NCT00121186|TerminatedPhase 2Results

Study Stopped

poor accrual

S0501 Fludarabine, Melphalan, and Donor Stem Cell Transplant Followed By Tacrolimus and Methotrexate in Treating Patients for Relapsed Lymphoma

Nonmyeloablative Allogeneic Stem Cell Transplantation For Relapsed Hodgkin's or Non-Hodgkin's Lymphoma After Autologous Transplantation ( A BMT Study)

SWOG Cancer Research Network ClinicalTrials.gov

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3 other identifiers

CDR0000435930S0501U10CA032102

Study Type

interventional

Target

Locations

1 country

Sites

Timeline

RegisteredJul 2005

StartedJul 2005

CompletionDec 2011

Brief Summary

RATIONALE: Giving low doses of chemotherapy, such as fludarabine and melphalan, before a donor bone marrow or peripheral blood stem cell transplant helps stop the growth of cancer cells. It also stops the patient's immune system from rejecting the donor's stem cells. The donated stem cells may replace the patient's immune system and help destroy any remaining cancer cells (graft-versus-tumor effect). Sometimes the transplanted cells from a donor can also make an immune response against the body's normal cells. Giving tacrolimus and methotrexate after transplant may stop this from happening. PURPOSE: This phase II trial is studying how well giving fludarabine together with melphalan followed by tacrolimus and methotrexate works in treating patients who are undergoing a donor stem cell transplant for relapsed lymphoma.

Trial Health

Monitor

Trial Health Score

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

Enrollment

participants targeted

Target at below P25 for phase_2 lymphoma

Timeline

Completed

Started Jul 2005

Typical duration for phase_2 lymphoma

Geographic Reach

1 country

33 active sites

Status

terminated

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

6.4 years study duration

Study Start

First participant enrolled

July 1, 2005

Completed

18 days until next milestone

First Submitted

Initial submission to the registry

July 19, 2005

Completed

2 days until next milestone

First Posted

Study publicly available on registry

July 21, 2005

Completed

2.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2008

Completed

3.9 years until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2011

Completed

4 months until next milestone

Results Posted

Study results publicly available

April 3, 2012

Completed

Last Updated

April 3, 2012

Status Verified

March 1, 2012

Enrollment Period

2.5 years

First QC Date

July 19, 2005

Results QC Date

March 5, 2012

Last Update Submit

March 5, 2012

Conditions

Lymphoma

Keywords

recurrent adult Hodgkin lymphomarecurrent small lymphocytic lymphomarecurrent mantle cell lymphomarecurrent grade 1 follicular lymphomarecurrent grade 2 follicular lymphomarecurrent grade 3 follicular lymphomarecurrent adult diffuse large cell lymphoma

Outcome Measures

Primary Outcomes (2)

Progression-free Survival
PFS rate at 1 year.
1, 3, and 12 months after protocol treatment, then every 3 months for 1 year, every 6 months for year 2, then annually thereafter until 5 years after registration
Overall Survival
OS rate at 1 year.
1, 3, and 12 months after protocol treatment, then every 3 months for 1 year, every 6 months for year 2, then annually thereafter until 5 years after registration

Study Arms (1)

Nonmyeloablative allogeneic stem cell transplant

EXPERIMENTAL

Patients are given fludarabine 30 mg/m\^2 on days -6 to -2 and melphalan 70 mg/m\^2 on days -3 and -2, then transplanted with donor peripheral blood stem cells or harvested bone marrow stem cells on day 0. Patients are then given post-transplant immunosuppression consisting of tacrolimus 0.06 mg/kg/day on days -3 to 100 and methotrexate 5 mg/m\^2 on days 1, 3, and 7.

Drug: fludarabine phosphateDrug: melphalanDrug: methotrexateDrug: tacrolimusProcedure: allogeneic bone marrow transplantationProcedure: peripheral blood stem cell transplantation