Allogeneic Cell Therapy for Adults With Hematologic Malignancies

Hematologic Diseases Clinical Trial

Official title:

Allogeneic Cell Therapy for Adults With Hematologic Malignancies

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00208962
• Other study ID #: IRB00000722
• Status: Completed
• Phase: Phase 2
• First received: September 13, 2005
• Last updated: August 11, 2014
• Start date: September 1998
• Est. completion date: August 2013

Study information

• Verified date: August 2014
• Source: Emory University
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial Summary

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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 32
• Est. completion date: August 2013
• Est. primary completion date: September 2007
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• To be eligible as a recipient for this study, patients must have chronic myelocytic leukemia (CML) in chronic phase and be older than 60 years of age, have advanced myelodysplastic syndrome (MDS) and be over 60 years of age, have chronic lymphocytic leukemia (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 central nervous system (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.

Study Design

Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Hematologic Diseases

Intervention

Procedure:
• chemotherapy and blood stem cell transplantation
A combination of conventional dose chemotherapy, granulocyte-colony stimulating factor (G-CSF) mobilized HLA-identical related allogeneic PBSC transplant, and post transplant infusions of donor leukocytes.

Locations

Country	Name	City	State
United States	Emory University Winship Cancer Institute	Atlanta	Georgia

Sponsors (1)

Lead Sponsor	Collaborator
Emory University

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Determine if conventional dose chemotherapy followed by allogeneic peripheral blood stem cell (PBSC) transplant and short course immunosuppression provide stable, sustained mixed donor-host chimerism.		100 days	Yes
Secondary	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.		6 months	Yes