Status:
UNKNOWN
Pediatric-type Therapy With Pre-transplant Blinatumomab for HR Patients - Phase II Study
Lead Sponsor:
Israeli Medical Association
Conditions:
Philadelphia-Negative ALL
High-Risk Cancer
Eligibility:
All Genders
18-30 years
Phase:
PHASE2
Brief Summary
Despite recent therapeutic advancements, the outcome of young adults with Philadelphia-negative (Ph-neg) acute lymphoblastic leukemia (ALL) and lymphoblastic lymphoma (LBL) remains unsatisfactory, esp...
Detailed Description
This is a national, multicenter, phase II clinical trial to evaluate the potential benefit of a modified pediatric-based approach in young adults with Ph-neg ALL. Safety and efficacy of pre-transplant...
Eligibility Criteria
Inclusion
- Age ≥ 18 years and \<30 years of age at the time of signing the informed consent document.
- Have a documented diagnosis of Ph-neg ALL, LBL or MPAL according to the WHO 2016 classification (appendix I).
- Females of childbearing potential (FCBP) may participate, providing they meet the following conditions:
- Agree to use at least two effective contraceptive methods (oral, injectable, or implantable hormonal contraceptive; tubal ligation; intra-uterine device; barrier contraceptive with spermicide; or vasectomized partner) throughout the study, and for 3 months following EOT; and have a negative serum or urine pregnancy test (investigator's discretion; sensitivity at least 25 mIU/mL) at screening; and have a negative serum or urine pregnancy test (investigator's discretion) within 72 hours prior to starting study therapy in the treatment phase (note that the screening serum pregnancy test can be used as the test prior to starting study therapy in treatment phase if it is performed within the 72-hour timeframe).
- Male subjects with a female partner of childbearing potential must agree to the use of at least two physician-approved contraceptive methods throughout the course of the study and should avoid fathering a child during the course of the study and for 3 months following the last dose of study drug.
- Understand and voluntarily sign an informed consent document prior to any study related assessments/procedures being conducted.
- Able to adhere to the study visit schedule and other protocol requirements.
Exclusion
- Age \<18 or over 30 years at the time of signing the informed consent document.
- Ph-positive disease.
- Known Human Immunodeficiency Virus (HIV).
- Known or suspected hypersensitivity to any of the study drugs.
- Pregnant or lactating females.
- Any significant medical condition, laboratory abnormality, or psychiatric illness that would prevent the subject from participating in the study.
- Any condition including the presence of laboratory abnormalities, which places the subject at unacceptable risk if he/she were to participate in the study.
- Participation to an investigational drug trial in the last month before randomization.
Key Trial Info
Start Date :
January 1 2021
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
May 1 2025
Estimated Enrollment :
110 Patients enrolled
Trial Details
Trial ID
NCT04334993
Start Date
January 1 2021
End Date
May 1 2025
Last Update
May 7 2021
Active Locations (4)
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1
Rambam Medical Center
Haifa, Israel
2
Shaarei Tzedek Medical Center
Jerusalem, Israel
3
Rabin Medical Center
Petah Tikva, Israel, 49100
4
Tel Aviv Medical Center
Tel Aviv, Israel