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

This study is ongoing, but not recruiting participants.
Information provided by (Responsible Party):
M.D. Anderson Cancer Center Identifier:
First received: July 12, 2007
Last updated: August 3, 2017
Last verified: August 2017
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.

Condition Intervention Phase
Leukemia Lymphoblastic Lymphoma Leukemia, Lymphoblastic, Acute Drug: Doxorubicin Drug: Cyclophosphamide Drug: Cytarabine Drug: Dexamethasone Drug: Methotrexate Drug: Vincristine Drug: Nelarabine Phase 2

Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment
Masking: No masking
Primary Purpose: Treatment
Official Title: Phase II Study of Hyper-CVAD Plus Nelarabine in Previously Untreated T-ALL and Lymphoblastic Lymphoma

Resource links provided by NLM:

Further study details as provided by M.D. Anderson Cancer Center:

Primary Outcome Measures:
  • 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.

Enrollment: 84
Actual Study Start Date: July 11, 2007
Estimated Study Completion Date: July 2019
Estimated Primary Completion Date: July 2019 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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.

Drug: Vincristine

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

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

  Show Detailed Description


Ages Eligible for Study:   Child, Adult, Senior
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 Is there an age limit? No

  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its identifier: NCT00501826

United States, Texas
University of Texas MD Anderson Cancer Center
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
  More Information

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 )
Study First Received: July 12, 2007
Last Updated: August 3, 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
Hormones, Hormone Substitutes, and Hormone Antagonists
Antineoplastic Agents, Hormonal processed this record on August 16, 2017