Actively Recruiting

Phase 2
Age: 0 - 25Years
All Genders
NCT04746209

Blinatumomab After TCR Alpha Beta/CD19 Depleted HCT

Led by Medical College of Wisconsin · Updated on 2021-09-17

25

Participants Needed

1

Research Sites

465 weeks

Total Duration

On this page

Sponsors

M

Medical College of Wisconsin

Lead Sponsor

A

Amgen

Collaborating Sponsor

AI-Summary

What this Trial Is About

This trial will assess the feasibility of alpha/beta T-cell and B-cell depleted allogeneic hematopoietic cell transplantation (HCT) followed by blinatumomab therapy for high-risk B cell acute lymphoblastic leukemia (ALL) as a means of reducing rates of subsequent relapse and improving survival, while also minimizing treatment-related morbidity/ mortality and late effects. The conditioning regimens will be dependent on the patient's minimal residual disease (MRD) status prior to HCT using high throughput sequencing.

CONDITIONS

Official Title

Blinatumomab After TCR Alpha Beta/CD19 Depleted HCT

Who Can Participate

Age: 0 - 25Years
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Diagnosis of B-ALL with no minimal residual disease in bone marrow by multiparameter flow cytometry (less than 0.01%) and meet one of the following: remission after first relapse or greater (at least CR2), very-high risk biology ALL proceeding to transplant in first remission, or first remission with persistent disease at end of consolidation (MRD greater than 0.01%)
  • Available unrelated or haploidentical donor
  • Age 25 years or younger at enrollment
  • Karnofsky Performance Status 60% or higher if age 16 or older; Lansky Play Score 60 or higher if under 16
  • Acceptable organ function within 14 days of registration including: renal clearance at least 60 mL/min/1.73m2, liver enzymes below 5 times upper limit normal, total bilirubin 3 mg/dL or less, heart ejection fraction 40% or higher, no dyspnea at rest, no oxygen requirement, DLCO over 50%, no active CNS infection, controlled seizures
  • Patients relapsed after transplant with no acute or chronic GVHD and off all immune suppression for at least 7 days
  • At least 42 days since any immunotherapy other than blinatumomab
  • No cranial or craniospinal radiation during protocol therapy; at least 90 days since prior total body, cranial, or craniospinal radiation
  • Sexually active females of childbearing potential must use contraception during treatment and for 2 months after blinatumomab
  • Sexually active men must use barrier contraception during treatment and for 2 months after blinatumomab
  • Provide voluntary written consent and must be enrolled in the Blinatumomab Bridging Therapy Trial
Not Eligible

You will not qualify if you...

  • Active extramedullary or chloromatous disease
  • Receiving other chemotherapy, radiation, immunotherapy, or anti-cancer treatments not specified in the protocol
  • Uncontrolled systemic fungal, bacterial, viral, or other infections
  • Pregnant or breastfeeding females
  • Known allergy to any chemotherapy or targeted agents in the protocol
  • Participation in another Phase 1 or 2 treatment study
  • Active malignancy other than B-ALL

AI-Screening

AI-Powered Screening

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Trial Site Locations

Total: 1 location

1

Children's Hospital of Wisconsin

Milwaukee, Wisconsin, United States, 53226

Actively Recruiting

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Research Team

M

Meredith Beversdorf, RN

CONTACT

E

Emily Ruszkiewicz, BS

CONTACT

How is the study designed?

Study Type

INTERVENTIONAL

Masking

NONE

Allocation

NON_RANDOMIZED

Model

PARALLEL

Primary Purpose

TREATMENT

Number of Arms

2

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