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NCT00053131 · ClinicalTrials.gov registry record · Phase 2

Combination Chemotherapy Followed By Filgrastim or Sargramostim in Treating Patients With Relapsed or Refractory Acute Myeloid Leukemia or Acute Lymphoblastic Leukemia

A Phase 2 study, sponsored by Roswell Park Cancer Institute.

Completed
Registry status
Phase 2
Development phase

NCT00053131: Completed Phase 2 study, sponsored by Roswell Park Cancer Institute.

NCT00053131 is a Phase 2 study that has completed, run by Roswell Park Cancer Institute. According to ClinicalTrials.gov, the official US trial registry.

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The verdict

NCT00053131, a Phase 2 study, has completed, sponsored by Roswell Park Cancer Institute.

COMPLETED
Registry status
Phase 2
Development phase

Study Summary

RATIONALE: Drugs used in chemotherapy use different ways to stop cancer cells from dividing so they stop growing or die. Colony-stimulating factors such as filgrastim and sargramostim may increase the number of immune cells found in bone marrow or peripheral blood and may help a person's immune system recover from the side effects of chemotherapy. It is not yet known whether combination chemotherapy is more effective followed by filgrastim or sargramostim in treating leukemia. PURPOSE: Randomized phase II trial to compare the effectiveness of combination chemotherapy followed by filgrastim with that of combination chemotherapy followed by sargramostim in treating patients who have relapsed or refractory acute myeloid leukemia or acute lymphoblastic leukemia.

Interventions

  • BIOLOGICAL filgrastim
  • DRUG cytarabine
  • BIOLOGICAL sargramostim
  • DRUG mitoxantrone hydrochloride

Trial Details

FieldValue
Start Date 1999-01
Est. Completion 2004-02
Phase Phase 2
Roswell Park Cancer Institute

365 total trials

What the finished NCT00053131 record still lists

NCT00053131 is an interventional study that assigns participants to a tested intervention. An enrollment target was not published in the registry record, which is common for early-stage or observational entries.

The record links to 0 conditions, and to 4 interventions - of which filgrastim is the first listed.

NCT00053131 does not publish any study locations in the registry export this page uses.

Frequently Asked Questions

What is clinical trial NCT00053131 about?

NCT00053131 is a clinical study titled "Combination Chemotherapy Followed By Filgrastim or Sargramostim in Treating Patients With Relapsed or Refractory Acute Myeloid Leukemia or Acute Lymphoblastic Leukemia". RATIONALE: Drugs used in chemotherapy use different ways to stop cancer cells from dividing so they stop growing or die. Colony-stimulating factors such as filgrastim and sargramostim may increase the number of immune cells found in bone marrow or peripheral blood and may help a person's immune syst...

What is the current status of trial NCT00053131?

This trial is currently completed. It is a Phase 2 study. The study started on 1999-01. Estimated completion is 2004-02.

What interventions are being tested in trial NCT00053131?

The interventions under investigation include: filgrastim (BIOLOGICAL), cytarabine (DRUG), sargramostim (BIOLOGICAL), mitoxantrone hydrochloride (DRUG).

Who is sponsoring clinical trial NCT00053131?

This trial is sponsored by Roswell Park Cancer Institute, which has 365 total clinical trials registered on ClinicalTrials.gov.

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Source: ClinicalTrials.gov NCT00053131, the US trial registry maintained by the National Library of Medicine. NCT00053131 (unsized enrollment · none site footprint · completed) retrieved and formatted by PlainTrial, see methodology.