Pediatric-type Therapy With Pre-transplant Blinatumomab for HR Patients - Phase II Study

NCT04334993 | Unknown Phase 2 FDA Drug

• 1 other identifier: AYA001
• Study Type: interventional
• Target: 110
• Locations: 1 country
• Sites: 4

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, especially in those patients with high-risk disease features. In young adults pediatric-based chemotherapy approaches improve outcome. Furthermore, there is evidence that pre-transplant antibody-based therapy may render patients with positive minimal residual disease (MRD+) to an MRD-negative status (MRD-) and that this may be associated with improved post-transplant outcome. This is prospective study to evaluate the potential benefit of a modified pediatric-based approach in young adults with Ph-neg ALL. Safety and efficacy of pre-transplant antibody-based consolidation in high-risk patients with Ph-neg ALL will be performed.

Conditions

Philadelphia-Negative ALL; High-Risk Cancer

Keywords

Philadelphia-Negative ALL; Pediatric therapy; Blinatumomab; Allogeneic transplantation

Outcome Measures

Primary Outcomes (1)

• Event-free survival (EFS)

  Measured from the date of entry on study until treatment failure, relapse from CR, or death from any cause, whichever occurs first

  2 years

Secondary Outcomes (3)

• Overall survival (OS)

  2 years

• Early death during induction

  60 days

• MRD status

  MRD will be assess by PCR after induction I (day 33), after induction II (week 12), after blinatumomab therapy (prior to HSCT) and at days 30 and 100 post alloHSCT.

Study Arms (1)

Blinatumomab pre-transplant to high risk Ph-negative ALL pts.

EXPERIMENTAL

Patients designated high risk based on protocol will receive 2 cycles of therapy followed by allogeneic transplantation. Patients ≥45 kg (fixed dose): Cycles 1 and 2: 28 mcg daily administered as a continuous infusion on days 1 to 28 of a 6-week treatment cycle.

Drug: Blinatumomab

Interventions

Blinatumomab DRUG

Patients with high risk disease features after 2 induction blocks as defined per protocol will be treated with CNS directed block followed by up to 2 cycles of blinatumomab (for B-cell ALL) followed by allogeneic stem cell transplantation.

Also known as: AIEOP-BFM 2009 protocol - multiagent chemothertapy protocol backbone

Blinatumomab pre-transplant to high risk Ph-negative ALL pts.

Eligibility Criteria

• Age: 18 Years - 30 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Israeli Medical Association: lead

Study Sites (4)

Rambam Medical Center

Haifa, Israel

RECRUITING

Shaarei Tzedek Medical Center

Jerusalem, Israel

RECRUITING

Rabin Medical Center

Petah Tikva, 49100, Israel

RECRUITING

Tel Aviv Medical Center

Tel Aviv, Israel

NOT YET RECRUITING

MeSH Terms

Interventions

blinatumomab

Central Study Contacts

Ofir Wolach, MD

CONTACT

+972-3-9378116; ofirw@clalit.org.il

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Masking Details: NR
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: This is a national, multicenter, phase II clinical trial

Study Record Dates

• First Submitted: March 31, 2020
• First Posted: April 6, 2020
• Study Start: January 1, 2021
• Primary Completion: May 1, 2023
• Study Completion: May 1, 2025
• Last Updated: May 7, 2021

Record last verified: 2020-08

Data Sharing

• IPD Sharing: Will not share

Locations

IL (4)