Phase 2
N=22
Bortezomib Plus Prednisone for Initial Therapy of Chronic Graft Versus Host Disease
Chronic Graft Versus Host Disease
Bottom Line
View on ClinicalTrials.gov: NCT00815919 ↗Enrolled (actual)
22
Serious AEs
9.1%
Results posted
Feb 2014
Primary outcome: Primary: Overall Response Rate After a 15 Week Course of Bortezomib Plus Prednisone in Patients With cGVHD — 2; 14; 1; 2 participants
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 2
- Interventions
- bortezomib (Drug); Prednisone (Drug)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Dana-Farber Cancer Institute
- Primary completion
- Jan 2012
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Overall Response Rate After a 15 Week Course of Bortezomib Plus Prednisone in Patients With cGVHD |
2; 14; 1; 2; 1 | — |
| SECONDARY Proportion of Patients Tolerating >50% Steroid Dose Reduction After a 15 Week Course of Bortezomib Plus Prednisone in Patients With cGVHD |
14 | — |
| SECONDARY The Toxicity of a 15 Week Course of Bortezomib Plus Prednisone in Patients With cGVHD |
7; 1; 0 | — |
| SECONDARY Proportion of cGVHD Patients Requiring Prednisone by 1 Year After Therapy |
11; 6 | — |
| SECONDARY Overall and cGVHD Progression-free Survival by 1 Year After Therapy |
14; 14; 73; 73 | — |
Summary
The purpose of this research study is to determine the effectiveness of bortezomib (Velcade) plus prednisone for treating chronic graft versus host disease (cGVHD) and the safety of this drug combination in this patient population. Chronic GVHD is a medical condition that may occur after allogeneic stem cell transplantation. The donor's immune system may recognize the participants body (the host) as foreign and attempt to "reject" it. Bortezomib has been used in other research studies, and information from those studies suggests that this drug may help to control the abnormal immune responses that underlie cGVHD.
Eligibility Criteria
Inclusion Criteria
- Recipients of allogeneic stem cell transplantation with myeloablative or non-myeloablative conditioning regimens
- 100 days or more past stem cell transplantation
- Recipients of matched or mismatched, related or unrelated adult donor stem cells
- Must have cGVHD requiring systemic therapy
- No addition or subtraction of other immunosuppressive medications. The dose of immunosuppressive medicines may be adjusted based on the therapeutic range of that drug. However, if cGVHD occurs during a taper of immune suppression, the medication(s) may not be increased back up to therapeutic level, but will continue a the taper dose for the 15 week study duration
- Adequate bone marrow, hepatic and renal function as outlined in the protocol
- Does not require hemodialysis
- 18 years of age or older
- ECOG Performance Status of 0-2 or Karnofsky performance score of 70% or greater
- Life expectancy of more than 3 months
Exclusion Criteria
- Systemic steroid therapy in the 4 weeks prior to enrollment
- Active malignant disease after transplantation. Complete resection of basal cell carcinoma or squamous cell carcinoma of the skin, an in situ malignancy, or low-risk prostate cancer after curative therapy will not be considered in this category
- Active uncontrolled infection
- Peripheral neuropathy CTC Grade 1 (or greater) with pain in the 4 weeks before enrollment. Other neurological deficits must be reviewed with the study PI prior to study entry
- Myocardial infarction within 6 months prior to enrollment or has NYHA Class III or IV heart failure, uncontrolled angina, severe uncontrolled ventricular arrhythmias, or electrocardiographic evidence of acute ischemia or active conduction system abnormalities
- Hypersensitivity to bortezomib, boron, or mannitol
- Female subject is pregnant or breast-feeding
- Serious medical or psychiatric illness likely to interfere with participation in this clinical study
Data sourced from ClinicalTrials.gov (NCT00815919). 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.