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A Phase II Study of Tacrolimus and Thymoglobulin, as Graft-versus-Host-Disease Prophylaxis in Patients Undergoing Related Donor Hematopoietic Cell Transplantation


Phase 2
18 Years
70 Years
Open (Enrolling)
Both
Hematological Malignancies

Thank you

Trial Information

A Phase II Study of Tacrolimus and Thymoglobulin, as Graft-versus-Host-Disease Prophylaxis in Patients Undergoing Related Donor Hematopoietic Cell Transplantation


Inclusion Criteria:



1. Suitable related donor as determined by the treating physician.

2. High resolution molecular HLA typing mandatory for HLA Class I and II.

3. Diagnosis of hematological malignancy: Patients with one of the following hematologic
malignancies, and felt to be transplant candidates by their treating physician are
eligible to enroll on this protocol. These hematologic malignancies include:
Non-Hodgkins lymphoma, Hodgkin's disease, AML or ALL, MDS, CML, Multiple Myeloma,
CLL, Myelofibrosis and other myeloproliferative disorders.

4. Age >=18 and able to cooperate with oral medication intake (age>18 for section 7,
immuno-correlative studies due to the volume of the blood draws)

5. Peripheral blood stem cells

6. Agrees to participate, and informed consent signed

7. KPS>60, ECOG performance status <=2

8. Creatinine <2.0 mg/dl or creatinine clearance >50 ml/min

9. Ejection fraction >45%

10. Serum bilirubin, Liver enzymes less than 3 X upper limit of normal

11. Lung function tests >45% predicted

Exclusion Criteria:

1. Age <18 years and >70 years

2. Bone marrow or Ex vivo engineered or processed graft (CD34+ enrichment, T-cell
depletion, etc).

3. Patients with documented uncontrolled Central Nervous System disease

4. Active donor or recipient serology positive for human immunodeficiency virus (HIV)

5. Known contraindication to administration of tacrolimus or Thymoglobulin

6. Active Hepatitis B or C

7. Women who are pregnant or nursing..

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:

Incidence and severity of acute GVHD

Outcome Time Frame:

Assessed first 6 months post transplant

Safety Issue:

No

Principal Investigator

Zaid Al-Kadhimi, M.D.

Investigator Role:

Principal Investigator

Investigator Affiliation:

Barbara Ann Karmanos Cancer Institute

Authority:

United States: Institutional Review Board

Study ID:

WSU 2009-095

NCT ID:

NCT01246206

Start Date:

November 2010

Completion Date:

November 2014

Related Keywords:

  • Hematological Malignancies
  • ● Non-Hodgkin lymphoma,
  • ● Hodgkin disease,
  • ● Acute Myelogenous or Acute Lymphocytic Leukemia
  • ● Myelodysplastic Syndromes,
  • ● Chronic Myelogenous Leukemia
  • ● Multiple Myeloma
  • ● Chronic Lymphocytic Leukemia
  • ● Myelofibrosis and other myeloproliferative disorders;
  • Neoplasms
  • Graft vs Host Disease
  • Hematologic Neoplasms

Name

Location

Barbara Ann Karmanos Cancer InstituteDetroit, Michigan  48201