NCT00020943|CompletedPhase 2

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

A Phase II Study Of Intensive Induction Chemotherapy Followed By Autologous Stem Cell Transplantation Plus Immunotherapy For Mantle Cell Lymphoma

Alliance for Clinical Trials in Oncology ClinicalTrials.gov

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3 other identifiers

CALGB-59909U10CA031946CDR0000068732

Study Type

interventional

Target

Locations

2 countries

Sites

Timeline

RegisteredJan 2003

StartedJun 2001

CompletionSep 2009

Brief Summary

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.

Trial Health

On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment

participants targeted

Target at P75+ for phase_2 lymphoma

Timeline

Completed

Started Jun 2001

Typical duration for phase_2 lymphoma

Geographic Reach

2 countries

81 active sites

Status

completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

8.3 years study duration

Study Start

First participant enrolled

June 1, 2001

Completed

1 month until next milestone

First Submitted

Initial submission to the registry

July 11, 2001

Completed

1.5 years until next milestone

First Posted

Study publicly available on registry

January 27, 2003

Completed

3.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2006

Completed

2.8 years until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2009

Completed

Last Updated

July 19, 2016

Status Verified

July 1, 2016

Enrollment Period

5.5 years

First QC Date

July 11, 2001

Last Update Submit

July 15, 2016

Conditions

Lymphoma

Keywords

stage I mantle cell lymphomacontiguous stage II mantle cell lymphomanoncontiguous stage II mantle cell lymphomastage III mantle cell lymphomastage IV mantle cell lymphoma

Outcome Measures

Primary Outcomes (1)

Progression Free Survival
2 years

Secondary Outcomes (2)

Response
2 years
Survival
5 years

Study Arms (1)

Chemo/immuno/autolog transplant

EXPERIMENTAL

Intensive chemotherapy followed by autologous stem cell transplant and immunotherapy for mantle cell lymphoma

Biological: filgrastimBiological: rituximabDrug: carmustineDrug: cyclophosphamideDrug: cytarabineDrug: doxorubicin hydrochlorideDrug: etoposideDrug: leucovorin calciumDrug: methotrexateDrug: prednisoneDrug: vincristine sulfateProcedure: peripheral blood stem cell transplantation

Interventions

filgrastimBIOLOGICAL

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

Also known as: G-CSF