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NCT02877303 · ClinicalTrials.gov registry record · Phase 2

Blinatumomab, Inotuzumab Ozogamicin, and Combination Chemotherapy as Frontline Therapy in Treating Patients With B Acute Lymphoblastic Leukemia

A Phase 2 study of B Acute Lymphoblastic Leukemia and B Lymphoblastic Lymphoma, sponsored by M.D. Anderson Cancer Center.

Recruiting
Registry status
Phase 2
Development phase
80
Enrollment target
1
Study location

NCT02877303: Recruiting Phase 2 study of B Acute Lymphoblastic Leukemia and B Lymphoblastic Lymphoma, sponsored by M.D. Anderson Cancer Center.

NCT02877303 is a Phase 2 study of B Acute Lymphoblastic Leukemia and B Lymphoblastic Lymphoma that is actively recruiting participants, run by M.D. Anderson Cancer Center. The registered enrollment target is 80 participants, below the 1,023-participant average among 20 other B Acute Lymphoblastic Leukemia trials with a reported enrollment target (92% lower). The trial reports 1 study location across 1 state. According to ClinicalTrials.gov, the official US trial registry.

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The verdict

NCT02877303, a Phase 2 study of B Acute Lymphoblastic Leukemia and B Lymphoblastic Lymphoma, is actively recruiting participants, sponsored by M.D. Anderson Cancer Center.

RECRUITING
Registry status
Phase 2
Development phase
80 participants
Enrollment target
1
Study location

Study Summary

This phase II trial studies how well blinatumomab, inotuzumab ozogamicin, and combination chemotherapy work as frontline therapy in treating patients with B acute lymphoblastic leukemia. Immunotherapy with monoclonal antibodies, such as blinatumomab, may induce changes in the body's immune system and may interfere with the ability of tumor cells to grow and spread. Inotuzumab ozogamicin is a monoclonal antibody, called inotuzumab, linked to a toxic agent called ozogamicin. Inotuzumab attaches to CD22 positive cancer cells in a targeted way and delivers ozogamicin to kill them. Drugs used in chemotherapy, such as cyclophosphamide, vincristine sulfate, doxorubicin hydrochloride, dexamethasone, cytarabine, mercaptopurine, methotrexate, and prednisone 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. Giving blinatumomab, inotuzumab ozogamicin, and combination chemotherapy may work better in treating patients with B acute lymphoblastic leukemia than chemotherapy alone.

Primary Outcome

Will be estimated using the method of Kaplan and Meier. Will compute the Bayesian posterior probability. Will perform a competing risk analysis treating stem cell transplant as a competing event for RFS.

Conditions Studied

B Acute Lymphoblastic Leukemia B Lymphoblastic Lymphoma

Interventions

  • DRUG Cyclophosphamide
  • DRUG Doxorubicin Hydrochloride
  • DRUG Dexamethasone
  • DRUG Cytarabine
  • BIOLOGICAL Blinatumomab

Study Locations (1)

Texas

  • M D Anderson Cancer Center - Houston

Trial Details

FieldValue
Enrollment Target 80 participants
Start Date 2016-11-01
Est. Completion 2026-11-01
Phase Phase 2
M.D. Anderson Cancer Center

2,692 total trials

What NCT02877303 shows while recruiting

NCT02877303 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 80 participants, a relatively small participant target, below the 1,023-participant average among 20 other B Acute Lymphoblastic Leukemia trials with a reported enrollment target (92% lower).

The record links to 2 conditions, with B Acute Lymphoblastic Leukemia appearing as the primary indexed condition, and to 5 interventions - of which Cyclophosphamide is the first listed.

NCT02877303 reports a single indexed study location in Texas.

Frequently Asked Questions

What is clinical trial NCT02877303 about?

NCT02877303 is a clinical study titled "Blinatumomab, Inotuzumab Ozogamicin, and Combination Chemotherapy as Frontline Therapy in Treating Patients With B Acute Lymphoblastic Leukemia". This phase II trial studies how well blinatumomab, inotuzumab ozogamicin, and combination chemotherapy work as frontline therapy in treating patients with B acute lymphoblastic leukemia. Immunotherapy with monoclonal antibodies, such as blinatumomab, may induce changes in the body's immune system an...

What is the current status of trial NCT02877303?

This trial is currently recruiting. It is a Phase 2 study. The enrollment target is 80 participants. The study started on 2016-11-01. Estimated completion is 2026-11-01.

What conditions does trial NCT02877303 study?

This clinical trial studies the following conditions: B Acute Lymphoblastic Leukemia, B Lymphoblastic Lymphoma.

What interventions are being tested in trial NCT02877303?

The interventions under investigation include: Cyclophosphamide (DRUG), Doxorubicin Hydrochloride (DRUG), Dexamethasone (DRUG), Cytarabine (DRUG), Blinatumomab (BIOLOGICAL).

Who is sponsoring clinical trial NCT02877303?

This trial is sponsored by M.D. Anderson Cancer Center, which has 2,692 total clinical trials registered on ClinicalTrials.gov.

Where is trial NCT02877303 being conducted?

This trial has 1 study location across Texas. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.

Learn More About Clinical Trials

Similar trials for B Acute Lymphoblastic Leukemia

Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.

Where NCT02877303's enrollment target sits among peer trials

80 8th of 20 higher than 13 of 20 other B Acute Lymphoblastic Leukemia trials

participants (enrollment target), bucketed by value

Each bar is a band; taller bars hold more other B Acute Lymphoblastic Leukemia trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.

Source ClinicalTrials.gov registry export · 2026-08-08

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More recruiting context for NCT02877303

Source: ClinicalTrials.gov NCT02877303, the US trial registry maintained by the National Library of Medicine. NCT02877303 (small enrollment · single site footprint · recruiting) retrieved and formatted by PlainTrial, see methodology.