Phase 2 N=82 Treatment

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

Advanced Hematologic Malignancies · Leukemia · Preleukemia

Bottom Line

View on ClinicalTrials.gov: NCT00943592 ↗

Enrolled (actual)

Serious AEs

53.7%

Results posted

Feb 2014

Primary outcome: Primary: Number of Participants With Hepatic Adverse Events During the Conditioning Regimen Prior to Stem Cell Transplantation — 48; 30 participants

Study Design & Population

Study type: Interventional
Phase: Phase 2
Interventions: Clofarabine (Drug); Melphalan (Drug); Campath (Drug); Stem Cell Transplant (Procedure)
Age: Adult, Older Adult · 18+ yrs
Sex: All
Sponsor: University of Chicago
Primary completion: Apr 2011

Outcome Measures

Outcome	Result	p-value
PRIMARY Number of Participants With Hepatic Adverse Events During the Conditioning Regimen Prior to Stem Cell Transplantation	48; 30	—
PRIMARY Number of Participants With Renal Adverse Events During the Conditioning Regimen Prior to Stem Cell Transplantation	26; 13; 3	—
PRIMARY Number of Participants With Skin Adverse Events During the Conditioning Regimen Prior to Stem Cell Transplantation	6; 8	—
PRIMARY Number of Participants With Other Adverse Events During the Conditioning Regimen Prior to Stem Cell Transplantation	12; 7; 7	—
SECONDARY Overall Survival (OS)	59	—
SECONDARY Progression-free Survival (PFS)	45	—
SECONDARY Treatment-related Mortality (TRM)	26	—
SECONDARY Relapse Rate	29	—

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 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

View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT00943592). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.