Clinical trial · Interventional
Chemotherapy With Liposomal Cytarabine CNS Prophylaxis for Adult Acute Lymphoblastic Leukemia & Lymphoblastic Lymphoma
A Phase II Study of Punctual, Cyclic, and Intensive Chemotherapy With Liposomal Cytarabine (Depocyt®) CNS Prophylaxis for Adults With Acute Lymphoblastic Leukemia and Lymphoblastic Lymphoma
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Why stopped (as posted): Original investigator for the trial has left
Summary
Brief summary (as posted)
The objective of this protocol is to improve survival for adults with acute lymphoblastic leukemia or acute lymphoblastic lymphoma by reducing systemic and central nervous system (CNS) relapse with acceptable toxicity using intensive chemotherapy with liposomal cytarabine (Depocyt®) CNS prophylaxis.
Conditions
Conditions (2)
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 |
| Adult Lymphoblastic Lymphoma | Adult Lymphoblastic Lymphoma | ONTOLOGY_EXACT | 0.98 |
Interventions
Interventions (13)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| AraC | Drug | — | UNRESOLVED |
| CTX | Drug | Cyclophosphamide | ALIAS |
| Dasatinib | Drug | Dasatinib | ALIAS |
| DNR | Drug | Daunorubicin | ALIAS |
| Etoposide | Drug | Etoposide | ALIAS |
| Hydrocortisone | Drug | — | UNRESOLVED |
| LCV | Drug | — | UNRESOLVED |
| Liposomal AraC | Drug | — | UNRESOLVED |
| MTX | Drug | Methotrexate |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- Chemotherapy for ALL
- description
- Course 1A: DNR 60 mg/m2 IV d1,2,3; VCR 1.4 mg/m2 d1,8,15,22 (cap 2 mg age \>50); PEG-asp 2000 IU/m2 IV d16, age \>50 1000 IU/m2, cap 3750 IU/m2; CTX 750 mg/m2 d1,15 age \< 40; Prednisone 60 mg/m2 PO d1-28; Liposomal AraC 25 mg IT d1, 15 1B: MTX 220 mg/m2 IV then 60 mg/m2/h for 36h d2-3,d16-17; LCV 50 mg/m2 IV q6h x3 then 10 mg/m2 PO/IV q6h til MTX \<0.1 uM; 6-MP 60 mg/m2 PO d2-8, d16-22; PEG-asp 2000 IU/m2 IV d18, age \>50 1000 IU/m2, cap 3750 IU/m2 1C: AraC 2 g/m2 IV d1-4; Etoposide 500 mg/m2 IV d1-4 1A-C repeat x1(2A-C) then 3rd Course B (3B) Maintenance (monthly, 24 mo): Prednisone 60 mg/m2 PO d1-5; VCR 1.4 mg/m2 IV d1 (cap 2 mg age \>50); MTX 20 mg/m2 PO wkly; 6-MP 60 mg/m2 PO qd PEG-asp 2000 IU/m2 IV d16, age \>50 1000 IU/m2, cap 3,750 IU/m2 (Mo. 1) Maintenance mo. 1-4: Liposomal AraC 50 mg IT d1 Dasatinib 140 mg PO qd if Ph/BCR-ABL+; Rituximab 375 mg/m2 IV d1,15 of 1A-C, 2A (Pre-B) 1:1 randomization: hydrocortisone v. placebo before PEG-asp 1B, 2B, \& Maint.
- interventionNames
- Drug: DNR
- Drug: VCR
- Drug: PEG-asp
- Drug: CTX
- Drug: Prednisone
- Drug: Liposomal AraC
- Drug: MTX
- Drug: LCV
- Drug: AraC
- Drug: Etoposide
- Drug: Dasatinib
- Drug: Rituximab
- Drug: Hydrocortisone
Primary outcomes (1)
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
- Maximum age
- 60 Years
Show eligibility criteria text
Inclusion Criteria: * Ability to understand and the willingness to sign a written informed consent. * Diagnosis of acute lymphoblastic leukemia or lymphoblastic lymphoma as defined by the World Health Organization \[94\] * Untreated disease EXCEPT for corticosteroids, hydroxyurea, leukapheresis, and/or tyrosine kinase inhibitors for up to 2 weeks prior to initiation of study therapy. * Age 18 through 60 years * ECOG performance status 0,1, or 2 (see Appendix A) * Adequate organ function defined as: * Total bilirubin \< 2 mg/dL (unless due to ALL) * AST(SGOT)/ALT(SGPT) \< 3 times institutional upper limit of normal (unless due to ALL) * Serum creatinine \< 2 mg/dL (unless elevated creatinine felt by investigator to be acute and reversible) OR creatinine clearance \>60 mL/min/1.73 m2 for patients with creatinine levels above institutional normal * Left ventricular ejection fraction ≥50% * Women of child-bearing potential and men with partners of child- bearing potential must agree to use adequate contraception (hormonal or barrier method of birth control; abstinence) prior to study entry, for the duration of study participation, and for 90 days following completion of therapy. Should a woman become pregnant or suspect she is pregnant while participating in this study, she should inform her treating physician immediately. * A woman of child-bearing potential is any female (regardless of sexual orientation, having undergone a tubal ligation, or remaining celibate by choice) who meets the following criteria: * Has not undergone a hysterectomy or bilateral oophorectomy; or * Has not been naturally postmenopausal for at least 12 consecutive months (i.e., has had menses at any time in the preceding 12 consecutive months) Exclusion Criteria: * Current or anticipated use of other investigational agents during the study * Known central nervous system mass lesion * History of allergic reactions attributed to compounds of similar chemical or biologic composition to liposomal cytarabine or other agents used in study inclusive of known allergy to polyethylene glycol. * History of unprovoked venous thrombosis/thromboembolism * Recurrent or chronic pancreatitis * Uncontrolled diabetes mellitus * Uncontrolled intercurrent illness that would limit compliance with study requirements including, but not limited to, ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, or psychiatric illness/social situations that would limit compliance with study requirements. * Pregnant or nursing. * Any condition, in the opinion of the investigator, that compromises compliance with study requirements * Known HIV positivity
References
Publications (1)
- RESULTLinker C, Damon L, Ries C, Navarro W. Intensified and shortened cyclical chemotherapy for adult acute lymphoblastic leukemia. J Clin Oncol. 2002 May 15;20(10):2464-71. doi: 10.1200/JCO.2002.07.116. PMID 12011123