NCT00233987|CompletedPhase 2ResultsDMC

S0410 Tandem Stem Cell Transplantation in Treating Patients With Progressive or Recurrent Hodgkin's Lymphoma

Tandem Autologous Stem Cell Transplantation for Patients With Primary Progressive or Recurrent Hodgkin's Disease (A BMT Study), Phase II

SWOG Cancer Research Network ClinicalTrials.gov

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3 other identifiers

CDR0000442392U10CA032102S0410

Study Type

interventional

Target

Locations

1 country

Sites

Timeline

RegisteredOct 2005

StartedOct 2005

CompletionDec 2017

Brief Summary

RATIONALE: Radiation therapy uses high-energy x-rays to kill cancer cells. Drugs used in chemotherapy work in different ways to stop the growth of cancer cells, either by killing the cells or by stopping them from dividing. Giving chemotherapy with a peripheral stem cell transplant may allow more chemotherapy to be given so that more cancer cells are killed. Tandem (two) autologous stem cell transplants may be an effective treatment for Hodgkin's lymphoma. PURPOSE: This phase II trial is studying how well tandem stem cell transplantation works in treating patients with progressive or recurrent Hodgkin's 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 Oct 2005

Longer than P75 for phase_2 lymphoma

Geographic Reach

1 country

53 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

12.2 years study duration

Study Start

First participant enrolled

October 1, 2005

Completed

4 days until next milestone

First Submitted

Initial submission to the registry

October 5, 2005

Completed

1 day until next milestone

First Posted

Study publicly available on registry

October 6, 2005

Completed

7.3 years until next milestone

Results Posted

Study results publicly available

February 5, 2013

Completed

1.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 1, 2014

Completed

3.1 years until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2017

Completed

Last Updated

March 1, 2018

Status Verified

January 1, 2018

Enrollment Period

9.1 years

First QC Date

October 5, 2005

Results QC Date

January 2, 2013

Last Update Submit

January 31, 2018

Conditions

Lymphoma

Keywords

recurrent adult Hodgkin lymphoma

Outcome Measures

Primary Outcomes (1)

2-year Progression-free Survival
Measured from date of randomization to date of first observation of progressive disease, or death due to any cause
At day 60, then every 6 months for 2 years

Secondary Outcomes (3)

Response Rate
At day 60, then every 6 months for 2 years
Overall Survival
At day 60, then every 6 months for 2 years, then annually for a total of 7 years
Number of Patients With Grade 3 Through Grade 5 Adverse Events That Are Related to Study Drug
Assessed after cycle 1 high dose therapy, after cycle 2 high dose therapy, and at 1 month and 2 months after the second stem cell infusion

Study Arms (1)

High-dose therapy plus tandem transplant

EXPERIMENTAL

Regimen consists of 2 cycles of high-dose therapy, each followed by stem cell infusion. Cycle 1 consists of high-dose melphalan followed by infusion of approximately 1.5 million cluster of differentiation 34 positive (CD34+) cells. Cycle 2 consists of either TBI-based or 1,3-bis(2-chloroethyl)-1-nitrosourea (BCNU)-based high-dose therapy followed by infusion of at least 2 million CD34+ cells.

Drug: carmustineDrug: cyclophosphamideDrug: etoposideDrug: melphalanProcedure: autologous-autologous tandem hematopoietic stem cell transplantationRadiation: radiation therapy