drugset
drugset / Trial / NCT00521859

Cloretazine (VNP40101M) With Hematopoietic Cell Transplantation for Hematologic Malignancies

NCT00521859 ↗

Phase 1 Completed 5 enrolled M.D. Anderson Cancer Center Vion Pharmaceuticals · collab
Non-randomizedSingle-groupOpen-labelTreatment

Summary

Primary: Define the maximal tolerated dose (MTD) of VNP40401M when given with hematopoietic cell transplantation (HCT) Secondary: * Describe the change in pharmacokinetic (PK) parameters with increasing doses of drug. * Describe and estimate the frequency of \> Grade 3 non-hematologic/non-infectious toxicities at the MTD. * Report the efficacy of the regimen. * Evaluate the rate of engraftment for the regimen.

Timeline

Start
2007-08
Primary completion
2010-12
Completion
2010-12

Drugs

EvaluationDrugModalityDoseRoute
Subject laromustine Other / unclassified 800 mg/m2 Intravenous
Background Fludarabine Small molecule 25 mg/m2 Intravenous

Indications

hematopoietic and lymphoid cell neoplasm