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Pilot Trial for Idiotype Vaccine Following High-Dose Chemotherapy and Hematopoietic Stem Cell Transplantation for Patients With Lymphoma Who Had Failed Induction Chemotherapy


N/A
19 Years
N/A
Not Enrolling
Both
Lymphoma

Thank you

Trial Information

Pilot Trial for Idiotype Vaccine Following High-Dose Chemotherapy and Hematopoietic Stem Cell Transplantation for Patients With Lymphoma Who Had Failed Induction Chemotherapy


Inclusion Criteria:



- histologically confirmed aggressive or indolent, B-cell non-hodgkins lymphoma

- original enrollment in vaccine protocol for newly diagnosed lymphoma and had
successful production of idiotype vaccine

- failed to achieve PR or CR with initial induction chemotherapy, received salvage
chemotherapy and then stem cell transplant and achieved a CR or good PR following
transplantation

->/= 19 years

- signed informed consent

- non-pregnant, non-lactating

Exclusion Criteria:

- serious disease or condition that, in the opinion of the investigator, would
compromise the subject's ability to participate in the study.

Type of Study:

Interventional

Study Design:

Allocation: Non-Randomized, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

Humoral and cellular responses to idiotype vaccine with KLH and GM-CSF adjuvant given to patients with lymphoma following high-dose chemotherapy and hematopoietic stem cell transplant.

Outcome Time Frame:

After vaccination

Safety Issue:

No

Principal Investigator

Julie Vose, MD

Investigator Role:

Principal Investigator

Investigator Affiliation:

UNMC

Authority:

United States: Institutional Review Board

Study ID:

267-00

NCT ID:

NCT00574886

Start Date:

July 2000

Completion Date:

April 2008

Related Keywords:

  • Lymphoma
  • Lymphoma

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