NCT03873493 - A Study Evaluating the Efficacy of Venetoclax Plus Ibrutinib in Participants With T-cell Prolymphocytic Leukemia | Biotech Hunter

Enrollment

Participants

Timeline

Start Date

January 14, 2020

Primary Completion Date

November 4, 2021

Study Completion Date

November 4, 2021

Conditions

LeukemiaT-cell Prolymphocytic Leukemia (T-PLL)Cancer

Interventions

DRUG

Venetoclax

Venetoclax tablets taken orally once a day (QD). Initially, venetoclax was administered utilizing a 5-step dose ramp-up over 5 days. Subjects were hospitalized and closely monitored for 7 days. The venetoclax ramp-up was administered in a daily manner: 20 mg on Week 1 Day 1, 50 mg on Week 1 Day 2, 100 mg on Week 1 Day 3, 200 mg on Week 1 Day 4, and 400 mg on Week 1 Day 5 and thereafter, once daily, until the end-of-treatment. The dose of venetoclax may have been increased to 600 mg QD at Week 8 or thereafter.

DRUG

Ibrutinib

Ibrutinib capsules taken orally once a day, 420 mg/day until the end-of-treatment.

Trial Locations (15)

1090

Medizinische Universitaet Wien /ID# 208497, Vienna

3000

Peter MacCallum Cancer Ctr /ID# 209554, Melbourne

34128

Azienda Sanitaria Universitaria Giuliano Isontina /ID# 211487, Trieste

50937

University Hospital Cologne /ID# 208834, Cologne

59037

CHRU Lille - Hopital Claude Huriez /ID# 208726, Lille

69495

HCL - Hôpital Lyon Sud /ID# 208731, Pierre-Bénite

75013

Hopital Pitie Salpetriere /ID# 208730, Paris

77030

University of Texas MD Anderson Cancer Center /ID# 207746, Houston

02215

Dana-Farber Cancer Institute /ID# 207728, Boston

55905-0001

Mayo Clinic - Rochester /ID# 207692, Rochester

00290

Helsinki University Hospital /ID# 208108, Helsinki

5631 BM

Maxima Medisch Centrum /ID# 207989, Eindhoven

9713 GZ

Universitair Medisch Centrum Groningen /ID# 207990, Groningen

OX3 9DU

Oxford University Hospitals NHS Foundation Trust /ID# 211264, Oxford

SW3 6JJ

The Royal Marsden NHS Foundation Trust /ID# 211263, London