Rituximab-HCVAD in Patients With B-Cell Non-Hodgkin's Lymphoma - Full Text View

Sponsor:	M.D. Anderson Cancer Center
Collaborator:	Genentech
Information provided by (Responsible Party):	M.D. Anderson Cancer Center
ClinicalTrials.gov Identifier:	NCT00290498

Purpose

The overall goal of this clinical research study was to find out which of two different chemotherapy drug combinations, R-CHOP and R-HCVAD, is more effective in treating B-cell lymphoma.

At this point, all participants will now be assigned to the R-HCVAD arm of the study. Researchers will study the safety and effectiveness of this drug combination.

Condition	Intervention	Phase
Lymphoma	Drug: Rituximab Drug: Cyclophosphamide Drug: Doxorubicin Drug: Vincristine Drug: Dexamethasone Drug: Methotrexate Drug: Cytarabine Drug: Prednisone	Phase II

Study Type:	Interventional
Study Design:	Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: Open Label Primary Purpose: Treatment
Official Title:	Rituximab-HCVAD Alternating Rituximab-Methotrexate-Cytarabine Versus Standard Rituximab-CHOP Every 21 Days for Patients With Newly Diagnosed High Risk Aggressive B-Cell Non-Hodgkin's Lymphomas in Patients 60 Years Old or Younger

Resource links provided by NLM:

MedlinePlus related topics: Cancer Lymphoma

Drug Information available for: Dexamethasone Cyclophosphamide Prednisone Vincristine Methotrexate Cytarabine hydrochloride Doxorubicin Doxorubicin hydrochloride Dexamethasone acetate Doxiproct plus Rituximab Cytarabine Dexamethasone Sodium Phosphate Vincristine sulfate

U.S. FDA Resources

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

Primary Outcome Measures:

Overall Response [ Time Frame: 4 Months ] [ Designated as safety issue: Yes ]

Estimated Enrollment:	66
Study Start Date:	August 2005
Estimated Primary Completion Date:	August 2014 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
Experimental: Arm A R-HCVAD + R-MTX/Ara-C ((Rituximab-HCVAD (rituximab, doxorubicin, cyclophosphamide, vincristine, and dexamethasone) alternating with Rituximab-Methotrexate-Cytarabine))	Drug: Rituximab Arm A: Rituximab 375 mg/m² by vein on day 1, Cycle 1 and alternating cycles. Arm B: Rituximab 375 mg/m² on day 1, Cycle 2 and alternating cycles. Other Name: Rituxan Drug: Cyclophosphamide Arm A: Cyclophosphamide 300 mg/m^2 by vein (IVPB) over 3 hours every 12 hours x 6 doses on Days 2-4, Cycle 1 and alternating cycles. Arm B: Cyclophosphamide 750 mg/m² by vein day 1 Other Names: Cytoxan Neosar Drug: Doxorubicin Arm A: Doxorubicin 50 mg/m^2/day by vein over 15 minutes (12 hours after last dose of cyclophosphamide) on Day 5, Cycle 1 and alternating cycles. Other Names: AD Hydroxydaunomycin hydrochloride Drug: Vincristine Arm A: Vincristine 1.4 mg/m^2 (maximum 2 mg) by vein (IVPB) on Days 5 (1-24 hours after last cyclophosphamide) and on day 12, Cycle 1 and alternating cycles. Arm B: Vincristine 1.4 mg/m^2 (maximum 2 mg) by vein (IVPB) on Days 5 (1-24 hours after last cyclophosphamide) and on day 12 of each cycle. Drug: Dexamethasone Arm A: Dexamethasone 40 mg by vein or by mouth daily x 4 on Days 2-5 and on days 12-15 of cycle 1 and alternating cycles. Other Name: Decadron Drug: Methotrexate Arm A: Methotrexate after finishing Rituximab, 200 mg/m2 by vein over 2 hours, then 800 mg/m2 by vein over 22 hours day 1 cycle 2.
Active Comparator: Arm B R-CHOP ((Rituximab-CHOP (Rituximab, cyclophosphamide, vincristine, and prednisone)) No longer recruiting for this study arm.	Drug: Rituximab Arm A: Rituximab 375 mg/m² by vein on day 1, Cycle 1 and alternating cycles. Arm B: Rituximab 375 mg/m² on day 1, Cycle 2 and alternating cycles. Other Name: Rituxan Drug: Cyclophosphamide Arm A: Cyclophosphamide 300 mg/m^2 by vein (IVPB) over 3 hours every 12 hours x 6 doses on Days 2-4, Cycle 1 and alternating cycles. Arm B: Cyclophosphamide 750 mg/m² by vein day 1 Other Names: Cytoxan Neosar Drug: Cytarabine Arm B: Cytarabine 3 g/m^2 by vein over 2 hours every 12 hours X 4 doses on days 3 & 4, cycle 2 and alternating cycles. Other Names: Ara-C Cytosar DepoCyt Cytosine arabinosine hydrochloride Drug: Prednisone Arm B: Prednisone 100 mg by mouth (as a pill, capsule, or tablet) once a day on Days 1-5, each cycle.

Arms

Assigned Interventions

Experimental: Arm A

R-HCVAD + R-MTX/Ara-C ((Rituximab-HCVAD (rituximab, doxorubicin, cyclophosphamide, vincristine, and dexamethasone) alternating with Rituximab-Methotrexate-Cytarabine))

Drug: Rituximab

Arm A: Rituximab 375 mg/m² by vein on day 1, Cycle 1 and alternating cycles. Arm B: Rituximab 375 mg/m² on day 1, Cycle 2 and alternating cycles.

Other Name: Rituxan

Drug: Cyclophosphamide

Arm A: Cyclophosphamide 300 mg/m^2 by vein (IVPB) over 3 hours every 12 hours x 6 doses on Days 2-4, Cycle 1 and alternating cycles.

Arm B: Cyclophosphamide 750 mg/m² by vein day 1

Other Names:

Cytoxan
Neosar

Drug: Doxorubicin

Arm A: Doxorubicin 50 mg/m^2/day by vein over 15 minutes (12 hours after last dose of cyclophosphamide) on Day 5, Cycle 1 and alternating cycles.

Other Names:

AD
Hydroxydaunomycin hydrochloride

Drug: Vincristine

Arm A: Vincristine 1.4 mg/m^2 (maximum 2 mg) by vein (IVPB) on Days 5 (1-24 hours after last cyclophosphamide) and on day 12, Cycle 1 and alternating cycles.

Arm B: Vincristine 1.4 mg/m^2 (maximum 2 mg) by vein (IVPB) on Days 5 (1-24 hours after last cyclophosphamide) and on day 12 of each cycle.

Drug: Dexamethasone

Arm A: Dexamethasone 40 mg by vein or by mouth daily x 4 on Days 2-5 and on days 12-15 of cycle 1 and alternating cycles.

Other Name: Decadron

Drug: Methotrexate

Arm A: Methotrexate after finishing Rituximab, 200 mg/m2 by vein over 2 hours, then 800 mg/m2 by vein over 22 hours day 1 cycle 2.

Active Comparator: Arm B

R-CHOP ((Rituximab-CHOP (Rituximab, cyclophosphamide, vincristine, and prednisone))

No longer recruiting for this study arm.

Drug: Rituximab

Arm A: Rituximab 375 mg/m² by vein on day 1, Cycle 1 and alternating cycles. Arm B: Rituximab 375 mg/m² on day 1, Cycle 2 and alternating cycles.

Other Name: Rituxan

Drug: Cyclophosphamide

Arm A: Cyclophosphamide 300 mg/m^2 by vein (IVPB) over 3 hours every 12 hours x 6 doses on Days 2-4, Cycle 1 and alternating cycles.

Arm B: Cyclophosphamide 750 mg/m² by vein day 1

Other Names:

Cytoxan
Neosar

Drug: Cytarabine

Arm B: Cytarabine 3 g/m^2 by vein over 2 hours every 12 hours X 4 doses on days 3 & 4, cycle 2 and alternating cycles.

Other Names:

Ara-C
Cytosar
DepoCyt
Cytosine arabinosine hydrochloride

Drug: Prednisone

Arm B: Prednisone 100 mg by mouth (as a pill, capsule, or tablet) once a day on Days 1-5, each cycle.

Show Detailed Description

Eligibility

Ages Eligible for Study:	16 Years to 60 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

Inclusion Criteria:

Confirmed diagnosis of previously untreated large B-cell Non Hodgkin's, Large Cell Lymphoma and B-Cell with high grade features. Other aggressive lymphomas such as Primary Mediastinal large B-cell Lymphomas will be also allowed to be included.
Patients with performance status of 0-2 (Zubrod Scale).
Serum bilirubin <1.5 mg/dl and serum creatinine < 2.0 mg/dl unless due to lymphoma; ANC >1000/mm^3 and platelets >100,000/mm^3 unless due to lymphoma.
Cardiac ejection fraction 50% or greater.
Ages 16 - 60 years (due to the fact that CHOP-R is not studied enough in younger patients and is not considered standard of care).
Patients must be willing to receive transfusions of blood products.
Age adjusted International Prognostic Index Score of 2 or more
Previous steroids are allowed (if used to relieve some symptoms such as SVC, etc).

Exclusion Criteria:

Pregnancy (excluded due to the teratogenicity of the involved chemotherapy agents
Positive HIV serology because of poor tolerance to this intense chemotherapy regimen
Burkitt's lymphomas, and Mantle cell lymphoma, transformed follicular center cell lymphoma, follicular grade III.
Any clinical or cytological diagnosis of CNS involvement
Any co-morbid medical, such as Child's Class C liver cirrhosis, end-stage renal disease, and symptomatic congestive heart failure, or psychiatric illnesses that preclude treatment with intense dose chemotherapy as determined by the primary investigator.
Concurrent or previous malignancy whose prognosis is poor (< 90% probability of survival at 5 years)
Active Hepatitis B or C. Chronic carriers for Hepatitis B will be excluded.

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00290498

Contacts

Contact: Luis E. Fayad, MD

713-792-2860

Locations

United States, Texas
UT MD Anderson Cancer Center	Recruiting
Houston, Texas, United States, 77030

Sponsors and Collaborators

M.D. Anderson Cancer Center

Genentech

Investigators

Principal Investigator:

Luis E. Fayad, MD

UT MD Anderson Cancer Center

More Information

Additional Information:

UT MD Anderson Cancer Center This link exits the ClinicalTrials.gov site

No publications provided

Responsible Party:	M.D. Anderson Cancer Center
ClinicalTrials.gov Identifier:	NCT00290498 History of Changes
Other Study ID Numbers:	2005-0054
Study First Received:	February 10, 2006
Last Updated:	December 15, 2011
Health Authority:	United States: Institutional Review Board

Keywords provided by M.D. Anderson Cancer Center:

Non-Hodgkin's Lymphoma
B-Cell Non-Hodgkin's Lymphoma
Lymphoma
Cyclophosphamide
Cytarabine
Doxorubicin
Hyper-CVAD
Methotrexate
Prednisone
Rituximab
Vincristine
R-CHOP

R-HCVAD
Dexamethasone
Decadron
Leucovorin
Ara-C
Cytosar
Cytoxan
DepoCyt
Cytosine arabinosine hydrochloride
AD
Hydroxydaunomycin hydrochloride
Neosar

Additional relevant MeSH terms:

Lymphoma
Lymphoma, Non-Hodgkin
Lymphoma, B-Cell
Neoplasms by Histologic Type
Neoplasms
Lymphoproliferative Disorders
Lymphatic Diseases
Immunoproliferative Disorders
Immune System Diseases
Cyclophosphamide
Cytarabine
Methotrexate
Rituximab
Dexamethasone
Doxorubicin

Prednisone
Vincristine
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
Antineoplastic Agents

ClinicalTrials.gov processed this record on February 09, 2012