Clinical trial · Interventional
Study of Liposomal Annamycin in Patients With Refractory or Relapsed Acute Lymphocytic Leukemia
Phase I/II Study of Liposomal Annamycin in Patients With Refractory or Relapsed Acute Lymphocytic Leukemia
NCT00271063CI-TRIAL-00001050unknownPhase 1 / Phase 2ClinicalTrials.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 Phase I/II multi-center, open label, dose escalation study to identify the maximum tolerated dose (MTD) of liposomal annamycin and to evaluate the safety of liposomal annamycin in patients with refractory or relapsed acute lymphocytic leukemia.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Acute Lymphocytic Leukemia | Acute Lymphoblastic Leukemia | ALIAS | 0.90 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Liposomal Annamycin | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (0)
[]Primary outcomes (2)
- measure
- To evaluate the safety and tolerability of L-Annamycin
- timeFrame
- 8 months
- measure
- MTD
- timeFrame
- 8 months
Secondary outcomes (2)
- measure
- To study multi drug-resistant (MDR)-1 encoded P-170 glycoprotein expression and MDR-1 multidrug-resistant-associated protein (MRP), lung-resistance associated protein LRP), and breast cancer resistance protein (BCRP) mRNA levels
- timeFrame
- 8 months
- measure
- To measure the pharmacokinetics of annamycin and its metabolite, annamycinol.
- timeFrame
- 8 months
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 15 Years
Show eligibility criteria text
Inclusion Criteria: * Diagnosis of refractory or relapsed ALL (acute lymphocytic leukemia) * Age greater than or equal to 15 years * No chemotherapy, radiation, or major surgery within 2 weeks prior to first dose of study drug and recovered from toxic side effects of that therapy, unless treatment is indicated due to progressive disease. * No investigational therapy within 4 weeks of first dose of study drug * ECOG performance status (PS) 0 to 2. * Adequate liver function * Adequate renal function * Signed informed consent Exclusion Criteria: * Concommitant therapy that includes other chemotherapy that is or may be active against ALL (except central nervous system \[CNS\] therapy) * Any condition which in the opinion of the investigator, places the subject at unacceptable risk if he/she were to participate in the study. * Cardiac ejection fraction less than 40% * Clinically relevant serious co-morbid medical conditions. * Pregnant, lactating or not using adequate contraception. * Known allergy to doxorubicin or anthracyclines.
References
Publications (0)
Data not yet available
No reference posted for this study.