Non Hodgkin Lymphoma Clinical Trial

Trial to Evaluate the Safety and Pharmacokinetics of HMPL-689 in Patients With Lymphomas

Summary

An open-label, dose escalation and expansion clinical trial to evaluate the safety, tolerability and PK of HMPL-689 in patients with relapsed or refractory lymphomas

View Full Description

Full Description

This is a Phase 1, open-label, multicenter study of HMPL-689 administered orally to patients with relapsed or refractory lymphoma.

HMPL-689 is a selective and potent small molecule inhibitor targeting the isoform phosphoinositide 3'-kinase delta (PI3Kδ), a key component in the B-cell receptor signaling pathway

This study will consist of a dose escalation stage (Stage 1) and a dose expansion stage (Stage 2).

Dose Escalation Stage (Stage 1):

This stage will end when any of the following criteria is met:

The dose level 1 demonstrates an excessive toxicity, ie, 3 dose limiting toxicities (DLTs) are observed out of the first 3 patients at dose level 1.
The maximum sample size is reached.
The MTD and/or RP2D is confirmed.

Dose Expansion Stage (Stage 2):

To further characterize the safety and explore the preliminary anti-tumor activity of HMPL-689 at RP2D, patients with B cell lymphoma will be enrolled in the dose expansion stage.

View Eligibility Criteria

Eligibility Criteria

Inclusion Criteria:

(ECOG) performance status of 0 or 1;
Histologically confirmed lymphoma (tumor types are restricted to CLL/SLL, FL (grade 1-3a), MCL, MZL, LPL/WM, PTCL or CBCL);

Patients with relapsed or refractory NHL for whom:

Standard of care treatment options no longer exist (Stage 1 only);
Standard of care treatment options no longer exist with the exception of PI3K-delta inhibitors (Stage 2 only);
Expected survival of more than 24 weeks.

Exclusion Criteria:

Patients who meet any of the following criteria will be excluded from study entry:

Primary central nervous system (CNS) lymphoma;
Any of the following laboratory abnormalities Absolute neutrophil count; <1.0×10^9/L, Hemoglobin <80 gL Platelets <50 ×10^9L

Inadequate organ function, defined by the following:

Total bilirubin ≥1.5 times the upper limit of normal (× ULN);
AST or ALT > 2.5 × ULN;
Estimated creatinine clearance (CrCl) per Cockcroft-Gault;
Dose Escalation stage of trial (Stage 1) - CrCl < 40 mL/min;
Dose Expansion stage of trial (Stage 2) - CrCl <30 mLmin;
International normalized ratio (INR) > 1.5 × ULN, activated partial thromboplastin time (aPTT) > 1.5 × ULN;
Serum amylase or lipase > ULN at screening or known medical history of serum amylase or lipase > ULN;
Patients with presence of second primary malignant tumors within the last 2 years;
Clinically significant history of liver disease;
Prior treatment with any PI3Kδ inhibitors;
Any prior use of the following: cancer therapy within 3 weeks of study treatment, GCSF within 7 days of screening, steroid therapy or targeted anti-neoplastic intent within 7 days of treatment, any use of strong CYP3A4 inducers within 2 weeks prior to initiation of study treatment, prior autologous transplant within 6 months of study treatment, prior allogenic stem cell transplant within 6 months of study treatment;
Clinically significant active infection or interstitial lung diseases (including drug induced pneumonitis);
Major surgical procedure within 4 weeks prior to initiation of study treatment;
Adverse events from prior anti-neoplastic therapy that have not resolved to Grade less than or equal to 1, except for alopecia;
New York Heart Association (NYHA) Class II or greater congestive heart failure;
Congenital long QT syndrome or QTc >470 msec;
Currently use medication known to cause QT prolongation or torsades de pointes;
History of myocardial infarction or unstable angina within 6 months prior to initiation of study treatment;
History of stroke or transient ischemic attack within 6 months prior to initiation of study treatment;
Inability to take oral medication, prior surgical procedures affecting absorption, or active peptic ulcer disease;
History of inflammatory bowel disease (e.g., Crohn's disease or ulcerative colitis);
Patients with ongoing chronic gastrointestinal diseases;
Any other diseases, metabolic dysfunction, physical examination finding, or clinical laboratory finding that, in the investigator's opinion, gives reasonable suspicion of a disease or condition that contraindicates the use of an investigational drug or that may affect the interpretation of the results or renders the patient at high risk from treatment complications.

Study is for people with:

Non Hodgkin Lymphoma

Phase:

Phase 1

Estimated Enrollment:

270

Study ID:

NCT03786926

Recruitment Status:

Recruiting

Sponsor:

Hutchmed

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There are 15 Locations for this study

See Locations Near You

Innovative Clinical Research Institute
Anaheim California, 92801, United States More Info
Richy Agajanian, MD
Contact
562-693-4477
[email protected]
Richy Agajanian, MD
Principal Investigator
Pacific Cancer Medical Center
Anaheim California, 92801, United States More Info
Veena Charu
Contact
Veena Charu, MD
Principal Investigator
Ventura County Hematology-Oncology Specialists
Oxnard California, 93030, United States More Info
Lynn Kong, MD
Contact
805-485-8709
[email protected]
Lynn Kong, MD
Principal Investigator
Winship Cancer Institute of Emory University
Atlanta Georgia, 30322, United States More Info
Jonathan Cohen, MD
Contact
404-778-1868
Jonathan Cohen, MD
Principal Investigator
Clinical Research Alliance, Inc
Westbury New York, 11590, United States More Info
Morton Coleman, MD
Contact
516-488-2918
[email protected]
Morton Coleman, MD
Principal Investigator
Levine Cancer Institute- Atrium Health
Charlotte North Carolina, 28204, United States More Info
Nilanjan Ghosh, MD
Contact
980-442-4363
Nilanjan Ghosh, MD
Principal Investigator
Baylor Scott and White Research Institute
Dallas Texas, 75246, United States More Info
Micah Burch
Contact
214-820-2687
Micah Burch, MD
Principal Investigator
Renovatio Clinical
Houston Texas, 77339, United States More Info
Jonathan Lu, MD
Contact
713-703-2398
[email protected]
Jonathan Lu, MD
Principal Investigator
University of Texas Health Science Center at San Antonio
San Antonio Texas, 78229, United States More Info
Tracy Rodriguez
Contact
210-450-1950
[email protected]
Adolfo Enrique Diaz Duque, MD
Principal Investigator
Medical Oncology Associates, P.S.
Spokane Washington, 99208, United States More Info
Arvind Chaudhry
Contact
Arvind Chaudhry, MD
Principal Investigator
Helsingin yliopistollinen keskussairaala
Helsinki , 00029, Finland More Info
Sirpa Leppa, MD
Contact
358504270820
[email protected]
Sirpa Leppa, MD
Principal Investigator
Tampereen yliopistollinen sairaala
Tampere , 33520, Finland More Info
Marjukka Pollari, MD
Contact
3583311611
[email protected]
Marjukka Pollari, MD
Principal Investigator
Hopital Henri Mondor
Créteil Cedex Val De Marne, 94010, France More Info
Corinne Haioun, Prof
Contact
33149812051
[email protected]
Corinne Haioun, Prof
Principal Investigator
CHU de Nantes - Hotel Dieu
Nantes , 44000, France More Info
Benoit Tessoulin, MD
Contact
33240083271
[email protected]
Benoit Tessoulin, MD
Principal Investigator
CHU de Bordeaux - Hôpital Haut-Lévêque
Pessac , 33604, France More Info
Kamal Bouabdallah, MD
Contact
33557656511
[email protected]
Kamal Bouabdallah, MD
Principal Investigator
Azienda Ospedaliera Universitaria Policlinico Sant'Orsola Malpighi IRCCS
Bologna , , Italy More Info
Lisa Argnani
Contact
[email protected]
Pier Luigi Zinzani, MD
Principal Investigator
Ospedale San Raffaele
Milan , , Italy More Info
Daniela DeLorenzo
Contact
[email protected]
Andres Ferreri, MD
Principal Investigator
KO-MED Centra Kliniczne
Biała Podlaska , , Poland More Info
Dominika Chwedoruk
Contact
[email protected]
Piotr Centkowski, MD
Principal Investigator
Uniwersyteckie Centrum Kliniczne
Gdańsk , , Poland More Info
Michal Taszner, MD
Contact
[email protected]
Michal Taszner, MD
Principal Investigator
BioResearch Group Sp. Z. o. o.
Kraków , , Poland More Info
Marta Marek
Contact
[email protected]
Katarzyna Jarus-Dziedzic, MD
Principal Investigator
NASZ LEKARZ Osrodek Badan Klinicznych
Toruń , , Poland More Info
Judyta Rudzinska
Contact
[email protected]
Dominik Chraniuk, MD
Principal Investigator
Uniwersytecki Szpital Kliniczny im. Jana Mikulicza Radeckiego
Wroclaw , 50-56, Poland More Info
Tomasz Wrobel, Prof
Contact
48717842754
[email protected]
Tomasz Wrobel, Prof
Principal Investigator
ICO Badalona - Hospital Universitari Germans Trias i Pujol
Barcelona , , Spain More Info
Marta Casares
Contact
[email protected]
Juan Manuel Sancho Cia, MD
Principal Investigator
ICO l'Hospitalet - Hospital Duran i Reynals
Barcelona , , Spain More Info
Anna Valer Serra
Contact
[email protected]
Eva Gonzalez Barca, MD
Principal Investigator
Fundacion Jimenez Diaz
Madrid , , Spain More Info
Raul Cordoba, MD
Contact
+349155048003854
[email protected]
Raul Cordoba, MD
Principal Investigator
Hospital Universitario Virgen del Rocio
Seville , , Spain More Info
Fatima de la Cruz Vicente
Contact
+34 955 01 20 00
Fatima de la Cruz Vicente
Principal Investigator
Hospital Universitario Virgen Macarena
Seville , , Spain More Info
Luis de la Cruz Merino
Contact
+34 955 00 80 00
Luis de la Cruz Merino, MD
Principal Investigator

How clear is this clinincal trial information?

Study is for people with:

Non Hodgkin Lymphoma

Phase:

Phase 1

Estimated Enrollment:

270

Study ID:

NCT03786926

Recruitment Status:

Recruiting

Sponsor:


Hutchmed

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