Clinical trial NCT03145480: Study of Ibrutinib & Obinutuzumab With/Without CHOP for Richter's Transformation or Richter's Syndrome Patients
Official title: Two-arm Phase II Trial Exploring the Use of the Targeted Agents Ibrutinib and Obinutuzumab for the Treatment of Patients With a Diagnosis of Richter's Transformation (RT) or Richter's Syndrome (RS)
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE2
Conditions: Richter Syndrome
Keywords: leukemia
richter
Lead sponsor: Northwell Health
Sponsor class: OTHER
Collaborators: name: Pharmacyclics LLC.
First posted: 2017-05-09
Enrollment: 3
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Intervention model description: parallel assignment based on fitness of participants
Primary purpose: TREATMENT

Brief summary: This research study studies the combination of ibrutinib and obinutuzumab with or without the standard chemotherapy regimen of CHOP to see how well these drugs work in treating patients with a diagnosis of Richter's Transformation or Richter's Syndrome. The Bruton's Tyrosine Kinase (BTK) inhibitor, ibrutinib, may stop growth of cancer cells by blocking the signal needed for cell growth. The monoclonal antibody obinutuzumab may block cancer growth by targeting cells present in Richter's Transformation. Giving ibrutinib with obinutuzumab may be a better treatment for patients with Richter's Transformation. Depending on fitness, the patients may receive ibrutinib and obinutuzumab in combination with a regimen known as CHOP (C= cyclophosphamide, H= hydroxydaunorubicin (also called doxorubicin), O= oncovin (also called vincristine, and P= prednisolone or prednisone (corticosteroids).


Eligibility criteria: Inclusion Criteria:

* confirmed Richter's transformation in treatment naïve and previously treated chronic lymphocytic leukemia/small lymphocytic lymphoma patients
* may have had prior exposure to ibrutinib and other B-cell signaling receptor agents
* Adequate hematologic function
* Adequate liver and kidney function
* Willing and able to participate in all required evaluations and procedures in this study protocol
* Female subjects of childbearing potential must not be pregnant upon study entry
* Male and female subjects who agree to use highly effective methods of birth control

Exclusion Criteria:

* known allergy to any of medications
* chemotherapy taken within 21 days of study treatment
* targeted therapy within 10 days of study treatment
* BCR inhibitors within 24 hours of study treatment
* major surgery within 4 weeks of first dose of study treatment
* women who are pregnant
* known infection with HIV or Hepatitis C
* Vaccinated with live, attenuated vaccines within 4 weeks of first dose of study drug

Primary outcomes:
measure: Overall Response Rate (ORR)
timeFrame: 6 months
Secondary outcomes:
measure: Number of Participants With Improved Hemoglobin and Platelet Counts.
timeFrame: 6 months
measure: Progression Free Survival (PFS)
timeFrame: 6 months
measure: To Evaluate Patient-reported Outcome (PRO) of Health-related Quality of Life by the Functional Assessment of Chronic Illness Therapy-Fatigue (FACiT-Fatigue)
timeFrame: 1 year
Other outcomes:
Locations:
city: New Hyde Park
country: United States
facility: Northwell Health/CLL Research and Treatment Program
state: New York
Study officials:
affiliation: Northwell Health
name: Jacqueline Barrientos, MD
role: PRINCIPAL_INVESTIGATOR
References: