Combination Chemotherapy in Treating Patients With Newly Diagnosed Mantle Cell Lymphoma

This study has been completed.
Sponsor:
Collaborator:
Information provided by (Responsible Party):
M.D. Anderson Cancer Center
ClinicalTrials.gov Identifier:
NCT00003311
First received: November 1, 1999
Last updated: October 5, 2012
Last verified: October 2012

November 1, 1999
October 5, 2012
March 1999
April 2007   (final data collection date for primary outcome measure)
Not Provided
Not Provided
Complete list of historical versions of study NCT00003311 on ClinicalTrials.gov Archive Site
Not Provided
Not Provided
Not Provided
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Combination Chemotherapy in Treating Patients With Newly Diagnosed Mantle Cell Lymphoma
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

RATIONALE: Drugs used in chemotherapy use different ways to stop cancer cells from dividing so they stop growing or die. Combining more than one drug may kill more cancer cells.

PURPOSE: Phase II trial to study the effectiveness of different regimens of combination chemotherapy in treating patients with newly diagnosed mantle cell lymphoma.

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.

Interventional
Phase 2
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Lymphoma
  • Biological: filgrastim
  • Drug: cyclophosphamide
  • Drug: cytarabine
  • Drug: dexamethasone
  • Drug: doxorubicin hydrochloride
  • Drug: methotrexate
  • Drug: vincristine sulfate
  • Experimental: Regimen A
    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.
    Interventions:
    • Biological: filgrastim
    • Drug: cytarabine
    • Drug: methotrexate
  • Experimental: Regimen B
    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.
    Interventions:
    • Biological: filgrastim
    • Drug: cyclophosphamide
    • Drug: dexamethasone
    • Drug: doxorubicin hydrochloride
    • Drug: vincristine sulfate
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
19
April 2007
April 2007   (final data collection date for primary outcome measure)

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
Both
16 Years and older
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00003311
CDR0000066258, MDA-DM-97200, NCI-T97-0101, DM97-200
No
M.D. Anderson Cancer Center
M.D. Anderson Cancer Center
National Cancer Institute (NCI)
Study Chair: Jorge E. Romaguera, MD M.D. Anderson Cancer Center
M.D. Anderson Cancer Center
October 2012

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP