Phase 2
N=36
Phase 2 Trial of Prophylactic Rituximab Therapy for Prevention of CGVHD
Leukemia, Mast-Cell · Mantle-cell Lymphoma
Bottom Line
View on ClinicalTrials.gov: NCT00186628 ↗Enrolled (actual)
36
Serious AEs
11.4%
Results posted
Nov 2017
Primary outcome: Primary: Chronic Graft-vs-Host Disease (cGvHD) — 20 percentage of participants
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 2
- Interventions
- Total lymphoid irradiation (Procedure); Rituximab (Drug); Anti-thymoglobulin, rabbit (ATG, rabbit ATG) (Drug); Cyclosporine (Drug); Mycophenylate mofetil (Drug); Filgrastim (Drug); Granisetron (Drug); Solumedrol (Drug); Acetaminophen (Drug); Diphenhydramine (Drug); Hydrocortisone (Drug)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Stanford University
- Primary completion
- Nov 2010
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Chronic Graft-vs-Host Disease (cGvHD) |
20 | — |
| SECONDARY Incidence of Relapse |
18 | .07 |
| SECONDARY Mortality |
0; 1; 2 | — |
| SECONDARY Overall Survival |
73; 69 | — |
Summary
To determine if rituximab administered after allogeneic transplantation decreases the incidence of chronic graft-vs-host disease (cGvHD)
Eligibility Criteria
Recipient Inclusion Criteria:
- Between 18 and 76 years of age
- Chronic lymphocytic leukemia (CLL):
- Unmutated IgG VH gene status
- Mutated IgG VH genes (> 2% nucleotide change compared to somatic sequence)
- Complete remission benefit most from allogeneic hematopoietic stem cell transplant (HSCT).
(Physicians will be encouraged to provide aggressive chemotherapy prior to nonmyeloablative transplantation.)
- Mantle cell lymphoma (MCL): Transplant physicians believe subject would benefit from allogeneic HSCT.
- Adequate renal (Cr 100
- Renal: creatinine > 2.4
- Karnofsky performance score ≤ 60%
- Patients with poorly controlled hypertension (systolic blood pressure > 150 or diastolic blood pressure > 90 repeatedly).
- Known life-threatening hypersensitivity to rituximab or other anti-B cell antibodies.
- Inability to comply with the allogeneic transplant treatment.
- Uncontrolled central nervous system (CNS) involvement with disease
Donor Exclusion Criteria:
- Identical twin to subject
- Contra-indication to subcutaneous G-CSF at a dose of 16 mg/kg/d for 5 consecutive days
- Serious medical or psychological illness
- Prior malignancy within the preceding five years, with the exception of non-melanoma skin cancers.
- HIV seropositivity
Data sourced from ClinicalTrials.gov (NCT00186628). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.