A Trial of Extracorporeal Photopheresis, Pentostatin, and Total Body Irradiation in Patients Undergoing Reduced Intensity Allogeneic Stem Cell Transplantation for the Treatment of Malignancies

NCT00402714 | Completed Phase 2 Results

• 1 other identifier: 0508000433
• Study Type: interventional
• Target: 14
• Locations: 1 country
• Sites: 3

Brief Summary

This is a study to explore the use of a reduced intensity transplant conditioning regimen. A conditioning regimen is the treatment that is given to prepare a body for the new bone marrow that will be received from a donor. Reduced intensity conditioning uses lower doses of chemotherapy than conventional conditioning regimens. The use of lower doses of drugs and radiation cause fewer side effects. Reduced intensity regimens have been offered to older patients or patients at increased risk for transplant-related side effects and have been shown to be safe and effective. Reduced intensity conditioning regimens are now considered for many patients who are undergoing transplant.

Conditions

Hematologic Malignancies

Keywords

Allogeneic Stem Cell Transplant

Outcome Measures

Primary Outcomes (1)

• Incidence of Grade 2-4 Acute Graft Versus Host Disease Following Allogeneic Stem Cell Transplantation in Patients Randomized to Photopheresis vs. no Photopheresis

  Day +100 following allogeneic stem cell transplant

Secondary Outcomes (1)

• Overall Survival

  2 years following stem cell transplant

Study Arms (2)

1

ACTIVE COMPARATOR

Extracorporeal photopheresis, pentostatin and total body irradiation

Procedure: extracorporeal photopheresis; Drug: Pentostatin; Radiation: Total Body Irradiation

2

ACTIVE COMPARATOR

Pentostatin and total body irradiation

Drug: Pentostatin; Radiation: Total Body Irradiation

Interventions

extracorporeal photopheresis PROCEDURE

Extracorporeal photopheresis (ECP) is the ex vivo exposure of the leukocyte rich fraction to ultraviolet light in the presence of 8-methoxypsoralen.

Also known as: UVAR® XTS Photopheresis System, UVADEX®, 8-methoxypsoralen, methoxsalen

1

Pentostatin DRUG

pentostatin 8mg/m2 over 48 hours by continuous infusion

Also known as: DCF, 2-Deoxycoformycin, Nipent

1

Total Body Irradiation RADIATION

600cGy TBI in 3 200cGy TBI fractions

1

Eligibility Criteria

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

You may qualify if:

• Patients must give informed consent to receive study treatment.
• Availability of a suitable 5/6 (Class I mismatch) or 6/6 HLA-matched related or 10 or 10 matched unrelated donor.
• Adequate cardiac function with an ejection fraction ≥ 35% by echocardiography or nuclear cardiography within three months of transplantation
• Adequate pulmonary function with corrected DLCO ≥ 40% by pulmonary function testing within the past three months of transplantation
• Adequate renal function with creatinine clearance ≥ 30 ml/min. as calculated by the Cockroft and Gault method.
• Adequate hepatic function with AST, ALT, alkaline phosphatase, and total bilirubin no more than 3 x ULN unless related to neoplastic disease.
• Adequate vascular access, either by pheresis flow catheter or peripheral vein intravenous catheter, to perform ECP, should the patient be randomized to ECP.
• Patients with prior autologous stem cell transplantation are eligible.
• Age 18 to 75 years.
• Life expectancy of greater than 3 months.
• ECOG performance status of 0, 1, or 2.
• Platelet counts ≥ 20,000/microliter, with or without transfusion support, at the time of ECP, should the patient be randomized to ECP.
• Weight ≥ 40 kg.
• Systolic blood pressure ≥ 90 mmHg on the day randomization occurs
• Negative pregnancy test. The effects of ECP on the developing human fetus at the recommended therapeutic dose are unknown. For this reason, women of childbearing potential must agree to use adequate contraception (hormonal or barrier method of birth control; abstinence) prior to study entry and for the duration of study participation. Should a woman become pregnant or suspect she is pregnant while participating in this study, she should inform her treating physician immediately.

You may not qualify if:

• Hypersensitivity or allergy to 8-methoxypsoralen.
• Prior allogeneic stem cell transplantation
• HLA-DR mismatch or no worse than one antigen-mismatched unrelated donor.
• Patients with acute leukemia or acute lymphocytic leukemia with \> 5% circulating blasts in peripheral blood or \> 5% blasts in bone marrow aspirate and biopsy at the time of registration
• Patients with chemorefractory non-Hodgkin's lymphoma or Hodgkin's disease or multiple myeloma
• Diagnosis of myelofibrosis
• Patients known to be positive for antibodies to HIC or have evidence for active HIC viral replication.
• Participation in another clinical trial for prevention of GVHD.
• Patient is pregnant or lactating.
• Lack adequate vascular access for ECP.
• Systolic blood pressure \< 90 mmHg at the time of randomization, should the patient be randomized to ECP.
• Evidence of active, ongoing infection.
• Unwilling to comply with all study procedures.
• Unable or unwilling to give signed informed consent.

Sponsors & Collaborators

• Yale University: lead
• Hospira, now a wholly owned subsidiary of Pfizer: collaborator

Study Sites (3)

Yale Comprehensive Cancer Center at Yale University School of Medicine

New Haven, Connecticut, 06520, United States

Location

Tufts-New England Medical Center

Boston, Massachusetts, 02111, United States

Location

Methodist Hospital - Texas Transplant Institute

San Antonio, Texas, 78229, United States

Location

MeSH Terms

Conditions

Hematologic Neoplasms

Interventions

Photopheresis; Methoxsalen; Pentostatin; Whole-Body Irradiation

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms; Hematologic Diseases; Hemic and Lymphatic Diseases

Intervention Hierarchy (Ancestors)

PUVA Therapy; Ultraviolet Therapy; Phototherapy; Therapeutics; Extracorporeal Circulation; Surgical Procedures, Operative; Furocoumarins; Coumarins; Benzopyrans; Pyrans; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds, 3-Ring; Coformycin; Formycins; Pyrimidine Nucleosides; Pyrimidines; Deoxyribonucleosides; Nucleosides; Nucleic Acids, Nucleotides, and Nucleosides; Radiotherapy; Investigative Techniques

Results Point of Contact

• Title: Francine Foss MD
• Organization: Yale University School of Medicine

francine.foss@yale.edu

2037375312

Study Officials

• Francine Foss, M.D.

  Yale University

  PRINCIPAL INVESTIGATOR

Publication Agreements

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

Study Design

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

Study Record Dates

• First Submitted: November 20, 2006
• First Posted: November 22, 2006
• Study Start: July 1, 2006
• Primary Completion: July 1, 2009
• Study Completion: August 1, 2009
• Last Updated: January 18, 2017
• Results First Posted: January 18, 2017

Record last verified: 2016-11

Locations

US (3)