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Clinical picture: CLL (Chronical Lymfatic Leukemia)

Trial: HOVON-associated M18-803 T-PLL


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


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1. Overview



Summary

A Prospective, Open-Label, Single-Arm, Phase 2, Multicenter Study Evaluating the Efficacy of Venetoclax Plus Ibrutinib in Subjects with T-Cell Prolymphocytic Leukemia


Status

open


Members

M. Bellido, Universitair Medisch Centrum, Groningen; m.bellido@umcg.nl
L. Tick, Maxima Medisch Centrum, Eindhoven; l.Tick@mmc.nl


Validity

Clinicaltrials.gov: NCT03873493


Study details



Type of study

Prospective Phase II study


Echelon level

Level C-HIC


Type of monitoring for this study

Study specific


Target number of patients

37


Date of activation

07-Feb-2020


Approved by

METc UMCG


Study objectives

Primary: To demonstrate the efficacy in subjects with R/R T-PLL treated with venetoclax plus ibrutinib.
Secondary:
- To assess safety and tolerability in subjects with T-PLL treated with venetoclax plus ibrutinib.
- To assess the ability of the subset of transplant-naïve subjects to proceed to further autologous/allogeneic stem cell transplantation (assessed by number of eligible subjects reaching transplant).


2. Patient eligibility criteria



Inclusion criteria

Adequate liver, kidney and hematology function per laboratory values as described in the protocol.
Diagnosis of T-cell prolymphocytic leukemia (T-PLL) that requires treatment.
Eastern Cooperative Oncology Group (ECOG) performance status less than or equal to 2.
Negative for human T-cell lymphotropic virus, type 1.
Received prior alemtuzumab (unless unsuitable or unavailable).
Has no malignancies other than T-PLL that:
o Currently require systemic therapies;
o Were not previously treated with curative intention (unless the malignant disease is in a stable remission due to the discretion of the treating physician); or
o Developed signs of progression after curative treatment


Exclusion criteria

History of or current decompensated cirrhosis including Child-Pugh class B or C, ascites, hepatic encephalopathy, or variceal bleeding.
Has human T-cell lymphotropic virus, type 1.
Prior allogeneic stem cell transplant within 6 months of study drug administration and requirement for graft versus host therapy.
Has an uncontrolled or active infection.
Previously treated with a B-cell lymphoma (BCL)-2 inhibitor.
Received a prohibited therapy within the specified time frame as described in the protocol.


3. Registration (& randomization) of patients



Registration

Active sites:
UMCG Groningen, M. Bellido (m.bellido@umcg.nl)
Maxima Medisch Centrum Eindhoven, L. Tick (l.tick@mmc.nl)


4. Participating parties



5. Participating sites



6. Instruction videos



7. Download documentation / forms




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