ADCT-602 in Treating Patients With Recurrent or Refractory B-cell Acute Lymphoblastic Leukemia
|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. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT03698552|
Recruitment Status : Recruiting
First Posted : October 8, 2018
Last Update Posted : October 16, 2018
|Condition or disease||Intervention/treatment||Phase|
|Blasts 5 Percent or More of Bone Marrow Nucleated Cells CD22 Positive Philadelphia Chromosome Positive Recurrent B Acute Lymphoblastic Leukemia Refractory B Acute Lymphoblastic Leukemia||Biological: ADCT-602||Phase 1 Phase 2|
I. Evaluate the safety and determine the maximum tolerated dose (MTD) of ADCT-602 in patients with relapsed or refractory B-cell (B)-acute lymphoblastic leukemia (ALL) in Phase 1.
II. Determine the recommended dose of ADCT-602 for Phase 2. III. Evaluate the efficacy (complete response [CR] with incomplete marrow recovery [CR/CRi] rate) of ADCT-602 in Phase 2.
I. Evaluate the clinical activity of ADCT-602, based on duration of response (DOR), overall survival (OS), and progression-free survival (PFS).
II. Characterize the pharmacokinetic (PK) profile of ADCT-602. III. Evaluate the immunogenicity of ADCT-602. IV. Characterize the effect of ADCT-602 exposure on the QT interval.
I. Obtain preliminary data on the correlation between the clinical activity and PK profile of ADCT-602 with the baseline expression of CD22 and other cluster of differentiation (CD) markers in peripheral blood.
II. Assess the impact of soluble CD22 (sCD22) on ADCT-602 PK.
OUTLINE: This is a dose escalation study followed by a phase II study.
Patients receive ADCT-602 intravenously (IV) over 30 minutes on day 1. Courses repeat every 21 in the absence of disease progression or unacceptable toxicity. Patients who achieve CR/CRi receive ADCT-602 every 28 days.
After completion of study treatment, patients are followed up at 30 days and then every 12 weeks for up to 1 year.
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||65 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||A Phase I/II Study to Evaluate the Safety and Anti-Tumor Activity of ADCT-602 Targeting CD22 in Patients With Relapsed or Refractory B-Cell Acute Lymphoblastic Leukemia|
|Actual Study Start Date :||August 24, 2018|
|Estimated Primary Completion Date :||December 31, 2020|
|Estimated Study Completion Date :||December 31, 2020|
Patients receive ADCT-602 by vein over 30 minutes on day 1. Courses repeat every 21 in the absence of disease progression or unacceptable toxicity. Patients who achieve CR/CRi receive ADCT-602 every 28 days.
Starting dose of ADCT-602: 30 μg/kg given by vein.
Other Name: ADCT-602 (CN); hLL2-cys-PBD (SY); ADCT602 (CN); ADCT 602 (CN); hLL2-cys-SG3249 (SY); ; ADC ADCT-602
- Maximum tolerated dose (MTD) as determined by dose limiting toxicities (DLTs) (Phase I) [ Time Frame: Up to 21 days ]The MTD is the highest dose level in which the study has treated 6 patients with at most 1 experiencing the DLT. The 3+3 algorithm along with DLTs observed during the first 21 days of the first treatment cycle will be used to guide dose escalation/de-escalation.
- Incidence of toxicity graded according to Common Terminology Criteria for Adverse Events (CTCAE) [ Time Frame: Up to 1 year ]Toxicity is defined as DLTs.
- Recommended phase II dose of ADCT-602 [ Time Frame: Up to 21 days ]The recommended dose of ADCT-602 for phase 2 is the MTD or a dose lower than MTD, which is defined based on toxicity and efficacy profile.
- Complete response (CR)/ CR with incomplete marrow recovery (CR/CRi) rate (Phase II) [ Time Frame: Up to 1 year ]Simon's two-stage design will be used. CR/CRi rate is defined as the best response (CR/CRi) noted during the study period.
- Overall response rate (ORR) [ Time Frame: Up to 1 year ]
- Overall survival (OS) [ Time Frame: Up to 1 year ]
- Progression-free survival (PFS) [ Time Frame: Up to 1 year ]
- Measure the amount of ADCT-602 in the body at different time points. [ Time Frame: Up to 1 year ]Blood for testing the amount of ADCT-602 in the body at different time points drawn 4 times over the 6 hours after the dose.
- ADCT-602 exposure on QT interval assessed by EKG [ Time Frame: Baseline up to 30 days after study drug stopped ]
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): NCT03698552
|Contact: Nitin Jainemail@example.com|
|United States, Texas|
|M D Anderson Cancer Center||Recruiting|
|Houston, Texas, United States, 77030|
|Contact: Nitin Jain 713-745-6080|
|Principal Investigator: Nitin Jain|
|Principal Investigator:||Nitin Jain||M.D. Anderson Cancer Center|