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Clinical Trial Details — Status: Active, not recruiting

Administrative data

NCT number NCT01429610
Other study ID # KALLA0804
Secondary ID
Status Active, not recruiting
Phase Phase 2
First received
Last updated
Start date November 2011
Est. completion date January 1, 2019

Study information

Verified date July 2018
Source Asan Medical Center
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.


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.


Recruitment information / eligibility

Status Active, not recruiting
Enrollment 78
Est. completion date January 1, 2019
Est. primary completion date January 1, 2018
Accepts healthy volunteers No
Gender All
Age group 15 Years and older
Eligibility 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)

Study Design


Related Conditions & MeSH terms


Intervention

Drug:
Rituximab+mVPDL
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

Locations

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

Sponsors (1)

Lead Sponsor Collaborator
Asan Medical Center

Country where clinical trial is conducted

Korea, Republic of, 

References & Publications (32)

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. — View 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. — View 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. — View Citation

Boissel N, Auclerc MF, Lhéritier 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, Fière 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. Epub 2003 Mar 1. — View 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. — View 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. — View 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. — View 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. Epub 2006 Mar 21. — View Citation

Dworzak MN, Schumich A, Printz D, Pötschger 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. — View Citation

Feugier P, Van Hoof A, Sebban C, Solal-Celigny P, Bouabdallah R, Fermé 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. Epub 2005 May 2. — View 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. — View Citation

Gökbuget N, Hoelzer D. Treatment with monoclonal antibodies in acute lymphoblastic leukemia: current knowledge and future prospects. Ann Hematol. 2004 Apr;83(4):201-5. Epub 2003 Nov 26. Review. — View 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. Epub 2007 Nov 29. — View 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. — View Citation

Hallböök H, Gustafsson G, Smedmyr B, Söderhäll 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. — View Citation

Hallek M, Fischer K, Fingerle-Rowson G, Fink AM, Busch R, Mayer J, Hensel M, Hopfinger G, Hess G, von Grünhagen U, Bergmann M, Catalano J, Zinzani PL, Caligaris-Cappio F, Seymour JF, Berrebi A, Jäger U, Cazin B, Trneny M, Westermann A, Wendtner CM, Eichhorst BF, Staib P, Bühler A, Winkler D, Zenz T, Böttcher S, Ritgen M, Mendila M, Kneba M, Döhner 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. — View 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, Wörmann B, Fuchs R, Planker M, Schimke J, Eimermacher H, Trümper 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. Epub 2005 Aug 25. — View 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. Epub 2006 Aug 8. — View 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. Epub 2006 Jun 26. — View Citation

Maury S, Huguet F, Leguay T, Lacombe F, Maynadié 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, Béné 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. — View Citation

Mohty M, Marchetti N, El-Cheikh J, Faucher C, Fürst 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. — View 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. — View 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. — View 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. Review. — View 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. Epub 2007 Aug 15. — View 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. — View 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. — View 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. — View 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. — View 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. — View 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. — View Citation

Zaja F, Bacigalupo A, Patriarca F, Stanzani M, Van Lint MT, Filì C, Scimè 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. Epub 2007 Jun 4. — View Citation

* Note: There are 32 references in allClick here to view all references

Outcome

Type Measure Description Time frame Safety issue
Primary relapse-free survival (RFS) rate 2 years
Secondary 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
4 weeks (from the initiation of induction treatment)
Secondary 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.
2 years
Secondary 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.
2 years
Secondary Cumulative incidence and maximal severity of acute / chronic graft-versus-host disease among alloHCT recipients 2 years
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