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

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00671658
First Posted: May 5, 2008
Last Update Posted: August 26, 2013
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. Read our disclaimer for details.
Information provided by (Responsible Party):
M.D. Anderson Cancer Center
  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 (ALL) 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 2

Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment
Masking: None (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:


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

Primary Outcome Measures:
  • Overall Response Rate [ Time Frame: Response assessed following first 21 day course ]
    ALL Response: Complete remission (CR) - Normalization peripheral blood & bone marrow 5% or < blasts in normocellular or hypercellular marrow granulocyte count of 1 x 109/L or > & platelet count >100 x 109/L. CR with incomplete platelet recovery (CRp)- per CR but platelet count <100 x 109/L. CR with incomplete recovery (CRi) - per CR but platelet count <100 x 109/L or absolute neutrophil count < 1 x 109/L. Partial response (PR) - As above except for presence of 6-25% marrow blasts. Lymphoblastic lymphoma (& ALL subtypes with extramedullary disease): CR - disappearance of all known disease. PR - >50% decrease in tumor size using sum of product, includes 50% volume decrease in lesions measurable in 3 dimensions. No Response (NR) - No significant change (includes stable disease). Lesions decreased size but <50% or lesions with slight enlargement <25% increase in size. Progressive Disease (PD) - Appearance of new lesions, 25% or > increase in size existing lesions (>50% if 1 lesion & <2).


Enrollment: 220
Study Start Date: November 2002
Study Completion Date: July 2013
Primary Completion Date: July 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: HYPER-CVAD
Rituximab 375 mg/m2 by vein. Cyclophosphamide (CTX) 300 mg/m2 by vein. Doxorubicin 50 mg/m2 by vein. Vincristine 2 mg by vein. Dexamethasone 40 mg by vein or by mouth (P.O.). 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. Cytarabine 100 mg intrathecal for Courses 1,3,5,7 - 3 gm/m2 by vein for Courses 2,4,6,8. G-CSF 10 ug/kg subcutaneous injection. Mesna 600 mg/m2 a day by vein. Pegylated asparaginase 2000 International units/m2 by vein. Pegfilgrastim 6 mg (flat dose) within 72 hrs after completion of chemotherapy. Solumedrol 40 mg by vein for Courses 2,4,6,8.
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

Information from the National Library of Medicine

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, Learn About Clinical Studies.


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

Inclusion Criteria:

  1. Newly diagnosed, previously untreated ALL or lymphoblastic lymphoma, or having achieved CR with one course of induction chemotherapy.
  2. Failure to one induction course of chemotherapy are eligible, but these patients will be analyzed separately.
  3. All ages are eligible.
  4. Zubrod performance less than or equal to 3
  5. 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).
  6. Adequate cardiac function as assessed by history and physical examination.
  7. No active co-existing malignancy with life expectancy less than 12 months due to that malignancy.

Exclusion Criteria:

1) N/A

  Contacts and Locations
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 ClinicalTrials.gov identifier (NCT number): NCT00671658


Locations
United States, Texas
UT MD Anderson Cancer Center
Houston, Texas, United States, 77030
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:
Responsible Party: M.D. Anderson Cancer Center
ClinicalTrials.gov Identifier: NCT00671658     History of Changes
Other Study ID Numbers: ID02-230
First Submitted: April 30, 2008
First Posted: May 5, 2008
Last Update Posted: August 26, 2013
Last Verified: August 2013

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
Precursor Cell Lymphoblastic Leukemia-Lymphoma
Leukemia, Lymphoid
Neoplasms by Histologic Type
Neoplasms
Lymphoproliferative Disorders
Lymphatic Diseases
Immunoproliferative Disorders
Immune System Diseases
Dexamethasone acetate
Prednisolone acetate
Methylprednisolone acetate
Dexamethasone
Methylprednisolone
Methylprednisolone Hemisuccinate
Prednisolone
Prednisolone hemisuccinate
Prednisolone phosphate
Liposomal doxorubicin
Pegaspargase
Cyclophosphamide
Rituximab
Doxorubicin
Methotrexate
Cytarabine
Vincristine
Asparaginase
BB 1101
Anti-Inflammatory Agents
Antiemetics