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Therapeutic Areas: Oncology | Hematology | Immunology
Disease Category: Lymphoma
Location: United States, IL

Clinical Trial Details

Overview

Research Study Summary

SWOG S1106 Phase II Randomized Study of Induction Therapy Comprising Rituximab, Cyclophosphamide, Doxorubicin Hydrochloride, Vincristine Sulfate, Dexamethasone, Methotrexate, Cytarabine, and Leucovorin Calcium Versus Rituximab and Bendamustine Hydrochloride Followed by Consolidation Therapy and Autologous Stem Cell Transplantation in Older Patients With Previously Untreated Mantle Cell Lymphoma

Purpose

This study is being done to find out what effects, good and/or bad, a combination of drugs called "R-HCVAD/MTX/ARA-C" vs. "R-bendamustine" followed by a stem cell transplant has on you and your mantle cell lymphoma. (7/12/12) The drugs in the R-HCVAD/MTX/ ARA-C combination are rituximab, cyclophosphamide, vincristine, doxorubicin, dexamethasone, methotrexate, and cytarabine. The drugs in R-bendamustine are rituximab and bendamustine. All of the drugs used in this protocol are FDA approved

Patient Inclusion Criteria:

  • All patients must have previously untreated stage III, IV, or bulky stage II mantle cell lymphoma (MCL)
  • Patients must not have clinical evidence of central nervous system (CNS) involvement by lymphoma
  • Any laboratory or radiographic tests performed prior to registration to assess CNS involvement must be negative
  • Patients must have a unilateral/bilateral bone marrow aspirate and biopsy for staging performed within 42 days prior to registration
  • If the biopsy cannot be performed but the aspirate is unequivocally consistent with mantle cell lymphoma, this will be considered adequate for staging purposes
  • Patients must be eligible for stem cell transplantation by institutional guidelines with the plan that transplant will be conducted at a cooperative group-approved transplant center
  • Patients must be planning to undergo stem cell transplantation within 84 days after day 1 of the last induction course

Patient Exclusion Criteria:

  • Zubrod performance status of 0-2
  • Bilirubin ≤ 3 times upper limit of normal (ULN)
  • Serum creatinine ≤ 2.0 times ULN
  • ALT and AST ≤ 2.5 times ULN
  • All patients ≥ 45 years of age must have an echocardiogram (ECHO) or MUGA scan within 42 days prior to registration (whichever method is used at baseline must be used at restaging)
  • Patients < 45 years of age should have ECHO/MUGA only if clinically indicated
  • Patients with an ejection fraction < institutional lower limit of normal (ILLN) are not eligible
  • Serum LDH and a CBC with differential must be measured within 28 days prior to registration
  • Patients known to be HIV positive, or who have a history of solid organ transplantation, are ineligible
  • No active hepatitis
  • No other prior malignancy is allowed except for the following: adequately treated basal cell or squamous cell skin cancer; in situ cervical cancer; adequately treated Stage I or II cancer from which the patient is currently in complete remission; or any other cancer from which the patient has been disease-free for 5 years
  • Pregnant or nursing women may not participate
  • Women or men of reproductive potential may not participate unless they have agreed to use an effective contraceptive method

To Learn more
Phase

2

Gender

Both Male and Female

Age

N/A

Overall Status

Recruiting

Facility Type

N/A

Contact

Janeen V. Bazan, RN OCN BSN CCRP, Oncology Research Nurse Program Coordinator
Sherman Health
1425 North Randall Road
Elgin, IL 60123
Phone: 224-783-2907
Fax: 224-783-3071

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If you would like to learn more about participating in this research study, please email the trial contact using the form below.

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CW ID: 183153

Date Last Changed: July 17, 2013


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