Know Cancer

or
forgot password

T-cel and B-cell Depletion in Allogeneic Peripheral Blood Stem Cell Transplantation by Using Immunomagnetic Negative and Positive Selection Procedures


Phase 3
18 Years
65 Years
Not Enrolling
Both
Leukemia, Myeloid, Leukemia, Lymphocytic, Myelodysplastic Syndrome, Leukemia, Myeloid, Chronic, Lymphoma

Thank you

Trial Information

T-cel and B-cell Depletion in Allogeneic Peripheral Blood Stem Cell Transplantation by Using Immunomagnetic Negative and Positive Selection Procedures


Inclusion Criteria:



- Patients with the diagnosis of:

- De novo acute myeloid leukaemia in first or second remission.

- Secondary acute myeloid leukaemia in first or second remission supervening
after myelodysplastic syndrome or cytotoxic / immunosuppressive therapy.

- Acute lymphoblastic leukaemia in first or second remission.

- Myelodysplastic syndrome.

- Chronic myeloid leukaemia, patients who are candidate for SCT.

- Malignant lymphoma following relapse or first line therapy resistant.

- Aggressive mantle cell lymphoma in first complete remission.

- Age 18-65 years.

- WHO performance 0-1 (see appendix ).

- Availability of an HLA-identical sibling or HLA, A, B, DRB, DQB -identical VUD donor.

- Life expectancy > 3 months.

- Witnessed written informed consent.

Exclusion Criteria:

- Patients with severe cardiac dysfunction (NYHA-classification II-IV)

- Patients with severe pulmonary dysfunction (vital capacity or diffusion < 70% of
predicted value).

- Patients with hepatic dysfunction, bilirubin or transaminases > 2.5 x upper normal
limit

- Patients with renal dysfunction, serum creatinin > 150 umol/liter or clearance < 40
ml/minute.

- Patients with a history of moderate ore severe CNS disturbances and psychiatric
problems.

- Prior treatment with chemotherapy, immunotherapy, radiation therapy or surgery within
the last 3 weeks before entering the study.

- Patients with active uncontrolled infections.

- Patients who are poor medical risks because of non malignant systemic disease.

- Patients with severe coagulopathy.

- Patients to be known HIV positive.

Type of Study:

Interventional

Study Design:

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

Outcome Measure:

relapse

Principal Investigator

Nicolaas Schaap, MD, PhD

Investigator Role:

Principal Investigator

Investigator Affiliation:

Radboud University

Authority:

Netherlands: The Central Committee on Research Involving Human Subjects (CCMO)

Study ID:

PSCT10

NCT ID:

NCT00306332

Start Date:

March 2006

Completion Date:

Related Keywords:

  • Leukemia, Myeloid
  • Leukemia, Lymphocytic
  • Myelodysplastic Syndrome
  • Leukemia, Myeloid, Chronic
  • Lymphoma
  • Allogeneic Stem cell transplantation
  • T-cell depletion
  • B-cell depletion
  • Immunomagnetic selection
  • Leukemia
  • Leukemia, Lymphoid
  • Leukemia, Myeloid
  • Leukemia, Myelogenous, Chronic, BCR-ABL Positive
  • Lymphoma
  • Myelodysplastic Syndromes
  • Preleukemia

Name

Location