Non-Myeloablative HLA-Mismatched Ex-Vivo T-cell Depleted Stem Cell Transplantation for Hematologic Malignancies

NCT00113646 | Terminated Phase 2

• 1 other identifier: 02-163
• Study Type: interventional
• Target: 14
• Locations: 1 country
• Sites: 1

Brief Summary

The purpose of this study is to determine if recipients of non-myeloablative ex-vivo T-cell depleted peripheral blood (PBSC) stem cell transplantation using a mismatched related donor will have less severe graft versus host disease (GVHD), transplant related mortality, and less graft failure compared to alternative haploidentical stem cell transplantation.

Conditions

Lymphoma; Leukemia; Multiple Myeloma; Myelodysplastic Syndrome

Keywords

Non-Myeloablative; T-cell Depleted; Mismatched; Stem Cell Transplantation

Outcome Measures

Primary Outcomes (1)

• To evaluate the risk of graft loss and severe GVHD or transplant related mortality at < 100 days following HLA-mismatched non-myeloablative stem cell transplantation.

  36 months

Secondary Outcomes (1)

• To evaluate progression free and overall survival following HLA mismatched non-myeloablative stem cell transplantation for hematologic malignancy.

  36 months

Interventions

MEDI-507 DRUG

MEDI-507 0.1 mg/kg on transplant day-8, 0.6 mg/kg on days-7 and -6

Non-myeloablative Ex-Vivo T-cell Depleted PBSC Transplant PROCEDURE

Cyclophosphamide 60 mg/kg on transplant days -7 and -6; Fludarabine 25 mg/m2 days -5,-4,-3,-2,-1; MEDI-507 0.1 mg/kg on day -8, 0.6 mg/kg on days -7,-6

Eligibility Criteria

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

You may qualify if:

• Disease Status: NHL, HD, MM that are chemorefractory or relapsed; CLL that is Rai stage III or IV, or lymphocyte doubling time of 6 months, or stage I/II resistant to \> 2 cycles of chemotherapy regimens; CML in accelerated or blast phase; MDS with life-threatening cytopenias; patients who have had a previous autologous or allogeneic bone marrow or stem cell transplant; other hematological disorders where allogeneic transplant is appropriate and the risk of conventional transplantation is considered to be unacceptably high.
• estimated disease free survival of less than one year
• ECOG performance status of 0, 1, or 2
• HLA 1 to 3 mismatched (at A, B, DR loci) related donor

You may not qualify if:

• Cardiac disease: symptomatic congestive heart failure, ejection fraction of \< 45%, active angina pectoris or uncontrolled hypertension.
• Pulmonary disease: severe chronic obstructive lung disease, or symptomatic restrictive lung disease, or corrected DLCO of \< 50%
• Renal disease: serum creatinine \> 2.0 mg/dl or creatinine clearance \< 50 ml/min
• Hepatic disease: serum bilirubin \> 2.0 mg/dl or alkaline phosphate, SGPT or SGOT \> 3 x normal
• Neurologic disease: symptomatic leukoencephalopathy, active CNS malignancy or other neuropsychiatric abnormalities believed to preclude transplantation
• HIV antibody or Hepatitis B surface antigen positivity
• Uncontrolled infection
• Presence of HAMA or HAHA in patient previously treated with monoclonal antibody therapy or who have received a product in which the preparation involved a monoclonal antibody affinity step

Sponsors & Collaborators

• Massachusetts General Hospital: lead
• Dana-Farber Cancer Institute: collaborator

Study Sites (1)

Massachusetts General Hospital

Boston, Massachusetts, 02116, United States

Location

MeSH Terms

Conditions

Lymphoma; Leukemia; Multiple Myeloma; Myelodysplastic Syndromes

Interventions

siplizumab

Condition Hierarchy (Ancestors)

Neoplasms by Histologic Type; Neoplasms; Lymphoproliferative Disorders; Lymphatic Diseases; Hemic and Lymphatic Diseases; Immunoproliferative Disorders; Immune System Diseases; Hematologic Diseases; Neoplasms, Plasma Cell; Hemostatic Disorders; Vascular Diseases; Cardiovascular Diseases; Paraproteinemias; Blood Protein Disorders; Hemorrhagic Disorders; Bone Marrow Diseases

Study Officials

• Thomas Spitzer, M.D.

  Massachusetts General Hospital, Harvard University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Director Cellular Therapy and Transplantation Laboratory

Study Record Dates

• First Submitted: June 9, 2005
• First Posted: June 10, 2005
• Study Start: November 1, 2002
• Primary Completion: December 1, 2007
• Study Completion: December 1, 2007
• Last Updated: March 16, 2018

Record last verified: 2018-03

Locations

US (1)