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

Phase 2

Completed

• Conditions: Acute Myelogenous Leukemia; Lymphoid Leukemia; Chronic Myelogenous Leukemia; Malignant Lymphoma; Hodgkin's Disease; Chronic Lymphocytic Leukemia; Myeloproliferative Disorder; Anemia, Aplastic; Myelodysplastic Syndromes
• Interventions: Drug: Fludarabine; Drug: Melphalan; Drug: Stem cells; Drug: Campath

• Registration Number: NCT00683046
• Lead Sponsor: University of Chicago

Brief 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.

Detailed Description

Not available

Study Timeline

• Study Start: 2001-11
• Study First Submitted: 2008-05-21
• Study First Submitted QC: 2008-05-22
• Study First Posted: 2008-05-23
• Results First Submitted: 2014-02-14
• Results First Submitted QC: 2014-02-14
• Results First Posted: 2014-03-31
• Primary Completion: 2014-12
• Study Completion: 2014-12
• Status Verified: 2016-10
• Last Update Submitted: 2016-10-07
• Last Update Posted: 2016-11-22

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 204

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.

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Exclusion Criteria

• N/A

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Drug Intervention	Fludarabine	-
Drug Intervention	Melphalan	-
Drug Intervention	Stem cells	-
Drug Intervention	Campath	-

Primary Outcome Measures

Name	Time	Method
Median Disease-free Survival	Patients evaluated continuously with disease specific re-evaluation at day 30, 3 months, 6 months, 1 year, and as indicated thereafter up to 10 years	All patients were administered the following drugs; 1. Fludarabine 30mg/m2 intravenously daily at the same time over 30 min on days -7,-6,-5,-4, and -3; 2. Melphalan 140mg/m2 IV on day -2; 3. Stem cell infusion on day 0; 4. Campath 20mg IV on day -7,-6,-5,-4, and -3

Secondary Outcome Measures

Name	Time	Method
Median Overall Survival	Patients evaluated continuously with disease specific re-evaluation at day 30, 3 months, 6 months, 1 year, and as indicated thereafter up to 10 years	All patients were administered the following drugs; 1. Fludarabine 30mg/m2 intravenously daily at the same time over 30 min on days -7,-6,-5,-4, and -3; 2. Melphalan 140mg/m2 IV on day -2; 3. Stem cell infusion on day 0; 4. Campath 20mg IV on day -7,-6,-5,-4, and -3

Trial Locations

Locations (1)

The University of Chicago; 🇺🇸 Chicago, Illinois, United States