Clinical trial · Interventional
PROCEDYTE: Depocyte® Administration (Liposomal Cytarabine) as Prophylaxis of Neuromeningeal Infiltration in Acute Lymphoblastic Leukemia
PROCEDYTE: An Open, Prospective, Multicentre Clinical Trial With Historic Control to Determine Efficacy and Safety of Depocyte® Administration (Liposomal Cytarabine) as Prophylaxis of Neuromeningeal Infiltration of Patients Between 16 and 30 Years Old With Standard Risk Acute Lymphoblastic Leukemia (ALL
- 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)
The primary objective is: * To determine the efficacy and safety of DepoCyte®, as the only intrathecal (IT) prophylaxis of neuromeningeal relapse for patients between 16 and 30 years old diagnosed with acute lymphoblastic leukemia of standard risk treated with the PETHEMA LAL-RI-08 Protocol Chemotherapy schedule. The secondary objectives are: * To evaluate the tolerability of IT DepoCyte® as CNS prophylaxis of CNS via IT for patients between 16 and 30 years old with ALL of standard risk. * To compare the frequency of relapse in CNS for patients between 16 and 30 years old with standard risk ALL treated with the PETHEMA LAL-RI-08 Protocol Chemotherapy schedule and receiving DepoCyte® as the only IT CNS prophylaxis, with that observed in an historic group of patients of identical risk that were treated with the PETHEMA LAL-RI/96 protocol (same systemic chemotherapy and double administration of triple intrathecal chemotherapy) * To evaluate the frequency of systemic relapses of standard risk ALL patients between 16 and 30 years old treated with the PETHEMA LAL-RI-08 Protocol and who receive DepoCyte® as the only IT prophylaxis of CNS involvement and to compare with those observed in the identical risk patients treated with PETHEMA LAL-RI/96 protocol (same systemic chemotherapy and double administration of triple IT chemotherapy)
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 Lymphoblastic Leukemia | Acute Lymphoblastic Leukemia | ONTOLOGY_EXACT | 0.98 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| DepoCyte | Drug | Cytarabine | ALIAS |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- Depocyte
- interventionNames
- Drug: DepoCyte
Primary outcomes (1)
- measure
- Efficacy and safety of DepoCyte®, as the only intrathecal (IT) prophylaxis of neuromeningeal relapse
- timeFrame
- 1 year
Secondary outcomes (2)
- measure
- Tolerability of IT DepoCyte
- timeFrame
- 2 months
- measure
- Compare the frequency of relapse in CNS with an historic group of patients of identical risk that were treated with the PETHEMA LAL-RI/96 protocol
- timeFrame
- 2 years
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 16 Years
- Maximum age
- 30 Years
Show eligibility criteria text
Inclusion Criteria: * According to the investigator opinion, patient must able to carry out with all the clinical trial requirements * Patient or Legal Representative must volunteer sign the inform consent before any study specific test, that is not part of the common patient attention, is performed. * Age 16 to 30 * Patient diagnosed with standard risk ALL no previously treated. Standard risk ALL is defined by the following criteria: * Leukocyte count \< 25x109/L * Absence of poor prognosis cytogenetic abnormalities: t(9;22) or demonstration of BCR-ABL rearrangements. 11q23 alterations or demonstration of ALL1-AF4 rearrangements. * Childbearing women must have a negative pregnancy test and must accept to use an effective contraception method. Exclusion Criteria: * CNS involvement at diagnosis, defined as presence of blasts in a centrifugated sample of craneospinal fluid with a cellular count of more than 5 cels/L, in the absence of traumatic puncture (more than 10 red blood cels/ml), or as neurological symptoms that suggest of neuromeningeal involvement and imaging tests compatible, in the absence of blasts in craneospinal fluid. * B mature cell phenotype (sIg+) or with the Burkitt ALL cytogenetic abnormalities (t\[8;14\], t\[2;8\], t\[8;22\]) * ALL with t(9;22) or BCR-ABL rearrangements. * Acute biphenotypic and bilineal leukemias * Acute undifferentiated leukemia * History of coronary or valvular disease or hypertensive cardiopathy * Chronic hepatopathy * Chronic respiratory insufficiency * Chronic renal insufficiency not due to ALL * Serious neurological disorders not due to ALL * Abnormal ECOG (WHO scale grade 3 and 4) not done by ALL * Pregnant or currently breast feeding women * Patients participating in other clinical trial or receiving any other investigational agent within 30 days previous to the study inclusion
References
Publications (0)
Data not yet available