Fixed-duration Therapy With Ibrutinib and Obinutuzumab (GA-101) in Treatment-naïve Patients With CLL (FIGHT)

  • STATUS
    Recruiting
  • End date
    Sep 15, 2027
  • participants needed
    53
  • sponsor
    Paolo Ghia
Updated on 19 April 2022
platelet count
chronic lymphocytic leukemia
lymphoma
gilbert's syndrome
progressive disease
neutrophil count
ibrutinib
obinutuzumab

Summary

This is a phase 2 multicenter national interventional pharmacological study aimed at determining the efficacy of a fixed duration treatment with ibrutinib and obinutuzumab in terms of uMRD in the BM at the end of treatment (+30 Days follow-up).

Treatment with ibrutinib and obinutuzumab will be administered according to the following

schedule

Ibrutinib 420 mg QD for 24 months (Cycles 1-24) Obinutuzumab starting from Cycle 13 Day 1 (100 mg Cycle 13 Day 1, 900 mg Cycle 13 Day 2, 1000 mg Cycle 13 Days 8 and 15, 1000 mg Cycles 14-18 Day 1).

At the end of Cycle 24 all responding patients will discontinue ibrutinib and proceed with follow-up. If disease relapse occurs at any time after discontinuing treatment, ibrutinib therapy will be reintroduced at the standard dose of 420 mg QD and response to treatment monitored over time. Patients with stable (SD) or progressive disease (PD) at the end of Cycle 24, will continue ibrutinib as long as the treating physician deems they are benefiting from treatment and will be followed up in the study for survival and response to subsequent therapies.

Details
Condition Chronic Lymphocytic Leukemia
Treatment Ibrutinib and obinutuzumab
Clinical Study IdentifierNCT04908228
SponsorPaolo Ghia
Last Modified on19 April 2022

Eligibility

Yes No Not Sure

Inclusion Criteria

Age ≥18 years
Diagnosis of chronic lymphocytic leukemia (CLL) or small lymphocytic lymphoma (SLL) that meets iwCLL diagnostic criteria
Previously untreated active disease requiring treatment per iwCLL criteria
ECOG PS 0 or 1
Measurable lymph node disease (>1.5 cm longest diameter) by CT scan
Adequate hematologic function defined as
Absolute neutrophil count (ANC) >750 cells/μL (750 cells/mm3 or 0.75 x 109/L)
Platelet count >30,000/μL (30,000 cells/mm3 or 30 x 109/L)
Hemoglobin >8.0 g/dL
Adequate hepatic and renal function defined as
Serum aspartate transaminase (AST) or alanine transaminase (ALT) ≤3.0 x upper limit of normal (ULN)
Estimated Creatinine Clearance (CrCl) ≥30 mL/min (Cockcroft- Gault)
Bilirubin ≤1.5 x ULN (unless bilirubin rise is due to Gilbert's syndrome or of non-hepatic origin)
Prothrombin time (PT)/International normal ratio (INR) <1.5 x ULN and PTT (activated
partial thromboplastin time [aPTT]) <1.5 x ULN (unless abnormalities are
unrelated to coagulopathy or bleeding disorder)

Exclusion Criteria

Any prior therapy (including but not limited to chemotherapy, targeted therapy
immunomodulating therapy, radiotherapy, and/or monoclonal antibody) used for treatment of
CLL or SLL
Patients carrying del(17p) and/or TP53 mutation as assessed by central laboratory
History of other malignancies, except
Malignancy treated with curative intent and with no known active disease present for
≥3 before the first dose of study drug and felt to be at low risk for recurrence by
the treating physician
Adequately treated non-melanoma skin cancer or lentigo maligna without evidence of
disease
Adequately treated carcinoma in situ without evidence of disease. 4. Known or
suspected history of Richter's transformation. 5. Known hypersensitivity to one or
more study drugs. 6. Known bleeding disorders (eg, von Willebrand's disease or
hemophilia). 7. History of stroke or intracranial hemorrhage within 6 months prior to
enrollment
Known history of human immunodeficiency virus (HIV) or active infection with
hepatitis C virus (HCV) or hepatitis B virus (HBV). Subjects who are positive for
hepatitis B core antibody, hepatitis B surface antigen (HBsAg), or hepatitis C
antibody must have a negative polymerase chain reaction (PCR) result before enrolment
Those who are PCR positive will be excluded. 9. Unable to swallow capsules/tablets or
malabsorption syndrome, disease significantly affecting gastrointestinal function, or
resection of the stomach or small bowel, symptomatic inflammatory bowel disease or
ulcerative colitis, or partial or complete bowel obstruction
Concomitant use of warfarin or other vitamin K antagonists. 11. Major surgery
within 4 weeks of first dose of study drug
Clear my responses

How to participate?

Step 1 Connect with a study center
What happens next?
  • You can expect the study team to contact you via email or phone in the next few days.
  • Sign up as volunteer to help accelerate the development of new treatments and to get notified about similar trials.

You are contacting

Investigator Avatar

Primary Contact

site

0/250

Additional screening procedures may be conducted by the study team before you can be confirmed eligible to participate.

Learn more

If you are confirmed eligible after full screening, you will be required to understand and sign the informed consent if you decide to enroll in the study. Once enrolled you may be asked to make scheduled visits over a period of time.

Learn more

Complete your scheduled study participation activities and then you are done. You may receive summary of study results if provided by the sponsor.

Learn more

Similar trials to consider

Loading...

Browse trials for

Not finding what you're looking for?

Every year hundreds of thousands of volunteers step forward to participate in research. Sign up as a volunteer and receive email notifications when clinical trials are posted in the medical category of interest to you.

Sign up as volunteer

user name

Added by • 

 • 

Private

Reply by • Private
Loading...

Lorem ipsum dolor sit amet consectetur, adipisicing elit. Ipsa vel nobis alias. Quae eveniet velit voluptate quo doloribus maxime et dicta in sequi, corporis quod. Ea, dolor eius? Dolore, vel!

  The passcode will expire in None.
Loading...

No annotations made yet

Add a private note
  • abc Select a piece of text from the left.
  • Add notes visible only to you.
  • Send it to people through a passcode protected link.
Add a private note