Non-Hodgkins Lymphoma
Conditions
Keywords
non-Hodgkins, lymphoma, stem cell transplant
Brief summary
Researchers hope to learn if adding rituximab with high doses of chemotherapy and stem cell transplantation will help patients get rid of their lymphoma cells from the bone marrow and stem cell collections.
Detailed description
Following the first relapse, patients with follicular type of Non-Hodgkin's lymphoma may have an option to receive high dose chemotherapy followed by autologous (from you) blood stem cell transplantation. One of the common causes of relapse is persistence of lymphoma cells in the bone marrow and in the collected stem cell products. Patients who do not have a complete response after traditional chemotherapy, have a greater chance of the lymphoma returning even after receiving high dose chemotherapy with stem cell transplantation. In order to improve the response and decrease the relapse rate, additional therapy may be used to kill the lymphoma cells by using antibodies both before and after the transplantation. Antibodies are protein made by white cells in our body to fight off infection and sometimes tumor. Rituxan (rituximab) is an antibody that is effective against your type of lymphoma. Researchers have reported that patients show an improved response and a lower chance of relapse when using rituximab with high dose chemotherapy with autologous stem cell transplantation. It is unknown how effective rituximab is in clearing persistence of minimal remaining disease in patients with follicular lymphoma.
Interventions
DRUGRituximab
375 MG/M2 (milligram per meter squared) given IV (intravenously) weekly x 4-8 doses.
Sponsors
University of Kansas Medical Center
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Patients with biopsy-proven refractory CD20+ (cluster of differentiation antigen 20) Follicular lymphoma or transplant eligible mantle cell lymphoma in CR1 (complete remission 1) or later. * Patients must be transplant eligible per KUCC BMT SOP (Kansas University Cancer Center Bone Marrow Transplant Standard Operation Procedures) with chemo-sensitive/marrow negative disease. * Patients planning to harvest and hold may also be included as long as above criteria are met.
Exclusion criteria
* Pregnancy * Zubrod performance status greater than 2 * Life expectancy is severely limited by concomitant illness. * Uncontrolled arrhythmias or symptomatic cardiac disease precluding transplantation * Symptomatic pulmonary disease precluding transplantation * Serum creatinine greater than 1.8 mg/dL * Serum bilirubin greater than 2 X upper limit of normal, SGPT (serum glutamate pyruvate transaminase) greater than 3 times upper limit of normal * Evidence of chronic active hepatitis or cirrhosis * Unable to sign informed consent. * Allergy to Rituximab
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Rate of PCR Negativity | up to 7 days | Number of participants that are tumor free by PCR (Polymerase Chain Reaction) analysis post-transplant. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Progression Free Survival (PFS) and Overall Survival (OS) | up to 60 months | Response will be determined by Response Evaluation Criteria in Solid Tumors (RECIST v1.0) criteria where applicable and/or biopsy proven relapse/progression of disease. |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Rituximab Rituximab: 375 MG/M2 given IV weekly x 4-8 doses. | 19 |
| Total | 19 |
Withdrawals & dropouts
| Period | Reason | FG000 |
|---|---|---|
| Overall Study | Was not transplanted | 5 |
Baseline characteristics
| Characteristic | Rituximab |
|---|---|
| Age, Categorical <=18 years | 0 Participants |
| Age, Categorical >=65 years | 0 Participants |
| Age, Categorical Between 18 and 65 years | 19 Participants |
| Ethnicity (NIH/OMB) Hispanic or Latino | 0 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 19 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 0 Participants |
| Sex: Female, Male Female | 2 Participants |
| Sex: Female, Male Male | 17 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | 0 / 19 |
| other Total, other adverse events | 1 / 19 |
| serious Total, serious adverse events | 0 / 19 |
Outcome results
Primary
Rate of PCR Negativity
Number of participants that are tumor free by PCR (Polymerase Chain Reaction) analysis post-transplant.
Time frame: up to 7 days
Population: 21 patients were initially enrolled; 2 were withdrawn after signing informed consent per physician decision. Of the remaining 19: 5 did not have harvestable stem cells; 14 completed stem cell collection and PCR evaluation.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Rituximab | Rate of PCR Negativity | 14 Participants |
Secondary
Progression Free Survival (PFS) and Overall Survival (OS)
Response will be determined by Response Evaluation Criteria in Solid Tumors (RECIST v1.0) criteria where applicable and/or biopsy proven relapse/progression of disease.
Time frame: up to 60 months
Population: Of the 14 patients that had harvestable cells, 3 chose to delay transplant. The remaining 11 patients underwent Autologous stem cell transplantation (Auto-SCT).
| Arm | Measure | Group | Value (MEDIAN) |
|---|---|---|---|
| Rituximab | Progression Free Survival (PFS) and Overall Survival (OS) | PFS in FL | 24 months |
| Rituximab | Progression Free Survival (PFS) and Overall Survival (OS) | OS in FL | 36 months |
| Rituximab | Progression Free Survival (PFS) and Overall Survival (OS) | PFS in ML | 36 months |
| Rituximab | Progression Free Survival (PFS) and Overall Survival (OS) | OS in ML | 48 months |