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

Sponsored by:	University of Chicago
Information provided by:	University of Chicago
ClinicalTrials.gov Identifier:	NCT00683046

Purpose

Objectives:

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.
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.
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.

Condition	Intervention	Phase
Acute Myelogenous Leukemia Lymphoid Leukemia Chronic Myelogenous Leukemia Malignant Lymphoma Hodgkin's Disease Chronic Lymphocytic Leukemia Myeloproliferative Disorder Anemia, Aplastic Myelodysplastic Syndromes	Drug: Fludarabine Drug: Melphalan Drug: Stem cells Drug: Campath	Phase II

MedlinePlus related topics: Anemia Cancer Hodgkin's Disease Leukemia, Adult Acute Leukemia, Adult Chronic Leukemia, Childhood Lymphoma

Drug Information available for: Fludarabine Fludarabine monophosphate Campath Alemtuzumab Melphalan Sarcolysin Melphalan hydrochloride

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Open Label, Single Group Assignment, Safety/Efficacy Study
Official Title:	T-Cell Depleted Allogeneic Stem Cell Transplantation for Patients With Hematologic Malignancies

Further study details as provided by University of Chicago:

Primary Outcome Measures:

Disease-free survival [ Time Frame: annually ] [ Designated as safety issue: No ]

Estimated Enrollment:	200
Study Start Date:	November 2001
Estimated Primary Completion Date:	July 2009 (Final data collection date for primary outcome measure)

Intervention Details:

Fludarabine 30 mg/m2 intravenously daily at the same time over 30 minutes on days -7,-6,-5,4,-3,.

Melphalan 140 mg/m2 IV on day -2.

Stem cell infusion on day 0.

Campath, 20 mg IV on day -7, 6, -5, -4, and -3.

Eligibility

Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

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:

N/A

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00683046

Locations

United States, Illinois
The University of Chicago	Recruiting
Chicago, Illinois, United States, 60637
Contact: Koen van Besien, MD 773-702-6696 kvbesien@medicine.bsd.uchicago.edu
Contact: Rebecca Malloy, RN 773-834-1475 rmalloy@medicine.bsd.uchicago.edu
Principal Investigator: Koen van Besien, MD

Sponsors and Collaborators

University of Chicago

More Information

No publications provided

Responsible Party:	The University of Chicago ( Koen van Besien, MD )
Study ID Numbers:	11300A
Study First Received:	May 21, 2008
Last Updated:	May 22, 2008
ClinicalTrials.gov Identifier:	NCT00683046 History of Changes
Health Authority:	United States: Institutional Review Board

Keywords provided by University of Chicago:

Relapsed or refractory acute myelogenous or lymphoid leukemia.
Acute myeloid or lymphocytic leukemia in first remission at high-risk for recurrence.Chronic myelogenous leukemia in accelerated phase or blast-crisis.
Chronic myelogenous leukemia in chronic phase
Chronic myelogenous leukemia in accelerated phase or blast-crisis
Recurrent or refractory malignant lymphoma or Hodgkin's disease.

Chronic lymphocytic leukemia, relapsed or with poor prognostic features.
Myeloproliferative disorder (polycythemia vera, myelofibrosis) with poor prognostic features.
Severe aplastic anemia after failure of immunosuppressive therapy.
Myelodysplastic syndromes (including PNH)
Multiple myeloma at high risk for disease recurrence.

Study placed in the following topic categories:

Antimetabolites
Polycythemia
Melphalan
Blast Crisis
Leukemia, Lymphoid
Immunologic Factors
Precancerous Conditions
Hematologic Neoplasms
Aplastic Anemia
Leukemia, Myeloid, Acute
Leukemia
Acute Myelocytic Leukemia
Preleukemia
Acute Myeloid Leukemia, Adult
Leukemia, Lymphocytic, Chronic, B-Cell

Alemtuzumab
Anemia, Aplastic
Leukemia, B-cell, Chronic
Alkylating Agents
Hodgkin Disease
Lymphoma
Polycythemia Vera
Myelofibrosis
Immunoproliferative Disorders
Hodgkin Lymphoma, Adult
Hematologic Diseases
Myelodysplastic Syndromes
Myeloproliferative Disorders
Anemia
Hodgkin's Disease

Additional relevant MeSH terms:

Antimetabolites
Melphalan
Leukemia, Lymphoid
Antimetabolites, Antineoplastic
Molecular Mechanisms of Pharmacological Action
Immunologic Factors
Hematologic Neoplasms
Precancerous Conditions
Antineoplastic Agents
Physiological Effects of Drugs
Leukemia, Myeloid, Acute
Leukemia
Preleukemia
Neoplasms by Site
Pathologic Processes

Leukemia, Lymphocytic, Chronic, B-Cell
Therapeutic Uses
Syndrome
Anemia, Aplastic
Alkylating Agents
Lymphoma
Hodgkin Disease
Disease
Neoplasms by Histologic Type
Immunoproliferative Disorders
Immune System Diseases
Hematologic Diseases
Myelodysplastic Syndromes
Myeloproliferative Disorders
Anemia

ClinicalTrials.gov processed this record on May 07, 2009