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

This study is currently recruiting participants. (see Contacts and Locations)
Verified September 2014 by M.D. Anderson Cancer Center
Sponsor:
Collaborator:
GlaxoSmithKline
Information provided by (Responsible Party):
M.D. Anderson Cancer Center
ClinicalTrials.gov Identifier:
NCT00501826
First received: July 12, 2007
Last updated: September 24, 2014
Last verified: September 2014
  Purpose

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: Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
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 ] [ Designated as safety issue: No ]
    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.


Estimated Enrollment: 60
Study Start Date: July 2007
Estimated Primary Completion Date: July 2016 (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

  Eligibility

Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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.

  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 ClinicalTrials.gov identifier: NCT00501826

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

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

Additional Information:
No publications provided

Responsible Party: M.D. Anderson Cancer Center
ClinicalTrials.gov Identifier: NCT00501826     History of Changes
Other Study ID Numbers: 2006-0328, NCI-2012-01518
Study First Received: July 12, 2007
Last Updated: September 24, 2014
Health Authority: United States: Institutional Review Board

Keywords provided by M.D. Anderson Cancer Center:
Leukemia
ALL
T-cell ALL
Lymphoblastic Lymphoma
Hyper-CVAD
Doxorubicin
Cyclophosphamide
Cytarabine
Dexamethasone
Methotrexate
Vincristine
Nelarabine

Additional relevant MeSH terms:
Lymphoma, Non-Hodgkin
Lymphoma
Leukemia
Precursor Cell Lymphoblastic Leukemia-Lymphoma
Neoplasms by Histologic Type
Neoplasms
Lymphoproliferative Disorders
Lymphatic Diseases
Immunoproliferative Disorders
Immune System Diseases
Leukemia, Lymphoid
Cyclophosphamide
Cytarabine
Methotrexate
Liposomal doxorubicin
Dexamethasone
Vincristine
Doxorubicin
Dexamethasone acetate
Dexamethasone 21-phosphate
BB 1101
Immunosuppressive Agents
Immunologic Factors
Physiological Effects of Drugs
Pharmacologic Actions
Antirheumatic Agents
Therapeutic Uses
Antineoplastic Agents, Alkylating
Alkylating Agents
Molecular Mechanisms of Pharmacological Action

ClinicalTrials.gov processed this record on September 30, 2014