Brief Summary

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. Peripheral stem cell transplantation may be able to replace immune cells that were destroyed by chemotherapy used to kill cancer cells. PURPOSE: Phase II trial to study the effectiveness of combination chemotherapy followed by donor 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 below P25 for phase_2

Timeline

Completed

Started Nov 2000

Geographic Reach

1 country

48 active sites

Status

completed

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

Trial Relationships

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Study Timeline

Key milestones and dates

2.3 years study duration

Study Start

First participant enrolled

November 1, 2000

Completed

1 month until next milestone

First Submitted

Initial submission to the registry

December 6, 2000

Completed

2.1 years until next milestone

First Posted

Study publicly available on registry

January 27, 2003

Completed

5 days until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 1, 2003

Completed

Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

February 1, 2003

Completed

Last Updated

July 19, 2016

Status Verified

July 1, 2016

Enrollment Period

2.3 years

First QC Date

December 6, 2000

Last Update Submit

July 15, 2016

Conditions

Graft Versus Host Disease Lymphoma

Keywords

graft versus host diseasestage I mantle cell lymphomacontiguous stage II mantle cell lymphomanoncontiguous stage II mantle cell lymphomastage III mantle cell lymphomastage IV mantle cell lymphomarecurrent mantle cell lymphoma

Outcome Measures

Primary Outcomes (1)

disease free survival
up to 5 years post-transplant

Study Arms (1)

chemotherapy + stem cell transplantation

EXPERIMENTAL

Patients receive carmustine, etoposide, cytarabine and melphalan on day -1. Patients undergo allogeneic peripheral blood stem cell (PBSC) transplantation on day 0. Patients also receive tacrolimus on day -2 and then orally twice daily until day 120 and methotrexate on days 1, 3, and 6 as graft-versus-host disease (GVHD) prophylaxis. Patients receive sargramostim daily beginning on day 7 and continuing until blood counts recover. Patients with no active GVHD who have persistent disease on day 150 or progressive disease at any time after PBSC transplantation receive donor lymphocytes IV over 2 hours. Patients may receive additional donor lymphocytes at least 8 weeks later if disease persists. Patients are followed at 6 and 12 months post-transplantation and then annually for 4 years.

Drug: carmustineDrug: melphalanDrug: etoposideDrug: cytarabineDrug: tacrolimusDrug: methotrexateDrug: sargramostimProcedure: transplant