Bortezomib-based GVHD Prophylaxis After Allogeneic Transplant for Patients Without Matched Related Donors

NCT ID: NCT01323920

Last Updated: 2017-05-30

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE2
• Total Enrollment: 35 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2011-05-31
• Study Completion Date: 2013-11-30

Brief Summary

A common problem after stem cell transplant is graft-versus-host-disease (GVHD). GVHD is a complication of transplantation where the donor graft attacks and damages some of your tissues. After stem cell transplant, all patients receive prophylactic medications against GVHD.

In this research study, we are studying the safety and effectiveness of a bortezomib based GVHD prophylaxic drug combination in participants after myeloablative allogeneic stem call transplantation from a matched unrelated donor, mismatched related or unrelated donor.

Detailed Description

Before your transplant you will receive conditioning therapy with fludarabine and busulfan given 7, 6, 5, and 4 days before your transplant. On day 0, you will receive selected blood cells taken from your sibling or unrelated donor.

You will receive 3 drugs for your GVHD prophylaxis:

Tacrolimus will be started 3 days before your transplant. It will be given intravenously and later by mouth. You will continue to take tacrolimus for 3 to 6 months after transplant.

Methotrexate will be given intravenously 1, 3, 6 and 11 days after your transplant.

Bortezomib will be given intravenously 1, 4, and 7 days after your transplant. On days 1, 4, 7, 30 and 3, 6 and 12 months after your transplant you will have a physical exam, blood work, and be asked to complete a questionnaire.

Conditions

Leukemia; Lymphoma; Myelodysplastic Syndrome

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Velcade/Tac/MTX

Drug: Bortezomib. Other Names: Velcade. Bortezomib 1.3 mg/m^2 IV

Drug: Tacrolimus. Tacrolimus 0.05 mg/kg PO bid

Drug: Methotrexate. Methotrexate 15 mg/m^2 IV

Group Type: EXPERIMENTAL

Bortezomib

Intervention Type: DRUG

Bortezomib 1.3 mg/m\^2 IV

Tacrolimus

Intervention Type: DRUG

Tacrolimus 0.05 mg/kg PO bid

Methotrexate

Intervention Type: DRUG

Methotrexate 15 mg/m\^2 IV

Interventions

Bortezomib

Bortezomib 1.3 mg/m\^2 IV

Intervention Type: DRUG

Tacrolimus

Tacrolimus 0.05 mg/kg PO bid

Intervention Type: DRUG

Methotrexate

Methotrexate 15 mg/m\^2 IV

Intervention Type: DRUG

Other Intervention Names

Velcade

Eligibility Criteria

Inclusion Criteria

• Histologically or cytologically confirmed advanced and/or aggressive hematologic malignancy (including myelodysplastic syndrome) that is unlikely to be cured by alternative therapies
• HLA-Matched unrelated donor; or 1-locus HLA-mismatched related or unrelated donor
• ECOG performance status 0-2
• Adequate organ function
• Able to understand and willing to sign a written informed consent document
• Agrees to practice adequate contraception per study requirements

Exclusion Criteria

• Pregnant or breastfeeding
• Recipient of prior allogeneic or autologous stem cell transplantation
• Prior abdominal radiation therapy
• HIV-positive on combination antiretroviral therapy
• Seropositive for hepatitis B or C
• Allergies to bortezomib, boron, or mannitol
• Myocardial infarction within last 6 months, NYHA Class III or IV heart failure, uncontrolled angina, severe uncontrolled ventricular arrhythmias
• Uncontrolled bacterial, viral or fungal infections
• Seizures or history of seizures
• History of another non-hematologic malignancy unless disease-free for at least 5 years
• Uncontrolled intercurrent illness

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 60 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Dana-Farber Cancer Institute

OTHER

Sponsor Role: lead

Responsible Party

John Koreth, MD

Principal Investigator

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

John Koreth, MBBS, DPhil

Role: PRINCIPAL_INVESTIGATOR

Dana-Farber Cancer Institute

Locations

Dana-Farber Cancer Institute

Boston, Massachusetts, United States

Countries

United States

References

Koreth J, Kim HT, Lange PB, Bindra B, Reynolds CG, Chammas MJ, Armand P, Cutler CS, Ho VT, Glotzbecker B, Nikiforow S, Ritz J, Blazar BR, Soiffer RJ, Antin JH, Alyea EP 3rd. A Bortezomib-Based Regimen Offers Promising Survival and Graft-versus-Host Disease Prophylaxis in Myeloablative HLA-Mismatched and Unrelated Donor Transplantation: A Phase II Trial. Biol Blood Marrow Transplant. 2015 Nov;21(11):1907-13. doi: 10.1016/j.bbmt.2015.05.027. Epub 2015 Jun 6.

Reference Type: DERIVED

PMID: 26055298 (View on PubMed)

Other Identifiers

11-007

Identifier Type: -

Identifier Source: org_study_id