Clinical trial · Interventional
Pegylated Liposomal Doxorubicin Versus Daunorubicin to Treat Acute Lymphoblastic Leukemia:
Pegylated Liposomal Doxorubicin-contained Versus Daunorubicin-contained VDCLD Regimen in Previously Untreated Adult Patients With Acute Lymphoblastic Leukemia: Complete Remission Rates and Changes of Leukemia Stem Cells
- 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)
To determine, compared with Daunorubicin(DNR), whether Pegylated liposomal doxorubicin (PLD) inducing higher complete remission (CR) rate, in untreated primary ALL adult patients with VDCLD regimen induction therapy. Second, to determine, compared with the DNR, whether chemotherapy containing PLD with a higher response rates and greater safety in adult ALL
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 |
|---|---|---|---|
| VDCLD regimen | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- PLD-contained VDCLD regimen
- description
- PLD 36 mg/m2 ivdrip over 60 minutes( d1、15),VCR 1.4mg/m iv(d1，8，15，22), CTX 800 mg/m2 ivdrip( d1), L-asp 6000u/m2 ivdrip(d19～28),Dex10mg ivdrip (d1～28).
- interventionNames
- Drug: VDCLD regimen
- type
- ACTIVE_COMPARATOR
- label
- DNR-contained VDCLD regimen
- description
- DNR 45 mg/m2 ivdrip over 60 minutes(d1～3),VCR 1.4mg/m2 iv(d1，d8，d15，d22), CTX 800 mg/m2 ivdrip(d1), L-asp 6000u/m2 ivdrip(d19～28),Dex10mg ivdrip(d1～28).
- interventionNames
- Drug: VDCLD regimen
Primary outcomes (1)
- measure
- Complete remission (CR) rates after the first course of regimen
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 14 Years
- Maximum age
- 60 Years
Show eligibility criteria text
Inclusion Criteria: Eligible men or women were age over 14，but less than 60 years; Eastern Cooperative Oncology Group performance status of 0 to2; Diagnosed with ALL (WHO classification, the primitive cells ≥ 20%); Previous untreated ALL patients had not received chemotherapy before (excluding dexamethasone, prednisone, and hydroxyurea). History of receiving blood transfusion, hematopoietic growth factors, vitamin, and palliative measures such as leukocyte removal, dexamethasone, prednisone, hydroxyurea (0.5-3g daily, more than three days) is allowed; The levels of LSCs in bone marrow were measured with flow cytometry before treatment; Subjects must be able to provide written informed consent. Exclusion Criteria: Mixed type of AL patients; Clinically significant active infections; Nursing (breastfeeding) or intending to be nursing during the study； Pregnancy, or intending to become pregnant during the study; Patients with cardiac dysfunction currently (especially congestive heart failure) or history of congestive heart failure; Patients with severe liver failure (ALT ≥ 5 times the upper limit of normal (ULN), total bilirubin ≥ 3mg/dL) Patients with renal insufficiency, creatinine clearance \<30ml/min, creatinine clearance rate is calculated as follows: Men: Ccr (ml / min) = (140 - age) × weight (kg) / \[0.8136 × serum creatinine (μmol / L )\] female: Ccr (ml / min) = (140 - age) × weight (kg) × 0.85 / \[0.8136 × serum creatinine (μmol / L)\]; Patients did not or will not participate in other trials of drugs 30 days before or 90 days after the beginning of this study,
References
Publications (0)
Data not yet available