Phase I/II Study of DFP-10917 in Patients With Acute Leukemia
A Phase I/II Study of DFP 10917 Given by Continuous Infusion in Patients With Relapsed or Refractory Acute Leukemia
1 other identifier
interventional
69
1 country
1
Brief Summary
The purpose of this study is to determine the safety and efficacy of DFP-10917 given via continuous 7 or 14 day infusion to patients with acute leukemias (AML or ALL).
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_1
Started Oct 2012
Longer than P75 for phase_1
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
October 3, 2012
CompletedFirst Posted
Study publicly available on registry
October 5, 2012
CompletedStudy Start
First participant enrolled
October 10, 2012
CompletedPrimary Completion
Last participant's last visit for primary outcome
January 18, 2017
CompletedStudy Completion
Last participant's last visit for all outcomes
October 11, 2017
CompletedOctober 25, 2019
October 1, 2019
4.3 years
October 3, 2012
October 23, 2019
Conditions
Outcome Measures
Primary Outcomes (1)
Number of patients with adverse events
Up to 30 days after the last dose
Study Arms (1)
DFP-10917
EXPERIMENTAL1. 7-day continuous infusion (in the vein): Starting dose 4 mg/m\^2 2. 14-day continuous infusion (in the vein): Starting dose 10 mg/m\^2 3. Phase II Only: 6 mg/m\^2 for the 14-day continuous infusion (in the vein)
Interventions
Eligibility Criteria
You may qualify if:
- Patients must have pathologically-confirmed acute leukemia, refractory or relapsed after standard therapy for the disease or for which conventional systemic chemotherapy is not reliably effective or no effective therapy is available Phase II Only: Patient must have histologically or pathologically confirmed diagnosis of AML based on WHO classification that is refractory after standard therapy, or for which conventional systemic chemotherapy is not reliably effective, or no effective therapy is available. Patients aged 60 years or older with newly diagnosed AML who are not eligible for, or who refuse, standard care are also eligible.
- Aged ≥ 18 years.
- ECOG Performance Status of 0, 1 or 2.
- Adequate clinical laboratory values (i.e., plasma creatinine \<= 1.5 x upper limit of normal (ULN) for the institution, bilirubin \<=1.5 x ULN, alanine transaminase (ALT) and aspartate transaminase (AST) \<= 2.5 x ULN).
- Absence of CNS involvement by leukemia.
- Absence of uncontrolled intercurrent illnesses, including uncontrolled infections, cardiac conditions, or other organ dysfunctions.
- Signed informed consent prior to the start of any study specific procedures.
- Women of child-bearing potential must have a negative serum or urine pregnancy test. Male and female patients must agree to use acceptable contraceptive methods for the duration of the study and for at least one month after the last drug administration.
You may not qualify if:
- The interval from prior treatment to time of study drug administration is \< 2 weeks for cytotoxic agents or \< 5 half-lives for noncytotoxic agents. Exceptions: Use of hydroxyurea is allowed before the start of study and may be administered up to day 5 of the first cycle.
- Any \>grade 1 persistent clinically significant toxicities from prior chemotherapy.
- Extensive prior radiotherapy to more than 30% of bone marrow reserves, or prior bone marrow/stem cell transplantation.
- Any concomitant condition that in the opinion of the investigator could compromise the objectives of this study and the patient's compliance.
- A pregnant or lactating woman.
- Current malignancies of another type. Exceptions: Patients may participate if they have previously treated and currently controlled prostate cancer, adequately treated in situ cervical cancer and basal cell skin cancer or other malignancies with no evidence of disease for 2 years or more.
- Patient has acute promyelocytic leukemia (APL).
- Patients with known HIV, HBV or HCV infection (note: testing for these infections is not required).
- Documented or known clinically significant bleeding disorder.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
MD Anderson Cancer Center
Houston, Texas, 77030, United States
Related Publications (1)
Kantarjian HM, Jabbour EJ, Garcia-Manero G, Kadia TM, DiNardo CD, Daver NG, Borthakur G, Jain N, Waukau JB, Kwari MI, Ravandi F, Anderson BD, Iizuka K, Jin C, Zhang C, Plunkett WK. Phase 1/2 study of DFP-10917 administered by continuous intravenous infusion in patients with recurrent or refractory acute myeloid leukemia. Cancer. 2019 May 15;125(10):1665-1673. doi: 10.1002/cncr.31923. Epub 2019 Jan 22.
PMID: 30668890RESULT
Related Links
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Study Design
- Study Type
- interventional
- Phase
- phase 1
- Allocation
- NA
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
October 3, 2012
First Posted
October 5, 2012
Study Start
October 10, 2012
Primary Completion
January 18, 2017
Study Completion
October 11, 2017
Last Updated
October 25, 2019
Record last verified: 2019-10