Phase 2
Completed N=82
Clofarabine-Melphalan-Alemtuzumab Conditioning in Patients With Advanced Hematologic Malignancies
Advanced Hematologic Malignancies · leukemia
Source: ClinicalTrials.gov NCT00943592 ↗
Enrolled (actual)
82
Serious AEs
53.7%
Results posted
Feb 2014
Primary outcomePrimary: Number of Participants With Hepatic Adverse Events During the Conditioning Regimen Prior to Stem Cell Transplantation — 48; 30 participants
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.
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 | — |
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
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. Informational only — not medical advice.