Study of IV CBL0137 in Previously Treated Hematological Subjects
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT02931110|
Recruitment Status : Suspended (Business reasons)
First Posted : October 12, 2016
Last Update Posted : May 21, 2020
|Condition or disease||Intervention/treatment||Phase|
|Hematological Malignancies||Drug: CBL0137||Phase 1|
Part 1 of the study will evaluate the safety and pharmacology of a range of CBL0137 doses administered IV in participants with previously treated lymphomas, including diffuse large B-cell lymphoma (DLBCL), follicular lymphoma (FL), mantle cell lymphoma (MCL), Hodgkin lymphoma (HL), chronic lymphocytic leukemia/small lymphocytic lymphoma (CLL/SLL), or multiple myeloma (MM). Cohorts of 3 to 6 subjects will be sequentially enrolled at progressively higher dose levels of CBL0137 using a standard 3+3 dose-escalation design. An additional 6 participants may be accrued at the maximum tolerated dose (MTD) or at the recommended dose (RD) to confirm CBL0137 safety and pharmacology as a prelude to further clinical evaluation.
Part 2 of the study provides cohort expansion to further explore the safety, pharmacology, and clinical activity of CBL0137 monotherapy in participants with specific previously treated hematological cancers, including DLBCL, FL, MCL, HL, CLL/SLL, acute lymphoblastic leukemia (ALL), acute myeloid leukemia (AML), and MM. Twelve evaluable participants with each disease type may be enrolled.
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||230 participants|
|Intervention Model:||Sequential Assignment|
|Masking:||None (Open Label)|
|Official Title:||A Phase 1 Dose-Escalation and Cohort-Expansion Study of Intravenous CBL0137 in Subjects With Previously Treated Hematological Cancers|
|Actual Study Start Date :||January 2017|
|Estimated Primary Completion Date :||November 2020|
|Estimated Study Completion Date :||December 2020|
Experimental: CBL0137 Dose Escalation
CBL0137 administered IV weekly on Days 1 and 8 of repeated 21 day treatment cycles. Number of Cycles: 2 or until progression or unacceptable toxicity develops
- Part 1: Maximum Tolerated Dose (MTD) and Recommended Dose (RD) [ Time Frame: At the end of Cycle 1 (each cycle is 21 days) ]MTD is defined as dose level at which ≥6 subjects have been treated and which is associated with a first-cycle dose-limiting toxicity (DLT) in ≤17% of the participants. RD may be the MTD or may be a lower dose within the tolerable dose range. Selection of the RD will be based on consideration of short- and long-term safety information together with available pharmacokinetic, pharmacodynamic, and efficacy data.
- Part 2: Overall Response Rate (ORR) [ Time Frame: Through study completion, an average of 1 year ]ORR is defined as the proportion of subjects who achieve a complete response (CR), complete response with incomplete blood count recovery (CRi), or partial response (PR) for those with DLBCL, FL, MCL, HL, or CLL/SLL; the proportion of subjects who achieve a CR, CRi, or unconfirmed CR (CRu) for those with ALL; the portion of subjects who achieve a CR or CRi for those with AML; and the proportion of subjects who achieve a stringent CR (sCR), CR, very good PR (VGPR), or PR for those with MM. An ORR of ≥20% is considered the minimum value of potential interest in each of the selected indications.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02931110
|United States, California|
|The Oncology Institute of Hope & Innovation|
|Whittier, California, United States, 90603|
|United States, Georgia|
|Augusta, Georgia, United States, 30912|
|United States, New York|
|Roswell Park Cancer Institute|
|Buffalo, New York, United States, 14263|
|United States, Ohio|
|University Hospitals Case Medical|
|Cleveland, Ohio, United States, 44106|