Clofarabine-Melphalan-Alemtuzumab Conditioning in Patients With Advanced Hematologic Malignancies
This study is ongoing, but not recruiting participants.
Sponsor:
University of Chicago
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
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Purpose
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.
| Condition | Intervention | Phase |
|---|---|---|
|
Advanced Hematologic Malignancies Leukemia Preleukemia |
Drug: Clofarabine Drug: Melphalan Drug: Campath Procedure: Stem Cell Transplant |
Phase 1 Phase 2 |
| Study Type: | Interventional |
| Study Design: | Allocation: Non-Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Single Group Assignment Masking: Open Label Primary Purpose: Treatment |
| Official Title: | Clofarabine-melphalan-alemtuzumab Conditioning in Patients With Advanced Hematologic Malignancies |
Resource links provided by NLM:
Further study details as provided by University of Chicago:
Primary Outcome Measures:
- Toxicity of conditioning regimen prior to stem cell transplantation. [ Time Frame: 100 days ] [ Designated as safety issue: Yes ]
Secondary Outcome Measures:
- 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 ]
| Estimated Enrollment: | 100 |
| Study Start Date: | August 2010 |
| Estimated Study Completion Date: | November 2013 |
| Primary Completion Date: | April 2011 (Final data collection date for primary outcome measure) |
Intervention Details:
-
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.
Eligibility| Ages Eligible for Study: | 18 Years to 75 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Criteria
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
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00943592
Locations
| United States, Illinois | |
| The University of Chicago | |
| Chicago, Illinois, United States, 60637 | |
Sponsors and Collaborators
University of Chicago
Investigators
| Principal Investigator: | Andrew Artz, MD | University of Chicago |
More Information
No publications provided
| Responsible Party: | Andrew Artz, MD, Assistant Professor of Medicine, University of Chicago |
| ClinicalTrials.gov Identifier: | NCT00943592 History of Changes |
| Obsolete Identifiers: | NCT00572546 |
| Other Study ID Numbers: | 14341B |
| Study First Received: | July 20, 2009 |
| Last Updated: | July 8, 2012 |
| Health Authority: | United States: Institutional Review Board |
Keywords provided by University of Chicago:
|
Melphalan Alemtuzumab Clofarabine |
Additional relevant MeSH terms:
|
Neoplasms Leukemia Preleukemia Myelodysplastic Syndromes Hematologic Neoplasms Neoplasms by Histologic Type Precancerous Conditions Hematologic Diseases Bone Marrow Diseases Neoplasms by Site Melphalan Clofarabine |
Alemtuzumab Campath 1G Myeloablative Agonists Immunosuppressive Agents Immunologic Factors Physiological Effects of Drugs Pharmacologic Actions Antineoplastic Agents Therapeutic Uses Antineoplastic Agents, Alkylating Alkylating Agents Molecular Mechanisms of Pharmacological Action |
ClinicalTrials.gov processed this record on May 22, 2013