Diffuse Large Cell Lymphoma, Lymphoma, Mantle Cell Lymphoma, Non-Hodgkin's Lymphoma, Other Subtypes of B-cell Lymphoma, Transformed Lymphoma
Conditions
Keywords
non-Hodgkin's lymphoma, diffuse large cell lymphoma, mantle cell lymphoma, transformed lymphoma, other subtypes of B cell lymphoma, recurrent lymphoma
Brief summary
Conventional therapy is effective for diffuse aggressive lymphomas and low grade lymphomas, but is limited by relapse occurs in 40 to 50% of subjects. This study assesses autologous stem cell transplant (ASCT) supplemented with high-dose therapy increases the event-free survival in diffuse aggressive lymphomas and low grade lymphomas, as an alternative to the limitations of conventional therapy. Preliminary studies with rituximab in low grade lymphomas indicate a response rate of about 50% with very little toxicity. Rituximab is hypothesized to be a candidate for post-transplant therapy because the majority of malignant lymphomas express the CD20 antigen; rituximab has impressive independent anti-tumor activity; and the antibody has little toxicity outside of the acute administration.
Detailed description
The first 4 subjects received rituximab weekly for 4 weeks at the standard dose of 375 mg/m2, starting 6 weeks after ASCT transplant. After an observation period to assess acute and late toxicity for the first 4 subjects, subsequent subjects received induction as above followed by an additional 4 week course at 6-months post-ASCT.
Interventions
DRUGRituximab 375 mg/m2
Sponsors
Stanford University
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
16 Years to 65 Years
Healthy volunteers
No
Inclusion criteria
* B-cell, CD20+ NHL * Evidence of engraftment post-autologous peripheral blood stem cell transplant (PBSC-T), aka autologous stem cell transplant (ASCT) * Eastern Cooperative Oncology Group (ECOG) performance status 0 to 1 * Creatinine \< 2 mg/dL * Bilirubin \< 2.0 mg/dL * Liver function tests (LFTs) \< 5 x upper limit of normal (ULN)
Exclusion criteria
* Graft source from bone marrow * Non-responders \[progressive disease (PD) or stable disease (SD)\] to prior anti-CD20 therapy * PD after ASCT * Post-ASCT radiotherapy * Concomitant treatment with radiotherapy, chemotherapy or immunotherapy including rituximab * Evidence of active pneumonitis * Evidence of active infection * Concurrent prednisone or other systemic steroid medication * Nitrosourea therapy within 6 weeks of the first treatment with rituximab * Presence of anti-murine antibody (HAMA) reactivity
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Event-free Survival (EFS) | 24 months | Events for EFS were defined as the earlier of post-ASCT relapse or death. |
Secondary
| Measure | Time frame |
|---|---|
| Overall Survival (OS) | 24 months |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Rituximab After ASCT Rituximab 375 mg/m2 starting 6 weeks after ASCT transplant, and for the 5th and subsequent subjects, a second course at the same dose 6 months after ASCT | 35 |
| Total | 35 |
Withdrawals & dropouts
| Period | Reason | FG000 |
|---|---|---|
| Overall Study | Adverse Event | 2 |
| Overall Study | Death | 1 |
| Overall Study | Disease progression | 2 |
| Overall Study | Intercurrent illness | 1 |
Baseline characteristics
| Characteristic | Rituximab After ASCT |
|---|---|
| Age, Customized aged 16 and older | 51 years |
| Lymphoma sub-types Diffuse large B-cell lymphoma (DLCL) | 25 participants |
| Lymphoma sub-types Mantle cell lymphoma (MCL) | 3 participants |
| Lymphoma sub-types Other B-cell lymphoma | 4 participants |
| Lymphoma sub-types Transformed lymphoma | 3 participants |
| Sex: Female, Male Female | 12 Participants |
| Sex: Female, Male Male | 23 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | — / — |
| other Total, other adverse events | 9 / 35 |
| serious Total, serious adverse events | 33 / 35 |
Outcome results
Primary
Event-free Survival (EFS)
Events for EFS were defined as the earlier of post-ASCT relapse or death.
Time frame: 24 months
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Rituximab After ASCT | Event-free Survival (EFS) | 83 percentage of not experiencing EFS event |
Secondary
Overall Survival (OS)
Time frame: 24 months
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Rituximab After ASCT | Overall Survival (OS) | 88 percentage of subjects remaining alive |