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Allogeneic Cell Therapy for Adults With Hematologic Malignancies

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
Amelia A Langston, Emory University
ClinicalTrials.gov Identifier:
NCT00208962
First received: September 13, 2005
Last updated: May 7, 2013
Last verified: May 2013
History of Changes
  Purpose

This is a research study involving the treatment of leukemia or lymphoma (lymph gland cancer) in adults who have leukemia or lymphoma that is unlikely to be cured with regular anticancer drugs or radiation treatments.


Condition Intervention Phase
Hematologic Diseases
 Procedure: chemotherapy and blood stem cell transplantation
 Phase 2

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Allogeneic Cell Therapy for Adults With Hematologic Malignancies

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Emory University:

Primary Outcome Measures:
  • Determine if conventional dose chemotherapy followed by allogeneic PBSC transplant and short course immunosuppression provide stable, sustained mixed donor-host chimerism. [ Time Frame: 100 days ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • Determine degree of donor-derived hematopoiesis and disease status on day +21, +40, +90, +140, and 180; overall survival and disease free survival at 6 months. [ Time Frame: 6 months ] [ Designated as safety issue: Yes ]

Estimated Enrollment: 40
Study Start Date: September 1998
Estimated Study Completion Date: September 2013
Primary Completion Date: September 2007 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: 1 Procedure: chemotherapy and blood stem cell transplantation
A combination of conventional dose chemotherapy, G-CSF mobilized HLA-identical related allogeneic PBSC transplant, and post transplant infusions of donor leukocytes.

Detailed Description:

This is a research study involving the treatment of leukemia or lymphoma (lymph gland cancer) in adults who have leukemia or lymphoma that is unlikely to be cured with regular anticancer drugs or radiation treatments. Intensive treatment with high doses of chemotherapy followed by a bone marrow transplant (BMT) from an HLA-(tissue-type) matched related donor would provide the best chance for cure of this leukemia or lymphoma. However, the success of BMT from relatives is limited in patients who are older than 50 years and/or have organ dysfunction by substantial complications due to the high dose chemotherapy related toxicity, graft-versus- host disease (GVHD), and relapse. Patients eligible for this study have an HLA matched sibling, but a BMT from the sibling would carry a high risk for severe side effects due to the patient's age, and/or organ dysfunction.

Researchers are evaluating a new treatment for adult patients with leukemia and lymphoma which involves regular dose chemotherapy and blood stem cell transplantation from an HLA-matched relative, with injections of donor immune cells (a type of white blood cells) given if you later relapse. In this study, the safety and feasibility of this treatment strategy are being investigated.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • To be eligible as a recipient for this study, patients must have CML in chronic phase and be older than 60 years of age, have advanced MDS and be over 60 years of age, have CLL and be over 50 years of age, or have low grade lymphoma and be over 50 years of age. HLA typing of the recipient's family will be used to identify potential donors. Please contact study nurse for additional eligibility criteria. Final eligibility will be determined by the health professionals conducting this clinical trial.

Exclusion Criteria:

  • Patients with an active, invasive/systemic fungal infection and patients with serologic evidence of antibodies to HIV I/II will be excluded from participating as recipients in this study. Additional exclusion factors include: patients who are pregnant or lactating, those with active CNS malignant disease, and patients whose life expectancy is limited by diseases other than the disease for which the transplant is being performed. Please contact study nurse for additional ineligibility criteria. Final eligibility will be determined by the health professionals conducting this clinical trial.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00208962

Locations
United States, Georgia
Emory University Winship Cancer Institute
Atlanta, Georgia, United States, 30322
Sponsors and Collaborators
Emory University
Investigators
Principal Investigator: Amelia Langston, MD Emory University Winship Cancer Institute
  More Information

No publications provided

Responsible Party: Amelia A Langston, Principal Investigator, Emory University
ClinicalTrials.gov Identifier: NCT00208962     History of Changes
Other Study ID Numbers: 0466-1998
Study First Received: September 13, 2005
Last Updated: May 7, 2013
Health Authority: United States: Institutional Review Board

Keywords provided by Emory University:
Hematologic Diseases

Additional relevant MeSH terms:
Neoplasms
Hematologic Diseases
Hematologic Neoplasms
Neoplasms by Site

ClinicalTrials.gov processed this record on May 22, 2013