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Clinical picture: NHL (Non Hodgkin Lymphoma)

Trial: HOVON-associated SADAL trial (Protocol KCP-330-009)


News
1. Overview
Study details
2. Patient eligibility criteria
3. Registration (& randomization) of patients
4. Participating parties
5. Participating sites
6. Instruction videos
7. Download documentation / forms


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News


HOVON-associated SADAL trial

Please note than inclusion criteria have been modified.
interim response and durability results for single agent oral selinexor in patients with heavily pretreated DLBCL:

• The Overall Response Rate was 33.3% (for a single agent, oral therapy)

• Response rates were similar across subgroups (60 mg, 100 mg, GCB, non-GCB, double hit / double expressor DLBCLs); Durability was better in the 60mg cohort (vs the 100 mg)

• In the least heavily pretreated patients on the study, 3rd line (after 2 prior therapies), the ORR was 40%

• Median DOR was >7 months including prolonged CRs (and PRs), some patients >1 year

• The median survival (OS) was 8 months, but it was <6 months for the non-responding patients and the median OS was not reached (estimated as >12 months) in responding patients

• Tolerability (and response durability) was greater on the 60mg arm response rates were very similar between the arms (60mv vs 100mg arm)

Based on these results, we amended the SADAL trial to only include the 60mg dose cohort only and we anticipate enrolling a total of 130 patients to form the basis of regulatory submissions to both EMA and FDA indicated as a treatment for patients with DLBCL whose disease has relapsed after at least two prior regimens and who are not candidates for transplantation.

1. Overview



Summary

KPT-330-009 SADAL
A Phase 2b Open-Label Study of Selinexor (KPT-330) in Patients with Relapsed/Refractory Diffuse Large B-Cell Lymphoma (DLBCL)


Status

open


Members

VUmc Amsterdam - J.M. Zijlstra
LUMC Leiden - J.S.P. Vermaat


Study details



Type of study

Prospective randomized Phase II study


Echelon level

Level A


Type of monitoring for this study

Study specific


Target number of patients

130


Date of activation

01-Sep-2016


Date closed

30-Sep-2018


Approved by

METC VUmc Amsterdam


Change history / amendement

No


Study objectives

Survival and safety follow up endpoints:
Primary: ORR |
Secondary: DOR, DCR, Safety, QOL |
Exploratory: PK, PD


2. Patient eligibility criteria



Inclusion criteria

Patients age ≥ 18 years, with previously treated, pathologically confirmed de novo DLBCL, or DLBCL transformed from a previously diagnosed indolent lymphoma (e.g., follicular lymphoma), with documented evidence of disease progression, and who, in the opinion of the investigator, are not candidates for high-dose chemotherapy with autologous stem cell rescue
• Patients must have received at least 2 but no more than 5 previous systemic regimens for the treatment of their DLBCL, including at least one course of anthracycline-based chemotherapy (unless absolutely contraindicated due to cardiac dysfunction, in which case other active agents such as etoposide, bendamustine or gemcitabine must have been given), and at least one course of anti-CD20 immunotherapy (e.g., rituximab), unless contraindicated due to severe toxicity
• Prior stem cell transplantation is allowed; induction, consolidation stem cell collection, preparative regimen and transplantation ± maintenance are considered a single line of therapy
For patients whose most recent anti-DLBCL therapy induced a PR or CR, at least 60 must have elapsed since the end of that therapy. For all other patients, at least 14 weeks must have elapsed since their most recent systemic anti-DLBCL therapy
• ECOG PS ≤ 2
• Life expectancy of ≥ 3 months at study entry


Exclusion criteria

• Patients with DLBCL with mucosa-associated lymphoid tissue (MALT) lymphoma, composite lymphoma (HL+NHL), or DLBCL transformed from diseases other than indolent NHL will be excluded from this study
• Primary mediastinal (thymic) large B-cell lymphoma (PMBL) and active central nervous system (CNS) lymphoma are excluded
• Patients must not be eligible for high-dose chemotherapy with autologous stem cell transplantation and documentation for ineligibility must be provided


3. Registration (& randomization) of patients



4. Participating parties



5. Participating sites



6. Instruction videos



7. Download documentation / forms




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