MDACC Study Summary 2005-0054

Study Summary
No. 2005-0054:.......Lymphoma......Luis E. Fayad......Lymphoma/Myeloma

Study Summary Title



Study Summary Number:	2005-0054

Study Title:	A Phase II Randomized Study of Rituximab-HCVAD alternating with 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

Physician

New Patient Referral



Name:	Luis E. Fayad	Patients Call:	800-392-1611 (in U.S.A.) 713-792-6161 (outside U.S.A.)

Dept:	Lymphoma/Myeloma	Referring MD Call:	800-392-1611 (in U.S.A.) 713-792-6161 (outside U.S.A.)

Phone:	713-792-2860 Contact us about clinical trials

General Information



Disease Group:	Lymphoma	Supported By:	N/A

Phase of Study:	Phase II	Return Visit:	Every 3 weeks during treatment (21 day cycles). After treatment: every 6 months for years 1,2, 3 and 4 for restaging; yearly afterwards if clinically indicated

Treatment Agents:	Cyclophosphamide Cytarabine Doxorubicin Hyper-CVAD Methotrexate Prednisone Rituximab Vincristine	Home Care:	not applicable

Treatment Loc:	Only at MDACC

Estimated Length of Stay in Houston:	not applicable


Description/ Intervention:	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.

Study Objectives / Outcomes

1. To evaluate the Overall response rate (ORR), Complete Response (CR + Cru), Disease-free survival (DFS), and progression-free survival (PFS) rate following therapy with Rituxan-HCVAD alternating with Rituximab with high-dose methotrexate/ara-C and standard R-CHOP in patients with newly diagnosed B-cell aggressive non-Hodgkin's lymphomas younger than 60 years old and with adjusted IPI 2 or higher adverse prognostic features. Progression-free survival will be done for 3-years
2. Secondary objectives include: overall survival, toxicity profile.

Study Status Information



Study Activation / Registration Date:	08/01/2005

IRB Review and Approval Date:	03/02/2005

Study Type:	Therapeutic

Recruitment Status:	Closed

Projected Accrual:	N/A

Enrollment Eligibility

If you do not meet the enrollment eligibility, there may be other treatment options for you. Please Contact the Referral Office for more information.

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.

Links

Registration Number: NCT00290498
Study Information on Clinical Trials Registry (clinicaltrials.gov)