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

Sponsor:	M.D. Anderson Cancer Center
Information provided by (Responsible Party):	M.D. Anderson Cancer Center
ClinicalTrials.gov Identifier:	NCT00671658

Purpose

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 or lymphoblastic lymphoma.

Condition	Intervention	Phase
Leukemia Acute Lymphoblastic Leukemia	Drug: Rituximab Drug: Cyclophosphamide (CTX) Drug: Doxorubicin Drug: Vincristine Drug: Dexamethasone Drug: Methotrexate (MTX) Drug: Cytarabine Drug: G-CSF Drug: Mesna Drug: Pegylated asparaginase Drug: Pegfilgrastim Drug: Solumedrol	Phase II

Study Type:	Interventional
Study Design:	Allocation: Non-Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Single Group Assignment Masking: Open Label Primary Purpose: Treatment
Official Title:	Phase II Study of The Modified Hyper-CVAD Program for Acute Lymphoblastic Leukemia

Resource links provided by NLM:

MedlinePlus related topics: Acute Lymphocytic Leukemia Cancer Chronic Lymphocytic Leukemia Leukemia Lymphoma

Drug Information available for: Dexamethasone Cyclophosphamide Prednisolone Prednisolone acetate Depo-medrol Vincristine Methotrexate Cytarabine hydrochloride Mesna Doxorubicin Doxorubicin hydrochloride Dexamethasone acetate Doxiproct plus Medrol veriderm Methylprednisolone Filgrastim Pegaspargase Granulocyte colony-stimulating factor Rituximab Pegfilgrastim Prednisolone sodium phosphate Cytarabine Prednisolone Sodium Succinate Dexamethasone Sodium Phosphate Vincristine sulfate Methylprednisolone Sodium Succinate Methylprednisolone hemisuccinate 6-Methylprednisolone L-Asparaginase

U.S. FDA Resources

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

Primary Outcome Measures:

Overall Response Rate [ Time Frame: After first course of chemotherapy - 21 days. ] [ Designated as safety issue: Yes ]
After the first course of chemotherapy, a chest X-ray may be taken. CT scans may be taken if needed. A bone marrow sample will be taken through a large needle in the hipbone to check for response.

Estimated Enrollment:	280
Study Start Date:	November 2002
Estimated Study Completion Date:	September 2015
Estimated Primary Completion Date:	September 2015 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
Experimental: HYPER-CVAD	Drug: Rituximab 375 mg/m2 by vein Other Name: Rituxan Drug: Cyclophosphamide (CTX) 300 mg/m2 by vein Other Names: Cytoxan Neosar Drug: Doxorubicin 50 mg/m2 by vein Other Names: Adriamycin Rubex Drug: Vincristine 2 mg by vein Other Names: Oncovin Vincasar Pfs Drug: Dexamethasone 40 mg by vein or by mouth (P.O.) Other Name: Decadron Drug: Methotrexate (MTX) 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 Other Name: Rheumatrex Drug: Cytarabine 100 mg intrathecal for Courses 1,3,5,7 3 gm/m2 by vein for Courses 2,4,6,8 Other Names: Ara-C Cytosar-U Arabinosylcytosine DepoCyt Drug: G-CSF 10 ug/kg subcutaneous injection Other Names: Filgrastim Neupogen Drug: Mesna 600 mg/m2 a day by vein Other Name: Mesnex Drug: Pegylated asparaginase 2000 International units/m2 by vein Other Names: Pegaspargase Oncaspar Polyethylene Glycol Conjucated Lasparaginase-H Drug: Pegfilgrastim 6 mg (flat dose) within 72 hrs after completion of chemotherapy Other Names: Neulasta PEG-G-CSF Drug: Solumedrol 40 mg by vein for Courses 2,4,6,8 Other Names: Methylprednisolone Depo-Medrol Medrol

Arms

Assigned Interventions

Experimental: HYPER-CVAD

Drug: Rituximab

375 mg/m2 by vein

Other Name: Rituxan

Drug: Cyclophosphamide (CTX)

300 mg/m2 by vein

Other Names:

Cytoxan
Neosar

Drug: Doxorubicin

50 mg/m2 by vein

Other Names:

Adriamycin
Rubex

Drug: Vincristine

2 mg by vein

Other Names:

Oncovin
Vincasar Pfs

Drug: Dexamethasone

40 mg by vein or by mouth (P.O.)

Other Name: Decadron

Drug: Methotrexate (MTX)

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

Other Name: Rheumatrex

Drug: Cytarabine

100 mg intrathecal for Courses 1,3,5,7

3 gm/m2 by vein for Courses 2,4,6,8

Other Names:

Ara-C
Cytosar-U
Arabinosylcytosine
DepoCyt

Drug: G-CSF

10 ug/kg subcutaneous injection

Other Names:

Filgrastim
Neupogen

Drug: Mesna

600 mg/m2 a day by vein

Other Name: Mesnex

Drug: Pegylated asparaginase

2000 International units/m2 by vein

Other Names:

Pegaspargase
Oncaspar
Polyethylene Glycol Conjucated Lasparaginase-H

Drug: Pegfilgrastim

6 mg (flat dose) within 72 hrs after completion of chemotherapy

Other Names:

Neulasta
PEG-G-CSF

Drug: Solumedrol

40 mg by vein for Courses 2,4,6,8

Other Names:

Methylprednisolone
Depo-Medrol
Medrol

Show Detailed Description

Eligibility

Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

Inclusion Criteria:

Newly diagnosed, previously untreated ALL or lymphoblastic lymphoma, or having achieved CR with one course of induction chemotherapy.
Failure to one induction course of chemotherapy are eligible, but these patients will be analyzed separately.
All ages are eligible.
Zubrod performance less than or equal to 3
Adequate liver function (bilirubin </= 3.0 mg/dl unless considered due to tumor) and renal function (creatinine </= 3.0 mg/dl, unless considered due to tumor).
Adequate cardiac function as assessed by history and physical examination.
No active co-existing malignancy with life expectancy less than 12 months due to that malignancy.

Exclusion Criteria:

1) N/A

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00671658

Contacts

Contact: Susan O'Brien, M.D.

713-792-7543

sobrien@mdanderson.org

Locations

United States, Texas
UT MD Anderson Cancer Center	Recruiting
Houston, Texas, United States, 77030
Contact: Susan O'Brien, M.D. 713-792-7543 sobrien@mdanderson.org
Principal Investigator: Susan O'Brien, M.D.

Sponsors and Collaborators

M.D. Anderson Cancer Center

Investigators

Principal Investigator:

Susan O'Brien, M.D.

M.D. Anderson Cancer Center

More Information

Additional Information:

M.D. Anderson's Website This link exits the ClinicalTrials.gov site

No publications provided

Responsible Party:	M.D. Anderson Cancer Center
ClinicalTrials.gov Identifier:	NCT00671658 History of Changes
Other Study ID Numbers:	ID02-230
Study First Received:	April 30, 2008
Last Updated:	October 13, 2011
Health Authority:	United States: Institutional Review Board

Keywords provided by M.D. Anderson Cancer Center:

Lymphoma
HYPER-CVAD
Leukemia
Acute Lymphoblastic Leukemia
ALL
Remission Duration
Chemotherapy
Asparaginase

Cyclophosphamide
Cytarabine
Dexamethasone
Doxorubicin
Leukine
Methotrexate
Rituximab
Vincristine

Additional relevant MeSH terms:

Leukemia
Leukemia, Lymphoid
Precursor Cell Lymphoblastic Leukemia-Lymphoma
Neoplasms by Histologic Type
Neoplasms
Lymphoproliferative Disorders
Lymphatic Diseases
Immunoproliferative Disorders
Immune System Diseases
Pegaspargase
Rituximab
Asparaginase
Cyclophosphamide
Cytarabine
Dexamethasone

Doxorubicin
Methotrexate
Methylprednisolone Hemisuccinate
Prednisolone
Vincristine
Dexamethasone acetate
Methylprednisolone acetate
Prednisolone acetate
Methylprednisolone
Dexamethasone 21-phosphate
Prednisolone phosphate
BB 1101
Antineoplastic Agents
Therapeutic Uses
Pharmacologic Actions

ClinicalTrials.gov processed this record on February 09, 2012