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Rituximab+mVPDL for CD20(+) Adult Acute Lymphoblastic Leukemia (RADICAL)

Primary Purpose

Precursor Cell Lymphoblastic Leukemia-Lymphoma

Status
Unknown status
Phase
Phase 2
Locations
Korea, Republic of
Study Type
Interventional
Intervention
Rituximab+mVPDL
Sponsored by
Asan Medical Center
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Precursor Cell Lymphoblastic Leukemia-Lymphoma focused on measuring acute lymphoblastic leukemia, rituximab, VPDL, CD20

Eligibility Criteria

15 Years - undefined (Child, Adult, Older Adult)All SexesDoes not accept healthy volunteers

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)

Sites / Locations

  • Chonnam National University Hwasun Hospital
  • Hematologic Oncology Clinic, National Cancer Center
  • Division of Hematology-Oncology, Dong-A University College of Medicine
  • Dong-A University College of Medicine
  • Inje University Busan Paik Hospital
  • Inje University Haeundae-Paik Hospital
  • Kosin University College of Medicine, Kosin University Gospel Hospital
  • Catholic University of Daegu School of Medicine
  • Keimyung University Dongsan Medical Center
  • Kyungpook National Unviersity Hospital
  • Yeungnam University College of Medicine
  • Chungnam National University Hospital
  • Asan Medical Center, University of Ulsan College of Medicine
  • Chung-Ang University Hospital
  • Ewha Womans University Mokdong Hospital
  • Korea University Anam Hospital
  • Seoul National University Hospital
  • Soonchunhyang University Hospital
  • Ulsan University Hospital, University of Ulsan College of Medicine

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Rituximab+mVPDL

Arm Description

Patients who were CD20(+), newly-diagnosed adult ALL and treated with rituximab + mVPDL treatment plan

Outcomes

Primary Outcome Measures

relapse-free survival (RFS) rate

Secondary Outcome Measures

complete remission (CR) rates
among total patients / each subset of subsets A. [Subset A] Precursor B-cell vs. T-cell Younger (age<60 years) vs. older (age≥60 years) Risk group: standard vs. high
relapse-free survival rates
among patients in each subset of A & B. [Subset A] Precursor B-cell vs. T-cell Younger (age<60 years) vs. older (age≥60 years) Risk group: standard vs. high. [Subset B] AlloHCT recipients vs. non-recipients.
overall survival rates
among total patients / each subset of A & B [Subset A] Precursor B-cell vs. T-cell Younger (age<60 years) vs. older (age≥60 years) Risk group: standard vs. high [Subset B] AlloHCT recipients vs. non-recipients.
Cumulative incidence and maximal severity of acute / chronic graft-versus-host disease
among alloHCT recipients

Full Information

First Posted
August 30, 2011
Last Updated
July 22, 2018
Sponsor
Asan Medical Center
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1. Study Identification

Unique Protocol Identification Number
NCT01429610
Brief Title
Rituximab+mVPDL for CD20(+) Adult Acute Lymphoblastic Leukemia
Acronym
RADICAL
Official Title
Phase 2 Study Evaluating the Efficacy of Rituximab Plus Modified VPDL for Newly Diagnosed CD20-Positive Adult Acute Lymphoblastic Leukemia
Study Type
Interventional

2. Study Status

Record Verification Date
July 2018
Overall Recruitment Status
Unknown status
Study Start Date
November 2011 (undefined)
Primary Completion Date
January 1, 2018 (Actual)
Study Completion Date
January 1, 2019 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Asan Medical Center

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief Summary
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.
Detailed Description
According to the recent results on the outcome of escalated daunorubicin-based protocol for adult ALL which has been performed by 'Adult ALL Working Party of the Korean Society of Hematology' (data were announced at 2010 Annual Meeting of ASCO, Chicago, IL), CR rate of 90.6% was satisfactory, but the 2-year / 3-year disease-free survival (DFS) were disappointing (43.6% and 39.9%, respectively), which means that the adequate post-remission therapy to control minimal residual disease after the achievement of CR is very important to improve the outcome of adult ALL. Allogeneic hematopoietic cell transplantation (AlloHCT) is recommended as a post-remission therapy for patients with adult ALL, and reduced intensity conditioning has been tried to decrease TRM rate. However, many patients received consolidation chemotherapy rather than alloHCT owing to the absence of HLA-matched donor, limitation of age, and combined comorbidities (among 190 patients who have been included in our previously-mentioned study, only 52.3% received alloHCT). Recently, stagnation in the treatment of adult ALL appears to be reached, maybe due to a borderline for further intensification of chemotherapeutic dose. Dose-escalation strategy has many difficulties in adoption for the treatment of adult ALL in terms of increased morbidity and mortality, not to mention the efficacy of such strategies. New, preferably non-chemotherapy approaches (maybe targeted therapy) are therefore urgently required. For Ph(+) ALL, the introduction of BCR/ABL tyrosine kinase inhibitor has improved the treatment outcome with tolerable toxicities. Applying a similar strategy to Ph(-) ALL, targeting leukemia surface antigens with monoclonal antibodies is another promising strategy. CD 20 expression of at least 20% has been known to be found in 22-48% of pre-B ALL, and appears to be associated with a poor prognosis, although there are controversies in pediatric patients. Based on the significant improvement of the outcome in B-cell NHL, preliminary data regarding the use of rituximab in frontline therapy for CD20-positive precursor B-cell ALL suggest its use may be beneficial. Especially, monoclonal antibodies are thought to be more effective when combined with chemotherapy and treated in the state of minimal residual disease, which suggests the interest of evaluating rituximab combined to current chemotherapy of adult ALL. Recent data on the efficacy of rituximab-combined chemotherapy showed that rates of CR and OS were superior with the modified hyperCVAD and rituximab regimens compared with standard hyper-CVAD (70% versus 38%, p<0.001) in younger (age < 60 years) CD20-positive subset, although it was an analysis of different patient groups who were treated with various regimen5.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Precursor Cell Lymphoblastic Leukemia-Lymphoma
Keywords
acute lymphoblastic leukemia, rituximab, VPDL, CD20

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
78 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Rituximab+mVPDL
Arm Type
Experimental
Arm Description
Patients who were CD20(+), newly-diagnosed adult ALL and treated with rituximab + mVPDL treatment plan
Intervention Type
Drug
Intervention Name(s)
Rituximab+mVPDL
Other Intervention Name(s)
Mabthera, VCS, Daunobrastina, Solondo, Leunase, Cytarabine, Efosin, DBLMethotrexate
Intervention Description
Induction: Dauno 90 mg/m2/d by civ (d1-3) Vinc 2 mg iv (d1, 8) Pred 60 mg/m2/d po (d1-14) for Ph(-): L-asp 4,000 units/m2/day im/sc (d17-28) for Ph(+): Imatinib 600mg/d po qd (d8-continue till the end of maintenance or just before alloHCT) Rituximab 375mg/m2/d (d8) Consolidation A (cycle1) D 45 mg/m2/day by continuous iv (d1, 2) V 2 mg iv (d1, 8) P 60 mg/m2/day po (d1-14) for Ph(-): L-asp (d1-14) for Ph(+): Imatinib Rituximab 375mg/m2/d (d8) Consolidation B (cycles2&4) Cyt 2,000 mg/m2/d iv over 2 hr (d1-4) Eto 150 mg/m2/d iv over 3 hr (d1-4) Rituximab 375mg/m2/d d8 Consolidation C (cycles 3&5) Methotrexate 220 mg/m2 iv bolus, then 60mg/m2/h for 36 hr (d1-2, 15-16) Leucovorin 50 mg/m2 iv every 6hr for 3 doses, Rituximab 375mg/m2/d (d8&22) Maintenance (for 2 years) - for Ph(-): 6- Mercaptopurine 60 mg/m2 po qd Methotrexate 20 mg/m2 po qw for Ph(+): imatinib 600mg/d po qd Consider alloHCT
Primary Outcome Measure Information:
Title
relapse-free survival (RFS) rate
Time Frame
2 years
Secondary Outcome Measure Information:
Title
complete remission (CR) rates
Description
among total patients / each subset of subsets A. [Subset A] Precursor B-cell vs. T-cell Younger (age<60 years) vs. older (age≥60 years) Risk group: standard vs. high
Time Frame
4 weeks (from the initiation of induction treatment)
Title
relapse-free survival rates
Description
among patients in each subset of A & B. [Subset A] Precursor B-cell vs. T-cell Younger (age<60 years) vs. older (age≥60 years) Risk group: standard vs. high. [Subset B] AlloHCT recipients vs. non-recipients.
Time Frame
2 years
Title
overall survival rates
Description
among total patients / each subset of A & B [Subset A] Precursor B-cell vs. T-cell Younger (age<60 years) vs. older (age≥60 years) Risk group: standard vs. high [Subset B] AlloHCT recipients vs. non-recipients.
Time Frame
2 years
Title
Cumulative incidence and maximal severity of acute / chronic graft-versus-host disease
Description
among alloHCT recipients
Time Frame
2 years

10. Eligibility

Sex
All
Minimum Age & Unit of Time
15 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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)
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Young Don Joo, MD, PhD
Organizational Affiliation
Inje University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Chonnam National University Hwasun Hospital
City
Hwasun
State/Province
Chollanamdo
Country
Korea, Republic of
Facility Name
Hematologic Oncology Clinic, National Cancer Center
City
Ilsan
State/Province
Kongki
Country
Korea, Republic of
Facility Name
Division of Hematology-Oncology, Dong-A University College of Medicine
City
Busan
Country
Korea, Republic of
Facility Name
Dong-A University College of Medicine
City
Busan
Country
Korea, Republic of
Facility Name
Inje University Busan Paik Hospital
City
Busan
Country
Korea, Republic of
Facility Name
Inje University Haeundae-Paik Hospital
City
Busan
Country
Korea, Republic of
Facility Name
Kosin University College of Medicine, Kosin University Gospel Hospital
City
Busan
Country
Korea, Republic of
Facility Name
Catholic University of Daegu School of Medicine
City
Daegu
Country
Korea, Republic of
Facility Name
Keimyung University Dongsan Medical Center
City
Daegu
Country
Korea, Republic of
Facility Name
Kyungpook National Unviersity Hospital
City
Daegu
Country
Korea, Republic of
Facility Name
Yeungnam University College of Medicine
City
Daegu
Country
Korea, Republic of
Facility Name
Chungnam National University Hospital
City
Daejeon
Country
Korea, Republic of
Facility Name
Asan Medical Center, University of Ulsan College of Medicine
City
Seoul
Country
Korea, Republic of
Facility Name
Chung-Ang University Hospital
City
Seoul
Country
Korea, Republic of
Facility Name
Ewha Womans University Mokdong Hospital
City
Seoul
Country
Korea, Republic of
Facility Name
Korea University Anam Hospital
City
Seoul
Country
Korea, Republic of
Facility Name
Seoul National University Hospital
City
Seoul
Country
Korea, Republic of
Facility Name
Soonchunhyang University Hospital
City
Seoul
Country
Korea, Republic of
Facility Name
Ulsan University Hospital, University of Ulsan College of Medicine
City
Ulsan
Country
Korea, Republic of

12. IPD Sharing Statement

Citations:
PubMed Identifier
12610173
Citation
Boissel 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.
Results Reference
background
PubMed Identifier
16955505
Citation
Hallbook 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.
Results Reference
background
PubMed Identifier
9519775
Citation
Todeschini 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.
Results Reference
background
PubMed Identifier
20572037
Citation
Thomas 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.
Results Reference
background
PubMed Identifier
19581540
Citation
Tomblyn 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.
Results Reference
background
PubMed Identifier
19179301
Citation
Bachanova V, Verneris MR, DeFor T, Brunstein CG, Weisdorf DJ. Prolonged survival in adults with acute lymphoblastic leukemia after reduced-intensity conditioning with cord blood or sibling donor transplantation. Blood. 2009 Mar 26;113(13):2902-5. doi: 10.1182/blood-2008-10-184093. Epub 2009 Jan 28.
Results Reference
background
PubMed Identifier
18048644
Citation
Goldstone AH, Richards SM, Lazarus HM, Tallman MS, Buck G, Fielding AK, Burnett AK, Chopra R, Wiernik PH, Foroni L, Paietta E, Litzow MR, Marks DI, Durrant J, McMillan A, Franklin IM, Luger S, Ciobanu N, Rowe JM. In adults with standard-risk acute lymphoblastic leukemia, the greatest benefit is achieved from a matched sibling allogeneic transplantation in first complete remission, and an autologous transplantation is less effective than conventional consolidation/maintenance chemotherapy in all patients: final results of the International ALL Trial (MRC UKALL XII/ECOG E2993). Blood. 2008 Feb 15;111(4):1827-33. doi: 10.1182/blood-2007-10-116582. Epub 2007 Nov 29.
Results Reference
background
PubMed Identifier
11583286
Citation
Pituch-Noworolska A, Hajto B, Mazur B, Sonta-Jakimczyk D, Balwierz W, Janota-Krawczyk E, Kowalska H, Malinowska I, Modzelewska M, Wasik M. Expression of CD20 on acute lymphoblastic leukemia cells in children. Neoplasma. 2001;48(3):182-7.
Results Reference
background
PubMed Identifier
19773266
Citation
Maury S, Huguet F, Leguay T, Lacombe F, Maynadie M, Girard S, de Labarthe A, Kuhlein E, Raffoux E, Thomas X, Chevallier P, Buzyn A, Delannoy A, Chalandon Y, Vernant JP, Rousselot P, Macintyre E, Ifrah N, Dombret H, Bene MC; Group for Research on Adult Acute Lymphoblastic Leukemia. Adverse prognostic significance of CD20 expression in adults with Philadelphia chromosome-negative B-cell precursor acute lymphoblastic leukemia. Haematologica. 2010 Feb;95(2):324-8. doi: 10.3324/haematol.2009.010306. Epub 2009 Sep 22.
Results Reference
background
PubMed Identifier
9166833
Citation
Borowitz MJ, Shuster J, Carroll AJ, Nash M, Look AT, Camitta B, Mahoney D, Lauer SJ, Pullen DJ. Prognostic significance of fluorescence intensity of surface marker expression in childhood B-precursor acute lymphoblastic leukemia. A Pediatric Oncology Group Study. Blood. 1997 Jun 1;89(11):3960-6.
Results Reference
background
PubMed Identifier
16896151
Citation
Jeha S, Behm F, Pei D, Sandlund JT, Ribeiro RC, Razzouk BI, Rubnitz JE, Hijiya N, Howard SC, Cheng C, Pui CH. Prognostic significance of CD20 expression in childhood B-cell precursor acute lymphoblastic leukemia. Blood. 2006 Nov 15;108(10):3302-4. doi: 10.1182/blood-2006-04-016709. Epub 2006 Aug 8.
Results Reference
background
PubMed Identifier
18703706
Citation
Thomas DA, O'Brien S, Jorgensen JL, Cortes J, Faderl S, Garcia-Manero G, Verstovsek S, Koller C, Pierce S, Huh Y, Wierda W, Keating MJ, Kantarjian HM. Prognostic significance of CD20 expression in adults with de novo precursor B-lineage acute lymphoblastic leukemia. Blood. 2009 Jun 18;113(25):6330-7. doi: 10.1182/blood-2008-04-151860. Epub 2008 Aug 14.
Results Reference
background
PubMed Identifier
18712674
Citation
Al Gwaiz LA, Bassioni W. Immunophenotyping of acute lymphoblastic leukemia using immunohistochemistry in bone marrow biopsy specimens. Histol Histopathol. 2008 Oct;23(10):1223-8. doi: 10.14670/HH-23.1223.
Results Reference
background
PubMed Identifier
16461321
Citation
Claviez A, Eckert C, Seeger K, Schrauder A, Schrappe M, Henze G, von Stackelberg A. Rituximab plus chemotherapy in children with relapsed or refractory CD20-positive B-cell precursor acute lymphoblastic leukemia. Haematologica. 2006 Feb;91(2):272-3.
Results Reference
background
PubMed Identifier
16502413
Citation
Thomas DA, Faderl S, O'Brien S, Bueso-Ramos C, Cortes J, Garcia-Manero G, Giles FJ, Verstovsek S, Wierda WG, Pierce SA, Shan J, Brandt M, Hagemeister FB, Keating MJ, Cabanillas F, Kantarjian H. Chemoimmunotherapy with hyper-CVAD plus rituximab for the treatment of adult Burkitt and Burkitt-type lymphoma or acute lymphoblastic leukemia. Cancer. 2006 Apr 1;106(7):1569-80. doi: 10.1002/cncr.21776.
Results Reference
background
PubMed Identifier
20660823
Citation
Thomas DA, O'Brien S, Faderl S, Garcia-Manero G, Ferrajoli A, Wierda W, Ravandi F, Verstovsek S, Jorgensen JL, Bueso-Ramos C, Andreeff M, Pierce S, Garris R, Keating MJ, Cortes J, Kantarjian HM. Chemoimmunotherapy with a modified hyper-CVAD and rituximab regimen improves outcome in de novo Philadelphia chromosome-negative precursor B-lineage acute lymphoblastic leukemia. J Clin Oncol. 2010 Aug 20;28(24):3880-9. doi: 10.1200/JCO.2009.26.9456. Epub 2010 Jul 26.
Results Reference
background
PubMed Identifier
11807147
Citation
Coiffier B, Lepage E, Briere J, Herbrecht R, Tilly H, Bouabdallah R, Morel P, Van Den Neste E, Salles G, Gaulard P, Reyes F, Lederlin P, Gisselbrecht C. CHOP chemotherapy plus rituximab compared with CHOP alone in elderly patients with diffuse large-B-cell lymphoma. N Engl J Med. 2002 Jan 24;346(4):235-42. doi: 10.1056/NEJMoa011795.
Results Reference
background
PubMed Identifier
15867204
Citation
Feugier P, Van Hoof A, Sebban C, Solal-Celigny P, Bouabdallah R, Ferme C, Christian B, Lepage E, Tilly H, Morschhauser F, Gaulard P, Salles G, Bosly A, Gisselbrecht C, Reyes F, Coiffier B. Long-term results of the R-CHOP study in the treatment of elderly patients with diffuse large B-cell lymphoma: a study by the Groupe d'Etude des Lymphomes de l'Adulte. J Clin Oncol. 2005 Jun 20;23(18):4117-26. doi: 10.1200/JCO.2005.09.131. Epub 2005 May 2.
Results Reference
background
PubMed Identifier
16123223
Citation
Hiddemann W, Kneba M, Dreyling M, Schmitz N, Lengfelder E, Schmits R, Reiser M, Metzner B, Harder H, Hegewisch-Becker S, Fischer T, Kropff M, Reis HE, Freund M, Wormann B, Fuchs R, Planker M, Schimke J, Eimermacher H, Trumper L, Aldaoud A, Parwaresch R, Unterhalt M. Frontline therapy with rituximab added to the combination of cyclophosphamide, doxorubicin, vincristine, and prednisone (CHOP) significantly improves the outcome for patients with advanced-stage follicular lymphoma compared with therapy with CHOP alone: results of a prospective randomized study of the German Low-Grade Lymphoma Study Group. Blood. 2005 Dec 1;106(12):3725-32. doi: 10.1182/blood-2005-01-0016. Epub 2005 Aug 25.
Results Reference
background
PubMed Identifier
18816698
Citation
Griffin TC, Weitzman S, Weinstein H, Chang M, Cairo M, Hutchison R, Shiramizu B, Wiley J, Woods D, Barnich M, Gross TG; Children's Oncology Group. A study of rituximab and ifosfamide, carboplatin, and etoposide chemotherapy in children with recurrent/refractory B-cell (CD20+) non-Hodgkin lymphoma and mature B-cell acute lymphoblastic leukemia: a report from the Children's Oncology Group. Pediatr Blood Cancer. 2009 Feb;52(2):177-81. doi: 10.1002/pbc.21753.
Results Reference
background
PubMed Identifier
20888994
Citation
Hallek M, Fischer K, Fingerle-Rowson G, Fink AM, Busch R, Mayer J, Hensel M, Hopfinger G, Hess G, von Grunhagen U, Bergmann M, Catalano J, Zinzani PL, Caligaris-Cappio F, Seymour JF, Berrebi A, Jager U, Cazin B, Trneny M, Westermann A, Wendtner CM, Eichhorst BF, Staib P, Buhler A, Winkler D, Zenz T, Bottcher S, Ritgen M, Mendila M, Kneba M, Dohner H, Stilgenbauer S; International Group of Investigators; German Chronic Lymphocytic Leukaemia Study Group. Addition of rituximab to fludarabine and cyclophosphamide in patients with chronic lymphocytic leukaemia: a randomised, open-label, phase 3 trial. Lancet. 2010 Oct 2;376(9747):1164-74. doi: 10.1016/S0140-6736(10)61381-5.
Results Reference
background
PubMed Identifier
19682801
Citation
Ratanatharathorn V, Pavletic S, Uberti JP. Clinical applications of rituximab in allogeneic stem cell transplantation: anti-tumor and immunomodulatory effects. Cancer Treat Rev. 2009 Dec;35(8):653-61. doi: 10.1016/j.ctrv.2009.07.004. Epub 2009 Aug 13.
Results Reference
background
PubMed Identifier
18780832
Citation
Dworzak MN, Schumich A, Printz D, Potschger U, Husak Z, Attarbaschi A, Basso G, Gaipa G, Ratei R, Mann G, Gadner H. CD20 up-regulation in pediatric B-cell precursor acute lymphoblastic leukemia during induction treatment: setting the stage for anti-CD20 directed immunotherapy. Blood. 2008 Nov 15;112(10):3982-8. doi: 10.1182/blood-2008-06-164129. Epub 2008 Sep 9.
Results Reference
background
PubMed Identifier
17706771
Citation
Stanciu-Herrera C, Morgan C, Herrera L. Anti-CD19 and anti-CD22 monoclonal antibodies increase the effectiveness of chemotherapy in Pre-B acute lymphoblastic leukemia cell lines. Leuk Res. 2008 Apr;32(4):625-32. doi: 10.1016/j.leukres.2007.07.002. Epub 2007 Aug 15.
Results Reference
background
PubMed Identifier
15538405
Citation
Gaipa G, Basso G, Maglia O, Leoni V, Faini A, Cazzaniga G, Bugarin C, Veltroni M, Michelotto B, Ratei R, Coliva T, Valsecchi MG, Biondi A, Dworzak MN; I-BFM-ALL-FCM-MRD Study Group. Drug-induced immunophenotypic modulation in childhood ALL: implications for minimal residual disease detection. Leukemia. 2005 Jan;19(1):49-56. doi: 10.1038/sj.leu.2403559.
Results Reference
background
PubMed Identifier
14648023
Citation
Gokbuget N, Hoelzer D. Treatment with monoclonal antibodies in acute lymphoblastic leukemia: current knowledge and future prospects. Ann Hematol. 2004 Apr;83(4):201-5. doi: 10.1007/s00277-003-0752-8. Epub 2003 Nov 26.
Results Reference
background
PubMed Identifier
21403127
Citation
Bachanova V, Sandhu K, Yohe S, Cao Q, Burke MJ, Verneris MR, Weisdorf D. Allogeneic hematopoietic stem cell transplantation overcomes the adverse prognostic impact of CD20 expression in acute lymphoblastic leukemia. Blood. 2011 May 12;117(19):5261-3. doi: 10.1182/blood-2011-01-329573. Epub 2011 Mar 14.
Results Reference
background
PubMed Identifier
16551963
Citation
Cutler C, Miklos D, Kim HT, Treister N, Woo SB, Bienfang D, Klickstein LB, Levin J, Miller K, Reynolds C, Macdonell R, Pasek M, Lee SJ, Ho V, Soiffer R, Antin JH, Ritz J, Alyea E. Rituximab for steroid-refractory chronic graft-versus-host disease. Blood. 2006 Jul 15;108(2):756-62. doi: 10.1182/blood-2006-01-0233. Epub 2006 Mar 21.
Results Reference
background
PubMed Identifier
18278073
Citation
Mohty M, Marchetti N, El-Cheikh J, Faucher C, Furst S, Blaise D. Rituximab as salvage therapy for refractory chronic GVHD. Bone Marrow Transplant. 2008 May;41(10):909-11. doi: 10.1038/bmt.2008.12. Epub 2008 Feb 18. No abstract available.
Results Reference
background
PubMed Identifier
16239908
Citation
Okamoto M, Okano A, Akamatsu S, Ashihara E, Inaba T, Takenaka H, Katoh N, Kishimoto S, Shimazaki C. Rituximab is effective for steroid-refractory sclerodermatous chronic graft-versus-host disease. Leukemia. 2006 Jan;20(1):172-3. doi: 10.1038/sj.leu.2403996. No abstract available.
Results Reference
background
PubMed Identifier
17549053
Citation
Zaja F, Bacigalupo A, Patriarca F, Stanzani M, Van Lint MT, Fili C, Scime R, Milone G, Falda M, Vener C, Laszlo D, Alessandrino PE, Narni F, Sica S, Olivieri A, Sperotto A, Bosi A, Bonifazi F, Fanin R; GITMO (Gruppo Italiano Trapianto Midollo Osseo). Treatment of refractory chronic GVHD with rituximab: a GITMO study. Bone Marrow Transplant. 2007 Aug;40(3):273-7. doi: 10.1038/sj.bmt.1705725. Epub 2007 Jun 4.
Results Reference
background
PubMed Identifier
16799614
Citation
Kebriaei P, Saliba RM, Ma C, Ippoliti C, Couriel DR, de Lima M, Giralt S, Qazilbash MH, Gajewski JL, Ha CS, Champlin RE, Khouri IF. Allogeneic hematopoietic stem cell transplantation after rituximab-containing myeloablative preparative regimen for acute lymphoblastic leukemia. Bone Marrow Transplant. 2006 Aug;38(3):203-9. doi: 10.1038/sj.bmt.1705425. Epub 2006 Jun 26.
Results Reference
background

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Rituximab+mVPDL for CD20(+) Adult Acute Lymphoblastic Leukemia

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