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Allogeneic Cell Therapy for Adults With Hematologic Malignancies


Phase 2
18 Years
N/A
Open (Enrolling)
Both
Hematologic Diseases

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Trial Information

Allogeneic Cell Therapy for Adults With Hematologic Malignancies


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.


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.

Type of Study:

Interventional

Study Design:

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

Outcome Measure:

Determine if conventional dose chemotherapy followed by allogeneic PBSC transplant and short course immunosuppression provide stable, sustained mixed donor-host chimerism.

Outcome Time Frame:

100 days

Safety Issue:

Yes

Principal Investigator

Amelia Langston, MD

Investigator Role:

Principal Investigator

Investigator Affiliation:

Emory University Winship Cancer Institute

Authority:

United States: Institutional Review Board

Study ID:

0466-1998

NCT ID:

NCT00208962

Start Date:

September 1998

Completion Date:

September 2013

Related Keywords:

  • Hematologic Diseases
  • Hematologic Diseases
  • Neoplasms
  • Hematologic Diseases
  • Hematologic Neoplasms

Name

Location
Emory University Winship Cancer Institute Atlanta, Georgia  30322