S0213 Chemotherapy Plus Rituximab in Treating Patients With Mantle Cell Lymphoma

Browse trials for

• Lymphoma 5,578
• Lymphoma, Mantle-Cell 783

Keywords

• stage III mantle cell lymphoma
• stage IV mantle cell lymphoma
• contiguous stage II mantle cell lymphoma
• noncontiguous stage II mantle cell lymphoma

Lymphoma

5,578 studies on the registry are indexed under Lymphoma; 825 are open to participants now.

This study's enrollment of 56 is above the median of 40 across 4,508 interventional studies indexed under Lymphoma.

Lead sponsor

SWOG Cancer Research Network is the lead sponsor of 328 studies on the registry; 37 are open to participants now.

Of its 17 completed or terminated interventional studies of FDA-regulated products, 17 (100%) have results posted.

Eligibility criteria

Study arms

• Experimental
  Hyper-CVAD + MTX/Ara-C + Rituximab

  21-day cycles of Hyper-CVAD and high-dose methotrexate/cytarabine are alternated beginning with Hyper-CVAD for a maximum of 8 cycles. Rituximab is given for cycles 1-6. Hyper-CVAD (cycles 1,3,5,7): rituximab 375 mg/m\^2 on day 1, mesna 600 mg/m\^2 on days 2-4, cyclophosphamide 300 mg/m\^2 on days 2-4, doxorubicin 16.6 mg/m\^2/day on days 5-7, vincristine 1.4 mg/m\^2 on days 5 and 12, dexamethasone 40 mg on days 2-5 and 12-15, and filgrastim 5 ug/kg on days 8-21. Methotrexate/Ara-C (cycles 2,4,6,8): rituximab 375 mg/m\^2 on day 1, methotrexate 1000 mg/m\^2 over days 2-3, Ara-C 12 g/m\^2 over days 3-4, leucovorin 170 mg over days 3-5, and G-CSF 5 ug/kg on days 5-21.

  Biological: filgrastim · Biological: rituximab · Drug: cyclophosphamide · Drug: cytarabine · Drug: dexamethasone · Drug: doxorubicin · Drug: leucovorin · Drug: methotrexate · Drug: vincristine

Interventions

• Biologicalfilgrastim

  5 ug/kg

  Also known as: G-CSF

• Biologicalrituximab

  375 mg/m\^2 on day 1 of cycles 1-6

• Drugcyclophosphamide

  300 mg/m\^2 on days 2-4 of cycles 1,3,5,7

  Also known as: cytoxan

• Drugcytarabine

  12 g/m\^2 over days 3-4 of cycles 2,4,6,8

  Also known as: Ara-C

• Drugdexamethasone

  40 mg on days 2-5 and 12-15 of cycles 1,3,5,7

• Drugdoxorubicin

  16.6 mg/m\^2/day for days 5-7 of cycles 1,3,5,7

  Also known as: adriamycin

• Drugleucovorin

  170 mg over days 3-5 of cycles 2,4,6,8

  Also known as: leucovorin calcium

• Drugmethotrexate

  1000 mg/m\^2 over days 2-3 of cycles 2,4,6,8

  Also known as: MTX

• Drugvincristine

  1.4 mg/m\^2 on days 5 and 12 of cycles 1,3,5,7

  Also known as: vincristine sulfate

Primary outcomes

1. Progression-free Survival

   Progression-Free Survival (PFS) rate at 1 year. PFS measured from date of registration to date of first observation of progressive disease or death due to any cause. Progressive disease is a 50% increase in the sum of products of greatest diameters (SPD) of target measurable lesions over the smallest sum observed if a complete response (confirmed, or unconfirmed) was not previously achieved; appearance of a new lesion/site; unequivocal progression of non-measurable disease; or death due to disease without prior documentation of progression.

   Time frame: assessed after cycle 4, after completion of treatment, then every 3 months until 1 year after registration

Secondary outcomes

1. Response

   Complete (CR), complete unconfirmed (CRU) and partial responses (PR). CR is complete disappearance of all measurable and non-measurable disease with the exception of nodes; no new lesions; previously enlarged organs must have regressed in size; and if bone marrow positive at baseline, it must be negative. CRU is complete disappearance of all measurable and non-measurable disease; regressed, non-palpable organs; and one or more exceptions not qualifying for CR (see protocol section 10). PR applies to patients with at least one measurable lesion who do not qualify for CR or CRU. PR is a 50% decrease in sum of products of greatest diameters (SPD) for up to six identified dominant lesions identified at baseline; no new lesions; no increase in the size of liver, spleen or other nodes; and splenic and hepatic nodules must have regressed in size by at least 50% in SPD.

   Time frame: assessed after cycle 4 and after completion of treatment (168 days)

2. Overall Survival

   Overall Survival rate at 1 year. Time to death is from date of registration to date of death due to any cause.

   Time frame: assessed after cycle 4, after completion of treatment, then every 3 months for 2 years, then every 6 months thereafter until 5 years

Baseline characteristics

Publications

• A multi center trial of hyperCVAD+rituxan in patients with newly diagnosed mantle cell lymphoma EM Epner; J Unger; T Miller; L Rimsza; C Spier; M LeBlanc; R Fisher. Blood 110(11):#387. (2007).