Clinical trial · Interventional
Clofarabine-Melphalan-Alemtuzumab Conditioning in Patients With Advanced Hematologic Malignancies
Clofarabine-melphalan-alemtuzumab Conditioning in Patients With Advanced Hematologic Malignancies
NCT00943592CI-TRIAL-00013894completedPhase 1 / Phase 2Results postedClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (3)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Advanced Hematologic Malignancies | Hematopoietic and Lymphoid Cell Neoplasm | CURATED_BROADER | 0.78 |
| Leukemia | Leukemia | ONTOLOGY_EXACT | 0.90 |
| Preleukemia | Myelodysplastic Syndrome | ALIAS | 0.90 |
Interventions
Interventions (4)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Campath | Drug | Alemtuzumab | ALIAS |
| Clofarabine | Drug | Clofarabine | ALIAS |
| Melphalan | Drug | Melphalan | ALIAS |
| Stem Cell Transplant | Procedure | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- Treatment
- interventionNames
- Drug: Clofarabine
- Drug: Melphalan
- Drug: Campath
- Procedure: Stem Cell Transplant
Primary outcomes (4)
- measure
- Number of Participants With Hepatic Adverse Events During the Conditioning Regimen Prior to Stem Cell Transplantation
- timeFrame
- Day 7 until Day 30
- description
- Toxicity was scored according to NCI/CTC version 3
- measure
- Number of Participants With Renal Adverse Events During the Conditioning Regimen Prior to Stem Cell Transplantation
- timeFrame
- Day 7 until Day 30
- description
- Toxicity was scored according to NCI/CTC version 3
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
- Maximum age
- 75 Years
Show eligibility criteria text
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
References
Publications (0)
Data not yet available
No reference posted for this study.