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NCT03147612 · ClinicalTrials.gov registry record · Phase 2

Low-Intensity Chemotherapy, Ponatinib and Blinatumomab in Treating Patients With Philadelphia Chromosome-Positive and/or BCR-ABL Positive Acute Lymphoblastic Leukemia

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

Active
Registry status
Phase 2
Development phase
22
Enrollment target
1
Study location

NCT03147612 is a Phase 2 study of Acute Lymphoblastic Leukemia and Refractory Acute Lymphoblastic Leukemia that is active but no longer recruiting, run by M.D. Anderson Cancer Center. The registered enrollment target is 22 participants, below the 382-participant average among 131 other Acute Lymphoblastic Leukemia trials with a reported enrollment target (94% lower). The trial reports 1 study location across 1 state.

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The verdict

NCT03147612, a Phase 2 study of Acute Lymphoblastic Leukemia and Refractory Acute Lymphoblastic Leukemia, is active but no longer recruiting, sponsored by M.D. Anderson Cancer Center.

ACTIVE NOT RECRUITING
Registry status
Phase 2
Development phase
22 participants
Enrollment target
1
Study location

Study Summary

This phase II trial studies how well low-intensity chemotherapy and ponatinib work in treating patients with Philadelphia chromosome-positive and/or BCR-ABL positive acute lymphoblastic leukemia that may have come back or is not responding to treatment. Drugs used in chemotherapy, such as cyclophosphamide, vincristine, dexamethasone, methotrexate, and cytarabine, 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 rituximab and blinatumomab, may induce changes in body's immune system and may interfere with the ability of cancer cells to grow and spread. Ponatinib may stop the growth of cancer cells by blocking some of the enzymes needed for cell growth. Granulocyte colony stimulating factor helps the bone marrow make recover after treatment. Giving low-intensity chemotherapy, ponatinib, and blinatumomab may work better in treating patients with acute lymphoblastic leukemia.

Interventions

  • DRUG Cyclophosphamide
  • DRUG Cytarabine
  • BIOLOGICAL Filgrastim
  • BIOLOGICAL Blinatumomab
  • DRUG Methotrexate

Study Locations (1)

Texas

  • M D Anderson Cancer Center - Houston

Trial Details

FieldValue
Enrollment Target 22 participants
Start Date 2018-02-08
Est. Completion 2027-02-28
Phase Phase 2

Sponsor

M.D. Anderson Cancer Center

2,692 total trials

What the Registry Record Tells You About NCT03147612

The ClinicalTrials.gov registry entry for NCT03147612 describes a study currently listed as active not recruiting, categorized as Phase 2. The registered enrollment target is 22 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 382-participant average among 131 other Acute Lymphoblastic Leukemia trials with a reported enrollment target (94% lower). The listed sponsor is M.D. Anderson Cancer Center, which has 2,692 total studies on file at ClinicalTrials.gov.

The record links to 6 conditions, with Acute Lymphoblastic Leukemia appearing as the primary indexed condition, and to 5 interventions - of which Cyclophosphamide is the first listed.

NCT03147612 reports 1 study location spanning 1 distinct geographic area - top geographies include Texas.

Frequently Asked Questions

What is clinical trial NCT03147612 about?

NCT03147612 is a clinical study titled "Low-Intensity Chemotherapy, Ponatinib and Blinatumomab in Treating Patients With Philadelphia Chromosome-Positive and/or BCR-ABL Positive Acute Lymphoblastic Leukemia". This phase II trial studies how well low-intensity chemotherapy and ponatinib work in treating patients with Philadelphia chromosome-positive and/or BCR-ABL positive acute lymphoblastic leukemia that may have come back or is not responding to treatment. Drugs used in chemotherapy, such as cyclophosp...

What is the current status of trial NCT03147612?

This trial is currently active not recruiting. It is a Phase 2 study. The enrollment target is 22 participants. The study started on 2018-02-08. Estimated completion is 2027-02-28.

What conditions does trial NCT03147612 study?

This clinical trial studies the following conditions: Acute Lymphoblastic Leukemia, Refractory Acute Lymphoblastic Leukemia, Recurrent Acute Lymphoblastic Leukemia, Blast Phase Chronic Myelogenous Leukemia, BCR-ABL1 Positive, Accelerated Phase Chronic Myelogenous Leukemia, BCR-ABL1 Positive.

What interventions are being tested in trial NCT03147612?

The interventions under investigation include: Cyclophosphamide (DRUG), Cytarabine (DRUG), Filgrastim (BIOLOGICAL), Blinatumomab (BIOLOGICAL), Methotrexate (DRUG).

Who is sponsoring clinical trial NCT03147612?

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

Where is trial NCT03147612 being conducted?

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

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Data sourced from official public datasets. See our methodology for details. Retrieved and formatted by PlainTrial Editorial

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