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

This study is ongoing, but not recruiting participants.
Sponsor:
Collaborator:
Genentech, Inc.
Information provided by (Responsible Party):
M.D. Anderson Cancer Center
ClinicalTrials.gov Identifier:
NCT00290498
First received: February 10, 2006
Last updated: September 3, 2014
Last verified: September 2014
  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 2

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:


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 ]
    Logistic regression utilized to assess effect of patient prognostic factors on response rate. Distributions of time-to-event endpoints including overall survival and progression free survival estimated using method of Kaplan and Meier. Comparison of time-to-event endpoints by important subgroups made using log-rank test.


Estimated Enrollment: 66
Study Start Date: August 2005
Estimated Primary Completion Date: August 2016 (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.

  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:

  1. 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.
  2. Patients with performance status of 0-2 (Zubrod Scale).
  3. 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.
  4. Cardiac ejection fraction 50% or greater.
  5. 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).
  6. Patients must be willing to receive transfusions of blood products.
  7. Age adjusted International Prognostic Index Score of 2 or more
  8. Previous steroids are allowed (if used to relieve some symptoms such as SVC, etc).

Exclusion Criteria:

  1. Pregnancy (excluded due to the teratogenicity of the involved chemotherapy agents
  2. Positive HIV serology because of poor tolerance to this intense chemotherapy regimen
  3. Burkitt's lymphomas, and Mantle cell lymphoma, transformed follicular center cell lymphoma, follicular grade III.
  4. Any clinical or cytological diagnosis of CNS involvement
  5. 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.
  6. Concurrent or previous malignancy whose prognosis is poor (< 90% probability of survival at 5 years)
  7. Active Hepatitis B or C. Chronic carriers for Hepatitis B will be excluded.
  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: NCT00290498

Locations
United States, Texas
University of Texas MD Anderson Cancer Center
Houston, Texas, United States, 77030
Sponsors and Collaborators
M.D. Anderson Cancer Center
Genentech, Inc.
Investigators
Principal Investigator: Luis E. Fayad, MD M.D. Anderson Cancer Center
  More Information

Additional Information:
No publications provided

Responsible Party: M.D. Anderson Cancer Center
ClinicalTrials.gov Identifier: NCT00290498     History of Changes
Other Study ID Numbers: 2005-0054, NCI-2012-01355
Study First Received: February 10, 2006
Last Updated: September 3, 2014
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, Non-Hodgkin
Lymphoma, B-Cell
Lymphoma
Neoplasms by Histologic Type
Neoplasms
Lymphoproliferative Disorders
Lymphatic Diseases
Immunoproliferative Disorders
Immune System Diseases
Cyclophosphamide
Methotrexate
Cytarabine
Rituximab
Liposomal doxorubicin
Dexamethasone
Vincristine
Doxorubicin
Prednisone
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

ClinicalTrials.gov processed this record on October 19, 2014