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Nonmyeloablative Stem Cell Transplantation With CD8-depleted or Unmanipulated Peripheral Blood Stem Cells: A Prospective Randomized Phase II Trial


Phase 2
N/A
70 Years
Not Enrolling
Both
Hematologic Malignancies

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Trial Information

Nonmyeloablative Stem Cell Transplantation With CD8-depleted or Unmanipulated Peripheral Blood Stem Cells: A Prospective Randomized Phase II Trial

Inclusion Criteria


1. Patients

1.1. Diseases

Malignant diseases confirmed histologically and not rapidly progressing:

- Hematologic malignancies

- AML;

- ALL;

- CML and other myeloproliferative disorders;

- MDS;

- Multiple myeloma;

- CLL;

- Non-Hodgkin's lymphoma;

- Hodgkin's disease.

- Non-hematologic malignancies

- Renal cell carcinoma (metastatic).

1.2. Inclusion criteria

- Male or female; female patients must use a reliable contraception method;

- Age lower than 70 yrs (family donor) or lower than 65 yrs (unrelated donor);

- HIV negative;

- No terminal organ failure;

- No uncontrolled infection, arrhythmia or hypertension;

- Family donor (HLA-identical) or unrelated donor (matched for A-B by low
resolution typing and for DRB1-DQB1 by high resolution typing);

- No previous radiation therapy precluding the use of 2 Gy TBI

- Informed consent given by patient or his/her guardian if of minor age.

1.3. Clinical situations

- Theoretical disease indication for a standard allo-transplant, but not feasible
because:

- Age > 55 yrs;

- Unacceptable end organ performance;

- Patient's refusal.

- Indication for a standard auto-transplant:

- perform mini-allotransplantation 2-6 months after standard autotransplant.

- Not an indication for intensification but a potential candidate for cellular
immunotherapy.

2. Donors

2.1. Inclusion criteria

- Related to the recipient (sibling, parent or child) or unrelated;

- Male or female;

- Weight > 15 Kg (because of leukapheresis);

- HIV negative;

- No major contraindication for allogeneic PBSC donation by generally accepted
criteria;

- Informed consent given by donor or his/her guardian if of minor age.

2.2. Exclusion criteria

- Any condition not fulfilling inclusion criteria;

- Unable to undergo leukapheresis because of poor vein access or other reasons.

Type of Study:

Interventional

Study Design:

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

Incidence of acute GVHD in CD8-depleted versus unmanipulated groups

Outcome Time Frame:

180 days

Safety Issue:

No

Principal Investigator

Yves Beguin, MD, PhD

Investigator Role:

Study Chair

Investigator Affiliation:

University of Li├Ęge

Authority:

Belgium: Institutional Review Board

Study ID:

Minitransplant - random

NCT ID:

NCT00693927

Start Date:

March 2002

Completion Date:

May 2008

Related Keywords:

  • Hematologic Malignancies
  • Hematopoietic cell transplantation
  • Allogeneic
  • Nonmyeloablative
  • CD8-depletion
  • PBSC
  • GVHD
  • Hematological malignancies and renal cell carcinoma
  • Neoplasms
  • Hematologic Neoplasms

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