Vyxeos(CPX-351) in Adults w R/R Acute Lymphoblastic Leukemia
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|ClinicalTrials.gov Identifier: NCT03575325|
Recruitment Status : Recruiting
First Posted : July 2, 2018
Last Update Posted : November 5, 2020
|Condition or disease||Intervention/treatment||Phase|
|Lymphoid Leukemia Acute Lymphoblastic Leukemia Refractory Acute Lymphoblastic Leukemia Relapsed Acute Lymphoblastic Leukemia||Drug: CPX-351||Phase 2|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||10 participants|
|Intervention Model:||Single Group Assignment|
|Intervention Model Description:||This is an open label, single arm, single center, phase 2 pilot study of Vyxeos induction & consolidation in relapsed and refractory ALL.|
|Masking:||None (Open Label)|
|Official Title:||A Single-Arm, Open-Label Phase 2 Pilot Study of Vyxeos (CPX-351) in Adults With Relapsed or Refractory Acute Lymphoblastic Leukemia|
|Actual Study Start Date :||October 4, 2018|
|Estimated Primary Completion Date :||October 2021|
|Estimated Study Completion Date :||October 2022|
Experimental: CPX-351 Treatment
Participants will receive induction with CPX-351 at a dose of 100 u/m^2 administered intravenously over 90 minutes on days 1, 3 and 5 of a 28 day cycle.
This may be followed by consolidation with CPX-351 at a dose of 65 u/m^2 administered intravenously over 90 minutes on days 1 and 3 of a 28 day cycle (up to 3 cycles).
The infusion of CPX-351 (cytarabine:daunorubicin) Liposome Injection will be performed through a central venous catheter, using an infusion pump to ensure that the drug is infused over the specified time period.
- Complete Remission Rate (CR) + CR with Incomplete Recovery (CRi) [ Time Frame: At day 28 ]Expansion from phase II pilot to a phase II trial will depend on demonstration of CR/CRi amongst 4 of the initial 10 treated patients. Investigators will measure remission rate at day 28 to address the primary endpoint of complete remission (with or without complete hematologic recovery), as defined by Cheson Criteria (ref 27). For those with extramedullary disease, Lugano criteria will be used to assess response. This is a standard assessment of drug efficacy for phase 2 clinical trial design in acute leukemias, as response correlates closely with progression free- and overall survival (PFS and OS).
- Progression Free Survival (PFS) [ Time Frame: 12 months ]Progression Free Survival as defined by Cheson and Lugano Criteria, namely progression, failure to respond, or death, as assessed from time of first treatment. Progression Free Survival will be reported as per Cheson Criteria, and analyzed using a standard Kaplan-Meier approach. Patients will undergo bone marrow biopsy evaluation after each cycle of therapy per standard of care to facilitated assessment.
- Overall Survival (OS) [ Time Frame: 12 months ]Overall Survival as defined by Cheson and Lygano Criteria, namely death due to any cause as assessed from time of first treatment. Overall Survival will be reported as per Cheson Criteria, and analyzed using a standard Kaplan-Meier approach. Patients will undergo bone marrow biopsy evaluation after each cycle of therapy per standard of care to facilitated assessment.
- Minimal Residual Disease (MRD) [ Time Frame: At day 28 ]MRD will be studied as a dichotomous endpoint using a cutoff of 1x10^4 cells/transcripts as the lower limit for residual leukemia, and presented as the percentage of participants reaching this landmark as their best response. MRD assessment will be obtained with each bone marrow biopsy assessment.
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): NCT03575325
|United States, Florida|
|H. Lee Moffitt Cancer Center and Research Institute||Recruiting|
|Tampa, Florida, United States, 33612|
|Contact: Elyce Turba 813-745-1706 firstname.lastname@example.org|
|Contact: Anthony McLaughlin 813-745-5941 email@example.com|
|Principal Investigator: Bijal Shah, M.D.|
|Principal Investigator:||Bijal Shah, M.D.||H. Lee Moffitt Cancer Center and Research Institute|