Phase 2
N=57
Study of RAD001 in Patients With Relapsed/Refractory Hodgkin Lymphoma That Has Progressed After High-dose Chemotherapy and Autologous Stem Cell Transplant and/or After Gemcitabine- or Vinorelbine- or Vinblastine-based Treatment.
Hodgkin Lymphoma
Bottom Line
View on ClinicalTrials.gov: NCT01022996 ↗Enrolled (actual)
57
Serious AEs
31.6%
Results posted
Apr 2016
Primary outcome: Primary: Overall Response Rate (ORR) Based on the Assessments by Investigator — 8.8; 36.8; 45.6 percentage of participants
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 2
- Interventions
- Everolimus (RAD001) (Drug)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Novartis Pharmaceuticals
- Primary completion
- Nov 2014
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Overall Response Rate (ORR) Based on the Assessments by Investigator |
8.8; 36.8; 45.6 | — |
| SECONDARY Time to Overall Response (TTR) Per Kaplan-Meier Estimate |
NA | — |
| SECONDARY Duration of Overall Response (DoR) |
350.8 | — |
| SECONDARY Disease Control Rate (DCR) |
80.7 | — |
| SECONDARY Duration of Disease Control |
321.9 | — |
| SECONDARY Progression Free Survival (PFS) by Kaplan-Meier Estimate |
8.0 | — |
Summary
This study will assess RAD001 in patients with refractory or relapsed Hodgkin Lymphoma that has progressed after high-dose chemotherapy and Autologous Stem cell transplant and/or after gemcitabine- or vinorelbine- or vinblastine-based treatment.
Eligibility Criteria
Inclusion Criteria
- Patients with a history of classical Hodgkin's lymphoma that has progressed after high-dose chemotherapy and Autologous Stem cell transplant and/or after gemcitabine- or vinorelbine- or vinblastine-based treatment
- Patients with at least one site of measurable disease measuring ≥ 2.0cm confirmed by PET and CT Scan (or MRI)
- Patients with adequate bone marrow, liver and renal function (confirmed by laboratory values)
- Patients with fasting serum cholesterol ≤300 mg/dL OR ≤7.75 mmol/L AND fasting triglycerides ≤ 2.5 x ULN
Exclusion Criteria
- Previous treatment with mTOR inhibitors
- Prior allogeneic stem cell transplant
- Chemotherapy, monoclonal antibody therapy, major surgery or treatment with other investigational drugs within 4 weeks of starting study treatment
- Another malignancy within 3 years of study entry (except adequately treated non-melanoma skin cancer and carcinoma in situ of the cervix)
- Severe and/or uncontrolled medical conditions that could affect participation in this study
- Female patients who are pregnant or breastfeeding; patients who are not willing to use adequate birth control during the study and for 8 weeks after the last study treatment Other protocol-defined inclusion/exclusion criteria may apply
Data sourced from ClinicalTrials.gov (NCT01022996). 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.