Modified Hyper-CVAD (Cyclophosphamide, Vincristine, Adriamycin, and Dexamethasone) Program for Acute Lymphoblastic Leukemia

Part of paid clinical trials in Houston, Texas.

Sponsor
M.D. Anderson Cancer Center
Study ID
NCT00671658
Phase
PHASE2
Status
Completed

Conditions

Eligibility Criteria

Sex
ALL
Age
N/A - N/A
Healthy Volunteers
Not accepted

Interventions

  • Rituximab — DRUG
    375 mg/m2 by vein
  • Cyclophosphamide (CTX) — DRUG
    300 mg/m2 by vein
  • Doxorubicin — DRUG
    50 mg/m2 by vein
  • Vincristine — DRUG
    2 mg by vein
  • Dexamethasone — DRUG
    40 mg by vein or by mouth (P.O.)
  • Methotrexate (MTX) — DRUG
    12 mg intrathecally (6 mg if via Ommaya reservoir) for Courses 1,3,5,7 200 mg/m2 by vein followed by 800 mg/m2 for Courses 2,4,6,8
  • Cytarabine — DRUG
    100 mg intrathecal for Courses 1,3,5,7 3 gm/m2 by vein for Courses 2,4,6,8
  • G-CSF — DRUG
    10 ug/kg subcutaneous injection
  • Mesna — DRUG
    600 mg/m2 a day by vein
  • Pegylated asparaginase — DRUG
    2000 International units/m2 by vein
  • Pegfilgrastim — DRUG
    6 mg (flat dose) within 72 hrs after completion of chemotherapy
  • Solumedrol — DRUG
    40 mg by vein for Courses 2,4,6,8

Study Details

The goal of this clinical research study is to learn if intensive chemotherapy (with monoclonal antibody therapy in some patients) given for 8 courses over 5 to 6 months followed by monthly maintenance chemotherapy for 2 ½ years can improve or cure acute lymphoblastic leukemia (ALL) or lymphoblastic lymphoma.

Key Dates

Start date
Nov 30, 2002
Status verified
Dec 2020
Primary completion
Jul 31, 2013
Completion
Jul 31, 2013

Study Design

Enrollment
220 participants (actual)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • Experimental: HYPER-CVAD
    Rituximab 375 mg/m\^2 intravenous (IV), Cyclophosphamide (CTX) 300 mg/m\^2 IV, Doxorubicin 50 mg/m\^2 IV, Vincristine 2 mg IV, Dexamethasone 40 mg IV or oral (PO). Methotrexate (MTX) 12 mg intrathecally (6 mg if via Ommaya reservoir) for Courses 1,3,5,7 - 200 mg/m\^2 IV followed by 800 mg/m\^2 for Courses 2,4,6,8. Cytarabine 100 mg intrathecal for Courses 1,3,5,7 - 3 gm/m\^2 IV for Courses 2,4,6,8. G-CSF 10 ug/kg subcutaneous injection. Mesna 600 mg/m2 a day IV, Pegylated asparaginase 2000 International units/m\^2 IV. Pegfilgrastim 6 mg (flat dose) within 72 hrs after completion of chemotherapy. Solumedrol 40 mg IV for Courses 2,4,6,8.

Primary Outcome Measure

Number of Participants With a Response [ Time Frame: Response assessed following first 21 day course up to end of treatment with 8 cycles, up to 210 days ]

Locations (1)

FacilityCityStateZIPSite coordinators
UT MD Anderson Cancer CenterHoustonTexas77030-

Find similar trials in Houston, TX

By condition
Leukemia (other)
By specialty
OncologyBlood cancer
By research site
UT MD Anderson Cancer Center· Houston, TX

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