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

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

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.

Study Overview

• Status: Completed
• Conditions: Leukemia; Preleukemia; Advanced Hematologic Malignancies
• Intervention / Treatment: Drug: Clofarabine; Drug: Melphalan; Drug: Campath; Procedure: Stem Cell Transplant

• Study Type: Interventional
• Enrollment (Actual): 82
• Phase: Phase 2; Phase 1

Contacts and Locations

Study Locations

• United States
  • Illinois
    • Chicago, Illinois, United States, 60637
      • The University of Chicago

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 75 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Treatment	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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Number of Participants With Hepatic Adverse Events During the Conditioning Regimen Prior to Stem Cell Transplantation	Toxicity was scored according to NCI/CTC version 3	Day 7 until Day 30
Number of Participants With Renal Adverse Events During the Conditioning Regimen Prior to Stem Cell Transplantation	Toxicity was scored according to NCI/CTC version 3	Day 7 until Day 30
Number of Participants With Skin Adverse Events During the Conditioning Regimen Prior to Stem Cell Transplantation	Toxicity was scored according to NCI/CTC version 3	Day 7 until Day 30
Number of Participants With Other Adverse Events During the Conditioning Regimen Prior to Stem Cell Transplantation	Toxicity was scored according to NCI/CTC version 3	Day 7 until Day 30

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Overall Survival (OS)		1 year
Progression-free Survival (PFS)	Progression is defined from stem cell infusion to disease relapse, i.e., recurrence of hematologic malignancy and/or need for treatment after transplant for disease or death from any cause, whichever occurred first.	1 year
Treatment-related Mortality (TRM)		1 year
Relapse Rate		1 year

Collaborators and Investigators

• Sponsor: University of Chicago

Study record dates

Study Major Dates

• Study Start: March 1, 2006
• Primary Completion (Actual): April 1, 2011
• Study Completion (Actual): November 1, 2013

Study Registration Dates

• First Submitted: July 20, 2009
• First Submitted That Met QC Criteria: July 21, 2009
• First Posted (Estimate): July 22, 2009

Study Record Updates

• Last Update Posted (Estimate): February 27, 2014
• Last Update Submitted That Met QC Criteria: January 9, 2014
• Last Verified: January 1, 2014

More Information

Terms related to this study

• Keywords: Melphalan; Alemtuzumab; Clofarabine
• Additional Relevant MeSH Terms: Neoplasms by Site; Hematologic Diseases; Precancerous Conditions; Neoplasms; Hematologic Neoplasms; Preleukemia; Physiological Effects of Drugs; Molecular Mechanisms of Pharmacological Action; Antimetabolites, Antineoplastic; Antimetabolites; Antineoplastic Agents; Immunosuppressive Agents; Immunologic Factors; Antineoplastic Agents, Alkylating; Alkylating Agents; Myeloablative Agonists; Antineoplastic Agents, Immunological; Clofarabine; Melphalan; Alemtuzumab
• Other Study ID Numbers: 14341B