Clinical trial NCT00943592: Clofarabine-Melphalan-Alemtuzumab Conditioning in Patients With Advanced Hematologic Malignancies
Official title: Clofarabine-melphalan-alemtuzumab Conditioning in Patients With Advanced Hematologic Malignancies
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
PHASE2
Conditions: Advanced Hematologic Malignancies
Leukemia
Preleukemia
Keywords: Melphalan
Alemtuzumab
Clofarabine
Lead sponsor: University of Chicago
Sponsor class: OTHER
First posted: 2009-07-22
Enrollment: 82
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.


Eligibility 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

Primary outcomes:
measure: Number of Participants With Hepatic Adverse Events During the Conditioning Regimen Prior to Stem Cell Transplantation
timeFrame: Day 7 until Day 30
measure: Number of Participants With Renal Adverse Events During the Conditioning Regimen Prior to Stem Cell Transplantation
timeFrame: Day 7 until Day 30
measure: Number of Participants With Skin Adverse Events During the Conditioning Regimen Prior to Stem Cell Transplantation
timeFrame: Day 7 until Day 30
measure: Number of Participants With Other Adverse Events During the Conditioning Regimen Prior to Stem Cell Transplantation
timeFrame: Day 7 until Day 30
Secondary outcomes:
measure: Overall Survival (OS)
timeFrame: 1 year
measure: Progression-free Survival (PFS)
timeFrame: 1 year
measure: Treatment-related Mortality (TRM)
timeFrame: 1 year
measure: Relapse Rate
timeFrame: 1 year
Other outcomes:
Locations:
city: Chicago
country: United States
facility: The University of Chicago
state: Illinois
Study officials:
affiliation: University of Chicago
name: Andrew Artz, MD
role: PRINCIPAL_INVESTIGATOR
References: