Trial intelligence / Profile preview

Clofarabine-Melphalan-Alemtuzumab Conditioning for Hematologic Malignancies

NCT00943592Phase 2

Key facts

Status: Completed
Start: Mar 2006
Primary completion: Apr 2011
Countries: 1
Sponsor: University of Chicago
Modality: Orthosteric Ligands, Metabolically Activated Prodrugs

Drugs: clofarabine
Conditions: acute myeloid leukemia (AML)acute lymphoblastic leukemia (ALL)chronic myeloid leukemia (CML)lymphomaHodgkin lymphoma (HL)

Overview

Phase 2, open-label, single-arm trial of clofarabine in acute myeloid leukemia (AML), acute lymphoblastic leukemia (ALL), chronic myeloid leukemia (CML) and 6 more, sponsored by University of Chicago. Primary endpoints: Number of Participants With Hepatic Adverse Events During the Conditioning Regimen Prior to Stem Cell Transplantation, Number of Participants With Renal Adverse Events During the Conditioning Regimen Prior to Stem Cell Transplantation and 2 more. Started Mar 2006; status: completed.

Design

1 arm

Study design: Non-randomizedOpen-label

Treatment
Clofarabine + Melphalan + Alemtuzumab followed by Stem Cell Transplant

Who it enrols

Patients with relapsed/refractory or high-risk hematologic malignancies (AML, ALL, CML, Lymphoma, Myeloma, CLL, MPN, MDS) with adequate organ function and Zubrod performance status < 2.

Endpoints

Primary

Number of Participants With Hepatic Adverse Events During the Conditioning Regimen Prior to Stem Cell TransplantationDay 7 to Day 30
Number of Participants With Renal Adverse Events During the Conditioning Regimen Prior to Stem Cell TransplantationDay 7 to Day 30
Number of Participants With Skin Adverse Events During the Conditioning Regimen Prior to Stem Cell TransplantationDay 7 to Day 30
Number of Participants With Other Adverse Events During the Conditioning Regimen Prior to Stem Cell TransplantationDay 7 to Day 30

Secondary

Overall Survival1 year
Progression-free Survival1 year
Treatment-related Mortality1 year
Relapse Rate1 year

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