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

NCT00113828 | Terminated Phase 2 DMC

• 1 other identifier: 04-222
• Study Type: interventional
• Target: 5
• Locations: 1 country
• Sites: 1

Brief Summary

The purpose of this trial is to determine if patients with hematologic diseases who have a HLA 6/6 matched related donor and are not eligible for a standard myeloablative stem cell transplant will have less severe graft versus host disease (GVHD), transplant related mortality, and less graft failure when treated with a non-myeloablative T-cell depleted stem cell transplant.

Conditions

Lymphoma; Leukemia; Multiple Myeloma; Myelodysplastic Syndrome

Keywords

Non-Myeloablative; Stem Cell Transplantation; T-cell Depletion; HLA-Matched

Outcome Measures

Primary Outcomes (1)

• To evaluate the risks of severe (grade III/IV) GVHD or transplant related mortality at < 100 days following HLA-matched non-myeloablative stem cell transplantation (or following "prophylactic" DLI given for chimerism conversion).

  100 days

Secondary Outcomes (3)

• To evaluate the incidence of acute and chronic GVHD.

  indefinite

• To evaluate the incidence of graft loss.

  100 days

• To evaluate progression free and overall survival.

  indefinite

Study Arms (1)

Transplantation

EXPERIMENTAL

T-cell depleted HLA-matched peripheral blood stem cell transplantation

Procedure: Non-myeloablative Ex-Vivo T-cell Depleted PBSC Transplant; Procedure: T-cell depleted peripheral blood stem cell transplant

Interventions

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

Rabbit anti-thymocyte globulin 0.5 mg/kg on transplant day-8, 2.5 mg/kg on day-7 and 3.0 mg/kg on day-6; cyclophosphamide 60 mg/kg on days-7,-6; fludarabine 25 mg/m2 on days -5, -4, -3, -2, -1. Non-myeloablative Ex-Vivo T-cell Depleted PBSC Transplant.

Also known as: Cyclosporine iv beginning on transplant day -1

Transplantation

T-cell depleted peripheral blood stem cell transplant PROCEDURE

Rabbit anti-thymocyte globulin 0.5 mg/kg on transplant day-8, 2.5 mg/kg on day-7, 3.0 mg/kg on day-6; cyclophosphamide 60 mg/kg on days -7, -6; fludarabine 25 mg/m2 on days -5 through -1. T-cell depleted peripheral blood stem cell transplant .

Also known as: Cyclosporine iv beginning on day -1.

Transplantation

Eligibility Criteria

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

You may qualify if:

• Disease statue: NHL, HD, or MM that are chemorefractory or relapsed; CLL that is Rai Stage III/IV, or lymphocyte doubling time of 6 months, or stage I/II that is resistant to \> 2 chemotherapy regimens; AML or ALL in 1st or subsequent remission with poor prognostic features; CML in accelerated or blast phae; MDS with life-threatening cytopenias; patients who have had a previous autologous or allogeneic bone marrow or stem cell transplant; other hematologic disorders which allogeneic stem cell transplantation is appropriate where 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-genotypically or phenotypically matched (at A, B, DR loci) related donor

You may not qualify if:

• Patients who life expectancy is limited by diseases other than their hematologic malignancy.
• Cardiac Disease: symptomatic congestive hearth failure, or RVG, or ejection fraction of \< 45%, active angina pectoris, or uncontrolled hypertension.
• Pulmonary Disease: severe chronic obstructive lung disease, or symptomatic restrictive lung disease, or 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 phosphatase, SGOT or SGPT \> 3 times normal.
• Neurologic Disease: symptomatic leukoencephalopathy, active CNS malignancy or other neuropsychiatric abnormalities believed to preclude transplantation
• HIV or HTLV I antibody or Hepatitis B surface antigen positivity
• Uncontrolled infection

Sponsors & Collaborators

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

Study Sites (1)

Massachusetts General Hospital

Boston, Massachusetts, 02114, United States

Location

MeSH Terms

Conditions

Lymphoma; Leukemia; Multiple Myeloma; Myelodysplastic Syndromes

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: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Director, Bone Marrow Transplant Program

Study Record Dates

• First Submitted: June 10, 2005
• First Posted: June 13, 2005
• Study Start: December 1, 2004
• Primary Completion: March 1, 2007
• Study Completion: March 1, 2007
• Last Updated: March 15, 2018

Record last verified: 2018-03

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)