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

Phase 1

Completed

• Conditions: Leukemia; Advanced Hematologic Malignancies; Preleukemia
• Interventions: Drug: Clofarabine; Drug: Melphalan; Drug: Campath; Procedure: Stem Cell Transplant

• Registration Number: NCT00943592
• Lead Sponsor: University of Chicago

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 available

Study Timeline

• Study Start: 2006-03
• Study First Submitted: 2009-07-20
• Study First Submitted QC: 2009-07-21
• Study First Posted: 2009-07-22
• Primary Completion: 2011-04
• Results First Submitted: 2013-09-17
• Study Completion: 2013-11
• Status Verified: 2014-01
• Results First Submitted QC: 2014-01-09
• Last Update Submitted: 2014-01-09
• Results First Posted: 2014-02-27
• Last Update Posted: 2014-02-27

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 82

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

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Exclusion Criteria

• Clinical progression

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Treatment	Stem Cell Transplant	-
Treatment	Clofarabine	-
Treatment	Melphalan	-
Treatment	Campath	-

Primary Outcome Measures

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

Secondary Outcome Measures

Name	Time	Method
Relapse Rate	1 year
Treatment-related Mortality (TRM)	1 year
Overall Survival (OS)	1 year
Progression-free Survival (PFS)	1 year	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.

Trial Locations

Locations (1)

The University of Chicago; 🇺🇸 Chicago, Illinois, United States