Clinical Trials /

Combination Chemotherapy and Nelarabine in Treating Patients With T-cell Acute Lymphoblastic Leukemia or Lymphoblastic Lymphoma

NCT00501826

Description:

This phase II trial studies the side effects and how well combination chemotherapy and nelarabine work in treating patients with T-cell acute lymphoblastic leukemia or lymphoblastic lymphoma. Drugs used in chemotherapy, such as cyclophosphamide, vincristine, doxorubicin, dexamethasone, methotrexate, cytarabine, mercaptopurine, prednisone, pegaspargase, nelarabine, and venetoclax work in different ways to stop the growth of cancer cells, either by killing the cells, by stopping them from dividing, or by stopping them from spreading.

Related Conditions:
  • Adult T-Cell Acute Lymphoblastic Leukemia
  • T-Cell Lymphoblastic Lymphoma
Recruiting Status:

Recruiting

Phase:

Phase 2

Trial Eligibility

Document

Title

  • Brief Title: Combination Chemotherapy and Nelarabine in Treating Patients With T-cell Acute Lymphoblastic Leukemia or Lymphoblastic Lymphoma
  • Official Title: Phase II Study of Hyper-CVAD Plus Nelarabine in Previously Untreated T-ALL and Lymphoblastic Lymphoma

Clinical Trial IDs

  • ORG STUDY ID: 2006-0328
  • SECONDARY ID: NCI-2012-01518
  • SECONDARY ID: 2006-0328
  • NCT ID: NCT00501826

Conditions

  • T Acute Lymphoblastic Leukemia
  • T Lymphoblastic Lymphoma

Interventions

DrugSynonymsArms
Cyclophosphamide(-)-Cyclophosphamide, 2H-1,3,2-Oxazaphosphorine, 2-[bis(2-chloroethyl)amino]tetrahydro-, 2-oxide, monohydrate, Carloxan, Ciclofosfamida, Ciclofosfamide, Cicloxal, Clafen, Claphene, CP monohydrate, CTX, CYCLO-cell, Cycloblastin, Cycloblastine, Cyclophospham, Cyclophosphamid monohydrate, Cyclophosphamide Monohydrate, Cyclophosphamidum, Cyclophosphan, Cyclophosphane, Cyclophosphanum, Cyclostin, Cyclostine, Cytophosphan, Cytophosphane, Cytoxan, Fosfaseron, Genoxal, Genuxal, Ledoxina, Mitoxan, Neosar, Revimmune, Syklofosfamid, WR- 138719Treatment (nelarabine and combination chemotherapy)
Cytarabine.beta.-Cytosine arabinoside, 1-.beta.-D-Arabinofuranosyl-4-amino-2(1H)pyrimidinone, 1-.beta.-D-Arabinofuranosylcytosine, 1-Beta-D-arabinofuranosyl-4-amino-2(1H)pyrimidinone, 1-Beta-D-arabinofuranosylcytosine, 1.beta.-D-Arabinofuranosylcytosine, 2(1H)-Pyrimidinone, 4-Amino-1-beta-D-arabinofuranosyl-, 2(1H)-Pyrimidinone, 4-amino-1.beta.-D-arabinofuranosyl-, Alexan, Ara-C, ARA-cell, Arabine, Arabinofuranosylcytosine, Arabinosylcytosine, Aracytidine, Aracytin, Aracytine, Beta-cytosine Arabinoside, CHX-3311, Cytarabinum, Cytarbel, Cytosar, Cytosine Arabinoside, Cytosine-.beta.-arabinoside, Cytosine-beta-arabinoside, Erpalfa, Starasid, Tarabine PFS, U 19920, U-19920, Udicil, WR-28453Treatment (nelarabine and combination chemotherapy)
DexamethasoneAacidexam, Adexone, Aknichthol Dexa, Alba-Dex, Alin, Alin Depot, Alin Oftalmico, Amplidermis, Anemul mono, Auricularum, Auxiloson, Baycadron, Baycuten, Baycuten N, Cortidexason, Cortisumman, Decacort, Decadrol, Decadron, Decadron DP, Decalix, Decameth, Decasone R.p., Dectancyl, Dekacort, Deltafluorene, Deronil, Desamethasone, Desameton, Dexa-Mamallet, Dexa-Rhinosan, Dexa-Scheroson, Dexa-sine, Dexacortal, Dexacortin, Dexafarma, Dexafluorene, Dexalocal, Dexamecortin, Dexameth, Dexamethasone Intensol, Dexamethasonum, Dexamonozon, Dexapos, Dexinoral, Dexone, Dinormon, Fluorodelta, Fortecortin, Gammacorten, Hexadecadrol, Hexadrol, Lokalison-F, Loverine, Methylfluorprednisolone, Millicorten, Mymethasone, Orgadrone, Spersadex, TaperDex, Visumetazone, ZoDexTreatment (nelarabine and combination chemotherapy)
Doxorubicin Hydrochloride5,12-Naphthacenedione, 10-[(3-amino-2,3,6-trideoxy-alpha-L-lyxo-hexopyranosyl)oxy]-7,8, 9,10-tetrahydro-6,8,11-trihydroxy-8-(hydroxyacetyl)-1-methoxy-, hydrochloride, (8S-cis)- (9CI), ADM, Adriacin, Adriamycin, Adriamycin Hydrochloride, Adriamycin PFS, Adriamycin RDF, ADRIAMYCIN, HYDROCHLORIDE, Adriamycine, Adriblastina, Adriblastine, Adrimedac, Chloridrato de Doxorrubicina, DOX, DOXO-CELL, Doxolem, Doxorubicin HCl, Doxorubicin.HCl, Doxorubin, Farmiblastina, FI 106, FI-106, hydroxydaunorubicin, RubexTreatment (nelarabine and combination chemotherapy)
Mercaptopurine3H-Purine-6-thiol, 6 MP, 6 Thiohypoxanthine, 6 Thiopurine, 6-Mercaptopurine, 6-Mercaptopurine Monohydrate, 6-MP, 6-Purinethiol, 6-Thiopurine, 6-Thioxopurine, 6H-Purine-6-thione, 1,7-dihydro- (9CI), 7-Mercapto-1,3,4,6-tetrazaindene, Alti-Mercaptopurine, Azathiopurine, BW 57-323H, Flocofil, Ismipur, Leukerin, Leupurin, Mercaleukim, Mercaleukin, Mercaptina, Mercaptopurinum, Mercapurin, Mern, NCI-C04886, Puri-Nethol, Purimethol, Purine, 6-mercapto-, Purine-6-thiol (8CI), Purine-6-thiol, monohydrate, Purinethiol, Purinethol, U-4748, WR-2785Treatment (nelarabine and combination chemotherapy)
MethotrexateAbitrexate, Alpha-Methopterin, Amethopterin, Brimexate, CL 14377, CL-14377, Emtexate, Emthexat, Emthexate, Farmitrexat, Fauldexato, Folex, Folex PFS, Lantarel, Ledertrexate, Lumexon, Maxtrex, Medsatrexate, Metex, Methoblastin, Methotrexate LPF, Methotrexate Methylaminopterin, Methotrexatum, Metotrexato, Metrotex, Mexate, Mexate-AQ, MTX, Novatrex, Rheumatrex, Texate, Tremetex, Trexeron, Trixilem, WR-19039Treatment (nelarabine and combination chemotherapy)
Nelarabine2-Amino-6-methoxypurine arabinoside, 506U78, Arranon, Compound 506U78, GW506U78Treatment (nelarabine and combination chemotherapy)
PegaspargaseL-Asparaginase with Polyethylene Glycol, Oncaspar, Oncaspar-IV, PEG-Asparaginase, PEG-L-Asparaginase, PEG-L-Asparaginase (Enzon - Kyowa Hakko), PEGLA, Polyethylene Glycol L-Asparaginase, Polyethylene Glycol-L-AsparaginaseTreatment (nelarabine and combination chemotherapy)
Prednisone.delta.1-Cortisone, 1, 2-Dehydrocortisone, Adasone, Cortancyl, Dacortin, DeCortin, Decortisyl, Decorton, Delta 1-Cortisone, Delta-Dome, Deltacortene, Deltacortisone, Deltadehydrocortisone, Deltasone, Deltison, Deltra, Econosone, Lisacort, Meprosona-F, Metacortandracin, Meticorten, Ofisolona, Orasone, Panafcort, Panasol-S, Paracort, Perrigo Prednisone, PRED, Predicor, Predicorten, Prednicen-M, Prednicort, Prednidib, Prednilonga, Predniment, Prednisone Intensol, Prednisonum, Prednitone, Promifen, Rayos, Servisone, SK-PrednisoneTreatment (nelarabine and combination chemotherapy)
VenetoclaxABT-0199, ABT-199, ABT199, GDC-0199, RG7601, Venclexta, VenclyxtoTreatment (nelarabine and combination chemotherapy)
Vincristine SulfateKyocristine, Leurocristine sulfate, Leurocristine, sulfate, Oncovin, Vincasar, Vincosid, Vincrex, Vincristine, sulfateTreatment (nelarabine and combination chemotherapy)

Purpose

This phase II trial studies the side effects and how well combination chemotherapy and nelarabine work in treating patients with T-cell acute lymphoblastic leukemia or lymphoblastic lymphoma. Drugs used in chemotherapy, such as cyclophosphamide, vincristine, doxorubicin, dexamethasone, methotrexate, cytarabine, mercaptopurine, prednisone, pegaspargase, nelarabine, and venetoclax work in different ways to stop the growth of cancer cells, either by killing the cells, by stopping them from dividing, or by stopping them from spreading.

Detailed Description

      PRIMARY OBJECTIVES:

      I. To determine the complete remission (CR) rate and progression-free survival following
      treatment with hyperfractionated cyclophosphamide, vincristine sulfate, doxorubicin
      hydrochloride, and dexamethasone (hyper-CVAD) in combination with nelarabine in previously
      untreated patients with T-cell acute lymphoblastic leukemia (ALL) and T-cell lymphoblastic
      lymphoma.

      II. To determine the safety and overall survival of previously untreated patients with T-cell
      ALL and T-cell lymphoblastic lymphoma.

      III. To determine the safety and efficacy of adding pegaspargase to the regimen.

      IV. To determine the safety and efficacy of adding venetoclax to the regimen.

      OUTLINE:

      COURSES 1, 3, 5, and 7 (hyper-CVAD): Patients receive cyclophosphamide intravenously (IV)
      over 3 hours twice daily (BID) on day 1-3, doxorubicin IV over 24 hours on day 4, vincristine
      IV over 15-30 minutes on days 4 and 11, and dexamethasone IV or orally (PO) once daily (QD)
      on days 1-4 and 11-14.

      COURSES 2, 4, 6, and 8 (methotrexate/cytarabine): Patients receive methotrexate IV over 24
      hours on day 1 and cytarabine IV over 2 hours BID on days 2 and 3.

      Patients also receive venetoclax PO QD on days 1-14 of each course. Courses of hyper-CVAD and
      methotrexate/cytarabine repeat every 21 days in the absence of disease progression or
      unacceptable toxicity.

      Patients also receive nelarabine IV over 2 hours once daily (QD) for 5 days and pegaspargase
      IV over 2 hours on day 5 after completion of course 4 and after the completion of course 5 in
      the absence of disease progression or unacceptable toxicity.

      MAINTENANCE COURSES 1-5, 8-17, and 20-30 (mercaptopurine, vincristine, methotrexate, and
      prednisone [POMP]): Patients receive mercaptopurine PO thrice daily (TID), methotrexate PO
      once weekly, vincristine sulfate IV on day 1, prednisone PO QD on days 1-5, and venetoclax PO
      QD on days 1-7. Courses repeat every 28 days in the absence of disease progression or
      unacceptable toxicity.

      INTENSIFICATION COURSES 6 and 7: Patients receive nelarabine IV QD over 2 hours on days 1-5
      and pegaspargase IV over 2 hours on day 5. Patients also receive venetoclax PO QD on days
      1-14. Courses repeat every 21-35 days in the absence of disease progression or unacceptable
      toxicity.

      INTENSIFICATION COURSES 18 and 19: Patients receive methotrexate IV over 2 hours on day 1,
      pegaspargase IV over 2 hours on day 2, and venetoclax PO QD on days 1-14 in the absence of
      disease progression or unacceptable toxicity.

      POMP maintenance therapy continues for 30 months in the absence of disease progression or
      unacceptable toxicity.

      After completion of study treatment, patients are followed up every 3-6 months.
    

Trial Arms

NameTypeDescriptionInterventions
Treatment (nelarabine and combination chemotherapy)ExperimentalSee Detailed Description
  • Cyclophosphamide
  • Cytarabine
  • Dexamethasone
  • Doxorubicin Hydrochloride
  • Mercaptopurine
  • Methotrexate
  • Nelarabine
  • Pegaspargase
  • Prednisone
  • Venetoclax
  • Vincristine Sulfate

Eligibility Criteria

        Inclusion Criteria:

          -  Previously untreated T cell ALL including T cell lymphoblastic lymphoma; failure to
             one induction course of chemotherapy are eligible; patients in CR after =< 2 courses
             are also eligible

          -  Eastern Cooperative Oncology Group (ECOG) performance status less than or equal to 3

          -  Serum bilirubin less than or equal to 2.0 mg/dL unless considered due to involvement
             by tumor when an upper limit of 5.0 mg/dL is acceptable

          -  Serum glutamic oxaloacetic transaminase (SGOT) or serum glutamate pyruvate
             transaminase (SGPT) less than or equal to 4 x upper limit of normal (ULN)

          -  Serum creatinine less than or equal to 2.0 mg/dL unless considered due to involvement
             by tumor when an upper limit of 2.5 mg/dL is acceptable

        Exclusion Criteria:

          -  Pregnant or nursing women
      
Maximum Eligible Age:N/A
Minimum Eligible Age:N/A
Eligible Gender:All
Healthy Volunteers:No

Primary Outcome Measures

Measure:Complete remission rate
Time Frame:3 years
Safety Issue:
Description:The sample size will provide an estimate of relapse rate at 3 years with a 95% confidence interval of width +/- 10%.

Details

Phase:Phase 2
Primary Purpose:Interventional
Overall Status:Recruiting
Lead Sponsor:M.D. Anderson Cancer Center

Last Updated

April 28, 2021