Combination Chemotherapy With or Without Blinatumomab in Treating Patients With Newly Diagnosed BCR-ABL-Negative B Lineage Acute Lymphoblastic Leukemia

Conditions

• Acute Lymphoblastic Leukemia
• B Acute Lymphoblastic Leukemia, Philadelphia Chromosome Negative

Eligibility Criteria

Sex

ALL

Age

30 Years - 70 Years

Healthy Volunteers

Accepted

Interventions

• Allogeneic Hematopoietic Stem Cell Transplantation — PROCEDURE
  Undergo allogeneic hematopoietic SCT
• Biospecimen Collection — PROCEDURE
  Undergo blood sample collection
• Blinatumomab — BIOLOGICAL
  Given IV
• Bone Marrow Aspiration — PROCEDURE
  Undergo bone marrow aspiration
• Bone Marrow Biopsy — PROCEDURE
  Undergo bone marrow biopsy
• Cyclophosphamide — DRUG
  Given IV
• Cytarabine — DRUG
  Given IT, IV, or SC
• Daunorubicin — DRUG
  Given IV
• Daunorubicin Hydrochloride — DRUG
  Given IV
• Dexamethasone — DRUG
  Given PO
• Etoposide — DRUG
  Given IV
• Leucovorin Calcium — DRUG
  Given IV or PO
• Lumbar Puncture — PROCEDURE
  Undergo lumbar puncture
• Mercaptopurine — DRUG
  Given PO
• Methotrexate — DRUG
  Given PO, IT or IV
• Pegaspargase — DRUG
  Given IM or IV
• Prednisone — DRUG
  Given PO
• Rituximab — BIOLOGICAL
  Given IV
• Vincristine — DRUG
  Given IV
• Vincristine Sulfate — DRUG
  Given IV
• X-Ray Imaging — PROCEDURE
  Undergo x-ray imaging

Study Details

This randomized phase III trial studies combination chemotherapy with blinatumomab to see how well it works compared to induction chemotherapy alone in treating patients with newly diagnosed breakpoint cluster region (BCR)-c-abl oncogene 1, non-receptor tyrosine kinase (ABL)-negative B lineage acute lymphoblastic leukemia. Drugs used in chemotherapy work in different ways to stop the growth of cancer cells, either by killing the cells, by stopping them from dividing, or by stopping them from spreading. Immunotherapy with monoclonal antibodies, such as blinatumomab, may help the body's immune system attack the cancer, and may interfere with the ability of tumor cells to grow and spread. It is not yet known whether combination chemotherapy is more effective with or without blinatumomab in treating newly diagnosed acute lymphoblastic leukemia.

Key Dates

Start date

May 19, 2014

Status verified

Mar 2026

Primary completion

Jun 23, 2023

Completion

Feb 25, 2027

Study Design

Enrollment

488 participants (actual)

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Arms

• Experimental: Arm I (blinatumomab, chemotherapy)
  See Detailed Description
• Active Comparator: Arm II (chemotherapy)
  See Detailed Description

Primary Outcome Measure

Overall Survival (OS) Among Patients Who Were MRD Negative After Induction and Intensification Chemotherapy [ Time Frame: Assessed every 3 months for 2 years, then every 6 months for 3 years, then annually for 5 years ]

Locations (532)

Find similar trials in Birmingham, AL

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