Cloretazine (VNP40101M) With Hematopoietic Cell Transplantation for Hematologic Malignancies
|ClinicalTrials.gov Identifier: NCT00521859|
Recruitment Status : Completed
First Posted : August 28, 2007
Last Update Posted : July 31, 2012
Define the maximal tolerated dose (MTD) of VNP40401M when given with hematopoietic cell transplantation (HCT)
- 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.
|Condition or disease||Intervention/treatment||Phase|
|Hematologic Malignancies||Drug: Cloretazine Drug: Fludarabine||Phase 1|
Show Detailed Description
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||5 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||Dose Escalation Trial of Cloretazine (VNP40101M) and Hematopoietic Cell Transplantation for Patients With Selected, Poor-Prognosis Hematologic Malignancies|
|Study Start Date :||August 2007|
|Actual Primary Completion Date :||December 2010|
|Actual Study Completion Date :||December 2010|
|Experimental: Cloretazine + Fludarabine||
800 mg/m^2 by vein daily
Other Name: VNP40101MDrug: Fludarabine
25 mg/m^2 by vein daily x 5 Days
- To study the highest tolerable dose of VNP40101M that can be given to patients with a form of leukemia, MDS, lymphoma, or myeloma in preparation for an autologous stem cell transplant. [ Time Frame: 2 Years ]
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00521859
|United States, Texas|
|UT MD Anderson Cancer Center|
|Houston, Texas, United States, 77030|
|Principal Investigator:||Roy B. Jones, MD, PhD||UT MD Anderson Cancer Center|