Clinical trial · Interventional
Rituximab+mVPDL for CD20(+) Adult Acute Lymphoblastic Leukemia
Phase 2 Study Evaluating the Efficacy of Rituximab Plus Modified VPDL for Newly Diagnosed CD20-Positive Adult Acute Lymphoblastic Leukemia
NCT01429610CI-TRIAL-00033951RADICALunknownPhase 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)
The investigators would like to propose a phase-2 prospective multicenter trial evaluating the efficacy of rituximab combination with our current chemotherapy strategy for adult Acute Lymphoblastic Leukemia (ALL), in order to prove out whether the addition of rituximab during induction, consolidation, and post-alloHCT status can improve the outcome in terms of relapse-free survival (RFS) when compared with our prior data as a historical control.
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 |
|---|---|---|---|
| Precursor Cell Lymphoblastic Leukemia-Lymphoma | Acute Lymphoblastic Leukemia | ALIAS | 0.90 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Rituximab+mVPDL | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- Rituximab+mVPDL
- description
- Patients who were CD20(+), newly-diagnosed adult ALL and treated with rituximab + mVPDL treatment plan
- interventionNames
- Drug: Rituximab+mVPDL
Primary outcomes (1)
- measure
- relapse-free survival (RFS) rate
- timeFrame
- 2 years
Secondary outcomes (4)
- measure
- complete remission (CR) rates
- timeFrame
- 4 weeks (from the initiation of induction treatment)
- description
- among total patients / each subset of subsets A. \[Subset A\] 1. Precursor B-cell vs. T-cell 2. Younger (age\<60 years) vs. older (age≥60 years) 3. Risk group: standard vs. high
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 15 Years
Show eligibility criteria text
Inclusion Criteria: * Patients who were previously untreated and had either ALL or high-risk lymphoblastic lymphoma. * Patients whose leukemic blast cells express ≥20% of CD20 antigens at time of diagnosis * No prior chemotherapy for leukemia (use of hydroxyurea or leukapheresis are permitted.) * Estimated life expectancy of more than 3 months * ECOG performance status of 2 or lower, Karnofsky scale \> 60 * Adequate cardiac function (EF\>45%) on echocardiogram or Heart scan (MUGA scan) * 15 years of age and over. * Adequate renal function (creatinine\<1.5 mg/dL) * Adequate hepatic function. (Bilirubin\<1.5 mg/dL, transaminases levels\<3 times the upper normal limit \[5 times for patients with liver metastasis or hepatomegaly\]). Even the initial level exceed the upper limits, patient will be acceptable when the levels on day 8 satisfies the inclusion criteria. * All patients gave written informed consent according to guidelines at each institution's committee on human research. Exclusion Criteria: * Acute biphenotypic leukemia, acute biclonal leukemia, or acute mixed leukemia * Presence of significant uncontrolled active infection * Presence of uncontrolled bleeding * Any coexisting major illness or organ failure * Patients with psychiatric disorder or mental deficiency severe as to make compliance with the treatment unlike, and making informed consent impossible * Nursing women, pregnant women, women of childbearing potential who do not want adequate contraception * Patients with a diagnosis of prior malignancy unless disease-free for at least 5 years following therapy with curative intent (except curatively treated nonmelanoma skin cancer, in situ carcinoma, or cervical intraepithelial neoplasia)
References
Publications (33)
- BACKGROUNDBoissel N, Auclerc MF, Lheritier V, Perel Y, Thomas X, Leblanc T, Rousselot P, Cayuela JM, Gabert J, Fegueux N, Piguet C, Huguet-Rigal F, Berthou C, Boiron JM, Pautas C, Michel G, Fiere D, Leverger G, Dombret H, Baruchel A. Should adolescents with acute lymphoblastic leukemia be treated as old children or young adults? Comparison of the French FRALLE-93 and LALA-94 trials. J Clin Oncol. 2003 Mar 1;21(5):774-80. doi: 10.1200/JCO.2003.02.053. Epub 2003 Mar 1. PMID 12610173
- BACKGROUNDHallbook H, Gustafsson G, Smedmyr B, Soderhall S, Heyman M; Swedish Adult Acute Lymphocytic Leukemia Group; Swedish Childhood Leukemia Group. Treatment outcome in young adults and children >10 years of age with acute lymphoblastic leukemia in Sweden: a comparison between a pediatric protocol and an adult protocol. Cancer. 2006 Oct 1;107(7):1551-61. doi: 10.1002/cncr.22189. PMID 16955505
- BACKGROUNDTodeschini G, Tecchio C, Meneghini V, Pizzolo G, Veneri D, Zanotti R, Ricetti MM, Solero P, April F, Perona G. Estimated 6-year event-free survival of 55% in 60 consecutive adult acute lymphoblastic leukemia patients treated with an intensive phase II protocol based on high induction dose of daunorubicin. Leukemia. 1998 Feb;12(2):144-9. doi: 10.1038/sj.leu.2400912. PMID 9519775
- BACKGROUNDThomas D, O'Brien S, Faderl S, Ravandi F, Jabbour E, Pierce S, Cortes J, Kantarjian H. Anthracycline dose intensification in adult acute lymphoblastic leukemia: lack of benefit in the context of the fractionated cyclophosphamide, vincristine, doxorubicin, and dexamethasone regimen. Cancer. 2010 Oct 1;116(19):4580-9. doi: 10.1002/cncr.25319. PMID 20572037
- BACKGROUNDTomblyn MB, Arora M, Baker KS, Blazar BR, Brunstein CG, Burns LJ, DeFor TE, Dusenbery KE, Kaufman DS, Kersey JH, MacMillan ML, McGlave PB, Miller JS, Orchard PJ, Slungaard A, Tomblyn MR, Vercellotti GM, Verneris MR, Wagner JE, Weisdorf DJ. Myeloablative hematopoietic cell transplantation for acute lymphoblastic leukemia: analysis of graft sources and long-term outcome. J Clin Oncol. 2009 Aug 1;27(22):3634-41. doi: 10.1200/JCO.2008.20.2960. Epub 2009 Jul 6.