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NCT03504644 · ClinicalTrials.gov registry record · Phase 1

Venetoclax and Vincristine in Treating Patients With Relapsed or Refractory T-cell or B-cell Acute Lymphoblastic Leukemia

A Phase 1 study of Recurrent B Acute Lymphoblastic Leukemia and Refractory B Acute Lymphoblastic Leukemia, sponsored by ECOG-ACRIN Cancer Research Group.

Active
Registry status
Phase 1
Development phase
40
Enrollment target
20
Study locations

NCT03504644 is a Phase 1 study of Recurrent B Acute Lymphoblastic Leukemia and Refractory B Acute Lymphoblastic Leukemia that is active but no longer recruiting, run by ECOG-ACRIN Cancer Research Group. The registered enrollment target is 40 participants, below the 148-participant average among 12 other Recurrent B Acute Lymphoblastic Leukemia trials with a reported enrollment target (73% lower). The trial reports 20 study locations across 7 states.

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The verdict

NCT03504644, a Phase 1 study of Recurrent B Acute Lymphoblastic Leukemia and Refractory B Acute Lymphoblastic Leukemia, is active but no longer recruiting, sponsored by ECOG-ACRIN Cancer Research Group.

ACTIVE NOT RECRUITING
Registry status
Phase 1
Development phase
40 participants
Enrollment target
20
Study locations

Study Summary

This phase Ib/II trial studies the side effects and best dose of venetoclax and how well it works when given together with vincristine in treating patients with T-cell or B-cell acute lymphoblastic leukemia that has come back (recurrent) or does not respond to treatment (refractory). Venetoclax may stop the growth of cancer cells by blocking Bcl-2, a protein needed for cancer cell survival. Chemotherapy drugs, such as vincristine, 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 venetoclax together with vincristine may work better in treating patients with acute lymphoblastic leukemia compared to vincristine alone.

Conditions Studied

Recurrent B Acute Lymphoblastic Leukemia Refractory B Acute Lymphoblastic Leukemia Recurrent Adult Lymphoblastic Lymphoma Recurrent T Acute Lymphoblastic Leukemia Refractory T Acute Lymphoblastic Leukemia Refractory T Lymphoblastic Lymphoma Recurrent B Lymphoblastic Lymphoma Refractory B Lymphoblastic Lymphoma Recurrent T Lymphoblastic Lymphoma

Interventions

  • DRUG Venetoclax
  • PROCEDURE Biospecimen Collection
  • PROCEDURE Computed Tomography
  • PROCEDURE Lumbar Puncture
  • PROCEDURE Positron Emission Tomography

Study Locations (20)

Alaska

  • Anchorage Associates in Radiation Medicine - Anchorage
  • Anchorage Radiation Therapy Center - Anchorage
  • Alaska Breast Care and Surgery LLC - Anchorage
  • Alaska Oncology and Hematology LLC - Anchorage
  • Alaska Women's Cancer Care - Anchorage
  • Anchorage Oncology Centre - Anchorage
  • Katmai Oncology Group - Anchorage
  • Providence Alaska Medical Center - Anchorage

Connecticut

  • Smilow Cancer Hospital Care Center at Saint Francis - Hartford
  • Smilow Cancer Center/Yale-New Haven Hospital - New Haven
  • Yale University - New Haven

Arizona

  • Mayo Clinic Hospital in Arizona - Phoenix
  • Mayo Clinic in Arizona - Scottsdale

Arkansas

  • Mercy Hospital Fort Smith - Fort Smith
  • CARTI Cancer Center - Little Rock

Florida

  • University of Florida Health Science Center - Jacksonville - Jacksonville
  • Mayo Clinic in Florida - Jacksonville

Idaho

  • Saint Luke's Cancer Institute - Boise - Boise
  • Saint Luke's Cancer Institute - Fruitland - Fruitland

California

  • Providence Saint Joseph Medical Center/Disney Family Cancer Center - Burbank

Trial Details

FieldValue
Enrollment Target 40 participants
Start Date 2018-08-13
Est. Completion 2028-12-31
Phase Phase 1

Sponsor

ECOG-ACRIN Cancer Research Group

75 total trials

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Full Details on ClinicalTrials.gov ↗

What the Registry Record Tells You About NCT03504644

The ClinicalTrials.gov registry entry for NCT03504644 describes a study currently listed as active not recruiting, categorized as Phase 1. The registered enrollment target is 40 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 148-participant average among 12 other Recurrent B Acute Lymphoblastic Leukemia trials with a reported enrollment target (73% lower). The listed sponsor is ECOG-ACRIN Cancer Research Group, which has 75 total studies on file at ClinicalTrials.gov.

The record links to 9 conditions, with Recurrent B Acute Lymphoblastic Leukemia appearing as the primary indexed condition, and to 5 interventions - of which Venetoclax is the first listed.

NCT03504644 reports 20 study locations spanning 7 distinct geographic areas - top geographies include Alaska, Connecticut, Arizona.

Frequently Asked Questions

What is clinical trial NCT03504644 about?

NCT03504644 is a clinical study titled "Venetoclax and Vincristine in Treating Patients With Relapsed or Refractory T-cell or B-cell Acute Lymphoblastic Leukemia". This phase Ib/II trial studies the side effects and best dose of venetoclax and how well it works when given together with vincristine in treating patients with T-cell or B-cell acute lymphoblastic leukemia that has come back (recurrent) or does not respond to treatment (refractory). Venetoclax may ...

What is the current status of trial NCT03504644?

This trial is currently active not recruiting. It is a Phase 1 study. The enrollment target is 40 participants. The study started on 2018-08-13. Estimated completion is 2028-12-31.

What conditions does trial NCT03504644 study?

This clinical trial studies the following conditions: Recurrent B Acute Lymphoblastic Leukemia, Refractory B Acute Lymphoblastic Leukemia, Recurrent Adult Lymphoblastic Lymphoma, Recurrent T Acute Lymphoblastic Leukemia, Refractory T Acute Lymphoblastic Leukemia.

What interventions are being tested in trial NCT03504644?

The interventions under investigation include: Venetoclax (DRUG), Biospecimen Collection (PROCEDURE), Computed Tomography (PROCEDURE), Lumbar Puncture (PROCEDURE), Positron Emission Tomography (PROCEDURE).

Who is sponsoring clinical trial NCT03504644?

This trial is sponsored by ECOG-ACRIN Cancer Research Group, which has 75 total clinical trials registered on ClinicalTrials.gov.

Where is trial NCT03504644 being conducted?

This trial has 20 study locations across Alaska, Arizona, Arkansas, California, Connecticut. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.

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Every figure on PlainTrial is rendered directly from the ClinicalTrials.gov registry, no number is typed in by an editor. This page mirrors this trial's own ClinicalTrials.gov registry record, live from the dataset. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error.