T2007-002 Clofarabine, Etoposide, Cyclophosphamide in Relapsed Acute Myelogenous Leukemia (AML)

Phase 2

Waitlist Available

Research Sponsored by Therapeutic Advances in Childhood Leukemia Consortium

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Be younger than 65 years old

Timeline

Screening 3 weeks

Treatment Varies

Follow Up between days 22-36 or on day 43 and weekly thereafter if peripheral counts haven't recovered

Awards & highlights

All Individual Drugs Already Approved

Approved for 20 Other Conditions

No Placebo-Only Group

Summary

Clofarabine is a drug approved by the FDA (Food and Drug Administration) for treating children (age 1-21) with leukemia. This research study will use clofarabine with two other cancer fighting drugs. Clofarabine will be used together with etoposide (VePesid®, VP-16) and cyclophosphamide (Cytoxan®).

Eligible Conditions

Acute Myelogenous Leukemia

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ between days 22-36 or on day 43 and weekly thereafter if peripheral counts haven't recovered

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~between days 22-36 or on day 43 and weekly thereafter if peripheral counts haven't recovered

This trial's timeline: 3 weeks for screening, Varies for treatment, and between days 22-36 or on day 43 and weekly thereafter if peripheral counts haven't recovered for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Achievement of Complete Remission (CR) at Reinduction

Death

Awards & Highlights

All Individual Drugs Already Approved

Therapies where all constituent drugs have already been approved are likely to have better-understood side effect profiles.

Approved for 20 Other Conditions

This treatment demonstrated efficacy for 20 other conditions.

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Trial Design

1Treatment groups

Experimental Treatment

Group I: Single Arm - Clofarabine with ChemoExperimental Treatment5 Interventions

All patients receive the same treatment regimen consisting of clofarabine, etoposide, cyclophosphamide, cytarabine, and filgrastim. Up to 4 courses of therapy may be given.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Cytarabine

FDA approved

Clofarabine

FDA approved

Etoposide

FDA approved

Cyclophosphamide

FDA approved