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TevaGastrim for Stem Cell Mobilization of HLA Matched Sibling Donors for Allogeneic Hematopoietic Stem Cell Transplantation in Patients With Acute Myelogenous Leukemia (AML) and Myelodysplastic Syndrome (MDS)


Phase 2
18 Years
70 Years
Open (Enrolling)
Both
Acute Myeloid Leukemia, Myelodysplastic Syndrome

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Trial Information

TevaGastrim for Stem Cell Mobilization of HLA Matched Sibling Donors for Allogeneic Hematopoietic Stem Cell Transplantation in Patients With Acute Myelogenous Leukemia (AML) and Myelodysplastic Syndrome (MDS)


Inclusion Criteria:



1. Age between 18 and 70 years.

2. Normal sibling donor that is HLA matched to a patient with AML or MDS that needs and
is eligible for allogeneic stem cell transplantation

3. Written informed consent.

Exclusion Criteria:

1. Inability to tolerate PBPC harvest.

2. Peripheral venous access not possible.

3. Positive pregnancy test for female donors.

4. Positive serology for hepatitis C and/or HBSAg, unless negative for antigen PCR.

5. Psychiatric, addictive, or any disorder which compromises ability to give truly
informed consent for participation in this study.

6. Treatment with other investigational drugs.

7. Known sensitivity to CHO derived products.

8. HIV positive.

9. History of malignant disease or current malignancy.

Type of Study:

Interventional

Study Design:

Endpoint Classification: Bio-equivalence Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

Mobilisation success rate

Outcome Description:

Mobilisation success rate is defined as the mobilisation of a PBSC graft containing >2x106 CD34+ cells/kg in ≤ 4 apheresis sessions. We will evaluate the time from chemotherapy to stem cell collection,number of collections required to reach >2x106 CD34+ cells/kg, number of CD34+ cells collected and percentage of patients reaching >5x10 CD34+ cells/kg in ≤ 4 apheresis sessions.

Outcome Time Frame:

4 weeks

Safety Issue:

Yes

Principal Investigator

Arnon Nagler, MD

Investigator Role:

Principal Investigator

Investigator Affiliation:

Chaim Sheba Medical Center

Authority:

Israel: Israeli Health Ministry Pharmaceutical Administration

Study ID:

SHEBA-11-9090-AN-CTIL

NCT ID:

NCT01542944

Start Date:

February 2012

Completion Date:

May 2014

Related Keywords:

  • Acute Myeloid Leukemia
  • Myelodysplastic Syndrome
  • Acute myeloid leukemia
  • Myelodysplastic syndrome
  • Stem Cell Mobilization
  • Allogeneic Stem Cell Transplantation
  • Leukemia
  • Leukemia, Myeloid, Acute
  • Leukemia, Myeloid
  • Myelodysplastic Syndromes
  • Preleukemia

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