CRISTALLO : A Prospective, Open-Label, Multicenter Randomized Phase III Study to Compare The Efficacy and Safety of A Combined Regimen of Venetoclax and Obinutuzumab Versus Fludarabine, Cyclophosphamide, and Rituximab (FCR)/Bendamustine and Rituximab (BR) in FIT Patients With Previously Untreated Chronic Lymphocytic Leukemia (CLL) Without DEL(17P) or TP53 Mutation

Male or<br/>FemaleGender Male or
Female

RecruitingStatus Recruiting

Systemic<br/>Therapy TrialTypeSystemic
Therapy Trial

ThreePhase Three

18+Age Over 18

Blood<br/>CancersCancer LocationBlood
Cancers

Systemic therapy,Treatment | Blood / Myeloma / LymphomaChronic Lymphocytic Leukaemia,Leukaemia

Trial Overview Read MoreRead more

This phase III trial is comparing the safety and effectiveness of two combinations of treatment for patients who have not yet received treatment for chronic lymphocytic leaukaemia.
 

This trial is treating patients with chronic lymphocytic leukaemia.

This is a systemic therapy trial.

You may be able to join this trial if:

  • You are able to swallow medication by mouth.
  • You have been diagnosed with cancer, but have not received any treatment.

You may be excluded from this trial if:

  • You have a certain disease or psychological condition.
  • You have been diagnosed with a prior or secondary type of cancer.
  • You have had certain treatments, surgical procedures or drugs.

Clinical trials have complex eligibility criteria - talk to your doctor about your interest in this trial.

Clinical Summary Read MoreRead more

Trial Identifiers

Use the hyperlinks, where available to access additional clinical trial information.

Scientific Title

A Prospective, Open-Label, Multicenter Randomized Phase III Study to Compare The Efficacy and Safety of A Combined Regimen of Venetoclax and Obinutuzumab Versus Fludarabine, Cyclophosphamide, and Rituximab (FCR)/Bendamustine and Rituximab (BR) in FIT Patients With Previously Untreated Chronic Lymphocytic Leukemia (CLL) Without DEL(17P) or TP53 Mutation

Commercial Sponsor

Hoffmann-La Roche

Summary

Eligible patients will be randomised into one of two treating arms (Arm A & Arm B). Arm A patients will receive 12 cycles of treatment with venetoclax and obinutuzumab; and Arm B patients will receive 6 cycles of treatment with either fludarabine, cyclophosphamide and rituximab or bendamustine and rituximab.

Recruiting Hospitals Read MoreRead more

Monash Health Haematology Research Unit
Clayton
Ms Micheleine Uhe
Micheleine.Uhe@monashhealth.org
03 9594 4044

Northern Hospital
Epping
Karen Matoga
karen.matoga@nh.org.au

PCCTU (Parkville Cancer Clinical Trials Unit) *
Parkville
Enquiries Line Coordinator
clinicaltrials.enquiries@petermac.org
03 8559 7456 (9am-2pm, Mon-Fri)

Trial Overview: General information about a clinical trial. This section provides an overview of who might be able to join this trial and what type of treatment is involved.

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