A Phase 2 interventional study of Cyclophosphamide and Cytarabine in Acute Lymphoblastic Leukemia, BCR-ABL1 Fusion Protein Expression and Blast Phase Chronic Myelogenous Leukemia, BCR-ABL1 Positive, sponsored by M.D. Anderson Cancer Center. Completed at 1 site in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2025-02-17.
Sponsored by M.D. Anderson Cancer Center · Phase 2, Interventional, and Treatment
This phase II trial studies how well combination chemotherapy and dasatinib works in treating participants with Philadelphia-positive or B-cell receptor-ABL positive acute lymphoblastic leukemia. Drugs used in chemotherapy, such as cyclophosphamide, vincristine, doxorubicin, dexamethasone, methotrexate, and cytarabine, work in different ways to stop the growth of tumor cells, either by killing the cells, by stopping them from dividing, or by stopping them from spreading. Dasatinib may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. Giving chemotherapy in combination with dasatinib may work better in treating participants with Philadelphia-positive or BCR-ABL positive acute lymphoblastic leukemia.
PRIMARY OBJECTIVES:
I. To evaluate the clinical efficacy (event-free survival) of an intensive short-term chemotherapy regimen (Hyper- cyclophosphamide, vincristine, doxorubicin, dexamethasone [CVAD] program) given in combination with the tyrosine kinase inhibitor dasatinib for Philadelphia (Ph)-positive and/or B-cell receptor BCR-ABL-positive acute lymphoblastic leukemia (ALL).
II. To evaluate other clinical efficacy (overall response rate and survival) and safety of an intensive short-term chemotherapy regimen (Hyper-CVAD program) given in combination with the tyrosine kinase inhibitor dasatinib for Philadelphia (Ph)-positive and/or BCR-ABL-positive acute lymphoblastic leukemia (ALL).
OUTLINE:
HYPER-CVAD THERAPY: Participants receive cyclophosphamide intravenously (IV) twice daily (BID) over 3 hours on days 1-3, vincristine IV over 30 minutes on days 4 and 11, and doxorubicin IV over 24-48 hours on day 4. Participants also receive dexamethasone orally (PO) or IV over 30 minutes on days 1-4 and 11-14, and dasatinib PO once daily (QD) on days 1-14 of course 1 and on days 1-21 for subsequent courses. Courses repeat every 21 days for up to 4 odd courses (1, 3, 5, and 7) in the absence of disease progression or unacceptable toxicity.
METHOTREXATE PLUS CYTARABINE: Participants receive methotrexate IV over 24 hours on day 1, dasatinib PO on days 1-21, and cytarabine IV BID over 2 hours on days 2 and 3. Courses repeat every 21 days for up to 4 even courses (2, 4, 6, and 8) in the absence of disease progression or unacceptable toxicity.
MAINTENANCE THERAPY: Participants receive vincristine IV over 30 minutes on day 1, prednisone PO on days 1-5, and dasatinib PO BID. Courses repeat every 28 days for up to 2 years in the absence of disease progression or unacceptable toxicity. During courses 6 and 13, participants may receive an additional course of hyper-CVAD therapy.
After completion of study treatment, participants are followed for up to 12 months.
5,441 studies on the registry are indexed under Leukemia; 636 are open to participants now.
This study's enrollment of 107 is above the median of 38 across 4,247 interventional studies indexed under Leukemia.
Browse Leukemia studies →M.D. Anderson Cancer Center is the lead sponsor of 2,999 studies on the registry; 581 are open to participants now.
Of its 599 completed or terminated interventional studies of FDA-regulated products, 402 (67%) have results posted.
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Exclusion Criteria:
History of significant bleeding disorder unrelated to cancer, including:
See detailed description in outline.
Drug: Cyclophosphamide · Drug: Cytarabine · Drug: Dasatinib · Drug: Dexamethasone · Drug: Doxorubicin · Drug: Methotrexate · Drug: Prednisone · Drug: Vincristine
Given IV
Also known as: (-)-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, Cyclophosphamidum, Cyclophosphan, Cyclophosphane, Cyclophosphanum, Cyclostin, Cyclostine, Cytophosphan, Cytophosphane, Cytoxan, Fosfaseron, Genoxal, Genuxal, Ledoxina, Mitoxan, Neosar, Revimmune, Syklofosfamid, WR- 138719
Given IV or IT
Also known as: .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-28453
Given PO
Also known as: BMS-354825, Sprycel
Given IV or PO
Also known as: Aacidexam, Adexone, Aknichthol Dexa, Alba-Dex, Alin, Alin Depot, Alin Oftalmico, Amplidermis, Anemul mono, Auricularum, Auxiloson, Baycuten, Baycuten N, Cortidexason, Cortisumman, Decacort, Decadrol, Decadron, 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, Dexamethasonum, Dexamonozon, Dexapos, Dexinoral, Dexone, Dinormon, Fluorodelta, Fortecortin, Gammacorten, Hexadecadrol, Hexadrol, Lokalison-F, Loverine, Methylfluorprednisolone, Millicorten, Mymethasone, Orgadrone, Spersadex, Visumetazone
Given IV
Also known as: Adriablastin, Hydroxyl Daunorubicin, Hydroxyldaunorubicin
Given IV or IT
Also known as: Abitrexate, 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-19039
Given PO
Also known as: .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, PRED, Predicor, Predicorten, Prednicen-M, Prednicort, Prednidib, Prednilonga, Predniment, Prednisonum, Prednitone, Promifen, Servisone, SK-Prednisone
Given IV
Also known as: LEUROCRISTINE, VCR, Vincrystine
Event-free Survival Rate (EFS)
Time from date of treatment start until the date of failure or death from any cause.
Time frame: Up to 17 years, 4 months, 2 days
Disease-free Survival
Time from date of treatment start until the date of first objective documentation of disease-relapse.
Time frame: Up to 17 years, 4 months, 2 days
Participants With a Response
Participants achieving complete remission (CR) + partial remission (PR) - Complete Remission (CR): Normalization of the peripheral blood and bone marrow with 5% or less blasts in normocellular or hypercellular marrow with a granulocyte count of 1 x 10\^9/L or above, and platelet count of 100 x 10\^9/L. Complete resolution of all sites of extramedullary disease is required for CR.
Time frame: Up to 17 years, 4 months, 2 days
Overall Survival
Time from date of treatment start until date of death due to any cause or last Follow-up.
Time frame: Up to 17 years, 4 months, 2 days
| Milestone | Treatment (Chemotherapy, Dasatinib) |
|---|---|
| Started | 107 |
| Completed | 107 |
| Not completed | 0 |
Time from date of treatment start until the date of failure or death from any cause.
| Months | Treatment (Chemotherapy, Dasatinib) |
|---|---|
| Event-free Survival Rate (EFS) | 21.3 (0.2 to 208) |
Time from date of treatment start until the date of first objective documentation of disease-relapse.
| Months | Treatment (Chemotherapy, Dasatinib) |
|---|---|
| Disease-free Survival | 25.3 (0.3 to 208) |
Participants achieving complete remission (CR) + partial remission (PR) - Complete Remission (CR): Normalization of the peripheral blood and bone marrow with 5% or less blasts in normocellular or hypercellular marrow with a granulocyte count of 1 x 10\^9/L or above, and platelet count of 100 x 10\^9/L. Complete resolution of all sites of extramedullary disease is required for CR.
| Participants | Treatment (Chemotherapy, Dasatinib) |
|---|---|
| Participants With a Response | 95 |
Time from date of treatment start until date of death due to any cause or last Follow-up.
| Months | Treatment (Chemotherapy, Dasatinib) |
|---|---|
| Overall Survival | 42.9 (0.2 to 208) |
Collected over Up to 17 years, 4 months, 2 days. Non-serious events are listed at a 5% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Treatment (Chemotherapy, Dasatinib) | 4/107 (3.7%) | 38/107 (35.5%) | 0/107 (0%) |
| Event | Treatment (Chemotherapy, Dasatinib) |
|---|---|
| Neutropenic FeverBlood and lymphatic system disorders | 13/107 |
| Pleural EffusionRespiratory, thoracic and mediastinal disorders | 11/107 |
| FeverGeneral disorders | 8/107 |
| PneumoniaInfections and infestations | 5/107 |
| DiarrheaGastrointestinal disorders | 4/107 |
| Nausea/VomitingGastrointestinal disorders | 4/107 |
| Gastrointestinal BleedGastrointestinal disorders | 3/107 |
| Urinary Tract InfectionInfections and infestations | 3/107 |
| abdominal PainGastrointestinal disorders | 2/107 |
| Bilateral Pleural EffusionRespiratory, thoracic and mediastinal disorders | 2/107 |
| Age, Categorical(Participants) | Treatment (Chemotherapy, Dasatinib) |
|---|---|
| <=18 years | 0 |
| Between 18 and 65 years | 87 |
| >=65 years | 20 |
| Age, Continuous(years) | Treatment (Chemotherapy, Dasatinib) |
|---|---|
| Median | 53 (21 to 80) |
| Sex: Female, Male(Participants) | Treatment (Chemotherapy, Dasatinib) |
|---|---|
| Female | 48 |
| Male | 59 |
| Race (NIH/OMB)(Participants) | Treatment (Chemotherapy, Dasatinib) |
|---|---|
| American Indian or Alaska Native | 0 |
| Asian | 7 |
| Native Hawaiian or Other Pacific Islander | 0 |
| Black or African American | 10 |
| White | 60 |
| More than one race | 0 |
| Unknown or Not Reported | 30 |
| Region of Enrollment(participants) | Treatment (Chemotherapy, Dasatinib) |
|---|---|
| United States | 107 |
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M.D. Anderson Cancer Center