 years
|
|
Investigations
Bilirubin
|
11.5%
7/61 • 2 years
|
|
Investigations
Alkaline phosphatase
|
9.8%
6/61 • 2 years
|
|
Metabolism and nutrition disorders
Hypermagnesemia
|
8.2%
5/61 • 2 years
|
Additional Information
Hugo Castro-Malaspina, MD
Memorial Sloan Kettering Cancer Center
Phone: 212-639-8197
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place