# A Study to Compare Blinatumomab Alone to Blinatumomab With Nivolumab in Patients Diagnosed With First Relapse B-Cell Acute Lymphoblastic Leukemia (B-ALL)

> **NCT04546399** · PHASE2 · RECRUITING · sponsor: **National Cancer Institute (NCI)** · enrollment: 461 (estimated)

## Conditions studied

- Down Syndrome
- Recurrent B Acute Lymphoblastic Leukemia

## Interventions

- **RADIATION:** 3-Dimensional Conformal Radiation Therapy
- **PROCEDURE:** Biospecimen Collection
- **BIOLOGICAL:** Blinatumomab
- **PROCEDURE:** Bone Marrow Aspiration
- **PROCEDURE:** Bone Marrow Biopsy
- **DRUG:** Calaspargase Pegol
- **DRUG:** Cytarabine
- **DRUG:** Dexamethasone
- **DRUG:** Hydrocortisone Sodium Succinate
- **PROCEDURE:** Lumbar Puncture
- **DRUG:** Mercaptopurine
- **DRUG:** Methotrexate
- **BIOLOGICAL:** Nivolumab
- **DRUG:** Pegaspargase
- **DRUG:** Pegcrisantaspase
- **DRUG:** Vincristine Sulfate

## Key facts

- **NCT ID:** NCT04546399
- **Lead sponsor:** National Cancer Institute (NCI)
- **Sponsor class:** NIH
- **Phase:** PHASE2
- **Study type:** INTERVENTIONAL
- **Status:** RECRUITING
- **Start date:** 2020-12-17
- **Primary completion:** 2028-06-30
- **Final completion:** 2028-06-30
- **Target enrollment:** 461 (ESTIMATED)
- **Last updated:** 2025-09-10


## Primary source

ClinicalTrials.gov registry: https://clinicaltrials.gov/study/NCT04546399

## Citation

> US National Library of Medicine, ClinicalTrials.gov registration NCT04546399, "A Study to Compare Blinatumomab Alone to Blinatumomab With Nivolumab in Patients Diagnosed With First Relapse B-Cell Acute Lymphoblastic Leukemia (B-ALL)". Retrieved via AI Analytics 2026-06-25 from https://api.ai-analytics.org/clinical/NCT04546399. Licensed CC0.

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