Chemotherapy and Rituximab With Peripheral Stem Cell Transplantation in Treating Patients With Mantle Cell Lymphoma

Conditions

• Lymphoma

Eligibility Criteria

Sex

ALL

Age

18 Years - 69 Years

Healthy Volunteers

Not accepted

Interventions

• filgrastim — BIOLOGICAL
  5 ug/kg subQ daily day 4 until ANC \>10,000 (or ANC\> 5000 2X)Tx 1, 2, 4 10 ug/kg subQ daily day 14 until completion of PBSC collection Tx 3
• rituximab — BIOLOGICAL
  375 mg/sq m IV infusion at , or = 400 mg/hr day 1 Tx 1, 2, days 5 \& 12 Tx 3, and weekly for 2 doses Tx 5
• carmustine — DRUG
  15 mg/kg IV infusion over 2 hours Day 6, Tx 4
• cyclophosphamide — DRUG
  2000 mg/sq m IV infusion over 2 hours Day 3, Tx 1 \& 2 100 mg/kg IV infusion over 2 hours Day 2, Tx 4
• cytarabine — DRUG
  2000 mg/sq m IV infusion BID over 2 hours x 8 doses Days 1-4, Tx 3
• doxorubicin hydrochloride — DRUG
  50 mg/sq m IVP Day 3, Tx 1\& 2
• etoposide — DRUG
  40 mg/kg total dose continuous IV infusion over 96 hours Days 1-4, Tx 3
• leucovorin calcium — DRUG
  50 mg/sq m IV infusion q 6 hours x 3 doses after MTX, then 10 mg/sq m IV/PO q 6 hrs until MTX levels \<0.05 uM, Tx 1 \& 2
• methotrexate — DRUG
  300 mg/sq m IV infusion over 4 hrs Day 2 Tx 1 \& 2
• prednisone — DRUG
  100 mg/sq m PO Days 3-7, Tx 1 \& 2
• vincristine sulfate — DRUG
  1.4 mg/sq m IVP Day 3, Tx 1 \& 2
• peripheral blood stem cell transplantation — PROCEDURE
  Stem cells collected during Tx 3 will be transfused follwing chemotx in Tx 4

Study Details

RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. Monoclonal antibodies such as rituximab can locate tumor cells and either kill them or deliver tumor-killing substances to them without harming normal cells. Peripheral stem cell transplantation may allow the doctor to give higher doses of chemotherapy drugs and kill more cancer cells. PURPOSE: Phase II trial to study the effectiveness of combining chemotherapy and rituximab with peripheral stem cell transplantation in treating patients who have mantle cell lymphoma.

Key Dates

Start date

Jun 30, 2001

Status verified

Jul 2016

Primary completion

Dec 31, 2006

Completion

Sep 30, 2009

Study Design

Enrollment

79 participants (actual)

Allocation

NON_RANDOMIZED

Intervention model

SINGLE_GROUP

Primary purpose

TREATMENT

Arms

• Experimental: Chemo/immuno/autolog transplant
  Intensive chemotherapy followed by autologous stem cell transplant and immunotherapy for mantle cell lymphoma

Primary Outcome Measure

Progression Free Survival [ Time Frame: 2 years ]

Locations (80)

Find similar trials in Anniston, AL

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