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A Clinical Trial of Buparlisib and Ibrutinib in Lymphoma | Clinical Trials | Clareo Health

COMPLETEDPHASE1

A Clinical Trial of Buparlisib and Ibrutinib in Lymphoma

Phase Ib Clinical Trial of Buparlisib and Ibrutinib in Mantle Cell Lymphoma, Follicular Lymphoma and Diffuse Large B Cell Lymphoma

NCT02756247•Memorial Sloan Kettering Cancer Center

View on ClinicalTrials.gov

Summary

The purpose of this study is to find out if the combination of buparlisib and ibrutinib will lead to better treatment results in patients with relapsed or refractory Follicular lymphoma, (FL) Mantle cell lymphoma (MCL) or Diffuse Large B-cell lymphoma (DLBCL). The investigators are using buparlisib and ibrutinib because both drugs seem to block different proteins that allow cancer cells to keep growing. Blocking these proteins may help by making the cancer cells undergo cell death, which will stop uncontrolled tumor growth.

Eligibility

Age

18 - No limit years

Sex

ALL

Healthy Volunteers

Inclusion Criteria

•Patient is ≥ 18 years of age at the time of signing Informed Consent
•Patient is able and willing to adhere to the study visit schedule and other protocol requirements
•Patient has histologically confirmed diagnosis of R/R mantle cell lymphoma, follicular lymphoma or diffuse large B cell lymphoma
•* Diffuse large B cell lymphoma patients has received at least 1 prior regimen and received, declined, or is ineligible for autologous or allogeneic stem cell transplant.
•* Follicular lymphoma patients have received at least 2 lines of therapy.
•* Mantle cell lymphoma patients has received at least 1 line of therapy
•* Allogeneic stem cell transplant recipients be greater than 6 months post transplant, not on immunosuppression for prevention of graft versus host disease for \>3 months and without active graft versus host disease are eligible
•* Autologous stem cell transplant recipients must have adequate bone marrow recovery and transfusion independent
•* Transformed histologies are permitted
•Patient has at least one measurable lesion (≥ 2 cm) according to Lugano Classification
+18 more criteria

Exclusion Criteria

•Patients previously treated with ibrutinib or PI3K inhibitor
•Patient has a history of non-compliance to medical regimen or inability to grant consent
•Patient has not recovered to Grade 1 or better (except alopecia) from related side effects of any prior antineoplastic therapy.
•Patient is concurrently using other approved or investigational antineoplastic agent
•Patient has had major surgery or a wound that has not fully healed within 4 weeks of starting study drugs.
•Patients who have had chemotherapy or radiotherapy within 2 weeks (6 weeks for nitrosoureas or mitomycin C) prior to entering the study or those who have not recovered from adverse events due to agents administered more than 2 weeks earlier
•Patient has evidence of active graft versus host disease (GVHD)
•Patient has active or history of central nervous system (CNS) disease or meningeal involvement.
•Patient has history of stroke or intracranial hemorrhage ≤ 6 months from starting study drugs.
•Patient has a score ≥ 12 on the PHQ-9 questionnaire, selects a response of "1, 2 or 3" to question number 9 on the PHQ-9 questionnaire regarding potential for suicidal thoughts or ideation (independent of the total score of the PHQ-9), score ≥ 15 on GAD-7 mood scale.
+13 more criteria

Locations (6)

Memorial Sloan Kettering Basking Ridge

Basking Ridge, New Jersey, United States

Memorial Sloan Kettering Monmouth

Middletown, New Jersey, United States

Memorial Sloan Kettering Commack

Commack, New York, United States

Memorial Sloan Kettering Westchester

Harrison, New York, United States

Memorial Sloan Kettering Cancer Center

New York, New York, United States

Memorial Sloan Kettering Nassau

Uniondale, New York, United States

Key Dates

Start Date

May 9, 2016

Primary Completion Date

October 6, 2022

Completion Date

October 6, 2022

Last Updated

October 10, 2022

Enrollment

ACTUAL participants

Conditions

LymphomaMantle Cell LymphomaFollicular LymphomaDiffuse Large B Cell Lymphoma

Interventions

Buparlisib

DRUG

Ibrutinib

DRUG

Phase II Study of Pirtobrutinib, Rituximab (PR) in Previously Untreated Low and Intermediate Risk MCL (Mantle Cell Lymphoma) Patients

NCT06263491

Mantle Cell Lymphoma

View study

RECRUITINGPHASE1

Azacitidine and Abatacept in Relapsed or Refractory T-Cell Lymphoma

NCT07388563

Lymphoma, T Cell, PeripheralT-cell Lymphoma+4 more

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Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: October 10, 2022Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

View ClinicalTrials.gov Terms and Conditions

A Clinical Trial of Buparlisib and Ibrutinib in Lymphoma

Inclusion Criteria

Exclusion Criteria

Phase II Study of Pirtobrutinib, Rituximab (PR) in Previously Untreated Low and Intermediate Risk MCL (Mantle Cell Lymphoma) Patients

Azacitidine and Abatacept in Relapsed or Refractory T-Cell Lymphoma

A Study of Zilovertamab Vedotin (MK-2140) in Combination With Standard of Care in Participants With Relapsed or Refractory Diffuse Large B-Cell Lymphoma (rrDLBCL) (MK-2140-003)

Comparing Rituximab and Mosunetuzumab Drug Treatments for People With Low Tumor Burden Follicular Lymphoma

Phase II Study of Pirtobrutinib With Venetoclax In Relapsed-Refractory MCL (Mantle Cell Lymphoma) Patients

A Study to Evaluate MK-1045 (CN201) in Participants With Relapsed or Refractory B-Cell Non-Hodgkin Lymphoma (MK-1045-001/CN201-101)