A Study of Blinatumomab in Patients With Pre B-cell ALL and B-cell NHL as Post-allo-HSCT Remission Maintenance

Phase 1

Active, not recruiting

• Conditions: Acute Lymphoblastic Leukemia; B-cell Non Hodgkin Lymphoma; Pre B-Cell Acute Lymphoblastic Leukaemia
• Interventions: Drug: Blinatumomab 9ug; Drug: Blinatumomab 28 ug; Drug: Blinatumomab; Drug: Dexamethasone

• Registration Number: NCT03114865
• Lead Sponsor: Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins

Brief Summary

The investigators primary objective is to determine the safety and toxicity of incorporating blinatumomab into the post-allogeneic hematopoietic stem cell transplant (HSCT) maintenance setting for patients with CD19+-B-cell malignancies (Acute Lymphoblastic Leukemia \[ALL\], Non-Hodgkin's Lymphoma \[NHL\]).

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2017-04-11
• Study First Submitted QC: 2017-04-13
• Study First Posted: 2017-04-14
• Study Start: 2017-09-05
• Status Verified: 2025-05
• Last Update Submitted: 2025-05-19
• Last Update Posted: 2025-05-22
• Primary Completion: 2026-06-30
• Study Completion: 2026-06-30

Recruitment & Eligibility

• Status: ACTIVE_NOT_RECRUITING
• Sex: All
• Target Recruitment: 44

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Post-alloHSCT Maintenance	Blinatumomab 28 ug	Blinatumomab will be administered as a continuous intravenous (IV) infusion over four weeks followed by a two-week treatment free interval. It is recommended that patients are hospitalized at least during the first three days of the first cycle and the first two days of the second cycles.
Post-alloHSCT Maintenance	Blinatumomab 9ug	Blinatumomab will be administered as a continuous intravenous (IV) infusion over four weeks followed by a two-week treatment free interval. It is recommended that patients are hospitalized at least during the first three days of the first cycle and the first two days of the second cycles.
Post-alloHSCT Maintenance	Blinatumomab	Blinatumomab will be administered as a continuous intravenous (IV) infusion over four weeks followed by a two-week treatment free interval. It is recommended that patients are hospitalized at least during the first three days of the first cycle and the first two days of the second cycles.
Post-alloHSCT Maintenance	Dexamethasone	Blinatumomab will be administered as a continuous intravenous (IV) infusion over four weeks followed by a two-week treatment free interval. It is recommended that patients are hospitalized at least during the first three days of the first cycle and the first two days of the second cycles.

Primary Outcome Measures

Name	Time	Method
Overall survival at two years post first treatment cycle	2 years	Percentage of enrolled participants who receive BMT and Blinatumomab and are alive at two years post BMT.

Secondary Outcome Measures

Name	Time	Method
Non-Relapse Mortality	2 years	Percentage of participants who experience non-relapse mortality after 2 years.
Progression-free survival	2 years	Percentage of participants who experience progression-free survival after 2 years.
Disease-free Survival	2 years	Percentage of participants who experience disease-free survival after 2 years.
Overall Survival	2 years	Percentage of participants who experience overall survival after 2 years.
Minimal Residual Disease	2 years	Percentage of participants who convert from MRD to no MRD after treatment.

Trial Locations

Locations (1)

Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins; 🇺🇸 Baltimore, Maryland, United States