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

NCT00683046 | Completed Phase 2 Results DMC

• 1 other identifier: 11300A
• Study Type: interventional
• Target: 204
• Locations: 1 country
• Sites: 1

Brief Summary

Objectives:

1. 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. 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. 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.

Conditions

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

Keywords

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.

Outcome Measures

Primary Outcomes (1)

• Median Disease-free Survival

  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

  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

Secondary Outcomes (1)

• 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

Study Arms (1)

Drug Intervention

EXPERIMENTAL

Drug: Fludarabine; Drug: Melphalan; Drug: Stem cells; Drug: Campath

Interventions

Fludarabine DRUG

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

Drug Intervention

Melphalan DRUG

Melphalan 140 mg/m2 IV on day -2.

Drug Intervention

Stem cells DRUG

Stem cell infusion on day 0.

Drug Intervention

Campath DRUG

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

Drug Intervention

Eligibility Criteria

• Age: Up to 100 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• N/A

Sponsors & Collaborators

• University of Chicago: lead

Study Sites (1)

The University of Chicago

Chicago, Illinois, 60637, United States

Location

MeSH Terms

Conditions

Leukemia, Myeloid, Acute; Leukemia, Lymphoid; Leukemia, Myelogenous, Chronic, BCR-ABL Positive; Lymphoma; Hodgkin Disease; Leukemia, Lymphocytic, Chronic, B-Cell; Myeloproliferative Disorders; Anemia, Aplastic; Myelodysplastic Syndromes; Recurrence; Blast Crisis; Polycythemia Vera; Primary Myelofibrosis

Interventions

fludarabine; Melphalan; Alemtuzumab

Condition Hierarchy (Ancestors)

Leukemia, Myeloid; Leukemia; Neoplasms by Histologic Type; Neoplasms; Hematologic Diseases; Hemic and Lymphatic Diseases; Lymphoproliferative Disorders; Lymphatic Diseases; Immunoproliferative Disorders; Immune System Diseases; Bone Marrow Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Leukemia, B-Cell; Anemia; Bone Marrow Failure Disorders; Cell Transformation, Neoplastic; Carcinogenesis; Neoplastic Processes; Bone Marrow Neoplasms; Hematologic Neoplasms; Neoplasms by Site

Intervention Hierarchy (Ancestors)

Nitrogen Mustard Compounds; Mustard Compounds; Hydrocarbons, Halogenated; Hydrocarbons; Organic Chemicals; Phenylalanine; Amino Acids, Aromatic; Amino Acids, Cyclic; Amino Acids; Amino Acids, Peptides, and Proteins; Antibodies, Monoclonal, Humanized; Antibodies, Monoclonal; Antibodies; Immunoglobulins; Immunoproteins; Blood Proteins; Proteins; Serum Globulins; Globulins

Results Point of Contact

• Title: Dr. Andrew Artz
• Organization: University of Chicago Medicine

aartz@medicine.bsd.uchicago.edu

773-834-8980

Study Officials

• Andrew Artz, MD

  University of Chicago

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 21, 2008
• First Posted: May 23, 2008
• Study Start: November 1, 2001
• Primary Completion: December 1, 2014
• Study Completion: December 1, 2014
• Last Updated: November 22, 2016
• Results First Posted: March 31, 2014

Record last verified: 2016-10

Locations

US (1)