Hyper-CVAD Plus Nelarabine in Untreated T-ALL/Lymphoblastic Lymphoma

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details. Identifier: NCT00501826
Recruitment Status : Recruiting
First Posted : July 16, 2007
Last Update Posted : November 14, 2017
Information provided by (Responsible Party):
M.D. Anderson Cancer Center

Brief Summary:

The goal of this clinical research study is to learn the effectiveness of intensive chemotherapy given in combination with nelarabine (followed by maintenance therapy) in the treatment of patients with T cel ALL and T cell lymphoblastic lymphoma. The safety of this treatment will also be studied.

This is an investigational study. All of the drugs used in this study are FDA approved and commercially available. Their use together in this study is investigational and for use in research only. Up to 100 patients will take part in this study. All will be enrolled at MD Anderson.

Condition or disease Intervention/treatment Phase
Leukemia Lymphoblastic Lymphoma Leukemia, Lymphoblastic, Acute Drug: Doxorubicin Drug: Cyclophosphamide Drug: Cytarabine Drug: Dexamethasone Drug: Methotrexate Drug: Vincristine Drug: Nelarabine Drug: Mesna Drug: 6-MP Drug: Prednisone Phase 2

  Show Detailed Description

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 100 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Phase II Study of Hyper-CVAD Plus Nelarabine in Previously Untreated T-ALL and Lymphoblastic Lymphoma
Actual Study Start Date : July 11, 2007
Estimated Primary Completion Date : July 2019
Estimated Study Completion Date : July 2019

Arm Intervention/treatment
Experimental: Hyper-CVAD + Nelarabine
Intensive chemotherapy (hyper-CVAD therapy) includes combination of 7 chemotherapy drugs: Adriamycin (doxorubicin), cyclophosphamide, cytarabine (Ara-C), dexamethasone, methotrexate, nelarabine, and vincristine.
Drug: Doxorubicin

Hyper-CVAD (odd courses 1, 3, 5, 7):

50 mg/m^2 IV over 24 hours on day 4 after last dose of Cyclophosphamide (CTX)

Other Names:
  • Adriamycin
  • Rubex

Drug: Cyclophosphamide

Hyper-CVAD (odd courses 1, 3, 5, 7):

300 mg/m^2 IV over 3 hours every 12 hours x 6 doses days 1, 2, 3 (total dose 1800 mg/m2).

Other Names:
  • Neosar
  • Cytoxan

Drug: Cytarabine

High-dose Methotrexate plus cytarabine (even courses 2, 4, 6, 8):

Cytarabine 3 gm/m^2 IV over 2 hours every 12 hours for 4 doses on days 2, 3

Other Names:
  • Ara-C
  • Cytosar
  • DepoCyt
  • Cytosine Arabinosine Hydrochloride

Drug: Dexamethasone

Hyper-CVAD (odd courses 1, 3, 5, 7):

40 mg IV or by mouth (PO) daily days 1-4 and 11-14.

Other Name: Decadron

Drug: Methotrexate

High-dose Methotrexate plus cytarabine (even courses 2, 4, 6, 8):

200 mg/m^2 IV over 2 hours followed by 800 mg/m^2 over 22 hours on day 1.

Maintenance (POMP) (courses 1 - 5, 8 - 17, and 20 - 30):

20 mg/m2 (rounded) by mouth weekly.

Drug: Vincristine

Hyper-CVAD (odd courses 1, 3, 5, 7):

2 mg IV days 4 and 11 (+/- 2 days)

Maintenance (POMP) (courses 1 - 5, 8 - 17, and 20 - 30):

Vincristine 2 mg by vein approximately every 28 days.

Drug: Nelarabine
650 mg/m^2 IV over 2 hours daily x 5 days every 21 to 35 days x 2 courses.
Other Name: Arranon

Drug: Mesna

Hyper-CVAD (odd courses 1, 3, 5, 7):

600 mg/m2/d IV CI daily, starting 1 hour prior to CTX and completing by 12 hrs after the last dose of CTX.

Other Name: Mesnex

Drug: 6-MP

Maintenance (POMP) (courses 1 - 5, 8 - 17, and 20 - 30):

50 mg by mouth three times daily.

Other Names:
  • Mercaptopurine
  • 6-mercaptopurine
  • Purinethol

Drug: Prednisone

Maintenance (POMP) (courses 1 - 5, 8 - 17, and 20 - 30):

200 mg by mouth daily days 1 to 5 approximately every 28 days, starting with vincristine (if given).

Primary Outcome Measures :
  1. Complete Remission (CR) Rate [ Time Frame: 3 Years ]
    Complete remission (CR) defined as normalization of peripheral blood and bone marrow with 5% or less blasts in a normocellular or hypercellular marrow with a granulocyte count of 1 x 109/L or above and a platelet count of 100 x 109/L or above. Complete resolution of all sites of extramedullary disease is required for CR. Remission interval is dated from end of the 4-week normalization period that defines CR, and assessed by methods of Kaplan and Meier.

Information from the National Library of Medicine

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Ages Eligible for Study:   Child, Adult, Older Adult
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

Inclusion Criteria:

  1. 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.
  2. ECOG performance status less than or equal to 3.
  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. SGOT or SGPT less than or equal to 4 x ULN.
  4. 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:

1) Pregnant or nursing women

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00501826

Contact: Farhad Ravandi-Kashani, MD 713-745-0394

United States, Texas
University of Texas MD Anderson Cancer Center Recruiting
Houston, Texas, United States, 77030
Sponsors and Collaborators
M.D. Anderson Cancer Center
Principal Investigator: Farhad Ravandi-Kashani, M.D. M.D. Anderson Cancer Center

Additional Information:
Responsible Party: M.D. Anderson Cancer Center Identifier: NCT00501826     History of Changes
Other Study ID Numbers: 2006-0328
NCI-2012-01518 ( Registry Identifier: NCI CTRP )
First Posted: July 16, 2007    Key Record Dates
Last Update Posted: November 14, 2017
Last Verified: November 2017

Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by M.D. Anderson Cancer Center:
T-cell ALL
Lymphoblastic Lymphoma

Additional relevant MeSH terms:
Precursor Cell Lymphoblastic Leukemia-Lymphoma
Lymphoma, Non-Hodgkin
Neoplasms by Histologic Type
Lymphoproliferative Disorders
Lymphatic Diseases
Immunoproliferative Disorders
Immune System Diseases
Leukemia, Lymphoid
Dexamethasone acetate
Liposomal doxorubicin
BB 1101
Anti-Inflammatory Agents
Autonomic Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Gastrointestinal Agents