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

NCT ID: NCT00683046

Last Updated: 2016-11-22

Study Results

Results available

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE2

Total Enrollment

204 participants

Study Classification

INTERVENTIONAL

Study Start Date

2001-11-30

Study Completion Date

2014-12-31

Brief Summary

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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.

Detailed Description

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Conditions

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Acute Myelogenous Leukemia Lymphoid Leukemia Chronic Myelogenous Leukemia Malignant Lymphoma Hodgkin's Disease Chronic Lymphocytic Leukemia Myeloproliferative Disorder Anemia, Aplastic Myelodysplastic Syndromes

Keywords

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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 Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Drug Intervention

Group Type EXPERIMENTAL

Fludarabine

Intervention Type DRUG

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

Melphalan

Intervention Type DRUG

Melphalan 140 mg/m2 IV on day -2.

Stem cells

Intervention Type DRUG

Stem cell infusion on day 0.

Campath

Intervention Type DRUG

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

Interventions

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Fludarabine

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

Intervention Type DRUG

Melphalan

Melphalan 140 mg/m2 IV on day -2.

Intervention Type DRUG

Stem cells

Stem cell infusion on day 0.

Intervention Type DRUG

Campath

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

Intervention Type DRUG

Eligibility Criteria

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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
Maximum Eligible Age

100 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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University of Chicago

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Andrew Artz, MD

Role: PRINCIPAL_INVESTIGATOR

University of Chicago

Locations

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The University of Chicago

Chicago, Illinois, United States

Site Status

Countries

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United States

Other Identifiers

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11300A

Identifier Type: -

Identifier Source: org_study_id