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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
M.D. Anderson Cancer Center
ClinicalTrials.gov Identifier:
NCT00671658
First received: April 30, 2008
Last updated: August 23, 2013
Last verified: August 2013
  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: 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:


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 ] [ Designated as safety issue: No ]
    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

Genders Eligible for Study:   Both
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
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: 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:
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: August 23, 2013
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
Immune System Diseases
Immunoproliferative Disorders
Lymphatic Diseases
Lymphoproliferative Disorders
Neoplasms
Neoplasms by Histologic Type
Asparaginase
BB 1101
Cyclophosphamide
Cytarabine
Dexamethasone
Dexamethasone 21-phosphate
Dexamethasone acetate
Doxorubicin
Liposomal doxorubicin
Methotrexate
Methylprednisolone
Rituximab
Vincristine
Abortifacient Agents
Abortifacient Agents, Nonsteroidal
Alkylating Agents
Anti-Infective Agents
Anti-Inflammatory Agents
Antibiotics, Antineoplastic
Antiemetics
Antimetabolites

ClinicalTrials.gov processed this record on November 24, 2014