Clofarabine-Melphalan-Alemtuzumab Conditioning in Patients With Advanced Hematologic Malignancies

This study is ongoing, but not recruiting participants.

Sponsor:

Information provided by (Responsible Party):

Andrew Artz, MD, University of Chicago

ClinicalTrials.gov Identifier:

NCT00943592

First received: July 20, 2009

Last updated: July 8, 2012

Last verified: July 2012

History of Changes

Tracking Information

First Received Date ^ICMJE

July 20, 2009

Last Updated Date

July 8, 2012

Start Date ^ICMJE

August 2010

Primary Completion Date

April 2011 (final data collection date for primary outcome measure)

Current Primary Outcome Measures ^ICMJE

Toxicity of conditioning regimen prior to stem cell transplantation. [ Time Frame: 100 days ] [ Designated as safety issue: Yes ]

Original Primary Outcome Measures ^ICMJE

Toxicity of conditioning regimen prior to stem cell transplantation. [ Time Frame: 5 years ] [ Designated as safety issue: Yes ]

Change History

Complete list of historical versions of study NCT00943592 on ClinicalTrials.gov Archive Site

Current Secondary Outcome Measures ^ICMJE

To explore the correlation between the pharmacologic determinants of clofarabine metabolism and cellular uptake and study outcomes. [ Time Frame: 100 days ] [ Designated as safety issue: No ]

Original Secondary Outcome Measures ^ICMJE

To explore the correlation between the pharmacologic determinants of clofarabine metabolism and cellular uptake and study outcomes. [ Time Frame: 5 years ] [ Designated as safety issue: No ]

Current Other Outcome Measures ^ICMJE

Not Provided

Original Other Outcome Measures ^ICMJE

Not Provided

Descriptive Information

Brief Title ^ICMJE

Clofarabine-Melphalan-Alemtuzumab Conditioning in Patients With Advanced Hematologic Malignancies

Official Title ^ICMJE

Clofarabine-melphalan-alemtuzumab Conditioning in Patients With Advanced Hematologic Malignancies

Brief Summary

This is a clinical research study designed to evaluate whether a conditioning regimen consisting of the combination of three drugs named melphalan, alemtuzumab and clofarabine supported by donor blood cells will result in rapid recovery and a high rate of long-lasting remissions in patients with leukemia, lymphoma and myeloma.

Detailed Description

Not Provided

Study Type ^ICMJE

Interventional

Study Phase

Phase 1
Phase 2

Study Design ^ICMJE

Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment

Condition ^ICMJE

Advanced Hematologic Malignancies
Leukemia
Preleukemia

Intervention ^ICMJE

Drug: Clofarabine
Clofarabine will be administered as a 2-hour IV infusion on Days 1 through 5 at approximately the same time everyday (4 dose levels).
Drug: Melphalan
Doses ranging from 100 to 140 mg/m2
Drug: Campath
20mg/d x5
Procedure: Stem Cell Transplant
Infusion of donor, bone marrow and auto.

Study Arm (s)

Not Provided

Publications *

Not Provided

* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.

Recruitment Information

Recruitment Status ^ICMJE

Active, not recruiting

Estimated Enrollment ^ICMJE

100

Estimated Completion Date

November 2013

Primary Completion Date

April 2011 (final data collection date for primary outcome measure)

Eligibility Criteria ^ICMJE

Inclusion Criteria:

Relapsed or refractory acute myelogenous or lymphoid leukemia
Chronic myelogenous leukemia in accelerated phase or blast-crisis
Chronic myelogenous leukemia in second or subsequent chronic phase
Recurrent or refractory malignant lymphoma or Hodgkin's disease
Multiple myeloma at high risk for disease recurrence
Chronic lymphocytic leukemia, relapsed or with poor prognostic features
Other Myeloproliferative disorder (polycythemia vera, essential thrombocythemia, myelofibrosis) with poor prognostic features
Myelodysplastic syndromes (including PNH) with > 5% blasts
Zubroid performance status < 2 (See Appendix B)
Life expectancy is not severely limited by concomitant illness
Adequate cardiac and pulmonary function. Patients with decreased LVEF or PFTS will be evaluated by cardiology or pulmonary prior to enrollment on this protocol
Calculated Creatinine Clearance > 50 ml/min
Serum bilirubin 2.0 mg/dl, SGPT < 3x upper limit of normal
No evidence of chronic active hepatitis or cirrhosis
HIV-negative
Patient is not pregnant
Patient or guardian able to sign informed consent

Exclusion Criteria:

Clinical progression

Gender

Both

Ages

18 Years to 75 Years

Accepts Healthy Volunteers

Contacts ^ICMJE

Contact information is only displayed when the study is recruiting subjects

Location Countries ^ICMJE

United States

Administrative Information

NCT Number ^ICMJE

NCT00943592

Other Study ID Numbers ^ICMJE

14341B

Has Data Monitoring Committee

Yes

Responsible Party

Andrew Artz, MD, University of Chicago

Study Sponsor ^ICMJE

University of Chicago

Collaborators ^ICMJE

Not Provided

Investigators ^ICMJE

Principal Investigator:

Andrew Artz, MD

University of Chicago

Information Provided By

University of Chicago

Verification Date

July 2012

^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP

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