Richter SyndromePhase 2NCT03145480
Study of Ibrutinib & Obinutuzumab With/Without CHOP for Richter's Transformation or Richter's Syndrome Patients
A Phase 2 study testing Obinutuzumab, Ibrutinib and CHOP in people with Richter Syndrome, run by Northwell Health at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Richter Syndrome
- What is being tested?
- Obinutuzumab, Ibrutinib and CHOP
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 3 participants
- Where
- 1 siteUnited States
- Study dates
- 19 Jun 2017to 28 Sep 2018
- Phase
- Phase 2
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
United States1 site
Northwell Health/CLL Research and Treatment Program
New Hyde Park, New York, 11042
About this study
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)
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).
- Conditions
- Richter Syndrome
- Being tested
- Obinutuzumab, Ibrutinib, CHOP
- Keywords
- leukemia, richter
- Medical subject headings
- Leukemia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ObinutuzumabDrug
Also called gazyva
100 mg on day 1 and 900 mg on day 2 Cycle 1, 1000 mg on day 8 and 15 of Cycle 1, and 1000 mg on day 1 of Cycles 2-6
IbrutinibDrug
Also called imbruvica
560mg po daily
CHOPOther
Also called CHOP Regimen
cyclophosphamide, doxorubicin, vincristine, and prednisone
| Study group | Role | What they receive |
|---|---|---|
| Fit arm | Experimental | ibrutinib and obinutuzumab in combination with the CHOP regimen Receives: Drug: Obinutuzumab; Drug: Ibrutinib; Other: CHOP |
| Frail arm | Experimental | ibrutinib and obinutuzumab Receives: Drug: Obinutuzumab; Drug: Ibrutinib |
What is being measured
The primary outcome is the main question the study is designed to answer.
Overall Response Rate (ORR)
ORR in subjects treated with combination of ibrutinib and obinutuzumab (with or without CHOP)
Measured: 6 months
Secondary outcomes (3)
Number of Participants With Improved Hemoglobin and Platelet Counts.
hematologic improvement
Measured: 6 months
Progression Free Survival (PFS)
time to progression post treatment of condition
Measured: 6 months
To Evaluate Patient-reported Outcome (PRO) of Health-related Quality of Life by the Functional Assessment of Chronic Illness Therapy-Fatigue (FACiT-Fatigue)
health-related quality of life using FACIT Fatigue Scale
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 May 2017
- Study start19 Jun 2017
- Primary completion28 Sep 2018
- Study completion28 Sep 2018
Why it stopped: Investigator decision to close study
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Richter SyndromeStudies of the same condition, open and under way.
- More trials run by Northwell HealthThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Model description
- parallel assignment based on fitness of participants
- Masking
- None (open label)
- Enrolment
- 3 participants (actual)
Sponsor and investigators
- Lead sponsor
- Northwell Health
- Sponsor type
- University, hospital or other
- Collaborators
- Pharmacyclics LLC.
- Responsible party
- Sponsor
- Investigators
- Jacqueline Barrientos, MD, Principal investigator, Northwell Health
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03145480
- Sponsor's protocol ID
- 16-727
- Status last verified
- May 2023
- First submitted
- 4 Apr 2017
- Last updated
- 1 Jun 2023
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 1 Jun 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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)
- ClinicalTrials.gov ID
- NCT03145480
- Acronym / sponsor ID
- 16-727
- Conditions
- Richter Syndrome
- Keywords
- leukemia, richter
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Investigator decision to close study
- Enrolment
- 3 participants (actual)
- Lead sponsor
- Northwell HealthUniversity, hospital or other
- Collaborators
- Pharmacyclics LLC.
- Study start
- 19 Jun 2017 (actual)
- Primary completion
- 28 Sep 2018 (actual)
- Study completion
- 28 Sep 2018 (actual)
- First posted
- 9 May 2017 (actual)
- Results
- Posted 1 Jun 2023
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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).
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- parallel assignment based on fitness of participants
| Arm | Type | Receives |
|---|---|---|
| Fit arm | Experimental | Drug: Obinutuzumab, Drug: Ibrutinib, Other: CHOPibrutinib and obinutuzumab in combination with the CHOP regimen |
| Frail arm | Experimental | Drug: Obinutuzumab, Drug: Ibrutinibibrutinib and obinutuzumab |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- 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
Key exclusion criteria (8 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| ObinutuzumabAlso: gazyva100 mg on day 1 and 900 mg on day 2 Cycle 1, 1000 mg on day 8 and 15 of Cycle 1, and 1000 mg on day 1 of Cycles 2-6 | Drug | Fit arm, Frail arm |
| IbrutinibAlso: imbruvica560mg po daily | Drug | Fit arm, Frail arm |
| CHOPAlso: CHOP Regimencyclophosphamide, doxorubicin, vincristine, and prednisone | Other | Fit arm |
Primary outcome
Overall Response Rate (ORR)
Time frame: 6 months
ORR in subjects treated with combination of ibrutinib and obinutuzumab (with or without CHOP)
3 secondary outcomes
Number of Participants With Improved Hemoglobin and Platelet Counts.
Time frame: 6 months
Progression Free Survival (PFS)
Time frame: 6 months
To Evaluate Patient-reported Outcome (PRO) of Health-related Quality of Life by the Functional Assessment of Chronic Illness Therapy-Fatigue (FACiT-Fatigue)
Time frame: 1 year
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Jun 2023.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: No
Related trials for Richter Syndrome
RecruitingPhase 2
A Prospective, Open-label, Randomized, Multicenter Phase-III Trial to Evaluate the Efficacy of Pirtobrutinib and Epcoritamab Compared With R-(Mini)-CHOP for Treatment of Patients With DLBCL-type Richter Transformation
Richter Transformation
Active, not recruitingPhase 1/2
Safety and Efficacy Study of Epcoritamab in Subjects With Relapsed/Refractory Chronic Lymphocytic Leukemia and Richter's Syndrome
Relapsed/Refractory Chronic Lymphocytic Leukemia, Small Lymphocytic Lymphoma
Not yet recruitingPhase 1
huCART19-IL18-CD428z Cells for the Treatment of Patients With HIV With CD19+ Cancers
Non-Hodgkin Lymphoma, Chronic Lymphocytic Leukemia
Active, not recruitingPhase 1
Copanlisib and Nivolumab in Treating Patients With Richter's Transformation or Transformed Indolent Non-Hodgkin Lymphoma
Chronic Lymphocytic Leukemia, Diffuse Large B-Cell Lymphoma
RecruitingPhase 2
Phase 2 Study of Glofitamab Monotherapy & With Polatuzumab Vedotin, Pirtobrutinib, or Atezolizumab in Richter's Transformation
Chronic Lymphocytic Leukemia, Richter's Transformation
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Jacqueline Barrientos, MD principal investigator
Northwell Health
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Obinutuzumab, Ibrutinib and CHOP in people with Richter Syndrome, run by Northwell Health at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 1 Jun 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 1 Jun 2023). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Overall Response Rate (ORR) (time frame: 6 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 1 Jun 2023.