T-Cell Depleted Allogeneic Stem Cell Transplantation for Patients With Hematologic Malignancies

Myelodysplastic Syndromes Clinical Trial

Official title:

T-Cell Depleted Allogeneic Stem Cell Transplantation for Patients With Hematologic Malignancies

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00683046
• Other study ID #: 11300A
• Status: Completed
• Phase: Phase 2
• First received: May 21, 2008
• Last updated: October 5, 2015
• Start date: November 2001
• Est. completion date: December 2014

Study information

• Verified date: October 2015
• Source: University of Chicago
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial Summary

Objectives:

1. To evaluate disease free survival after Campath 1H-based in vivo T-cell depletion and non-myelo-ablative ablative stem cell transplantation in patients with hematologic malignancies.

2. To evaluate the incidence and severity of acute and chronic GVHD after Campath 1H-based in vivo T-cell depletion, in patients with hematologic malignancies undergoing non-myelo-ablative stem cell transplantation.

3. To evaluate engraftment and chimerism after Campath 1H-based in vivo T-cell depletion and non-myelo-ablative ablative stem cell transplantation in patients with hematologic malignancies.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 204
• Est. completion date: December 2014
• Est. primary completion date: December 2014
• Accepts healthy volunteers: No
• Gender: Both
• Age group: N/A to 100 Years

Eligibility

Inclusion Criteria:

• Zubrod performance status 2 (See Appendix B).

• Life expectancy is not severely limited by concomitant illness.

• Adequate cardiac and pulmonary function. Patients with decreased LVEF or PFTS will be evaluated by cardiology or pulmonary prior to enrollment on this protocol.

• Serum creatinine <1.5 mg/dL or Creatinine Clearance >50 ml/min .

• Serum bilirubin 2.0 mg/dl, SGPT <3 x upper limit of normal

• No evidence of chronic active hepatitis or cirrhosis.

• HIV-negative

• Patient is not pregnant

• Patient or guardian able to sign informed consent.

Exclusion Criteria:

Study Design

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

Related Conditions & MeSH terms

• Acute Myelogenous Leukemia
• Anemia, Aplastic
• Chronic Lymphocytic Leukemia
• Chronic Myelogenous Leukemia
• Hodgkin Disease
• Hodgkin's Disease
• Leukemia
• Leukemia, Lymphocytic, Chronic, B-Cell
• Leukemia, Lymphoid
• Leukemia, Myelogenous, Chronic, BCR-ABL Positive
• Leukemia, Myeloid
• Leukemia, Myeloid, Acute
• Lymphoid Leukemia
• Lymphoma
• Malignant Lymphoma
• Myelodysplastic Syndromes
• Myeloproliferative Disorder
• Myeloproliferative Disorders
• Preleukemia

Intervention

Drug:
• Fludarabine
Fludarabine 30 mg/m2 intravenously daily at the same time over 30 minutes on days -7,-6,-5,4,-3,.
• Melphalan
Melphalan 140 mg/m2 IV on day -2.
• Stem cells
Stem cell infusion on day 0.
• Campath
Campath, 20 mg IV on day -7, 6, -5, -4, and -3.

Locations

Country	Name	City	State
United States	The University of Chicago	Chicago	Illinois

Sponsors (1)

Lead Sponsor	Collaborator
University of Chicago

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Median Disease-free Survival	All patients were administered the following drugs; Fludarabine 30mg/m2 intravenously daily at the same time over 30 min on days -7,-6,-5,-4, and -3; Melphalan 140mg/m2 IV on day -2; Stem cell infusion on day 0; Campath 20mg IV on day -7,-6,-5,-4, and -3	Patients evaluated continuously with disease specific re-evaluation at day 30, 3 months, 6 months, 1 year, and as indicated thereafter	No
Secondary	Median Overall Survival	All patients were administered the following drugs; Fludarabine 30mg/m2 intravenously daily at the same time over 30 min on days -7,-6,-5,-4, and -3; Melphalan 140mg/m2 IV on day -2; Stem cell infusion on day 0; Campath 20mg IV on day -7,-6,-5,-4, and -3	Patients evaluated continuously with disease specific re-evaluation at day 30, 3 months, 6 months, 1 year, and as indicated thereafter	No