A Study of HMPL-523 in Relapsed or Refractory Hematologic Malignancies

Status Active, not recruiting

Clinical Trial Summary

The purpose of this study is to evaluate the safety and tolerability of HMPL-523 administered to patients with relapsed or refractory Hematologic Malignancies

To determine the maximum tolerated dosage/recommended phase 2 dosage and characterize the dose limited toxicities associated with HMPL-523 when administered to patients with relapsed or refractory Hematologic Malignancies

Clinical Trial Description

There are two stages in this study: a dose-escalation stage (stage 1) and a dose-expansion stage (stage 2).

Dose-escalation stage (stage 1). The conventional 3+3 design (3 patients per dose cohort, with the potential to add additional 3 patients to the same cohort to further evaluate toxicity) will be applied for dose escalation and maximum tolerated dosage determination. Approximately 18 to 27 evaluable patients will be enrolled. The actual number of patients depends on the dose limited toxicities situation as well as the maximum tolerated dosage reached at this stage.

Dosing will include QD (quaque die) and bis in die (BID) cohorts. A cycle of study treatment will be defined as 28 days of continuous dosing.

Dose-expansion stage (stage 2). In this stage, approximately 40 patients with B-cell Non-Hodgkin's Lymphomas or Chronic Lymphocytic Leukemia will be enrolled with 600mg once daily as starting dose. The tumor types of the expansion stage are restricted to Chronic lymphocytic leukemia/ small lymphocytic lymphoma (CLL/SLL), Mantle cell lymphoma (MCL), Follicular Lymphoma (FL) (Grade 1-3a), Marginal zone lymphoma (MZL) and Waldenstrom's macroglobulinemia / Lymphoplasmacytic lymphoma (WM/LPL). Subjects will receive HMPL-523 600mg once daily with every 28-day treatment cycle until disease progression, death, or intolerable toxicity, whichever comes first. ;

Study Design

Related Conditions & MeSH terms

Clinical Trial Details

NCT number	NCT02503033
Study type	Interventional
Source	Hutchison Medipharma Limited
Contact
Status	Active, not recruiting
Phase	Phase 1
Start date	November 2015
Completion date	March 2021

View Details

See also
Status	Clinical Trial	Phase
Recruiting	`NCT05433090` - An Inpatient Advance Care Planning Intervention for Older Patients With Hematologic Malignancies	N/A
Completed	`NCT00061620` - Phase I Study of Continuous Infusion Schedule of FMdC in Hematologic Malignancies	Phase 1
Enrolling by invitation	`NCT02473757` - Gene Therapy Follow-up Protocol for People Previously Enrolled in CAR-T Cell Studies
Not yet recruiting	`NCT06296368` - DISCOVERY: Evaluating a Decision Support Tool for Adults Seen in Hematology/Oncology Clinics	N/A
Recruiting	`NCT02032446` - Umbilical Cord Derived Mesenchymal Stromal Cells For The Treatment of Severe Steroid-resistant Graft Versus Host Disease	Phase 1/Phase 2
Recruiting	`NCT02884375` - Elderly CAncer Patient	N/A
Recruiting	`NCT01203722` - Reduced Intensity, Partially HLA Mismatched BMT to Treat Hematologic Malignancies	Phase 1/Phase 2
Completed	`NCT00780052` - Infusional C-myb ASODN in Advanced Hematologic Malignancies	Phase 1
Recruiting	`NCT04098393` - Giving Chemotherapy for a Shortened Amount of Time Before a Stem Cell Transplantation	Phase 1
Recruiting	`NCT06028828` - Risk-ADAPTed Conditioning Regimen for Allogeneic Hematopoietic Stem Cell Transplantation	Phase 2
Completed	`NCT04538599` - RD13-01 for Patients With r/r CD7+ T/NK Cell Hematologic Malignancies	Phase 1
Completed	`NCT03609827` - Study of Melphalan Drug Exposure in Pediatric Hematopoietic Stem Cell Transplant Patients
Completed	`NCT01380756` - Study Evaluating Orally Administered AMG 900 in Adult Subjects With Acute Myeloid Leukemia	Phase 1
Recruiting	`NCT05849207` - Post-Transplant Cyclophosphamide in Patients Aged >/= 70 Years Undergoing Haploidentical Transplant	Phase 1
Not yet recruiting	`NCT05028478` - A Study of CN202 in Adult Subjects With Locally Advanced or Metastatic Solid Tumors or Hematologic Malignancies	Phase 1/Phase 2
Active, not recruiting	`NCT02494258` - A Study to Evaluate Long-term Safety of CC-486 (Oral Azacitidine) in Subjects With Hematological Disorders	Phase 2
Completed	`NCT03212560` - Exercise Capacity and Physical Activity Levels in Newly Diagnosed Hematologic Malignant Patients
Active, not recruiting	`NCT02600208` - Peripheral Blood Stem Cell Transplantation for Hematologic Malignancies With Alpha Beta TCell and B Cell Depletion Using the CliniMACS Device	Phase 2/Phase 3
Completed	`NCT02145403` - Phase 1/2 Study of Carfilzomib for the Prevention of Relapse and GVHD in Allo-HCT for Hematologic Malignancies	Phase 1/Phase 2
Completed	`NCT01949545` - Study of the Pharmacokinetics and Safety of Carfilzomib in Patients With Advanced Malignancies and Hepatic Impairment	Phase 1