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Phase II CCOP Trial of High Dose Methotrexate/ARA-C and HCVAD for Newly Diagnosed Nodular and Diffuse Mantle Cell Lymphoma and Their Blastic Variants


Phase 2
16 Years
N/A
Not Enrolling
Both
Lymphoma

Thank you

Trial Information

Phase II CCOP Trial of High Dose Methotrexate/ARA-C and HCVAD for Newly Diagnosed Nodular and Diffuse Mantle Cell Lymphoma and Their Blastic Variants


OBJECTIVES:

- Evaluate the complete response rate and duration of response in patients with newly
diagnosed diffuse or nodular mantle cell lymphoma or their blastic variant treated with
high-dose methotrexate and cytarabine and high-dose cyclophosphamide, dexamethasone,
doxorubicin, and vincristine (HCVAD).

OUTLINE: This is a multicenter study. Patients may receive either regimen A or both regimen
A and regimen B, depending upon response.

- Regimen A: Patients receive methotrexate IV over 24 hours on day 1. Cytarabine is
administered IV over 2 hours every 12 hours on days 2 and 3. Filgrastim (G-CSF) is
administered subcutaneously (SC) daily beginning on day 4 and continuing until blood
counts recover. Treatment repeats every 21 days for up to 8 courses.

- Regimen B: Patients receive cyclophosphamide IV over 3 hours every 12 hours on days
1-3. Doxorubicin is administered IV over 24 hours on days 4 and 5. Vincristine is
administered IV over 30 minutes on days 4 and 11. Dexamethasone is administered orally
or IV on days 1-4 and 11-14. G-CSF is administered SC beginning on day 6 and continuing
until blood counts recover. Treatment repeats every 21 days for up to 7 courses.

Patients are followed every 3 months for 1 year, every 4 months for 1 year, every 6 months
for 2 years, and then annually thereafter.

PROJECTED ACCRUAL: A total of 21-45 patients will be accrued for this study within 4 years.

Inclusion Criteria


DISEASE CHARACTERISTICS:

- Histologically confirmed previously untreated nodular or diffuse mantle cell lymphoma
or their blastic variant

- No CNS involvement

- Not a candidate for stem cell transplantation or refuses one

PATIENT CHARACTERISTICS:

Age:

- 16 and over

Performance status:

- Zubrod 0-2

Life expectancy:

- Not specified

Hematopoietic:

- Absolute neutrophil count greater than 1,000/mm^3*

- Platelet count greater than 100,000/mm^3* NOTE: * Unless lymphoma involvement

Hepatic:

- Bilirubin less than 1.5 mg/dL (unless lymphoma involvement)

Renal:

- Creatinine less than 2.0 mg/dL (unless lymphoma involvement)

Cardiovascular:

- Cardiac ejection fraction at least 50% (for patients over age 40)

Other:

- Must be willing to receive blood transfusion

- Not pregnant or nursing

- Fertile patients must use effective contraception

- HIV negative

- No other co-morbid medical or psychiatric illness that would preclude treatment

- No prior or concurrent malignancy with poor prognosis (less than 90% probability of
survival at 5 years)

PRIOR CONCURRENT THERAPY:

Biologic therapy

- See Disease Characteristics

Chemotherapy

- Not specified

Endocrine therapy

- Not specified

Radiotherapy

- Not specified

Surgery

- Not specified

Type of Study:

Interventional

Study Design:

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Principal Investigator

Jorge E. Romaguera, MD

Investigator Role:

Study Chair

Investigator Affiliation:

M.D. Anderson Cancer Center

Authority:

United States: Federal Government

Study ID:

CDR0000066258

NCT ID:

NCT00003311

Start Date:

March 1999

Completion Date:

April 2007

Related Keywords:

  • Lymphoma
  • stage I mantle cell lymphoma
  • contiguous stage II mantle cell lymphoma
  • noncontiguous stage II mantle cell lymphoma
  • stage III mantle cell lymphoma
  • stage IV mantle cell lymphoma
  • Lymphoma
  • Lymphoma, Mantle-Cell

Name

Location

University of Texas - MD Anderson Cancer CenterHouston, Texas  77030-4009