Graft vs Host Disease
Conditions
Keywords
Chronic Graft vs Host Disease, Alemtuzumab, Rituximab, Low-dose, Alemtuzumab and rituximab combination
Brief summary
The purpose of this study is to determine whether low-doses alemtuzumab and rituximab combination are effective in the treatment of chronic graft-versus-host disease (GVHD) after first-line therapy failure.
Detailed description
Graft-versus-host disease (GVHD) is the most common long-term complication in patients who underwent allogeneic transplantation. First-line therapy for chronic GVHD is based on immunosuppressive agents (usually cyclosporine and corticosteroids) achieving satisfactory response in around 30% of patients. There is no ideal second-line treatment for chronic GVHD; however, numerous studies have been published with therapeutic options such as alemtuzumab (anti-CD52) and rituximab (anti-CD20). This is a prospective, longitudinal, nonrandomized study in which alemtuzumab and rituximab will be administered at low-doses to patients with refractory chronic GVHD. Clinical response will be evaluated based on the Working Group Report 2006, published by the National Institute of Health Consensus. Follow-up sessions will be weekly for four weeks, every two weeks until achieve response, and finally every four weeks.
Interventions
Alemtuzumab at 10mg subcutaneously daily for 3 doses (days 1, 2 and 3) Rituximab at 100mg intravenously weekly for 4 doses (days 4, 11, 18 and 25
Sponsors
Hospital Universitario Dr. Jose E. Gonzalez
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 65 Years
Healthy volunteers
No
Inclusion criteria
* Patients with chronic graft-versus-host disease. * Patients over 18 years old. * Patients who received first-line treatment with no response (failure), relapse or steroid dependance.
Exclusion criteria
* Patients with active bacterial or viral infections. * Patients with hematologic disease progression. * Patient's intolerance to drugs.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Clinical Response of Patients With Refractory Chronic GVHD Based on the Working Group Report 2006. | 30, 90 and 365 days | Overall response of participants to alemtuzumab and rituximab combination at day +30, +90 and +365 of follow-up |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Side Effects | 365 days | Percentage of participants who experienced side effects |
Countries
Mexico
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Patients With Chronic GVHD Patients with chronic GVHD after first-line therapy failure. | 15 |
| Total | 15 |
Baseline characteristics
| Characteristic | Patients With Chronic GVHD |
|---|---|
| Age, Categorical <=18 years | 0 Participants |
| Age, Categorical >=65 years | 0 Participants |
| Age, Categorical Between 18 and 65 years | 15 Participants |
| Age, Continuous | 41 years STANDARD_DEVIATION 20 |
| Gender Female | 5 Participants |
| Gender Male | 10 Participants |
| Region of Enrollment Mexico | 15 participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | — / — |
| other Total, other adverse events | 7 / 15 |
| serious Total, serious adverse events | 10 / 15 |
Outcome results
Primary
Clinical Response of Patients With Refractory Chronic GVHD Based on the Working Group Report 2006.
Overall response of participants to alemtuzumab and rituximab combination at day +30, +90 and +365 of follow-up
Time frame: 30, 90 and 365 days
Population: All consecutive patients were included in an intention to treat analysis to evaluate clinical response to alemtuzumab and rituximab combination.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Treatment Group | Clinical Response of Patients With Refractory Chronic GVHD Based on the Working Group Report 2006. | Overall response at +30-day evaluation | 100 percentage of participants |
| Treatment Group | Clinical Response of Patients With Refractory Chronic GVHD Based on the Working Group Report 2006. | Overall response at +90-day evaluation | 78 percentage of participants |
| Treatment Group | Clinical Response of Patients With Refractory Chronic GVHD Based on the Working Group Report 2006. | Overall response at +365-day evaluation | 80 percentage of participants |
Secondary
Side Effects
Percentage of participants who experienced side effects
Time frame: 365 days
Population: 15 consecutive patients were included for the analysis with periodical clinical evaluations to assess adverse effects.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Treatment Group | Side Effects | 10 Participants |