Modified Hyper-CVAD (Cyclophosphamide, Vincristine, Adriamycin, and Dexamethasone) Program for Acute Lymphoblastic Leukemia
This study is ongoing, but not recruiting participants.
Sponsor:
M.D. Anderson Cancer Center
Information provided by (Responsible Party):
M.D. Anderson Cancer Center
ClinicalTrials.gov Identifier:
NCT00671658
First received: April 30, 2008
Last updated: September 6, 2012
Last verified: September 2012
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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 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:
Drug Information available for:
Dexamethasone
Cyclophosphamide
Prednisolone
Prednisolone acetate
Methylprednisolone acetate
Methotrexate
Methylprednisolone
Prednisolone sodium phosphate
Cytarabine
Prednisolone phosphate
Dexamethasone acetate
Prednisolone sodium succinate
Vincristine sulfate
Methylprednisolone sodium succinate
Dexamethasone sodium phosphate
Asparaginase
Methotrexate sodium
Mesna
Doxorubicin
Doxorubicin hydrochloride
Filgrastim
Pegaspargase
Granulocyte colony-stimulating factor
Rituximab
Pegfilgrastim
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
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:
Drug: Doxorubicin
50 mg/m2 by vein
Other Names:
Drug: Vincristine
2 mg by vein
Other Names:
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:
Drug: G-CSF
10 ug/kg subcutaneous injection
Other Names:
Drug: Mesna
600 mg/m2 a day by vein
Other Name: Mesnex
Drug: Pegylated asparaginase
2000 International units/m2 by vein
Other Names:
Drug: Pegfilgrastim
6 mg (flat dose) within 72 hrs after completion of chemotherapy
Other Names:
Drug: Solumedrol
40 mg by vein for Courses 2,4,6,8
Other Names:
|
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
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: | September 6, 2012 |
| 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 Mesna Methylprednisolone Methylprednisolone Hemisuccinate Pegaspargase Rituximab Asparaginase |
Cyclophosphamide Cytarabine Dexamethasone Doxorubicin Methotrexate Prednisolone Vincristine Dexamethasone acetate Methylprednisolone acetate Prednisolone acetate Dexamethasone 21-phosphate Prednisolone hemisuccinate Prednisolone phosphate BB 1101 Protective Agents |
ClinicalTrials.gov processed this record on June 17, 2013