Peripheral Blood Stem Cell Transplantation (PBSCT)From Haploidentical Related Donors

NCT00618969 | Completed Phase 2 DMC

• 1 other identifier: BIO 07-122
• Study Type: interventional
• Target: 2
• Locations: 1 country
• Sites: 1

Brief Summary

The purpose of this study is to transplant haploidentical related peripheral blood stem cells (PBSCs) that come from a relative such as a parent, sibling, a child or other relative who has a half-matched tissue type with the recipient (rather than being completely matched) following administration of a reduced-intensity regimen of busulfan, melphalan and alemtuzumab.

Conditions

Hematologic Neoplasms; Anemia, Aplastic; Hemoglobinuria, Paroxysmal; Multiple Myeloma

Keywords

Haploidentical; peripheral blood stem cell transplantation; leukemia; myeloma; Hodgkin's disease; non-Hodgkin's lymphoma

Outcome Measures

Primary Outcomes (1)

• The primary efficacy endpoint is the presence of donor lymphohematopoietic chimerism (defined as at least 50% donor cells in the peripheral blood)in peripheral blood by day +100.

  by day +100 (i.e., 100 days after haploidentical PBSCT).

Secondary Outcomes (1)

• To determine the safety of haploidentical related allogeneic PBSCT using a preparative regimen of busulfan, melphalan and alemtuzumab.

  non-relapse mortality at day +100

Study Arms (1)

Haploidentical allogeneic PBSC transp

EXPERIMENTAL

Non-myeloablative preparative regimen (reduced-intensity) of busulfan, melphalan and alemtuzumab followed by a haploidentical-related peripheral blood stem cell transplant.

Other: haploidentical allogeneic PBSC transp

Interventions

haploidentical allogeneic PBSC transp OTHER

Days -5 and -4: IV busulfan 3.2 mg/kg/dose daily for 2 days Day -3: IV melphalan 100 mg/m2 as a single dose Days -2 and -1: IV alemtuzumab 30 mg/dose daily for 2 days Day 0: Transplantation of haploidentical related allogeneic peripheral blood stem cells (PBSCs)- target cell dose 10 x 106 donor CD34+ cells per kilogram of recipient weight

Also known as: Myleran,, Busulfex,, Busulphan, Alkeran,, L-PAM, L-Sarcolysin,, Phenylalanine Mustard, MABCAMPATH®,, CAMPATH®, partially matched family related donor transplant

Haploidentical allogeneic PBSC transp

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Age between 18 years and 75 years.
• one of these diagnoses: acute myeloid leukemia in remission or relapse, acute lymphocytic leukemia in remission or relapse, chronic myeloid leukemia, chronic lymphocytic leukemia, Hodgkin's disease or non-Hodgkin's lymphoma, multiple myeloma, myelodysplastic syndrome, severe aplastic anemia, or paroxysmal nocturnal hemoglobinuria.
• Subjects with hematologic malignancies must have received at least one previous course of chemotherapy or biological therapy (i.e., a subject cannot be enrolled on this study for initial treatment of the malignancy).
• Absence of a healthy related or unrelated volunteer allogeneic donor with whom the subject is either completely HLA matched at HLA-A, -B, -C and -DRB1 (8/8 HLA match) or mismatched at no more than one HLA locus (7/8 HLA match).
• Availability of a healthy haploidentical relative (parent, sib or child) who is able to donate peripheral blood stem cells by apheresis.

You may not qualify if:

• Eligibility for another clinical therapeutic protocol or standard-of-care treatment that offers higher probability of cure or long-term control of subject's malignancy.
• Availability of a related or unrelated 7/8 or 8/8 HLA-matched allogeneic donor.
• Severe organ dysfunction
• Untreated or progressive central nervous system involvement by malignancy.
• Subject is pregnant or breast feeding.
• Karnofsky score below 50.
• Seropositivity for human immunodeficiency virus (HIV).
• Life expectancy less than 12 weeks with conventional treatments.
• For subjects who are fertile, refusal to practice contraception upon entering this study and for at least 12 months after PBSCT or after cessation of post-transplant immunosuppressive treatments, whichever occurs later.

Sponsors & Collaborators

• University of Arizona: lead

Study Sites (1)

Arizona Cancer Center/University Medical Center

Tucson, Arizona, 85719, United States

Location

MeSH Terms

Conditions

Hematologic Neoplasms; Anemia, Aplastic; Hemoglobinuria, Paroxysmal; Multiple Myeloma; Leukemia; Neoplasms, Plasma Cell; Hodgkin Disease; Lymphoma, Non-Hodgkin

Interventions

Busulfan; Melphalan; Alemtuzumab

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms; Hematologic Diseases; Hemic and Lymphatic Diseases; Anemia; Bone Marrow Failure Disorders; Bone Marrow Diseases; Anemia, Hemolytic; Myelodysplastic Syndromes; Neoplasms by Histologic Type; Hemostatic Disorders; Vascular Diseases; Cardiovascular Diseases; Paraproteinemias; Blood Protein Disorders; Hemorrhagic Disorders; Lymphoproliferative Disorders; Immunoproliferative Disorders; Immune System Diseases; Lymphoma; Lymphatic Diseases

Intervention Hierarchy (Ancestors)

Butylene Glycols; Glycols; Alcohols; Organic Chemicals; Mesylates; Alkanesulfonates; Alkanesulfonic Acids; Alkanes; Hydrocarbons, Acyclic; Hydrocarbons; Sulfonic Acids; Sulfur Acids; Sulfur Compounds; Nitrogen Mustard Compounds; Mustard Compounds; Hydrocarbons, Halogenated; 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

Study Officials

• Andrew M Yeager, MD

  University of Arizona

  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: SPONSOR

Study Record Dates

• First Submitted: February 8, 2008
• First Posted: February 20, 2008
• Study Start: February 1, 2008
• Primary Completion: December 1, 2013
• Study Completion: February 1, 2016
• Last Updated: March 3, 2016

Record last verified: 2016-03

Locations

US (1)